MINUTES OF 229th MEETING OF CENTRAL LICENSING BOARD Ali Akhai S/o Muhammad Jawed Akhai CNIC No. 42006-3326327-5. 5. Mr. Jawed Ghulam Mohammad S/o Ghulam Mohammad CNIC No. 42201-0556944-9

Page 1 of 116

MINUTES OF 257th

MEETING OF CENTRAL LICENSING BOARD HELD ON

JANUARY 24-25, 2018 *=*=*=*=*

257th

meeting of the Central Licensing Board (CLB) was held on January 24-25, 2018 in the

Committee Room, Drug Regulatory Authority of Pakistan, 4th

Floor, T.F. Complex, G-9/4, Islamabad

under the Chairmanship of Mr. Ghulam Rasool Dutani, Director Drug Licensing, Drug Regulatory

Authority of Pakistan, Islamabad.

Following members attended the meeting: -

S. No. Name & Designation Status

1. Dr. Sheikh Akhter Hussain.

Director (QA/LT), DRAP, Islamabad

Member

2. Mr. Munawar Hayat,

Chief Drug Controller, Primary and Secondary Health Care

Department, Govt. of Punjab, Lahore

Member

3. Syed Welayat Shah,

Chief Drug Inspector, Department of Health, Govt. of Khyber

Pakhtunkhwa, Peshawar

Member

4. Syed Saleem Shah,

Chief Drug Inspector, Department of Health, Govt. of Balochistan,

Quetta

Member

5. Syed Muied Ahmed, Expert in manufacturing of drugs. Member

6. Dr.Ikram-ul-Haque , Expert inQC/QA of drugs. Member

7. Prof. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of

Sindh, Jamshoro

Member

8. Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs Member

9. Prof Dr. Jamshaid Ali Khan, Department of Pharmacy, University of

Peshawar, Peshawar

Member

10. Mr. KhurramShahzad Mughal,

Consultant M/o Law, Justice and Human Rights, as representative of

M/o Law and Justice, Islamabad.

Member

11. Mr. Manzoor Ali Bozdar, Additional Director (Lic.), DRAP,

Islamabad.

Secretary/Member

12. Mr Sabooor Ahmed Sheikh and Mr. Arshad Mehmood as

Representatives of PPMA

Observer

13. Mr. Nadeem Alamgir, Representative of Pharma Bureau. Observer

14. Mr. Kamran Anwar, Representative of PCDA. Observer

The meeting started with the recitation of verses from the Holy Qura’an. The Chairman Central

Licensing Board welcomed the honorable members and participants of the meeting. He stated that all

the legal and codal formalities would be taken into account for disposal of cases and respective

Divisions shall be responsible for the contents, errors and omissions of agenda and minutes. Mr.

Zeeshan Nazir, Deputy Director (QA/QC), Mr. Abdul Sattar Sohrani, Deputy Director (QC) Dr.

Muhammad Usman AD (Lic.), Dr. Muhammad Ashfaq AD (Lic) and Dr. Zunaira Farayad, AD (Lic)

DRAP Islamabad assisted the Secretary Central Licensing Board in presenting the agenda.

Page 2 of 116

The Board also appreciated the services of Mr. Faqeer Muhammad Shaikh, ex-Chairman, Central

Licensing Board for his inclusive approach of conduct of the business of the Board.

Item-I CONFIRMATION OF THE MINUTES OF 256th

MEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 256th

meeting held on

November 9-10, 2017. The Board also approved the corrections of the following items which were

decided in previous meetings.

Page 3 of 116

Case NO. 1 RESTRUCTURING OF LICENSED PREMISES WITHOUT PRIOR

APPROVAL FROM DRAP OF M/S LISKO PAKISTAN (PVT) LTD, KARACHI

A copy of letter is received from Mr. Kirshan, Assistant Director / Federal Inspector of

Drugs, Karachi addressed to the Director M/s Lisko Pakistan (Pvt) Ltd, Karachi, wherein he has stated

that as follow:-

“I am directed to inform you that the undersigned visited the premises (Lisko Pakistan

(Private) Limited, L-10/D, Block-21, Federal "B" Industrial Area) on dated 26-10-2017

regarding the subject matter and as per telephonic discussion with you that the construction

work for bottle store was undergoing on the first floor of the building without approval

intimation to Area FID.

2. As per your statement, during the course of construction work, the roof of the floor

fallen down due to overload on dated 24-10-2017 and eventually one of the labors died and the

four injured.

3. During the visit the undersigned found the factory premises were sealed by Sindh

Building Control Authority (SBCA) (annexure attached).

4. You are hereby directed to explain that why the permission was not taken from

DRAP.

5. You are further directed that explain your position within 7 days of receipt of this

office letter and intimate the DRAP for approval before resuming the activities in factory

premises”.

Proceedings and Decision of Central Licensing Board in 256th

meeting

The Board considering the facts on the record and after thread bare deliberation decided to serve Show

Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs

(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 19 and

Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Drug

Manufacturing Licence No. 000520 of M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small

Industrial Estate, Lahore Road, Sargodha by way of formulation may not be suspended or cancelled

by Central Licensing Board.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:

In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as

M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha

under Drug Manufacturing Licence No. 000520 by way of formulation Instead of M/s Lisko Pakistan

(Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi under Drug Manufacturing Licence

No. 000110 by way of formulation.


meeting

The Board approved the correction in decision of the 256th

meeting of the Central Licensing Board

and decision may be read as under:

“The Board considering the facts on the record and after thread bare deliberation decided to

serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule,

12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the

provision of Rule, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising)

Rules, 1976 as to why their Drug Manufacturing Licence No. 000110, M/s Lisko Pakistan (Pvt)

Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi by way of formulation may not

be suspended or cancelled by Central Licensing Board.”

Page 4 of 116

Case NO. 2 GRANT OF ADDITIONAL SECTIONS OF M/S THERAMED

PHARMACEUTICAL (PVT) LTD, 45-KM, MULTAN ROAD, LAHORE .

M/s Theramed Pharmaceutical

(Pvt) Ltd, 45-Km, Multan Road,

Lahore

DML No. 000696

(Formulation)

10-10-2017 The Board approved the grant of following

additional sections /amendment as under:-

Section (06)

1. Oral Liquid (General) Section.

2. Dry Powder Suspension (General)

Section.

3. Capsule (General) Section.

4. Tablet (General) Section.

5. Tablet (Psychotropic) Section

(New).

6. Capsule (Psychotropic) Section

(New).


The following sections were mistakenly written in Minutes of 256th

meeting of Central Licensing

Board of the firm M/s Theramed Pharmaceutical (Pvt) Ltd, Lahore regarding grant of additional

sections.

1. Oral Liquid (General) Section.

2. Dry Powder Suspension (General) Section.



However, the firm already possess the aforesaid sections and Tablet (Psychotropic) Section (New) &

Capsule (Psychotropic) Section (New) are new sections.


meeting




“The Board approved the grant of following additional sections /amendment as under:-

Section (02)

1. Tablet (Psychotropic) Section (New).

2. Capsule (Psychotropic) Section (New).”

Case No. 3 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE M/S AIMS

PHARMACEUTICALS, PLOT NO. 291, INDUSTRIAL TRIANGLE KAHUTA

ROAD, ISLAMABAD.

Case Background

The Case for grant of renewal of DML of M/s Aims Pharmaceuticals, Plot No. 291, Industrial Triangle

Kahuta Road, Islamabad for the period of 21-03-2017 to 20-03-2020 was placed in 256th

meeting of

Central Licensing Board held on 9th

and 10th

November, 2017 and board decided as under:-

“The Board approved the renewal of Drug Manufacturing License for the further period

w.e.f 21-03-2017 to 20-03-2022.

It is submitted that the recommendations of the panel were as under:-

“Keeping in view the above said observations, people met on site, documents reviewed;

the panel unanimously recommended not to grant renewal of DML to M/s Aims

Page 5 of 116

Pharmaceuticals till the rectification of the shortcomings pointed out by the panel and

verification of compliance of these by the same panel.”

Due to typographical mistake the words board approved the renewal were inadvertently mentioned

in minutes.


meeting




“The Board considered the case and did not approve the renewal of Drug Manufacturing Licence. The

Board further decided that the licensee shall rectify the shortcomings noted by the panel within a

period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising)

Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding

rectifications made and accordingly panel would be constituted to verify the improvements made.

Manufacturing in the premises shall remain suspended till decision by the Board. The Central

Licening Board will take a decision on the recommendations of the panel either to grant renewal of

licence or reject the application and inform the licencee accordingly.”

Case No.4 CHANGE OF MANAGEMENT OF M/S MARTIN DOW LTD, KARACHI

M/s Martin Dow Ltd, Karachi License No. 000267 by way of formulation has submitted request for

change in management of the firm as per Form -29 with prescribed Fee Challan of 50,000/- as under;

Previous Management Interim Management New Management

1. Mr. Muhammad Jawed Akhai

S/o A. Sattar Akhai CNIC

No.42000-1658201-1.

2. Mr. Muqtadir M.A Jawad S/o

Shafiq Ahmed CNIC

No.42201-5392112-5,

3. Mr. Muhammad Hanif S/o

Abdul Sattar CNIC No.

42006-8272276-9.

4. Mr. Ali Akhai S/o

Muhammad Jawed Akhai

CNIC No. 42006-3326327-5.

5. Mr. Jawed Ghulam

Mohammad S/o Ghulam

Mohammad CNIC No.

42201-0556944-9.

1. Mr. Muhammad

Jawed Akhai S/o A.

Sattar Akhai CNIC

No.42000-1658201-1.

2. Mr. Muqtadir M.A

Jawad S/o Shafiq

Ahmed CNIC

No.42201-5392112-5.

3. Rizwan Omar S/o

Omar A Muhamamd

CNIC No. 42201-

3609527-7.

1. Mr. Muhammad Jawed

Akhai S/o A. Sattar Akhai

CNIC No.42000-1658201-1


Shafiq Ahmed CNIC

No.42201-5392112-5.

3. Syed Dawood S/o Syed

Fasih Uddin Ahmed, LB-

0060600

Decision of CLB:

The Board considered and endorsed the change of management from old to new management of M/s

Inshal Pharmaceuticals Industries, Rawat, Islamabad by way of formulation as per partnership deed as

under:

Previous Management / as per

Form-29

Interim Management as

per Form-29

New Management as per

Form-29



CNIC No.42000-1658201-1.

2. Mr. Muqtadir M.A Jawad

S/o Shafiq Ahmed CNIC

No.42201-5392112-5,


1. Mr. Muhammad

Jawed Akhai S/o A.

Sattar Akhai CNIC

No.42000-1658201-1.

2. Mr. Muqtadir M.A

Jawad S/o Shafiq

Ahmed CNIC



CNIC No.42000-1658201-1



No.42201-5392112-5.

3. Mr. Syed Dawood S/o Mr.

Page 6 of 116

Abdul Sattar CNIC No.

42006-8272276-9.

4. Mr. Ali Akhai S/o

Muhammad Jawed Akhai

CNIC No. 42006-3326327-

5.

5. Mr. Jawed Ghulam

Mohammad S/o Ghulam

Mohammad CNIC No.

42201-0556944-9.

No.42201-5392112-5.

3. Rizwan Omar S/o

Omar A Muhamamd

CNIC No. 42201-

3609527-7.

Syed Fasih Uddin Ahmed,

LB-0060600


In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as

M/s Inshal Pharmaceuticals Industries, Rawat, Islamabad Instead of M/s Martin Dow Ltd, Plot No. 37,

Sector 19, Korangi Industrial Area, Karachi under Drug Manufacturing Licence No. 000267 by way of

formulation.


meeting




“The Board considered and endorsed the change of management from old to new management of M/s

Martin Dow Ltd, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi by way of formulation as

per Form-29 as under:

Previous Management / as per

Form-29

Interim Management as

per Form-29

New Management as per

Form-29

1. Mr. Muhammad Jawed Akhai

S/o A. Sattar Akhai CNIC

No.42000-1658201-1.


Shafiq Ahmed CNIC No.42201-

5392112-5,


Abdul Sattar CNIC No. 42006-

8272276-9.

4. Mr. Ali Akhai S/o Muhammad

Jawed Akhai CNIC No. 42006-

3326327-5.

5. Mr. Jawed Ghulam

Mohammad S/o Ghulam

Mohammad CNIC No. 42201-

0556944-9.

1. Mr. Muhammad

Jawed Akhai S/o A.

Sattar Akhai CNIC

No.42000-1658201-1.

2. Mr. Muqtadir M.A

Jawad S/o Shafiq

Ahmed CNIC

No.42201-5392112-5.

3. Rizwan Omar S/o

Omar A Muhamamd

CNIC No. 42201-

3609527-7.



CNIC No.42000-1658201-1,

CEO.



No.42201-5392112-5.

3. Mr. Syed Dawood S/o Mr.

Syed Fasih Uddin Ahmed,

LB-0060600, Director

Case No. 05 CHANGE OF MANAGEMENT OF M/S CKD PHARMACEUTICALS

PAKISTAN (PVT) LTD, 50/28, KORANGI INDUSTRIAL AREA, KARACHI.

M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No.

000144 by way of formulation has submitted request for change in management of the firm as per

Form-29 from S.E.C.P along with prescribed Fee Challan of 50,000/- as under:-

Existing Management as per sale

deed and Form-29

Retiring Management Proposed Management as

per Form-29

Page 7 of 116

1. Mr. Ahsan Sultan Ahmed S/o

Sultan Ahmed CNIC No.

42201-3110080-9.

2. Mr. Shahab Ahmed S/o

Muhammad Ahmed CNIC

No. 42301-0887778-3.

3. Mr. Anas Sultan Ahmed S/o


42201-0775491-9.

1. Mr. Ahsan Sultan Ahmed

S/o Sultan Ahmed CNIC

No. 42201-3110080-9.


Muhammad Ahmed CNIC

No. 42301-0887778-3.

3. Mr. Anas Sultan Ahmed


No. 42201-0775491-9.

1. Mr. Syed Mustafa

Hussain Kazmi S/o

Syed Abrar Hussain

Kazmi CNIC No.

42201-0716021-7.

Decision of CLB:


CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No. 000144

by way of formulation as per Form 29 of SECPas under;


deed and Form-29

Retiring Management New Management as per

Form-29



42201-3110080-9.


Muhammad Ahmed CNIC No.

42301-0887778-3.



42201-0775491-9.

1.Mr. Ahsan Sultan Ahmed


No. 42201-3110080-9.

2.Mr. Shahab Ahmed S/o

Muhammad Ahmed CNIC

No. 42301-0887778-3.

3.Mr. Anas Sultan Ahmed S/o


42201-0775491-9.

1. Mr. Syed Mustafa

Hussain Kazmi S/o Syed

Abrar Hussain Kazmi

CNIC No. 42201-

0716021-7.


In the aforesaid minutes of Central Licensing Board the name of one director i.e. Mrs. Naureen Liaqat

W/o Liaqat Ali CNIC No. 42000-0451927-2 was inadvertently not mentioned while preparation of

agenda and accordingly minutes were approved. Now M/s CKD Pharmaceutical Pakistan (Pvt) Ltd.,

Karachi has intimated in writing that the correction may be made as per Form-29 and name of the said

director may be included. Accordingly, following proposal is made;


deed and Form-29

Retiring Management Proposed Management as

per Form-29

Page 8 of 116



42201-3110080-9.



42301-0887778-3.



42201-0775491-9.



No. 42201-3110080-9.


Muhammad Ahmed CNIC

No. 42301-0887778-3.



42201-0775491-9.

1. Mr. Syed Mustafa Hussain

Kazmi S/o Syed Abrar

Hussain Kazmi CNIC No.

42201-0716021-7.

2. Mrs. Naureen Liaqat W/o

Liaqat Ali CNIC No.

42000-0451927-2


meeting




“The Board considered and endorsed the change of management from old to new management

of M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi,

DML No. 000144 by way of formulation as per Form 29 of SECPas under


deed and Form-29

Retiring Management Proposed Management as per

Form-29



42201-3110080-9.



42301-0887778-3.



42201-0775491-9.


S/o Sultan Ahmed CNIC No.

42201-3110080-9.


Muhammad Ahmed CNIC

No. 42301-0887778-3.



42201-0775491-9.

3. Mr. Syed Mustafa Hussain

Kazmi S/o Syed Abrar

Hussain Kazmi CNIC No.

42201-0716021-7.

4. Mrs. Naureen Liaqat W/o

Liaqat Ali CNIC No.

42000-0451927-2

.”

Case No. 06 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S

ROGEN PHARMACEUTICALS, PLOT NO. 30-, S-4, NATIONAL

INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

Case Background

The Case for grant of renewal of DML of M/s Rogen Pharmaceuticals, Plot No. 30-, S-4, National

Industrial Zone, Rawat, Islamabad was placed in 256th

meeting of Central Licensing Board held on

9th

and 10th

November, 2017 and board decided as under:-

“The Board approved the renewal of Drug Manufacturing License for the further period w.e.f

02-04-2014 to 01-04-2019”.

It is submitted that the period of DML Renewal was inadvertently mentioned as 02-04-2014 to 01-04-

2019 instead of the correct period i.e 19-07-2015 to 18-07-2020.


meeting

Page 9 of 116




“The Board approved the renewal of Drug Manufacturing License for the further period w.e.f 19-07-

2015 to 18-07-2020”

Page 10 of 116

LICENSING DIVISION

Item-II: GRANT OF NEW DRUG MANUFACTURING LICENSES.

The Board considered the following cases of grant of new drug manufacturing licenses in the light of

recommendations of respective panel of experts/inspectors and decided as under:

S# Name of the firm Date of Inspection

/ Type of License Decision of CLB

1. M/s Winlet Pharmaceuticals

(Pvt) Ltd, 30-Km, Sargodha

Lahore Road, Sargodha.

12-10-2017 &

12-12-2017

(Formulation)

The Board approved the grant of Drug

Manufacturing Licence by way of

formulation with following sections:

Sections 04:

1. Tablet (General) Section

2. Capsule (General) Section

3. Oral Dry Powder Suspension

(General) Section.

4. Liquid Syrup (General) Section.

2. M/s Relizon

Pharmaceuticals, Plot No.

118, Sunder Industrial

Estate, Raiwind Road,

Lahore

05-12-2017

Formulation




Sections (03):



3. Dry Powder Suspension (General)

Section.

3. M/s Multicaps, Plot No. A-

92, S.I.T.E, Super Highway

Industrial Area, Karachi.

13-01-2018

Semi-Basic


Manufacturing Licence by way of Semi-

Basic Manufacture with following

sections:

Section (01):

1. Empty Hard Gelatin Capsules for the

sizes including (00, 0, 1, 2, 3 & 4).

4. M/s Neutro Pharma (Pvt)

Ltd., 9.5-Km, Sheikhupura

Road, Lahore.

02-01-2018

Semi-Basic


Manufacturing Licence by way of Semi-

Basic Manufacture for the pellatization

only for the following Active

Pharmaceutical Ingredients;

1. Duloxetine

2. Dexlansoperazole

3. Esomeprazole Magnesium

Dihydrate

4. Fluconazole

5. Orlistat

6. Pantoprazole

7. Ciprofloxacin

8. Lansoperazole+Domperidone

9. Itraconazole

10. Indomethacin

11. Diclofenac Potassium

Page 11 of 116

12. Esomeprazole

13. Galanthamine Hydrobromide

14. Ferrous Fumarate

15. Folic Acid

16. Clarithromycin

17. Azithromycin

18. Diclofenac Sodium

19. Tizanidine

20. Omeprazole

21. Theophylline

22. Flurbiprofen

23. Tamsulin

24. Esomeprazole Magnesium Hydrate

5 M/s MeDPharm Research

Lab, 28-Km, Ferozepur

Road, Lahore

12-01-2018

Formulation




Sections (07):



3. Dry Powder for Suspension

(General) Section.

4. Sachet (General) Section.

5. Capsule (Cephalosporin) Section.

6. Dry Power for Suspension

(Cephalosporin) Section.

7. Dry Powder for Injection


Page 12 of 116

Item-III: GRANT OF ADDITIONAL SECTIONS/ EXPANSION/ AMENDMENTS ETC.

The Board considered following cases of Grant of Additional Sections & Expansion/Amendments of

already licensed units in the light of recommendations by respective panel of experts/inspectors and

decided as under: -

S# Name of the firm / DML No. Date of

Inspection Decision of CLB

1 M/s Novartana

Pharmaceuticals, 87-B, Sunder

Industrial Estate, Lahore.

DML No. 000738

(Formulation)

21-11-2017 The Board did not approve the grant of

following additional section and as and

when the section will be ready for

inspection, the firm may apply for

constitution of panel:-

Section (01)

1. Liquid Injectable Ampoule / Vial

(General) Section.

2 M/s GlaxoSmithKline Pakistan

Ltd, Plot No. 5, Sector 21,

Korangi Industrial Area,

Karachi

DML No. 000248

(Formulation)

31-10-2017

&

21-12-2017

The Board approved the grant of

following additional sections

/amendment:-

Section (03)

1. Liquid Injection Section (Revised).

2. Tablet (General) Section (Revised).

3. Eye Drop Section (New).

3 M/s Citi Pharma (Pvt) Ltd, 3.5-

Km, Head Balloki Road, Phool

Nagar, District Kasur.

DML No. 000429

(Semi Basic)


following Additional APIs and as and

when the area will be ready for


constitution of panel:-:-

APIs (03)

1. Cephradin.

2. Cephalexin.

3. Cefixime.

4 M/s Pacific Pharmaceuticals,

Ltd, 30-Km, Multan Road,

Lahore.

DML No. 000295

(Formulation)

16-08-2017

06-11-2017

07-11-2017

The Board approved the grant of

following additional sections:-

Sections (03)

1. Tablet (Psychotropic / Narcotic)

(New)

2. Capsule (Psychotropic /

Narcotic) (New)

3. Tablet (Hormone) (New)

However, Board did not approve

Section for Anti T.B drugs till

improvements are made.

Moreover, the area FID will werify the

working of HVAC system befor the firm

starts the production activity.

Page 13 of 116

5 M/s PharmEvo (Pvt) Ltd, Plot

No. A-29, North Western

Industrial Zone, Port Qasim,

Karachi.

DML No. 000504

(Formulation)

02-01-2018 The Board approved the grant of

amendments in following sections

except packaging warehouse:-

Amendments in Sections (06)

1. Tablet (General) Section (Revised)

2. Capsule (General) Section (Revised)

3. Ointment / Cream (General) Section

(Revised)

4. Sachet (General) Section (Revised)

5. Oral Liquid (General) Section

(Revised)

6. Relocation of in process lab.

(Revised)

The Board advised the firm to submit

Layout plan for approval where

changes are reported by the panel being

made.

6 M/s Kanel Pharma, Plot No. 6,

Street No. SS-3, National

Industrial Zone, Rawat.

DML No. 000758

(Formulation).



Sections (05).

1. Cream / Ointment Section (General)

(New).

2. Topical Lotion Section (General)

(New).

3. Capsule Section (Ceph).

4. Dry Suspension Section (Ceph)

(New).

5. Dry Vial Injection (Ceph) (New).

7 M/s Pharmagen Ltd, Kot Nabi

Wala, 34-Km, Ferozepur

Road, Lahore

DML No. 000325

(Semi Basic)


following APIs:-

Through Semi Basic Manufacture

(Alternate Method in addition to

existing Method)

1. Amoxycillin Trihydrate

2. Ampicillin Trihydrate

3. Cephalexin Hydrate

4. Cefaclor

5. Cefadroxil

Through Semi Basic Manufacture

1. Ledipasvir

2. Daclatasvir Dihydrochloride

3. Velpatasvir

Page 14 of 116

4. Vildagliptin

8 M/s Honig Pharmaceutical

Laboratories, 14 KM Adyala

Road, Rawalpindi

DML No. 000550

(Formulation).



Sections (02).


(General).

2. Capsule (General).

9 M/s Innvotek Pharmaceutical,

Plot No. 35, Industrial

Triangle, Kahuta Road,

Islamabad.

DML No. 000487

(Formulation).


following additional sections

/amendment:-

Section (02).

1. Tablet Section General

(Revised).

2. Capsule Section General

(Revised)

10 M/s Sayyed Pharmaceutical

Industries (Pvt) Ltd, Plot No.

67/2, Phase-3, Industrial

Estate, Hattar

DML No. 000697

(Formulation).



Sections (03).

1. Dry Powder Injection


2. Sachet (General) Section.

3. Stores (Finished Goods, Packing

material, Liquid and Product

recall)

11 M/s Tas Pharmaceuticals (Pvt)

Ltd., Plot No. 209, Industrial


Islamabad

DML No. 000375

(Formulation).


following additional section

/amendment and as and when the

sections will be ready for inspection, the

firm may apply for constitution of

panel:-

Sections (04).

1. Tablet Section (Psychotropic) –

Page 15 of 116

New.

2. Tablet General – Amended /

Revised.

3. Packing Hall in place of Syrup

Section.

4. Regularization of Cream /

Ointment Section General.

12 M/s Skims Pharmaceuticals,

10-B, Value Addition City

Khurrianwala, Faisalabad.

DML No. 000830

(Formulation).



Sections (04).

1. Tablet Section (General).



(General) Section.

4. Oral Dry Powder Sachet

(General) Section.

13 M/s Grand Pharma (Pvt) Ltd.,

Plot No. 5-A, Street No. N-5,

National Industrial Zone,

Rawat, Rawalpindi

DML No. 000680

(Formulation).



Section (01).

1. New Ware House for storage of

eggs at Veterinary Biological

Facility.

14 M/s Hudson Pharma (Pvt)

Ltd., Plot No. D-93, North

Western Industrial Zone, Port

Qasim, Karachi.

DML No. 000842

(Formulation).



Sections (02).

1. Ointment/Cream/Lotion/Gel

(General) Section.


The Board did not approve the grant of

following additional section and as and




1. Eye/Ear & Nasal Drops (General)

Section

15 M/s Chemiworld (Pvt) Ltd.,

Plot No.97-J, Industrial Estate,

Hayatabad, Peshawar.

DML No. 000579 (Basic

Manufacture)


following additional API:-

API (01). 1. Iron Polysaccharide Complex

The Board did not approve the grant of

following additional APIs and as and

when the area will be ready for



APIs (02). 1. Iron Sucrose Complex

2. Iron Protein Succinylate

16 M/s Saakh Pharma (Pvt) Ltd.,

C-7/1, North Western

Insustrial Zone,


following additional API and as and

Page 16 of 116

Karachi

DML No. 000588 (Semi

Basic)


insection, the firm may apply for


Additional APIs (03):

1. Paracetamol

2. Ciprofloxacin HCL

3. Sulphamethoxazole

Page 17 of 116

Item-IV: GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE.

The Board considered the following cases of grant of Renewal of Drug Manufacturing Licenses in the

light of recommendations by panel of experts/inspectors subject to confirmation of deposition of CRF

as admissible under the rules and decided as under: -

S.

No

Name of the firm/

Type of License

Date of

Inspection Decision of CLB

1. M/s General Pharma, Farm

Road, 03-Km, G.T. Road,

Manhes (Kotli Wagha)

Komoke.

DML No. 000689

(Formulation)

04-10-2017

The Board approved the renewal of

Drug Manufacturing Licence for the

further period w.e.f 20-07-2015 to

19-07-2020.

2. M/s Healthtek (Pvt) Ltd, Plot

No. 14, Sector 19, Korangi

Industrial Area, Karachi.

DML No. 000618

(Formulation)

02-11-2017 The Board approved the renewal of



17-07-2022

3. M/s Safe Pharmaceuticals

(Pvt), Ltd, Plot No. C-1-20,

Sector 6-B,North Karachi

Industrial Area, Karachi

06-02-2015 to 05-02-2020.

DML No. 000349

(Formulation)

05-10-2017 The Board considered the case and did

not approve the renewal of Drug

Manufacturing Licence on

recommendations of the panel. The

Board further decided that the licensee

shall rectify the shortcomings noted by

the panel within a period not less than

one month under Rule, 13 of the Drugs

(Licensing, Registering and

Advertising) Rules, 1976 from the date

of issuance of decision of the Board.

The licensee shall inform regarding

rectifications made and accordingly

panel would be constituted to verify the

improvements made. Manufacturing in

the premises shall remain suspended till

decision by the Board. The Central

Licening Board will take a decision on

the recommendations of the panel either

to grant renewal of licence or reject the

application and inform the licencee

accordingly.

4. M/s Albro Pharmaceuticals

(Pvt) Ltd, 340-S, Quaid-e-

Azam Industrial Estate, Kot

Lakhpat, Lahore.

14-06-2015 to 13-06-2020.

DML No. 000175

(Formulation)

25-09-2017 The Board considered the case and

decided to defer the case till next

meeting of the Board for want of

personal hearing regarding update from

the licensee on the decision of the

Central Licencing Board for purchase of

plot and completion of facility.

Page 18 of 116

5. M/s GlaxoSmithKline Pakistan

Ltd, Plot No. 5, Sector 21,

Korangi Industrial Area,

Karachi

DML No. 000248

(Formulation)

31-10-2017

&

21-12-2017




11-08-2020

6. M/s PharmEvo (Pvt) Ltd, Plot

No. A-29, North Western

Industrial Zone, Port Qasim,

Karachi.

DML No. 000504

(Formulation)




04-10-2022.

7. M/s Innvotek Pharmaceutical,

Plot No. 35, Industrial


Islamabad.

DML No. 000487

(Formulation).




04-05-2021.

8. M/s Pfizer Pakistan Ltd, B-2,

S.I.T.E, Karachi

DML No. 000025

(Formulation)

30-10-2017




21-06-2020. However it was advised the

firm must have separate facility for

manufacturing of their only registered

corticosteroid product while they have

already allocated dedicated compression

Cubical and packing line. The matter

may also be referred to Drug

Registeration Board for their

consideration. It was also decided that

the firm may be advised to file

application for regularization of capsule

(General) section which is already

mentioned in the their layout.

9. M/s Kanel Pharma, Plot No. 6,

Street No. SS-3, National


DML No. 000758

(Formulation).




03-10-2022.

Page 19 of 116

10. M/s Ethical Laboratories (Pvt)

Ltd, 14-Km, Link Katar Bund

Road, Thokar Niaz Baig,

Lahore.

DML No. 000100

(Formulation)




13-05-2019 for following sections.


2. Eye Drops (Non-Steroidal)

Section.

3. Eye Drops (Steroidal) Section.

The Board considered the case and did

not approve the renewal of Oral

Liquid Section (General) and Capsule

Section (General). The Board further

decided that the licensee shall rectify the

shortcomings noted by the panel within

a period not less than one month under

Rule, 13 of the Drugs (Licensing,

Registering and Advertising) Rules,

1976 from the date of issuance of

decision of the Board. The licensee shall

inform regarding rectifications made in

Oral Liquid Section (General) and

Capsule Section (General) and

accordingly panel would be constituted

to verify the improvements made.

Manufacturing in the premises shall

remain suspended till decision by the

Board. The Central Licening Board will

take a decision on the recommendations

of the panel either to grant renewal of

Oral Liquid Section (General) and

Capsule Section (General) or reject the


accordingly.

11. M/s Medisynth

Pharmaceuticals, Plot No. 55,

Street No. S-5, National


DML No. 000718

(Formulation).




13-06-2021

Page 20 of 116

12. M/s Honig Pharmaceutical

Laboratories, 14 KM Adyala

Road, Rawalpindi

DML No. 000550

(Formulation)




27-08-2019

13. M/s Tas Pharmaceuticals (Pvt)

Ltd., Plot No. 209, Industrial


Islamabad

DML No. 000375

(Formulation).

16-11-2015 to 15-11-2020.


not approve the renewal of Drug

Manufacturing Licence. The Board

further decided that the licensee shall

rectify the shortcomings noted by the

panel within a period not less than one

month under Rule, 13 of the Drugs








the premises shall remain suspended till

decision by the Board. The Central

Licening Board will take a decision on

the recommendations of the panel either

to grant renewal of licence or reject the


accordingly.

14. M/s Aptcure (Pvt) Ltd.,8-

Pharmacity, 30-Km, Multan

Road, Lahore

DML No. 000648

(Formulation).


Drug Manufacturing Licence w.e.f

24-10-2013 to 23-10-2018

1

1

15.

M/s Munawar Pharma (Pvt)

Ltd., 31-Km, Ferozpur Road,

Lahore.

DML No. 000379

(Formulation).




11-01-2019.

Page 21 of 116

16. M/s SPL Pharmaceuticals,

Phase-III, Industrial Estate,

Hattar.

DML No. 000605

(Formulation)




18-02-2022

17. M/s Ottoman Pharma, 10-Km,

Raiwind Road, Lahore.

DML No. 000502

(Formulation)




04-08-2022

18. M/s Werrick Pharmaceuticals,

216-217, I-10/3, Industrial

Area, Islamabad


Basic).




30-10- 2021

19. M/s Medipharm (Pvt) Ltd.,

108, Kot Lakhpat, Industrial

Estate, Lahore.

DML No. 000243

(Formulation).





not approve the renewal of

Psychotropic section. The Board

further decided that the licensee shall

rectify the shortcomings noted by the

panel within a period not less than one

month under Rule, 13 of the Drugs








the Psychotropic section shall remain

suspended till decision by the Board.

The Central Licening Board will take a

decision on the recommendations of the

panel either to grant renewal of

Psychotropic section or reject the


accordingly.

20. M/s Medisave

Pharmaceuticals, Plot No. 578-

579,Sunder Industrial Estate,

Lahore

DML No. 000681

(Formulation).

11-12-2017

&

10-01-2018




25-01-2020.

Page 22 of 116

21. M/s Medicraft Pharmaceuticals

(Pvt) Ltd., 126-B, Industrial

Estate, Hayatabad, Peshawar.

DML No. 000390

(Formulation).

22-01-2018 The Board approved the renewal of the

following previously defferd section;

Section (01):

1. Syrup Section (General)

22. M/s Saakh Pharma (Pvt) Ltd.,

C-7/1, North Western

Insustrial Zone,

Karachi


Basic)




28-03-2021.

Page 23 of 116

Item No. V MISCELLANEOUS CASES.

Case No. 1 CHANGE OF MANAGEMENT OF M/S HONIG PHARMACEUTICAL

LABORATORIES, 14 KM, ADYALA ROAD, RAWALPINDI.

M/s Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way

of (Formulation)has submitted request for change in management of the firm as per partnership deed

along with prescribed Fee Challan of 50,000/- as under:-

Previous Management Retiring Management New Management

1. Muhammad Maskeen Bhatti S/o

Haji Khuda Buksh

CNIC # 37405-5553312-3.

2. Muhammad Rizwan Baig S/o

Muhammad Yaqoob Baig

CNIC # 37405-2183954-1.

3. Muhammad Saleem Bhatti S/o

Nuhammad Maskeen Bhatti

CNIC # 37405-5961906-9.

4. Tanveer Akhtar Bhatti S/o

Muhammad Maskeen Bhatti

CNIC # 37405-6851774-7.

5. Tahir Mehmood S/o Ch.

Muhammad Yousaf

CNIC # 37405-0330867-1.

6. Abu Bakkar S/o Abdul Rasheed

CNIC # 35202-2206953-5.

1. Muhammad Maskeen Bhatti

S/o Haji Khuda Buksh CNIC #

37405-5553312-3.



CNIC # 37405-2183954-1.



CNIC # 37405-5961906-9.



CNIC # 37405-6851774-7.


Muhammad Yousaf

CNIC # 37405-0330867-

6. Abu Bakkar S/o Abdul

Rasheed

CNIC # 35202-2206953-5.

1. Iftkhar Ahmed S/o Imtiaz

Ahmad

CNIC # 37405-6039992-3.

2. Muhammad Faisal Latif S/o

Ch. Muhammad Latif

CNIC # 37405-5664181-3.

Decision of CLB:


Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way of

(Formulation) as per partnership deed as under ;


1. Muhammad Maskeen Bhatti S/o

Haji Khuda Buksh

CNIC # 37405-5553312-3.



CNIC # 37405-2183954-1.



CNIC # 37405-5961906-9.



CNIC # 37405-6851774-7.


Muhammad Yousaf

CNIC # 37405-0330867-1.

6. Abu Bakkar S/o Abdul Rasheed

CNIC # 35202-2206953-5.

1. Muhammad Maskeen Bhatti

S/o Haji Khuda Buksh

CNIC # 37405-5553312-3.



CNIC # 37405-2183954-1.



CNIC # 37405-5961906-9.



CNIC # 37405-6851774-7.


Muhammad Yousaf

CNIC # 37405-0330867-

6. Abu Bakkar S/o Abdul

Rasheed

CNIC # 35202-2206953-5.

1. Iftkhar Ahmed S/o Imtiaz

Ahmad

CNIC # 37405-6039992-3.

2. Muhammad Faisal Latif S/o

Ch. Muhammad Latif

CNIC # 37405-5664181-3.

Page 24 of 116

Case No. 2. CHANGE OF MANAGEMENT OF M/S SHAIGAN PHARMACEUTICALS

(PVT) LTD, ISLAMABAD.

M/s Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 by way of (Formulation) has

submitted request for change in management of the firm as per Form 29 along with prescribed Fee

Challan of 50,000/- as under:-


1. Mr. Waheed Ahmed S/o Rashid Ahmed

CNIC # 37405-4456480-7.

2. Mrs. Mahrukh Waheed D/o Waheed

Ahmed

CNIC # 37405-1101276-6.

3. Mrs. Qamar-un-Nisa W/o Rashid

Ahmed

CNIC # 210-36-056283.

1. Mrs. Qamar-un-Nisa W/o

Rashid Ahmed

CNIC # 210-36-056283.

1. Mr. Waheed Ahmed S/o

Rashid Ahmed

CNIC # 37405-4456480-7.

2. Mrs. Mahrukh Waheed D/o

Waheed Ahmed

CNIC # 37405-1101276-6.

3. Mr. Basil Ahmed S/o

Washeed Ahamed

CNIC # 37405-6039509-3.

Decision of CLB:


Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 by way of (Formulation) as per

Form 29 as under:


1. Mr. Waheed Ahmed S/o Rashid

Ahmed

CNIC # 37405-4456480-7.

2. Mrs. Mahrukh Waheed D/o Waheed

Ahmed

CNIC # 37405-1101276-6.

3. Mrs. Qamar-un-Nisa W/o Rashid

Ahmed

CNIC # 210-36-056283.

1. Mrs. Qamar-un-Nisa W/o

Rashid Ahmed

CNIC # 210-36-056283.

1. Mr. Waheed Ahmed S/o

Rashid Ahmed

CNIC # 37405-4456480-7.

2. Mrs. Mahrukh Waheed

D/o Waheed Ahmed

CNIC # 37405-1101276-6.

3. Mr. Basil Ahmed S/o

Washeed Ahamed

CNIC # 37405-6039509-3.

Case No. 3. CHANGE OF MANAGEMENT OF M/S GULF PHARMACEUTICALS, PLOT

NO. 49, STREET NO. S-5, RAWALPINDI INDUSTRIAL ZONE (RIZ),

ISLAMABAD.

M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad,

DML No. 750 by way of (Formulation) has submitted request for change in management of the firm

as per partnership deed along with prescribed Fee Challan of 50,000/- as under:-

Previous Management Incoming Management New Management

1. Mr. Muhammad Munawar Khan S/o

Muhammad Ashfaq

CNIC No. 37405-5834516-9.

1. Mr. Muhammad Wassi Shan S/o

Muhammad Inyat Ullah

CNIC No. 37405-2288811-1.

1. Mr. Muhammad Munawar

Khan S/o Muhammad Ashfaq

CNIC No. 37405-5834516-9.

2. Mr. Muhammad Wassi Shan

S/o Muhammad Inyat Ullah

CNIC No. 37405-2288811-1.

Decision of CLB:

The Board considered and endorsed the change of management from old to new management of M/s Gulf Pharmaceuticals,

Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad, DML No. 750 by way of (Formulation) as per

partnership deed as under:

Previous Management Incoming Management New Management

1. Mr. Muhammad Munawar Khan S/o

Muhammad Ashfaq

CNIC No. 37405-5834516-9.

1. Mr. Muhammad Wassi Shan S/o

Muhammad Inyat Ullah

CNIC No. 37405-2288811-1.

1. Mr. Muhammad Munawar

Khan S/o Muhammad Ashfaq

CNIC No. 37405-5834516-9.

2. Mr. Muhammad Wassi Shan

S/o Muhammad Inyat Ullah

CNIC No. 37405-2288811-1.

Page 25 of 116

Case No. 4. CHANGE OF MANAGEMENT OF M/S UNIMARK PHARMACEUTICALS,

PLOT NO. 7-A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No.

000557 by way of (Formulation) has submitted request for change in management of the firm as per

Form 29 along with prescribed Fee Challan of 50,000/- as under:-

Previous Management

(Sole Proprietor).

Incoming Management New Management

1. Talat Munir Baig S/o Sadiq Hussain

Baig

CNIC # 37405-1017139-3.

1. Zarqa W/o Riaz Ahmed

CNIC # 16202-5656628-0.

1. Talat Munir Baig S/o Sadiq

Hussain Baig

CNIC # 37405-1017139-3.


CNIC # 16202-5656628-0.

Decision of CLB:


UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No.

000557 by way of (Formulation) as per Form-29 as under:

Previous Management

(Sole Proprietor).

Incoming Management New Management

1. Talat Munir Baig S/o Sadiq Hussain

Baig

CNIC # 37405-1017139-3.


CNIC # 16202-5656628-0.

1. Talat Munir Baig S/o Sadiq

Hussain Baig

CNIC # 37405-1017139-3.


CNIC # 16202-5656628-0.

Case No. 5. CHANGE OF TITLE OF M/S UNIMARK PHARMACEUTICALS, PLOT NO. 7-

A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad, has

submitted request for change of Title of the firm along with prescribed Fee Challan of 50,000/- as

under:-

Previous Title of the firm

(Sole Proprietor).

Current Title of the firm as per Form 29

UniMark Pharmaceuticals, Plot No. 7-A, National

Industrial Zone, Rawat, Islamabad.

UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7-

A, National Industrial Zone, Rawat, Islamabad.

Decision of CLB:

The Board considered and approved the change of title of M/s UniMark Pharmaceuticals, Plot No. 7-

A, National Industrial Zone, Rawat, Islamabad DML No. 000557 by way of (Formulation) as per

Form-29 as under:

Previous Title of the firm

(Sole Proprietor).

Current Title of the firm as per Form 29

UniMark Pharmaceuticals, Plot No. 7-A, National

Industrial Zone, Rawat, Islamabad.

UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7-

A, National Industrial Zone, Rawat, Islamabad.

Page 26 of 116

Case No. 6 CHANGE OF MANAGEMENT OF M/S CALIPH PHARMACEUTICALS

(PVT) LTD., PLOT NO.17, SPECIAL INDUSTRIAL ZONE (EPZ), RISALPUR.

M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur No. 000748 by way of formulation has submitted

request for change in management of the firm as per Form-A of SECP alongwith prescribed Fee

Challan of Rs.50,000/- as under;

Previous management Retiring management New management

1. Mr. Mumtaz Ali S/o Naeem

Shah

CNIC. No. 16101-3653393-9

2. Mr. Hameed ur Rehman

CNIC. No. 16101-5527602-9

3. Mr. Muhammad Saleem S/o

Feroz Bakht,

CNIC. No. 21103-4249119-3

4. Mr. Abdul Haq S/o Rehmat

Khan,

CNIC. No. 15303-1202154-1

1. Mr. Mumtaz Ali S/o Naeem

Shah

CNIC. No. 16101-3653393-9


CNIC. No. 16101-5527602-9

3. Mr. Muhammad Saleem S/o

Feroz Bakht,

CNIC. No. 21103-4249119-3


Khan,

CNIC. No. 15303-1202154-1

1. Mr. Muhammad Azmat

Ali S/o Fazal Mannan

CNIC No. 17301-

3861340-1

2. Mr. Amjad Ali Zeb S/o

Muhammad Aurangzeb

CNIC No. 42201-

3056252-3

Decision of CLB:


Caliph Pharmaceuticals (Pvt) Ltd. Risalpur DML No. 000748 by way of (Formulation) as per Form-A

of SECP as under:


1. Mr. Mumtaz Ali S/o

Naeem Shah

CNIC. No. 16101-

3653393-9


CNIC. No. 16101-

5527602-9

3. Mr. Muhammad Saleem

S/o Feroz Bakht,

CNIC. No. 21103-

4249119-3

4. Mr. Abdul Haq S/o

Rehmat Khan,

CNIC. No. 15303-

1202154-1

1. Mr. Mumtaz Ali S/o

Naeem Shah

CNIC. No. 16101-

3653393-9


CNIC. No. 16101-

5527602-9

3. Mr. Muhammad Saleem

S/o Feroz Bakht,

CNIC. No. 21103-

4249119-3


Khan,

CNIC. No. 15303-

1202154-1

1. Mr. Muhammad Azmat Ali

S/o Fazal Mannan

CNIC No. 17301-3861340-1

2. Mr. Amjad Ali Zeb S/o

Muhammad Aurangzeb

CNIC No. 42201-3056252-3

Page 27 of 116

Case No. 7 CHANGE OF MANAGEMENT OF M/S MED ASIA PHARMACEUTICALS

(PVT) LTD., PLOT NO.7, NOWSHERA INDUSTRIAL ESTATE, RISALPUR.

M/s Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur has submitted request for change in management of

the firm as per Form-A of SECP alongwith prescribed Fee Challan of Rs.50,000/- as under;


1. Mr. Sher Muhammad S/o

Muhammad Akram,

CNIC No.17301-3889455-1

2. Mr. Muhammad Yousaf

Khalil S/o Malik Nusa Khan,

CNIC No.17301-1490031-5

3. Mr. Kashif Khan S/o

Muhammad Hayat,

CNIC No.17301-1347227-1

4. Mr. Muhammad Tahir S/o

Sahib Gul, CNIIC No.16101-

9356882-3

5. Mr. Muhammad Fayaz S/o

Kachkol, CNIC No.17101-

7193842-7


Muhammad Akram,

CNIC No.17301-3889455-1


Khalil S/o Malik Nusa Khan,

CNIC No.17301-1490031-5


Muhammad Hayat,

CNIC No.17301-1347227-1


Sahib Gul, CNIIC No.16101-

9356882-3



7193842-7

1. Col. (R) Anwar Ul Haq

S/o Ch. Muhammad Shafi

CNIC No. 61101-

1920315-5

2. Mr. Mujeeb Alam S/o

Shah Jehan, CNIC

No. 17301-1457033-9

3. Mr. Shabeer Ahmad S/o

Faraz Ullah, CNIC

No. 17101-0277504-1

Decision of CLB:


Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur by way of (Formulation) as per Form-A of SECP as

under:



Muhammad Akram,

CNIC No.17301-3889455-1


Khalil S/o Malik Nusa

Khan,

CNIC No.17301-1490031-5


Muhammad Hayat,

CNIC No.17301-1347227-1


Sahib Gul, CNIIC

No.16101-9356882-3



7193842-7


Muhammad Akram,

CNIC No.17301-3889455-1


Khalil S/o Malik Nusa

Khan,

CNIC No.17301-1490031-5


Muhammad Hayat,

CNIC No.17301-1347227-1


Sahib Gul, CNIC

No.16101-9356882-3



7193842-7

1. Col. (R) Anwar Ul Haq S/o

Ch. Muhammad Shafi

CNIC No. 61101-1920315-5

2. Mr. Mujeeb Alam S/o Shah

Jehan,

CNIC No. 17301-1457033-9

3. Mr. Shabeer Ahmad S/o

Faraz Ullah,

CNIC No. 17101-0277504-1

Page 28 of 116

Case No. 8 CHANGE OF MANAGEMENT OF M/S POPULAR CHEMICAL WORKS

(PVT) LTD, LAHORE UNDER DML NO. 000076 (FORMULATION)

M/s Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore, License No.

000076 by way of formulation has submitted request for change in management of the firm as per

Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as

under;

Decision of CLB:


Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore License No. 000076

by way of (Formulation) as per Form-A of SECP as under:

Previous Management as

per Form-1A

Retiring Management

Current Management as per

Form-29 from SECP

1. Mr. Mian Asad Shuja-ur-

Rehman S/o Shuja-Ur-

Rehman CNIC No. 35201-

0587490-1.

2. Mr. Mian Tariq Rehman.


1. Mr. Mian Misbah-Ur-Rehman

S/o Mian Ghulam Qadir

CNIC No. 35202-2773300-3.

2. Mr. Abdul Hameed Piracha

S/o Mian Abdul Raheem

Piracha

CNIC No. 35202-2910398-7.

3. Mr. Mian Omer Rehman S/o

Mian Misbah-Ur-Rehman

CNIC No. 35202-7045808-3.



Rehman

CNIC No. 35201-0587490-1.


per Form-1A

Retiring Management


Form-29 from SECP




0587490-1.



1. Mr. Mian Misbah-Ur-Rehman

S/o Mian Ghulam Qadir

CNIC No. 35202-2773300-3.

2. Mr. Abdul Hameed Piracha

S/o Mian Abdul Raheem

Piracha CNIC No. 35202-

2910398-7.

3. Mr. Mian Omer Rehman S/o

Mian Misbah-Ur-Rehman

CNIC No. 35202-7045808-3.




0587490-1.

Page 29 of 116

Case No. 9 CHANGE OF MANAGEMENT OF M/S ZAKFAS PHARMACEUTICALS

(PVT) LTD, MULTAN

M/s Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of formulation

hasSubmitted request for change in management of the firm as per Form-29 with prescribed Fee

Challan of Rs.50, 000/-. The detail of management of the firm is as under;

Decision of CLB:


Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of (Formulation) as per Form-

29 of SECP as under:

Previous Management as per

Form-1A

Retiring Management Current Management as per

Form-29 from SECP

1. Mr. Malik Noor Samad

Awan S/o Malik Ghulam

Hyder Awan CNIC

No.36302-8840665-3.

2. Mr. Malik Kashif Kamran

Awan S/o Malik Noor Samad

Awan CNIC No. 36302-

8850165-3.

3. Mr. Malik Atif Adnan Awan

S/o Malik Noor Samad Awan

CNIC No. 36302-5044246-9.

4. 4. Mr. Faisal Faizan Awan


CNIC No. 36302-5301868-7.

1.Mr. Malik Noor Samad

Awan S/o Malik

Ghulam Hyder Awan

CNIC No.36302-

8840665-3.

1.Mr. Malik Kashif Kamran



8850165-3.

2.Mr. Malik Atif Adnan Awan


CNIC No. 36302-5044246-9.

3.Mr. Faisal Faizan Awan S/o

Malik Noor Samad Awan

CNIC No. 36302-5301868-7.


Form-1A


Form-29 from SECP

1.Mr. Malik Noor Samad Awan

S/o Malik Ghulam Hyder

Awan CNIC No.36302-

8840665-3.

2.Mr. Malik Kashif Kamran



8850165-3.

3.Mr. Malik Atif Adnan Awan


CNIC No. 36302-5044246-9.

4.4. Mr. Faisal Faizan Awan


CNIC No. 36302-5301868-7.

1.Mr. Malik Noor Samad

Awan S/o Malik

Ghulam Hyder Awan

CNIC No.36302-

8840665-3.

1. Mr. Malik Kashif Kamran



8850165-3.

2. Mr. Malik Atif Adnan Awan


CNIC No. 36302-5044246-9.

3. Mr. Faisal Faizan Awan S/o

Malik Noor Samad Awan

CNIC No. 36302-5301868-7.

Page 30 of 116

Case No. 10 CHANGE OF TITLE OF M/S PAKHEIM INT’L (PVT) LTD, 28-KM,

FEROZEPUR ROAD, LAHORE

M/s Pakheim Int’l (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore under DML No. 000492 by way of

formulation has submitted request for change of title of the firm as per Form-29 with prescribed Fee

Challan of Rs.50,000/- as under;

Title and legal status of the firm at previous

renewal of DML as per Form-1A

Title and legal status of the firm at

Current renewal of DML

as per Form-1A & Form-29

M/s Pakheim Pharma, 28-Km, Ferozepur Road,

Lahore. (Partnership firm)

M/s Pakheim International Pharma (Pvt) Ltd,

28-Km, Ferozepur Road, Lahore. (Private

Limited firm)

Decision of CLB:

The Board considered and approved the change of title of M/s Zakfas Pharmaceuticals (Pvt) Ltd,

Multan, License No. 000603 by way of (Formulation) as per Form-29 of SECP as under:

Title and legal status of the firm at previous

renewal of DML as per Form-1A

Title and legal status of the firm at Current

renewal of DML

as per Form-1A & Form-29

M/s Pakheim Pharma, 28-Km, Ferozepur Road,

Lahore. (Partnership firm)

M/s Pakheim International Pharma (Pvt) Ltd,

28-Km, Ferozepur Road, Lahore. (Private

Limited firm)

Case No. 11. CHANGE OF MANAGEMENT OF M/S CURATECH PHARMA (PVT) LTD, 35-

KM, MULTAN ROAD, LAHORE

M/s Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of

formulation has submitted request for change of management of the firm as per Form-29 with

prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;


Form-1A & Form-29 from

SECP


Form-29 from SECP

1. Mr. Sajid Ijaz Shah

S/o Ijaz Hussain

CNIC No. 33104-8350132-9

2. Mr. Iftikhar Ahmad

Siddiqui S/o Abdul Rasheed

CNIC No. 61101-3310031-7

3. Mr. Bashir Ahmad Qureshi

S/o Ijaz Ahmad

CNIC No. 35202-7995621-1


S/o Ijaz Hussain

CNIC No. 33104-8350132-9



CNIC No. 61101-3310031-7


S/o Ijaz Ahmad

CNIC No. 35202-7995621-1

1. Mr. Muhammad Asher

Khurram S/o M.I. Iftikhar

CNIC No.35202-1650603-9

2. Mr. Muhammad Imran

Khurram S/o M.I. Iftikhar

CNIC No 35202-5323653-1

3. Mr. M.I. Khurram S/o Haji

BArkat Ali

CNIC No. 35202-2013319-7

Page 31 of 116

Decision of CLB:


Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of

(Formulation) as per Form-29 of SECP as under:


Form-1A & Form-29 from

SECP


Form-29 from SECP


S/o Ijaz Hussain

CNIC No. 33104-8350132-9

2. Mr. Iftikhar Ahmad Siddiqui

S/o Abdul Rasheed

CNIC No. 61101-3310031-7


S/o Ijaz Ahmad

CNIC No. 35202-7995621-1


S/o Ijaz Hussain

CNIC No. 33104-8350132-9



CNIC No. 61101-3310031-7


S/o Ijaz Ahmad

CNIC No. 35202-7995621-1

1. Mr. Muhammad Asher

Khurram S/o M.I. Khurram

CNIC No.35202-1650603-9

2. Mr. Muhammad Imran

Khurram S/o M.I. Khurram

CNIC No 35202-5323653-1

3. Mr. M.I. Khurram S/o Haji

Barkat Ali CNIC No.

35202-2013319-7

Case No.12 CHANGE OF TITLE OF M/S WINTHROX LABORATORIES,

K-129-A, PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI.

M/s Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Super Highway, Karachi under DML No.

000807 by way of formulation has submitted request for change of title of the firm as per Form-29

with prescribed Fee Challan of Rs.50,000/- as under;

Previous Legal Status and Title as per

Partnership Deed of The Firm

Proposed Legal Status and Title as per

Form-29 of The Firm

Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E,

Super Highway, Karachi.

1. Rizwan Umer Sheikh, Partner.

2. Tabassum Tariq, Partner.

Winthrox Laboratories (Pvt) Ltd, K-129-A,

Phase-II, S.I.T.E, Super Highway, Karachi.

1. Rizwan Umer Sheikh, Director.

2. Tabassum Tariq, Director.

Decision of CLB:

The Board considered and approved the change of title of M/s Winthrox Laboratories, K-129-A,

Phase-II, S.I.T.E, Super Highway, Karachi under DML No. 000807 by way of (Formulation) as per

Form-29 of SECP as under:

Previous Legal Status and Title as per

Partnership Deed of The Firm

Proposed Legal Status and Title as per

Form-29 of The Firm

Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E,

Super Highway, Karachi.

3. Rizwan Umer Sheikh, Partner.

4. Tabassum Tariq, Partner.

Winthrox Laboratories (Pvt) Ltd, K-129-A,

Phase-II, S.I.T.E, Super Highway, Karachi.

3. Rizwan Umer Sheikh, Director.

4. Tabassum Tariq, Director.

Page 32 of 116

Case No. 13 CHANGE OF MANAGEMENT OF M/S SAMI PHARMACEUTICALS (PVT)

LTD, F-95, OFF HUB RIVER ROAD, S.I.T.E, KARACHI

M/s Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No.

000072 by way of formulation has submitted request for change of management of the firm as per


under;

Decision of CLB:


Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No. 000072

by way of (Formulation) as per Form-29 of SECP as under:


Form-29 from SECP


Form-29 from SECP

1. Mr. Shamim Ahmed S/o

S.M. Rafi CNIC No.

42201-0709868-7.

2. Ms. Nafees Yasin W/o

Muhamamd Yasin CNIC

No. 42301-4246934-6.

3. Ovais Shamim S/o Shamim

Ahmed CNIC No. 42201-

0709876-5.

4. Mr. Zubair Shamim S/o

Shamim Ahmed CNIC No.

42201-0709872-3.

5. Mr. Shoaib Shamim S/o


42201-0709871-7.

6. Mr. Junaid Shamim S/o


42201-0709876-3.

7. Mr. Abdul Salam S/o Zik-

ur-Rehman CNIC No.

42201-6555398-5.

1. Ms. Nafees Yasin

W/o Muhamamd

Yasin CNIC No.

42301-4246934-6.

1. Mr. Shamim Ahmed S/o S.M.

Rafi CNIC No. 42201-0709868-

7.

2. Mr. Muhammad Yasin Malik S/o

Hameed Eid Muhammad CNIC

No. 42301-0668555-7.



0709876-5.



42201-0709872-3.



42201-0709871-7.

6. Mr. Junaid Shamim S/o Shamim


0709876-3.

7. Mr. Abdul Salam S/o Zik-ur-


6555398-5.


Form-29 from SECP


Form-29 from SECP

1. Mr. Shamim Ahmed S/o

S.M. Rafi CNIC No. 42201-

0709868-7.

2. Ms. Nafees Yasin W/o

Muhamamd Yasin CNIC No.

42301-4246934-6.



0709876-5.



1. Ms. Nafees Yasin

W/o Muhamamd

Yasin CNIC No.

42301-4246934-6.

1. Mr. Shamim Ahmed S/o S.M.

Rafi CNIC No. 42201-0709868-

7.

2. Mr. Muhammad Yasin Malik S/o

Hameed Eid Muhammad CNIC

No. 42301-0668555-7.

3. Mr. Ovais Shamim S/o Shamim


0709876-5.



Page 33 of 116

Case No. 14 CHANGE OF MANAGEMENT OF M/S MAPLE PHARMACEUTICALS (PVT)

LTD, PLOT NO. 147, SECTOR 23, KORANGI INDUSTRIAL AREA, KARACHI

M/S Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML

No. 000620 by way of formulation has submitted request for change of management of the firm as per


under;


Form-29 from SECP


Form-29 from SECP

1. Mr. Mehtabuddin Feroz S/o

Ferozuddin CNIC No. 42201-

1613369-5.

2. Mr. Shafiuddin Feroz S/o


2816202-7.

3. Mr. Taufiq Feroz S/o


3557318-9.

4. Mr. Sohail Feroze S/o


0841143-9.

5. Mr. Mohsin Shafi Feroz S/o

Shafiuddin Feroze CNIC

No. 42201-1967477-1.

6. Mr. Ahsan Feroz S/o

Shafiuddin Feroze CNIC No.

42201-7653450-7.

7. Mr. Tehsin Feroz S/o


42201-0721036-1.

8. Mr. Raheel Shafi S/o

Shafiuddin Feroz CNIC No.

42201-9232879-3.

1.Mr. Mehtabuddin Feroz

S/o Ferozuddin CNIC No.

42201-1613369-5.

2.Mr. Taufiq Feroz S/o

Ferozuddin CNIC No.

42201-3557318-9.

3.Mr. Sohail Feroz S/o

Ferozuddin CNIC No.

42201-0841143-9.


Ferozuddin CNIC No.

42201-2816202-7.

2. Mr. Mohsin Shafi Feroz

S/o Shafiuddin Feroze

CNIC No. 42201-

1967477-1.



No. 42201-7653450-7.

4. Mr. Tehseen Feroz S/o


No. 42201-0721036-1.

5. 5. Mr. Raheel Shafi S/o

Shafiuddin Feroz CNIC

No. 42201-9232879-3.

42201-0709872-3.



42201-0709871-7.

6. Mr. Junaid Shamim S/o


42201-0709876-3.



6555398-5.

42201-0709872-3.



42201-0709871-7.

6. Mr. Junaid Shamim S/o Shamim


0709876-3.



6555398-5.

Page 34 of 116

Decision of CLB:

The Board considered and endorsed the change of management from old to new management of M/S

Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML No.

000620 by way of (Formulation) as per Form-29 of SECP as under:


Form-29 from SECP


Form-29 from SECP



1613369-5.



2816202-7.

3. Mr. Taufiq Feroz S/o Ferozuddin

CNIC No. 42201-3557318-9.

4. Mr. Sohail Feroz S/o Ferozuddin

CNIC No. 42201-0841143-9.



42201-1967477-1.

6. Mr. Ahsan Feroz S/o Shafiuddin

Feroze CNIC No. 42201-

7653450-7.

7. Mr. Tehsin Feroz S/o Shafiuddin


0721036-1.

8. Mr. Raheel Shafi S/o Shafiuddin


9232879-3.


Ferozuddin CNIC No.

42201-1613369-5.

2. Mr. Taufiq Feroz S/o

Ferozuddin CNIC No.

42201-3557318-9.

3. Mr. Sohail Feroz S/o

Ferozuddin CNIC No.

42201-0841143-9.



2816202-7.



42201-1967477-1.



42201-7653450-7.

4. Mr. Tehseen Feroz S/o


42201-0721036-1.

5. Mr. Raheel Shafi S/o


42201-9232879-3.

Case No. 15 CHANGE OF MANAGEMENT OF M/S HUMAYUN INTERNATIONAL PHARMA

(PVT) LTD, 20-KM, SATIANA ROAD, FAISALABAD

M/s Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by

way of formulation has submitted request for change of management of the firm as per Form-29 with

prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;


Form-29 from SECP


Form-29 from SECP

1. Mr. Humayun Chaudhry S/o

Chaudhry Imam-udDin C.E.O /

Director.

2. Mr. Tahir Humayun S/o Humayun

Chaudhry Director CNIC No.

33100-4362414-1.

3. Ms. Saima Tahir W/o Tahir

Humayun Director CNIC No.

33100-8987772-6

1. Mr. Humayun

Chaudhry S/o

Chaudhry Imam-ud-

Din C.E.O / Director

1. Mr. Tahir Humayun

S/o Humayun Chaudhry

Director CNIC No. 33100-

4362414-1

2. Ms. Saima Tahir

W/o Tahir Humayun

Director

CNIC No. 33100- 8987772-6.

Page 35 of 116

Decision of CLB:


Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by

way of (Formulation) as per Form-29 of SECP as under:


Form-29 from SECP


Form-29 from SECP

1. Mr. Humayun Chaudhry S/o

Chaudhry Imam-udDin C.E.O /

Director.

2. Mr. Tahir Humayun S/o Humayun

Chaudhry Director CNIC No.

33100-4362414-1.


Humayun Director CNIC No.

33100-8987772-6

1.Mr. Humayun Chaudhry

S/o Chaudhry Imam-ud-

Din C.E.O / Director

1. Mr. Tahir Humayun

S/o Humayun Chaudhry

Director CNIC No. 33100-

4362414-1


Humayun Director

CNIC No. 33100- 8987772-6.

Case No.16 M/S MEDLEY PHARMACEUTICALS (DML NO. 000237) PLOT NO. 41/A,

PUNJAB SMALL INDUSTRIES ESTATE, JHANG BAHTAR ROAD, WAH

CANTT.

Case Background.

M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang

Bahtar Road, Wah Cantt., submitted the application for renewal of DML No. 000675 by way of

formulation on 30-06-2014 for the period of 30-06-2014 to 01-07-2019, as due date of renewal of said

DML was 30-06-2014.

After evaluation of the renewal application of the firm, a letter for completion of application for

renewal of DML was issued for following shortcomings: -

i. Appointment letter, Job acceptance letter, resignation of proposed production

Incharge from previous firm, resignation of Production Incharge previously

working in your firm, undertaking on letter head of the firm that proposed

Production Incharge is whole time employee of the firm.

ii. Appointment letter, Job acceptance letter, resignation of proposed Quality

Control Incharge from previous firm, resignation of Quality Control Incharge

previously working in your firm, undertaking on letter head of the firm that

proposed Quality Control Incharge is whole time employee of the firm.

iii. Nothing Due Certificate issued by Statistical Officer, DRAP, Islamabad

regarding deposition of Central Research Fund up 31-12-2014.

With reference to above letter, the firm submitted following documents;

i. Appointment letter, Job acceptance letter, resignation of proposed production

Incharge from previous firm, resignation of Production Incharge previously

working in your firm, undertaking on letter head of the firm that proposed

Production Incharge is whole time employee of the firm.

ii. Appointment letter, Job acceptance letter, resignation of proposed Quality

Control Incharge from previous firm, resignation of Quality Control Incharge

previously working in your firm, undertaking on letter head of the firm that

proposed Quality Control Incharge is whole time employee of the firm.

Upon evaluation of firm’s reply, a shortcoming still deficient regarding technical persons. A letter was

issued to the firm with following shortcomings:-

i. Attested documents of technical staff (Production & Quality Control Incharge)

as per check list.

Page 36 of 116

In response to letter, the firm has submitted for the approval of new technical staff and upon

evaluation of documents following shortcomings have still been observed:

For Quality Control Incharge Miss. Nabeela Noor.

i. Attested copy of Appointment letter.

ii. Attested Copy of CNIC.

iii. Attested copy of Job acceptance letter.

iv. Attested copy of Experience Certificate (s) covering the period of not less than 10

years.

v. Attested copy of Resignation / retirement of earlier Quality Control Manager.

vi. Attested copy of Resignation or termination letter of appointee from the previous

firm / promotion letter / transfer letter from the same firm (QC Incharge).

For Production Mr. Mohammad Imran.

i. Attested copy of Appointment letter.

ii. Attested copy of Job acceptance letter.

iii. Attested copy of Experience Certificate (s) covering the period of not less than 10

years.

iv. Attested copy of Resignation / retirement of earlier Production Manager.

v. Attested copy of Resignation or termination letter of appointee from the previous

firm / promotion letter / transfer letter from the same firm (Production Incharge).

A file is received from B&A relating to CRF issue of the M/s Medley Pharmaceuticals with following

observations:-

Extract at place below taken from File No.2-282/STO(R&D) Para 7-10/N).

“For issuance of NDC, required documents have been submitted by the licensee M/s

Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries

Estate, Jhang Bahtar Road, Wah Cantt., i.e audited financial statements and income tax

returns, for F.Y 2015 & 2016 alongwith original bank receipts on account of CRF. The

same were checked as per SOP’s / procedure in vogue, IFRS and IAS, but found basic

accounting mistakes in preparation of financial statements, that made financial

statements suspicious. Therefore for M/s Medley was asked to submit duly

authenticated / attested aforesaid documents in order to proceed further (Page 81/Corr).

But the firm taken it leniently and again submitted the same documents by affixing

attested rubber stamp page 91-106/Corr).

Accordingly to establish authenticity of relevant documents, it was decided to approach

concerned audit firm M/s Nasir Absar & Co. to get verify the above said financial

statements. Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant

on behalf of M/s Nasir Absar & Co. and then he came to this office on 14-05-17 and

shown their strong concerns about using their letter head and name were forged as the

firm is only dealing with tax matters. Hence, the above financial statements are of

fraud. As this office required some written evidence from their side, then M/s Nasir

Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to

auditor were issued on 24-05-17 at page (110/Corr).

In reply, M/s Nasir Absar & Co. vide letter No.NCAL/DRAP/002 dated 13-0717 at

page (112)/Corr). has recommended to this office (“to take strict action as allowed

under the Drugs Act, 1976 and its ancillary rules for forging, falsifying and

misleading to this office in this regard)” against M/s Medley Pharmaceuticals.

In the light above it is emerged that M/s Medley is not contributing towards CRF since

2014 (July 2014) as per rules and also submitted forged, falsified and misleading

annual audited financial statements of outstanding periods i.e July, 2014 to June 2016.

This is clear violation of rule 19 sub rule (14), Chapter II of “The Drugs (Licensing,

Registration and Advertising) Rules, 1976”. The same also attracts necessary action as

mentioned in rule 12 of aforesaid rules because it seems that the licensee is managing

to avoid the actual amount of CRF.

Page 37 of 116

In the light of para 7-11/N, Licensing Division may proceed to take necessary action

under relevant rules and regulation, please”.


meeting



(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)

and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their

application for renewal of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries

Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 by way of

formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled

by Central Licensing Board.

Accordingly, show cause notice dated 05-01-2018 and letter of personal hearing dated 17-01-2018 has

been issued to the firm.

Reply of the Show Cause Notice.

With this letter we are enclosing our shortcomings for Renewal of License No. 000237

i.e Documents for Production Incharge and Quality Control Incharge. All the necessary

documents are attached hereby.

As for the matter of CRF issue as stated in Show Cause Notice, it is stated that our

representative person for auditing and CRF of firm Mr. Anwar and CEO Mr. Javied

Iqbal Chishti of the firm passed away in 2016 because of which the matter could not be

handled properly and lead to some misconceptions. It is humbly requested to you that

kindly give us time to dig out the matter more efficiently and come out with authentic

audit reports so as to prove ourselves clean in the matter as firm has receive NOC of

year 2014 and duly submitted all CRF in time.

Current Status.

The firm has submitted documents of new Production & Quality Control Incharge which are complete

and only shortcoming remaining is up- to-date Nothing Due Certificate.


meeting

Mr. Zia , Director of the firm appeared before the Board. He contested that CEO of the firm is died

and they have taken up the matter with the concerned firm for audit of the accounts. He was of the

view that matter would be resolved very soon. The Board apprised him that secretariat for the Central

Licening Board only accepts the nothing due certificate issued from the Division of the Budget and

Accounts. The Board considering the facts on the record and after thread bare deliberation decided to

suspend the Drug Manufacturing Licence No. 000237 by way of formulation issued in the name of

M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah

Cantt till settelemnt of Central Research Fund under Section 41 of the Drugs Act, 1976 read with

Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the

provision of Rule, 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976.

Page 38 of 116

Case No. 17 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ZEB

LABORATOIRES (PVT) LTD, LAHORE

M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital,

Lahore had applied for renewal of DML No. 000122 by way of formulation for the period of 22-09-13

to 21-09-2018 on 20-09-2013.

The application for the renewal of DML of the firm was evaluated and a letter for following

shortcomings / deficiencies was issued to the firm on 21st July, 2017 under Rule 5{2A} of Drugs

(Licensing, Registering, Advertising) Rules, 1976:-

1. Attested Detail of management at the time of previous renewal of DML and latest

management at renewal of DML along with CNIC copies of all Director / Partners.

2. Attested Nothing due certificate regarding CRF from STO (updated).

3. Approval letter of Production Incharge and Quality Control Incharge, if any change

then provide set of documents for proposed Production Incharge and Quality Control

(as per check list) along with prescribe fee of Rs. 10,000/-.

4. Approved Master Layout Plan / Proof of licensed section from CLB.

5. All documents should be duly attested.

The firm submitted their reply on 21st

August, 2017 After evaluation of the submitted documents, final

reminder was issued on 15th

September, 2017 to the firm with following shortcomings: -

1. Form 29 for year 2016-17 duly attested by S.E.C.P.

2. Nothing due certificate regarding CRF from STO (Valid upto 31-12-2017).

3. Detail of premises including approved sections from CLB.

4. Section wise detail of machinery for manufacture.

5. Detail of machinery for Quality Control Lab.

6. Copy of CNIC of appointee (Production Incharge and Quality Control Incharge).

7. Registration certificate from Pharmacy Council (Production Incharge).

8. Experience Certificate of Production Incharge as under Drugs (Licensing, Registering and

Advertising) Rules, 1976 (Not less than 10 years in relevant field of Production).

9. Resignation / retirement of earlier Production Incharge and Quality Control Incharge.

10. Resignation or termination letter of appointee from the previous firm / promotion letter /

transfer letter from the same firm (Production Incharge and Quality Control Incharge).

11. Undertaking as whole time employee (Production Incharge and Quality Control Incharge).

12. All Documents should be duly attested.

Firm submitted documents on 29th

September, 2017in reply to Final Reminder but following

documents are still deficient /short and application for renewal of DML is still incomplete.

i. Nothing due certificate regarding CRF from STO.

ii. Form 29 for year 2016-2017 duly attested from S.E.C.P.

iii. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules,

1976 for proposed Production Incharge (Not less than 10 years).

iv. Resignation or termination letter of Quality Control Incharge from the previous firm /

promotion letter / transfer letter from the same firm.

Page 39 of 116

As per available record, there seems to be change of management of the firm. The detail of which is as

under:

Change of management from last renewal


per Form-1A

(Page-21/Corr)

Retiring

Management

Current Management

as per Form-29 (Page-

400-401/Corr)

1. Mr. Fateh-Ullah Khan

S/o Zafar-Ullah Khan.

2. Mr. Asad-Ullah Khan S/o

Zafar-Ullah Khan.

3. Mr. Khair- Ullah Khan

S/o Zafar-Ullah Khan.

4. Mr. Kaleem-Ullah Khan

S/o Fateh-Ullah Khan.

5. Mr. Saif-Ullah Khan S/o

Fateh-Ullah Khan.

1. Mr. Asad-Ullah

Khan S/o Zafar-

Ullah Khan.

2. Mr. Khair- Ullah

Khan S/o Zafar-

Ullah Khan.

1. Mr. Fateh-Ullah Khan

S/o Zafar-Ullah

Khan.

2. Mr. Kaleem-Ullah

Khan S/o Fateh-Ullah

Khan.

3. Mr. Saif-Ullah Khan

S/o Fateh-Ullah

Khan.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.

The Show Cause notice dated 05th

January, 2018 was issued to the M/s Zeb Laboratories (Pvt) Ltd,

Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore.

A letter of Personal hearing has been issued on 17th January, 2018.

Meanwhile a letter is receive from the firm, wherein the firm has stated that they had stopped

production of common generic drugs due to some business decisions. The firm is, therefore,

surrendering their Drug Manufacturing License No. 000122 (Formulation) in the name of M/s

Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore


meeting

Mr. Fatehullah Khan, Chief Executive of the firm appeared before the Board. He apprised the Board

that they intend to surrender the Drug Manufacturing Licence by way of formulation for the purpose

of utilizing the premises for HOTC products. The Board considering the facts on the record and after

thread bare deliberation decided to cancel the Drug Manufacturing Licence No. 000122 by way of

formulation issued in the name of M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad

near Shoukat Khanum Hospital, Lahore on the request of the firm under Section 41 of the Drugs Act,

1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976

Page 40 of 116

Case No. 18 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DR. SETHI

PHARMA INDUSTRIES, CHICHAWATNI.

M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni had applied for renewal of DML No.

000293 by way of formulation for the period of 22-07-2015 to 21-07-2020 on 10-07-2015


shortcomings / deficiencies was issued to the firm on 1st November, 2016 under Rule 5{2A} of Drugs


1. Details of management / proprietor / director alone with copies of CNIC attested.

2. Legal status of firm, Partnership deed, Form”C”, which one is applicable.

3. Affidavit that whether there is any change in management and provided information

is correct.

4. L.O.P of firm.

5. Proof of approval of licensed sections from CLB.

6. Registration of earlier Q.C Incharge

7. Complete experience certificates dully attested for 10 years.

8. Registration of appointee from previous firm.

9. Fee challan for approval.

The firm submitted their reply on 23th

November, 2016 After evaluation of the submitted documents,

Final Reminder was issued on 11th

July, 2017 to the firm with following shortcomings: -

1. Approved copy of L.O.P and Section approval letters for section from Licensing

Board.

2. Attested copies of experience letter for 10 years for proposed Q.C Incharge.

3. Resignation of earlier Q.C Incharge and present nominee.

Page 41 of 116


July, 2017 to Final Reminder and following documents are still

deficient /short and application for renewal of DML is still incomplete.

1. Approved copy of L.O.P and Section approval letters for section from Licensing

Board.

2. Attested copies of experience letter for 10 years for proposed Q.C Incharge.

3. Resignation of earlier Q.C Incharge and present nominee.

4. Affidavit as sole proprietor on stamp paper.


meeting





application for renewal of M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni Drug

Manufacturing Licence No000293 by way of formulation may not be rejected or Drug Manufacturing

Licence may not be suspended or cancelled by Central Licensing Board.



January, 2018 was issued to the M/s Dr. Sethi Pharma Industries, 3-

Burewala Road, Chichawatni

Reply of the show cause is received from the firm and documents were evaluated. Firm has submitted

all the required documents for renewal of DML No. 000293 (Formulation) and application for renewal

of DML is complete.

The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018.


meeting

Mr. Mehmood Durrani , Production Manager of the firm appeared before the Central Licensing Board

and contented that requirements has been completed by him and showcuase issued to him may be

recalled. The Borad after hearing the representative of the firm advised him to comply the legal

requirements in time in future and decided to cease the operation of the showcause notice issued to the

firm with immediate effect.

Case No. 19 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S PULSE

PHARMACEUTICALS (PVT) LTD, LAHORE.

M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore had

applied for renewal of DML No. 000564 by way of formulation for the period of 31-12-2014 to 30-12-

2019 on 15-12-2014.


shortcomings / deficiencies was issued to the firm on 30th

March, 2015 under Rule 5{2A} of Drugs


1. To provide approval letters of Capsule (Antibiotic) and Oral Dry Powder suspension

(Antibiotic) which are mentioned in last inspection report of renewal of DML but in

licensing Division, there is no proof for grant of these sections.

Page 42 of 116

2. To furnish latest Form-29 issued by Security Exchange Commission of Pakistan

(S.E.C.P) and CNIC photocopies of all Directors.

3. To furnish documents / information of proposed Technical Expert with respect to Rule

16 of the Drug (L, R & A) Rules 1976 after promulgation of SRO 1134(1)/2014. The

technical experts shall possess minimum 10 years experience after academic

qualification.


May, 2015.After evaluation of the submitted documents, Final

Reminder was issued on 17th

September, 2016 to the firm with following shortcomings: -

1. As per Form-29, there seems change in management, if change then the requisite

fee.

2. Job acceptance letter of Q.C Incharge.

3. Resignation letter of earlier Q.C Incharge.

4. Prescribe fee of Rs. 5000/ for approval of technical staff.

Firm did not submit their reply to Final Reminder and following documents are still deficient /short

and application for renewal of DML was incomplete.

i. As per Form 29, there seems change in management, if change then the prescribe fee

alongwith CNIC copies of all Directors.

ii. Form-29 duly attested from S.E.C.P.

iii. Nothing due certificate regarding CRF from STO (Updated).

iv. Duly attested Appointment letter (Q.C Incharge).

v. Duly attested Copy of academic degrees (Q.C Incharge).

vi. Duly attested copy of experience certificates (Q.C Incharge).

vii. Undertaking as whole time employee on stamp paper.

viii. Duly attested resignation letter of appointee from previous firm (Q.C Incharge).

ix. Job acceptance letter of Q.C Incharge.

x. Resignation letter of earlier Q.C Incharge.

xi. Prescribe fee of Rs. 10.000/ for approval of technical staff.

xii. Duly attested copy of experience certificates (Production Incharge).

Accordingly, case was placed before the Board in its 256th

meeting held on 9-10th

November, 2017.


meeting





application for renewal of M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua

Aasil Road), Lahore Drug Manufacturing Licence No000564 by way of formulation may not be

rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.



January, 2018 was issued to the M/s Pulse Pharmaceuticals (Pvt)

Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore

A letter of Personal hearing has been issued on 17th

January, 2018.

Page 43 of 116

Firm has replied to show cause notice on 22-01-2018. Application for renewal of DML is still short of

following documents;

1. Form-29 duly attested from SECP.

2. Up-to-date Nothing Due Certificate (CRF) from STO, DRAP.

3. Resignation/retirement of earlier Production Incharge duly attested.


meeting

Mr. Umar Mehmood, Executive of the firm appeared before the Central Licensing Board and

presented documents which were considered and found complete. He also contended that that

requirements has been completed and showcuase issued to him may be recalled. The Borad after

hearing the representative of the firm advised him to comply the legal requirements in time in future

and decided to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No. 20 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DRUGPHARM

(PVT) LTD, LAHORE

M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore had applied for renewal of

DML No. 000366 by way of formulation for the period of 24-04-2016 to 23-04-2021 on 15-04-2016.



August, 2016 under Rule 5{2A} of Drugs


1. Classes of Drugs.

2. Dosage forms of drugs.

3. Change (s) in name of proprietor / directors / partners.

4. Detail of premises including approved layout plan of the factory / proof of section

from CLB.

5. Copy of approval production and QC Incharge

6. Noting due certificate regarding CRF from STO.

7. Form-29 from S.E.C.P and CNIC of partners


September, 2016 After evaluation of the submitted documents, a

letter was issued on 30th

January, 2017 to the firm with following shortcomings: -

1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors.

2. Any change in directors from last renewal along with Form-29 at previous renewal.

3. N.O.C for C.R.F (attested up to 2015).

4. Approved copy of Layout Plan.

5. Approved of technical staff or application / documents.



February, 2017 After evaluation of the submitted documents,


June, 2017 to the firm with following shortcomings: -







Page 44 of 116

Firm did not submit their reply to Final Reminder and following documents are still deficient /short

and application for renewal of DML is still incomplete.







Moreover, The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is

stated that a case No. 37/17 is filed before Hon’ble Drug Court, Quetta in respect of M/s DrugPharm

(Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore. Accused are not appearing before the Court

despite issuance of Non bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan,

Quetta has ordered to cancel the Drug Manufacturing Licence of said firm and report in this regard

may be forwarded to Chairman Drug Court, Balochistan, Quetta.


meeting





application for renewal of M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore

Drug Manufacturing Licence No. 000366 by way of formulation may not be rejected or Drug

Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.



January, 2018 was issued to the M/s Drug Pharm (Pvt) Ltd, 28-Km,

Lahore Sheikhupura Road, Lahore


January,2018.


meeting

No representative of the of the firm appeared before the Board. The Board considering the facts on

the record and after thread bare deliberation decided to cancel Drug Manufacturing Licence No.

000366 by way of formulation issued in the name of M/s Drugpharm (Pvt) Ltd, 28-Km, Lahore

Sheikhupura Road, Lahore on the orders of the Court under Section 41 of the Drugs Act, 1976 read

with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying

the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising)

Rules, 1976.

Case No. 21 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S FRIENDS

PHARMA (PVT) LTD, 31-KM, FEROZEPUR ROAD, LAHORE

The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a

case No. 42/16 is filed before Hon’ble Drug Court, Quetta in respect of M/s Friends Pharma (Pvt) Ltd,

31-Km, Ferozepur Road, Lahore. Accused are not appearing before the Court despite issuance of Non

Page 45 of 116

bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to

cancel the Drug Manufacturing Licence of said firm and report in this regard may be forwarded to

Chairman Drug Court, Balochistan, Quetta.


meeting



(Licensing, Registering and Advertising) Rules, 1976 for cancellation of Drug Manufacturing

Licence.



January, 2018 was issued to the M/s Friends Pharma (Pvt) Ltd, 31-

Km, Ferozepur Road, Lahore.


January, 2018.


meeting

Mr. Nadeem Zafar, chief Executive of the company appeared before the Board and submitted orders

of the Honourbale High Court, Balochistan, Quetta. Honourbale High Court, Balochistan, Quetta has

suspended the ordes of the Drug Court, Balochistan, Quetta, dated 10th

November, 2017 and 30th

December, 2017 to the extent of the issuance of warrant of arrest and for initiating proceedings against

the company. Keeping in view the facts and verbal assurance by the chief Executive of the company

for appearance before the Drug Court, Balochistan, the Board decided to cease the operation of

showcause notice and report shall be submitted to the Drug Court, Balochistan, Quetta.

Case NO. 22 M/S HELICON PHARMACEUTEK PAKISTAN (PVT) LTD., MODEL TOWN

ROAD, FAISALABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A)

RULES, 1976.

M/s Helicon Pharmaceutek Pakistan (Pvt) Ltd, Faisalabad had submitted application

dated 06-11-2015 for the renewal of DML No. 000117. After evaluation of the renewal application of

the firm, a letter for completion of application for renewal of DML was issued for following

shortcomings/attested documents dated 28-12-2016: -

i. Details of management/Form-29 from S.E.C.P. Previous Form-29 and any change in

management, CNIC copies of all Directors.

ii. Details of premises including approved L.O.P

iii. Approval of technical staff or proposed documents for technical staff as per check list

iv. Proof of all licensed sections.

v. N.O.C for C.R.F

2. Firm did not submit the reply of the above shortcoming letter; accordingly a final reminder was

issued by Secretary CLB dated 17-02-2017.Firm submitted reply alongwith deficient documents

against the final reminder for the completion of their DML renewal application as under:

i. Unattested form-29 from SECP

ii. Copy of L.O.P

iii. Nothing Due certificate UPTO 31-12-2005

iv. Mr. Rafaqat Ali , production Incharge

v. Miss ZahidaMaqsood, Q.C Incharge

Page 46 of 116

3. Following documents /information is still deficient /short;

i. Firm submitted the name of Miss ZahidaMaqsood as Q.C. Incharge, However it is

revealed from record that she had resigned from her post on 2-1-2009 and her

resignation was accepted by the management of firm. According Mr. Muhammad

Rafiq Khan S/o Sultan Jan Khan was approved as Q.C. Incharge vide this office

letter of even Number dated 21-07-2009 Firm did not reply for approval of

approved of Q.C. Incharge Miss ZahidaMaqsood to this office was submitted

resignation of Mr. Muhammad Rafiq Khan till to date as per available record of

licensing Division.

ii. Firm submitted form-29 (un-attested) and seems change in management, however

fee Challan for change of management is not provided

iii. Letter of approved Section from CCB is not provided.

iv. Latest nothing due certificate for C.R.F from S.T.) is not provided. Firm submitted

certificate up to 2015.


meeting.

4. The Board considering the facts on the record and after thread bare deliberation decided to

serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of

the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of

Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why

the application for renewal of DML No. 000117 by way of formulation ofM/s Helicon Pharmaceutek

Pakistan (Pvt.) Ltd, Faisalabad may not be rejected by Central Licensing Board or their Drug



5. The Show Cause notice dated 21st July, 2017 was issued to the M/s Helicon Pharmaceutek

Pakistan (Pvt.) Ltd, Faisalabad.Reply of the show cause is received from the firm which is as under:-

“This show cause notice is seem to be a result of misreading/ non reading of our reply

received on dated 20.03.2017 and reply to your letter dated 28.12.2016 and 17.02.2017.We were

required to provide following five information's/ queries

i. Detail of management form-29 duly attested from S.E.C.P. previous Form-29

and any change in management. CNIC copies of all direction.

ii. Detail of premises including approved layout plan.

iii. Proof of all licensed sections.

iv. Approval of technical staff or proposed documents for technical person as per

check list.

v. Nothing due Certificate for CR.F.

We have already thoroughly replied all these queries/ observations by providing all

requisite information and by attaching the requisite documents. We reproduce for your kind

information along with the extract of requisite reply para wise as below. Which proves that this

show cause/notice is unwarranted and liable to withdrawn forth with

Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P.

any change in management. CNIC copies of all directors.

Page 47 of 116

Reply: Form 29 duly certified on 06 August 2016 diary no. 918622 from joint registrar S.

E.C.P. Faisalabad elaborating he following information of all the directors.

Query 2. Detail of premises including approved layout plan.

Reply: The detail of premises including layout plan is attached here with again. This factory

was licensed in 1962 and then under Drug Act 1976 and since then continuing at this premises

duly inspected and approved and renewed as per layout plan.

Query 3.Proof of all licensed sections.

Reply: The license sections have been duly inspected while granting the registrations and

while renewing the drug manufacturing license. This is the sufficient proof of licensed section.

More over all our registrations are current and renewed.

Query 4. Approval of technical staff proposed documents for technical person as per check list.

Reply: The following approved technical staff is working continuously without any

interruptions

After fulfillment of all requisite qualifications. As under

Sr. No Name Job assigned Qualification

1. Mr. Rafaqat Ali Production Manager B. Pharmacy

2. Ms. ZahidaMaqsood Quality Control Manager B. Pharmacy

copy of approval letter of Ministry of Health is attached for ready reference.

Query 5. Nothing due certificate for C.R.F,

Reply: Letter dated 20th March 2015 issued by the statistical officer DRAP Islamabad

narrating this "Nothing due certificate is valid up to 31.12.2015" copy attached.

We are amongst the pioneer manufacturing units serving the country. In the recent past

we have donated 50% of our registered drugs to a charity. Thus we are not working for profit.

it is not out of place to mention that in line with the suggestions of the inspection

panels, we have closed down few sections and are intending to shift the production to a third

party arrangement till such time that we have alternative manufacturing facility to under take

these by our self for which we have made positive arrangements. We have sufficiently replied

to your queries on the basis of which we were issued this un warranted show cause notice. We

therefore request personal hearing to clarify our stance for ends of justice as poor patients are

likely to suffer incase of any adverse consequences arising out of misreading's

We may be accorded some convenient date with sufficient lead time for personal

hearing as well”.

Observations of the Licensing Division

6. Observations of the Licensing Division are as under:

Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P.

any change in management. CNIC copies of all directors.

Page 48 of 116

Observation: The firm has submitted copy of form-29 which is not duly attested from

S.E.C.P. and not provided CNIC copies of all directors.

Query 2. Detail of premises including approved layout plan.

Observation: The firm did not submit approved layout plan.

Query 3.Proof of all licensed sections.

Observation: Not provided by the firm

Query 4. Approval of technical staff proposed documents for technical person as per check

list.

Observation: It is revealed from the record that Ms. ZahidaMaqsood (approved Quality

Control Incharge) had resigned from her post on 02-01-2009 and her resignation was accepted

by the management of firm (page 56/Corr). Accordingly Mr. Muhammad Rafiq Khan S/o

Sultan Jan Khan was approved as Quality Control Incharge vide this office letter of even

number date 21-07-2009 (page 69/Corr). Afterwards, the firm neither applied for approval of

Ms. Zahida Maqsood as Quality Control Incharge nor submitted resignation of Mr.

Muhammad Rafiq Khan till date to Licensing Division.

Query 5. Nothing due certificate for C.R.F,

Observation: The Nothing due certificate for C.R.F. is valid upto 31-12-2015.

The firm has been called for personal hearing


meeting

No person appeared before the Board. Letter issued to the firm for personal hearing is received

undelivered. The Board therefore, decided to defer the case till next meeting of the Board.


A letter of Personal hearing has been issued on 1st November, 2017. The firm has replied in the

response of Personal hearing letter and informed that due to paucity of time, they could not properly

prepared for the personal hearing and their technical person is on leave for medical reasons. The firm,

therefore, requested that the personal hearing may kindly be adjourned to the forthcoming meeting of

Central Licensing Board.


meeting.

Mr. Tariq Mahmood Accounts Manager appeared on behalf of the firm the Board. He contended that

their technical person is on leave for medical reasons therefore, time may be granted for next hearing

to defend the case. The Board, therefore, decided to provided one opportunity for personal appearance

before the Board.



January,2018.


meeting.

Mr. Tariq Mahmood, Accounts Manager appeared on behalf of the firm before the Board. He

contended that he may be given time of two weeks to complete the application. The Board considering

Page 49 of 116

the facts on the record and after thread bare deliberation decided to suspend Drug Manufacturing

Licence No. 000117 by way of formulation in the name of M/s Helicon Pharmaceutek Pakistan (Pvt.)

Ltd, Faisalabad till completion of requirements as per Schedule B and codal formalities under Section

41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising)

Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing,

Registering and Advertising) Rules, 1976.

Page 50 of 116

Case No. 23. INSPECTION REPORT OF M/S HIMONT PHARMACEUTUCALS, LAHORE.

A panel inspection report pertaining to M/s Himont Pharmaceuticals (Pvt) Ltd, 17-Km,

Ferozepur Road, Lahore forwarded vide letter No. F. No. 1-59/2017-FID IV dated 21st

June, 2017, on

the subject cited above. The panel observed that in Cephalosporin Section approved change room was

not being used and it has been converted into washing area. The firm was using another room for

entrance which was not provided with proper change over facility for workers. It was observed that the

workers in the section were just wearing a coat over their street cloths. The panel was of the opinion

that in this sensitive area of manufacturing the workers should wear proper uniform to avoid any

chance of cross contamination, additionally it may pose a greater risk on workers and others safety due

to exposure to the Cephalosporin powders sticking on the cloths. The panel advised the firm to provide

proper change over facility for the workers. In the Capsule (General) Section, the firm has provided

only manual Capsule filling machines, which seems not to be appropriate to meet the latest GMP

requirements. The Panel recommended the renewal Drug Manufacturing License to all approved

sections except Capsule (General) and Cephalosporin (injectable, oral dry powder suspension &

capsule) section. The case was accordingly placed before the Central Licensing Board in its 255th

meeting held on 16-17th

August, 2017.

The Central Licensing Board considered the facts of the case, legal provisions and decided as

under;

“The Board decided to issue Show Cause Notice to the firm under Section 41

of the Drugs Act, 1976 read with Rule 12 of the Drugs (Licensing, Registering and

Advertising) Rules, 1976 for suspension or cancellation for Capsule (General) and

Cephalosporin (injectable, oral dry powder suspension & capsule) section on the

recommendations of the panel of experts”.



January, 2018 was issued to the M/s Himont

Pharmaceuticals (Pvt) Ltd, 17-Km, Ferozepur Road, Lahore.

Reply of the show cause is received from the firm which is as under:-

Sr.

No

Observations Status

1 General Capsule Area

It was noted that in the general capsule section the firm

has provided only manual capsule filling machine which

seemed not to be appropriate to meet

The latest GMP requirement Capsule polisher and

metal detector to be installed.

Complied semi-

automatic machine

installed

Complied. Capsule

polisher and metal

detector installed.

2 Capsule Area (Cephalosporin)

Capsule was neat and clean provided with the required

machine and equipment. HVAC system was installed and

functional. It was note provided with proper change over just

wearing a coat over their street cloths addition to cross

Complied. Change over

facility provided

Complied, Capsule

polisher and metal

detector installed.

Page 51 of 116

contamination may also pose a greater risk on workers own

and others safety due to exposure to the Cephalosporin

powders sticking on the cloths. The firm was also advised to

provide capsule polisher and metal detector in the section.

3 Oral Dry Powder Suspension(Cephalosporin )

Metal was neat and clean provide with the require machine and

equipment. HVAC system was installed and functional. It was

not provided with proper change over facility for workers. The

workers in the section were just wearing a coat over their street

cloths which in addition to cross contamination may also pose

a greater risk on workers and others safety due to exposure

Cephalosporin powders sticking on the cloths.

Complied, Change

over facility provided

4 Dry Powder Injectable (Cephalosporin)

Section was neat and clean provided with the require machine

and equipment. HVAC system was installed and functional. It

was noted that entrance to this section was not provided with

proper change over facility for workers. The workers in section

were just wearing a coat over their street cloths which in

addition to cross contamination may also pose a greater risk on

workers own and others safety due to exposure to the

Cephalosporin powders sticking on the cloths.

Complied, Change

over facility provided

5 Quality Control

In quality department the firm possesses necessary equipment

to carry out the testing / analysis for the products being

manufactured quality control equipment were installed and

calibrated. Among the major instruments the firm possesses

the HPLC, UV spectrophotometer. Karl Fisher, TOC, and

liquid particle analyzer etc. The microbiology lab was also

equipped. However, it was noted that FTIR was out of order;

the firm was advised to make it functional at earliest.

FTIR has been sent for

diagnosis and

rectification of problem

to Perkin Elmer

Company.



meeting.

Dr. Maqsood Ahmed, Head Quality Operations appeared before the Board and contended that all

rectifications have been made as per advice of the panel of experts. He further requested that panel of

experts may be constituted for verification of the improvemengts made in Capsule (General) and

Cephalosporin (injectable, oral dry powder suspension & capsule) section. The Board after hearing the

represenetative of the firm decided to constitute same panel for verification of improvements made.

The Board also authorized that Chief Drug Controller may be replaced with Mr. Anjum Pervaiz in the

panel.

Page 52 of 116

Case No. 24. INSPECTION REPORT OF M/S REKO PHARMACAL, LAHORE.

A panel inspection report pertaining to M/s M/s Reko Pharmacal (Pvt) Ltd., 13-KM,

Multan Road, Lahore forwarded vide letter No. F. No. 1-21/2012-FID (F) dated 12th

June, 2017, on the

subject cited above. The panel observed that Liquid Injectable (General) Section was neat and clean.

HVAC system was installed and functional. However, it was noted that firm has not provided

appropriate vial filling machine and hence did not possess proper vial manufacturing facility. The firm

has provided the necessary equipment and instrument for test / analysis of products except the liquid

injectable dosage forms. It was noted the firm has not provided TOC and liquid particle analyzer,

required for conducting test / analysis of liquid injectable dosage forms. Hence the firm did not

possess the Quality Control facility for liquid injectable. The case was accordingly placed before the

Central Licensing Board in its 254th

meeting held on 15th

June, 2017.

The Central Licensing Board considered the facts of the case, legal provisions and decided as

under; “The Board decided to issue Show Cause Notice to the firm under Section 41 of the

Drugs Act, 1976 read with Rule 12 of the Drugs (Licensing, Registering and

Advertising) Rules, 1976 for suspension / cancellation of Liquid Injectable Section on

the recommendations of the Panel of Inspectors till the provision of proper

manufacturing and testing facilities”.


October, 2017 was issued to the M/s Reko Pharmacal (Pvt)

Ltd., 13 KM, Multan Road, Lahore.

Now the firm has replied to Show Cause notice the observations of panel and reply of

the firm is as under:

Observations of panel Reply of the firm

Liquid Injectable (General) Section was neat

and clean. HVAC system was installed and

functional. However, it was noted that firm

has not provided appropriate vial filling

machine and hence did not possess proper

vial manufacturing facility

In respect to the specific observation of the panel

regarding manual vial machine in the vial filling

section, we are in the process of upgrading the

vial section and have ordered the new automatic

vial filling machine (quotation is attached) which

will replace the manual vial filling machine.

The firm has provided the necessary equipment

and instrument for test / analysis of products

except the liquid injectable dosage forms. It

was noted the firm has not provided TOC

and liquid particle analyzer, required for

conducting test / analysis of liquid injectable

dosage forms. Hence the firm did not possess

the Quality Control facility for liquid

injectable.

As per instruction / observations of panel

inspection report pertaining to M/s Reko

Pharmacal (Pvt) Ltd, we have upgraded our

testing facilities of liquid injectable dosage

forms. We have purchased and installed the TOC

analyzer and liquid particle counter and all tests

for injectable dosage form are being conducted

on these instruments (copies of invoices of TOC

analyzer and liquid particle counter attached )

Furthermore, the firm has requested that they would highly appreciate if the CLB note the

required change and withdraw the whole cause and renew their injectable section.


Page 53 of 116


meeting.

Ms. Seemal Khalid, Director and Mr. Sameer Iftikhar appeared before the Board and contended that

all rectifications have been made as per advice of the panel of experts. She further requested that panel

of experts may be constituted for verification of the improvemengts made in Liquid Injectable Section.

The Board after hearing the represenetative of the firm decided to constitute same panel for

verification of improvements made and installation of liquid injectable filling machine..

Case No. 25 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SATURN

PHARMACEUTICALS (PVT) LTD, LAHORE

M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore had applied for renewal

of DML No. 000734 by way of formulation for the period of 15-06-2016 to 14-06-2021 on 9-05-2016.



June, 2017 under Rule 5{2A} of Drugs


1. Duly signed and stamped Form-1A.

2. Detail of management Previous at the time of grant of DML and latest management

present renewal of DML along with CNIC copies of directors.

3. Nothing due certificate regarding CRF from STO (Updated).

4. Approval letter / proof of proposed Production Incharge and Quality Control Incharge

if any change then provide complete set of documents for proposed Production

Incharge and Quality Control Incharge (as per check list) along with prescribe fee.

5. Documents should be duly attested.

The firm submitted their reply on 31st

July, 2017 After evaluation of the submitted documents, final

reminder was issued on 15th

August, 2017 to the firm with following shortcomings: -









Firm replied on 13-09-2017 to Final Reminder by stating that they have already submitted documents

but unfortunately these documents were not duly attested. Now it is our humble request in your honor

that duly attested copies will be provided in your office within few days. Following documents are

still deficient /short and application for renewal of DML is incomplete.

Page 54 of 116










meeting





application for renewal of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road,

Lahore Drug Manufacturing Licence No. 000734 by way of formulation may not be rejected or Drug




January, 2018 was issued to the M/s Saturn Pharmaceuticals (Pvt)

Ltd, 25-Km, Thokar Raiwind Road, Lahore

Reply of show cause notice

The firm has submitted the documents in reply of the show cause notice. Upon evaluation following

documents are found to be deficient;

1. Duly attested resignation/retirement of earlier Production and Quality Control Incharge.

2. Nothing Due Certificate regarding CRF.

3. Duly attested appointment and job acceptance letter of QC Incharge.


January, 2018.


meeting

Mr. Ghulam Yasin Paracha , Chief Executive of the firm appeared before the Board and contended

that they have applied for nothing due certificate on 12-01-2018 and no production is being carried out

in the premises. The Board considering the facts on the record and after thread bare deliberation

decided to suspend the Drug Manufacturing Licence No. 000734 by way of formulation issued in the

name of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore till settlement

of CRF and other codal formalities under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the

Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule,

5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976

Page 55 of 116

Case No. 26 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S CHISHTI

PHARMACEUTICAL INDUSTRIES, CHICHAWATNI

M/s Chishti Pharmaceutical Industries, Chichawatni had applied for renewal of DML No. 000483 by

way of formulation for the period of 19-12-2015 to 18-12-2020 on 15-12-2015


shortcomings / deficiencies was issued to the firm on 1st November, 2016 under Rule 5{2A} of Drugs


1. Details of management at the time grant of DML and previous renewal of DML

and present renewal of DML.

2. Details of premises including layout plan / proof of section from Central

Licensing Board.



December, 2016 After evaluation of the submitted documents,


August, 2017 to the firm with following shortcomings: -

1. Proposed Change in management agreement i.e revised deed from previous to

present management alongwith attested copies of CNIC’s.

2. Requisite fee Rs. 50,000/- for change of management.

3. Form-D from registrar of firms.

4. Complete set of documents for QC Incharge (as per check list) along with prescribe

fee Rs. 5,000/-.




September, 2017 in reply to Final Reminder but following

documents are still deficient /short and application for renewal of DML is still incomplete.

1. There seems to be Change in management, revised Partnership deed alongwith

attested copies of CNIC’s of partners.

2. Requisite fee Rs. 50,000/- for change of management.

3. Form-D from registrar of firms.

4. Complete set of documents for QC Incharge (as per check list) along with prescribe

fee Rs. 5,000/-.




meeting





Page 56 of 116

application for renewal of M/s Chishti Pharmaceutical Industries, Chichawatni Drug Manufacturing

Licence No000483 by way of formulation may not be rejected or Drug Manufacturing Licence may

not be suspended or cancelled by Central Licensing Board.



January, 2018 was issued to the M/s Chishti Pharmaceutical

Industries, Chichawatni


January, 2018.

The firm has replied to show cause notice and documents submitted by the firm are evaluated and

application is found to be deficient of following documents;

1. Complete set of duly attested documents for approval of Quality Control Incharge

alongwith requisite fee of Rs. 5000/-.


meeting

Mr. Muhammad Arshad Chisti, Chief Executive of the firm appeared before the Central Licensing

Board and submitted documents which have been perused found as per requirement. The Borad after

hearing the representative of the firm advised him to comply the legal requirements in time in future

and decided to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No.27 HIRRA PHARMACEUTICAL LABORATORIES (PVT) LTD, LAHORE

M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt

had applied for renewal of DML No. 000449 by way of formulation for the period of 1-08-2015 to 31-

07-2020 on 30-07-2015.



October, 2016 under Rule 5{2A} of Drugs


1. Form 29 from S.E.C.P. newly details of management along with CNIC copies &

any change in management

2. Section wise details of machinery

3. Name & qualification along with documents for QC Incharge & Production

Incharge


5. Proof of all licensed Sections.

The firm did not submit their reply and Final Reminder was issued on 19th

June, 2017 to the firm with

following shortcomings: -

1. Form 29 from S.E.C.P. newly details of management along with CNIC copies & any

change in management

2. Section wise details of machinery

3. Name & qualification along with documents for QC Incharge & Production Incharge


5. Proof of all licensed Sections.

Page 57 of 116


July, 2017 in reply to Final Reminder but following documents are

still deficient /short and application for renewal of DML is still incomplete.

1. Form-29 duly attested from S.E.C.P alongwith CNIC copies of all directors.

2. Duly attested document for approval of proposed QC Incharge & Production Incharge

alongwith prescribe fee.

3. Proof of all licensed Sections approved by Central Licensing Board.

4. Prescribe fee of 50,000/- for change of management.

5. Prescribe fee of 50,000/- for change of Legal Status from M/s Hirra Pharmaceutical

Laboratories to Hirra Pharmaceutical Laboratories (Pvt) Ltd.

6. All document should be duly attested.


meeting





application for renewal of M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road

(Ladhaky Bhula). Lahore-Cantt Drug Manufacturing Licence No. 000449 by way of formulation may

not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central

Licensing Board.



January, 2018 was issued to the M/s Hirra Pharmaceutical

Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt


January,2018.


meeting

Dr. Kamran Ahmed, Director of the firm appeared before the Central Licensing Board and submitted

documents which have been perused found as per requirement. The Borad after hearing the

representative of the firm advised him to comply the legal requirements in time in future and decided

to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No. 28 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S QINTAR

PHARMACEUTICALS, SARGODHA

M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, had

applied for renewal of DML No. 000520 by way of formulation for the period of 19-06-2013 to 18-06-

2018 on 13-06-2013.


shortcomings / deficiencies was issued to the firm on 22-10-2013 under Rule 5{2A} of Drugs


Page 58 of 116

1. Copy of new partnership deed duly attested by office of Registrar of firm as the name of

partners as mentioned in your above said application are different than mention in

previous application dated 10-06-2008 for the same purpose i.e. grant of renewal of Drug

Manufacturing License at that time.

2. Attested copy of Certificate of Registrar of firm duly issued by the office of Registrar of

firm’s alongwith attested copies of CNIC of all the present Directors / Partner.

3. No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP,

Islamabad till to date.


February, 2017 and a letter was issued on 8th

August, 2017 under

Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.

1. Prescribe fee of Rs. 50,000/- for change of management and original challan retained

by STO (R&D), DRAP, Islamabad.

2. Attested Nothing due certificate regarding CRF from STO (Updated).


September, 2017 in reply to letter issued on 8th

August, 2017 and a

letter for following shortcomings / deficiencies was issued to the firm on 18th

October, 2017 under

Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. Form-D from Registrar of firms.

2. Copy of previous partnership deed.

3. NOC from previous partners on stamp paper.


File is received from Budget & Account Division related to CRF issue of M/s Qintar Pharmaceuticals,

14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha with following observations.

Extract taken from 2-194/2008-STO (R&D)

13. For issuance of NDC, required documents have been submitted by the licensee M/s Qintar

Pharmaceuticals (DML No. 000520 11-A Punjab Small Industrial Estate Lahore), i.e. audited financial

statements and income tax returns, for FY 2014, 2015 & 2016 along with original bank receipts on

account of CRE. The same were checked as per SOP procedure in vogue, IFRS and IAS, but found

basic accounting mistakes in preparation financial statements, that made financial statements

suspicious. Therefore, for M/s Qintar was asked to submit duly authenticated attested aforesaid

documents in order to proceed further (page 109 /Corr.). But the firm taken it leniently and again

submitted the same documents by affixing at rubber stamp.

14. Accordingly to establish authenticity of relevant documents it was decided to approach concerned

audit firm M/s. Nasir Absar & Co. to get verify the above said financial statements. Therefore,

telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir Absar & Co. and

then he came to this office on 14-05-17 and shown their strong concerns about using their letter head

and name were forged as the firm is only dealing with tax matters. Hence, the above financial

statements are of fraud. As this office required some written evidence from their side, then M/s Nasir

Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to auditor were issued

on 24-05-17

Page 59 of 116

15. In reply, M/s Nasir Absar & Co. vide letter No NCAI/DRAP/001 dated 13-07-17 at page

(180/Corr.) has requested to this office ("to take strict action as allowed under the Drugs Act, 1976

and its ancillary rules for forging, falsifying and misleading to this office in this regard)", against

M/s Qintar Pharmaceuticals.

16. In the light above it is emerged that M/s Qintar is not contributing towards CRF since 2013 (July

2013) as per rules and also submitted forged, falsified and misleading annual audited financial

statements of outstanding periods i.e. July 2013 to June 2016. This is clear violation of rule 19 sub rule

(14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules 1976". The same also

attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that the licensee is

managing to avoid actual amount of CRF.


meeting





application for renewal of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore

Road, Sargodha, Drug Manufacturing Licence No. 000520 by way of formulation may not be

rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.



January, 2018 was issued to the M/s Qintar Pharmaceuticals, 14-A,

Punjab Small Industrial Estate, Lahore Road, Sargodha

A letter of Personal hearing has been issued on 17th January, 2018.

Firm has replied to Show Cause Notice and application of renewal of DML is complete except

following documents:

1. Updated Noting due certificate regarding CRF from STO.

Moreover, firm has stated that in case of CRF, we recruited authorized person Mr. Anwar Ahmed

(Late) for dealing all matters of DRAP including CRF on behalf of Qintar Pharmaceutical.

Unfortunately, he died few months ago, therefore, we could not communicate properly with Budget

and Accounts Department to resolve matters about audited financial statements. We are requesting to

CLB to please give us some time for issuance of NDC from Budget & Accounts Department. We also

make sure that this kind of negligence will not happen again.


meeting

Mr. Zeeshan Masood, Managing Director of the firm appeared before the Board. He contested that

representative of the firm is died who used to deal with the subject matter and they have taken up the

matter with the concerned firm for audit of the accounts. He was of the view that matter would be

resolved very soon. The Board apprised him that secretariat for the Central Licening Board only

Page 60 of 116

accepts the nothing due certificate issued from the Division of the Budget and Accounts. The Board

considering the facts on the record and after thread bare deliberation decided to suspend the Drug

Manufacturing Licence No. 000520 by way of formulation issued in the name of M/s Qintar

Pharmaceuticals 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha till settlement of

Central Research Fund under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs

(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 (2A)

of the Drugs (Licensing, Registering and Advertising) Rules, 1976.

Case No. 29 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S T.G PHARMA,

KARACHI

M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi had applied for renewal of DML

No. 000547 by way of formulation for the period of 24-07-2014 to 23-07-2019 on 23-07-2014.


shortcomings / deficiencies was issued to the firm on 23rd

February, 2016 and 2nd

March, 2017 under

Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of

firm.

ii) No Objection Certificate for Central Research Fund (CRF) (updated) issued by

Statistical Officer DRAP, Islamabad

iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s.

iv) List of total section of the firm and their letters of approval which were issued by

Central Licensing Board.

v) Approval letter of QC Incharge and Production Incharge if (not available) then

provide complete documents of technical persons i.e QC Incharge and Production

Incharge according to checklist (enclosed).

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 10th

July,

2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following

shortcomings.

i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of

firm.

ii) Nothing due certificate regarding CRF from STO (Updated).

iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s. .

iv) Approval letters of sections issued by the Central Licensing Board

v) Approval letter of proposed Quality Control Incharge and Production Incharge, if any

change then provide set of duly attested documents for Proposed Quality Control

Incharge and Production Incharge (as per check list) along with prescribe fee.

vi) Documents should be duly attested.

Page 61 of 116


meeting





application for renewal of M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi Drug

Manufacturing Licence No. 000547 by way of formulation may not be rejected or Drug




January, 2018 was issued to the M/s T.G Pharma, E-30, Sector 15,

Korangi Industrial Area, Karachi.

No reply of the show cause notice is received from the firm.


January, 2018


meeting

No person appeared on behalf of the firm. The Board decided to defer the case for giving one more

opportunity and service of notice through Federal Inspector of Drugs.

Case No. 30 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SULTAN

COTTON & BANDAGES, MIRPURKHAS.

M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial Estate, Mirwah Road,

Mirpurkhas Karachi, had applied for renewal of DML No. 000585 by way of formulation for the

period of 08-11-2015 to 07-11-2020 on 27-10-2015.




i. Latest Form-29 from S.E.C.P. dully attested alongwith CNIC copies of

management at the time of previous renewal and now at present renewal.

ii. Latest N.O.C. of CRF.

iii. Detail of Premises with Proof of approved sections.

iv. Job Acceptance letter of QC incharge/Production incharge.

v. Required Fee for change of QC incharge/Production incharge.

vi. Experience certificates of at least 10 years of proposed Production Incharge/QC

Incharge.

vii. Resignation letter of proposed Production Incharge/QC Incharge from previous

firm.

viii. Registration certificate from Pharmacy Council of proposed Production

Incharge dully attested.

Page 62 of 116

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 26th

July,


shortcomings.

1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at

the time of previous renewal and now at present renewal.


3. Detail of Premises with Proof of approved sections.

4. Job Acceptance letter of QC Incharge and Production Incharge.

5. Required Fee of Rs 10,000/- for change of QC Incharge and Production Incharge.

6. Experience certificates of at least 10 years of proposed Production Incharge and QC

Incharge.

7. Resignation letter of proposed Production Incharge and QC Incharge from previous

firm.

8. Registration certificate from Pharmacy Council of proposed Production Incharge dully

attested.

9. Documents should be duly attested.


August, 2017in reply to Final Reminder but following documents are


1. Attested Photocopy of Partnership deed (Latest) and CNIC copies of Both Partners.

2. Attested Approval letters of all sections issued by the Central Licensing Board.

3. Copy of academic degrees, as under Drugs (Licensing, Registering and Advertising) Rules,

1976 (Production Incharge and Quality Control Incharge).

4. Attested Experience Certificate of Production Incharge and Quality Control Incharge as

under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years

in relent field).


meeting





application for renewal of M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial

Estate, Mirwah Road, Mirpurkhas Drug Manufacturing Licence No. 000585 by way of formulation

may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central

Licensing Board.



January, 2018 was issued to the M/s Sultan Cotton & Bandages, Plot

No. 145-146, Sindh Small Industrial Estate, Mirwah Road, Mirpurkhas .

Reply of the show cause notice is received from the firm on 19th

January, 2018 which is evaluated and

application for renewal of DML of firm is now found to be complete.


January, 2018

Page 63 of 116


meeting

Dr. Muhammad Saleem apeared before the Central Licensing Board and contented that requirements

has been completed by him and showcuase issued to him may be recalled. The Borad after hearing the

representative of the firm advised him to comply the legal requirements in time in future and decided

to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No. 31 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S KAILGON

AGRO INDUSTRIES (Pvt) Ltd, HUB.

M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan had submitted application

dated 10-02-2016 for the renewal of DML No. 000277 for the tenure 11-02-2016 to 10-02-2021 .


renewal of DML was issued for following shortcomings/attested documents dated 09-09-2016: -

i. Fee for change of management/Directors.

ii. Proof of all licensed sections issued from Central Licensing Board.

iii. N.O.C for C.R.F.

2. Firm did not submit the reply of the above shortcoming letter; accordingly a reminder was

issued by Secretary CLB dated 09-03-2017 to submit documents for renewal of DML .Firm did not

submit reply along with deficient documents against the reminder for the completion of their DML

renewal application. In the meanwhile firm also applied for change of both technical personsand letter

dated: 27-03-2017of shortcomings was issued to the firm to submitdocuments for approval of

Production Incharge & Q.C. incharge.

3. A Final Reminder dated 16-06-2017 was issued to the firm to submit following documents for

renewal of DML& for approval of technical staff(Production Incharge & Q.C. Incharge):

i. Attested form-29 along with Form -A from SECP(Updated).

ii. Approval letters of sections issued from CLB.

iii. Nothing Due certificate(Updated)

iv. Prescribed fee of Rs.50,000 for change of management.

v. N.O.C from previous management to new management.

vi. Prescribed fee of Rs.5000 for change of Q.C. Incharge

vii. Attested academic certificates of Q.C. Incharge.

viii. Resignation of Production Incharge & QC incharge from previous firm.

ix. Attested CNIC copy of QC incharge.

x. Resignation of earlier appointed Production Inchage.

4. Firm submitted documents on 29-06-2017 in reply to Final Reminder but following documents

are still deficient /short;

i. Attested form-29 along with Form -A from SECP(Updated).

ii. Prescribed fee of Rs.50,000 for change of management.

iii. Resignation of earlier appointed Production Incharge.

iv. Relevant Experience certificates of Production Incharge & QC Incharge.

Page 64 of 116

v. Prescribed fee of Rs.5000 for change of Q.C. Incharge

vi. Attested academic certificates of Q.C. Incharge.

vii. Resignation of Production Incharge & QC incharge from previous firm.

viii. Attested CNIC copy of QC incharge.


meeting.




Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the

application for renewal of DML No. 000277 by way of formulation of M/s Kailgon agro

industries(Pvt) Ltd , Hub, Balochistan may not be rejected by Central Licensing Board or the Drug




September, 2017 was issued to the M/s Kailgon Agro

Industries(Pvt) Ltd , Hub, Balochistan

In reply to show cause notice firm has submitted the required documents for renewal of DML but

upon evaluation following documents are still found deficient.

i. Proposed Quality Control Incharge does not fulfill the requirement of Rule 16 (e) of

(L,R&A) Rules 1976 in term of Qualification.

ii. Attested Form-29 for year 2017 from S.E.C.P.

iii. Resignation of earlier appointed Production Incharge.

iv. Resignation or termination letter of appointee from the previous firm / promotion

letter / transfer letter from the same firm (Production Incharge).

v. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 (Not less than 10 years in relevant field) of proposed Production

Incharge Mr. Muhammad Akhtar.

The firm has been called for personal hearing vide Licensing Division letter date 1st November, 2017.


meeting.

No person appeared on behalf of the firm the Board, therefore, decided to provide one opportunity for

personal appearance before the Board.



January,2018.


meeting.

Mr. Shahab Hashmi, Director of the firm appeared before the Board and contended that mail at

company address is not reaching in time and therefore they are facing difficulty for submitting reply in

time. He further contended that they have applied for change in management at SECP office Quetta

but due to law and order situation he is unable to travel to Quetta as soon as he get certificate

regarding updated management he would submit accordingly. The Board considering the facts on the

record and after thread bare deliberation decided to suspend Drug Manufacturing Licence No. 000277

Page 65 of 116

by way of formulation in the name of M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan till

completion of codal formalities under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the

Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule,

16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976.

Case No. 32 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S

WYETH PAKISTAN LTD, KARACHI.

M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, had applied for renewal of DML

No. 000006 by way of formulation for the period of 31-03-2015 to 30-03-2020 on 02-03-2015.




i) Detail management on firm letter head, Form-29, attested copies of CNIC’s.

ii) Approval letter of QC Incharge and Production Incharge if not then provide

complete documents of technical persons i.e QC Incharge and Production Incharge

as per checklist (enclosed).

iii) List of total section of the firm and their letters of grant which were approved in

meetings of Central Licensing Board.

iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer

DRAP, Islamabad

Firm did not submit the shortcoming documents and a Reminder-I letter was issued on 15th

February,


shortcomings.

i) Detail management on firm letter head, Form-29, attested copies of CNIC’s.

ii) Approval letter of QC Incharge and Production Incharge if not then provide

complete documents of technical persons i.e QC Incharge and Production Incharge

as per checklist (enclosed).

iii) List of total section of the firm and their letters of grant which were approved in

meetings of Central Licensing Board.

iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer

DRAP, Islamabad


February, 2017 and a Final Reminder letter was issued on 29th

March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of

following shortcomings.

1. Detail of premises including approved layout plan / Proof of Sections from CLB.

2. Prescribed fee of Rs. 50,000/- for change of management / directors as it seems like

management is changed from last renewal till at present renewal.

3. Set of documents for Proposed Quality Control Incharge and Production Incharge as

per check list.

Page 66 of 116

4. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules,

1976 (Not less than 10 years for proposed Quality Control Incharge and Production

Incharge).



April, 2017 in reply to Final Reminder but following documents are


1. Updated Form-29 and Form-A duly attested from S.E.C.P alongwith CNIC copies of

all Director.

2. Set of documents for Proposed Production Incharge as per check list with relevant

Qualification and Experience.

3. Appointment letter (Quality Control Incharge).

4. Job acceptance letter by the appointee (Quality Control Incharge).

5. Resignation or termination letter of appointee from the previous firm / promotion letter

/ transfer letter from the same firm (Quality Control Incharge).



meeting





application for renewal of M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, Drug

Manufacturing Licence No. 000006 by way of formulation may not be rejected or Drug




January, 2018 was issued to the M/s Wyeth Pakistan Ltd, S-33,

Hawkes Bay Road, SITE, Karachi.

In reply to the showcause notice firm has submitted the shortcoming documents and application for

renewal of DML in now complete.


January, 2018


meeting

Dr. Sadia, Head of Regulatory Affairs and Mr. Rashid, Director Production apeared before the Central

Licensing Board and contented that requirements has been completed by him and showcuase issued to

him may be recalled. The Borad after hearing the representative of the firm advised him to comply the

legal requirements in time in future and decided to cease the operation of the showcause notice issued

to the firm with immediate effect.

Page 67 of 116

Case No. 33 RENEWAL OF DRUG MANUFACTURING LICENCE M/S GABA

PHARMACEUTICAL LABORATORIES, KARACHI.

M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, has applied for renewal

of DML No. 000168 by way of formulation for the period of 29-06-2015 to 28-06-2020 on 15th

May,

2015.



September, 2016 under Rule 5{2A} of Drugs


i. Legal status of firm i.e. sole proprietor, partnership, private limited or public limited

company.

ii. Detail of management / partners /directoralong with CNIC copies and relevant

Form i.e. Form-C,D or Form-29 (whichever is applicable).

iii. Form-1A duly signed / stamped by Authorized person.

iv. Detail of premises including layout plan.

v. NOC of CRF issued from statistical officer of DRAP (Updated).

vi. Resignation / retirement of earlier Production Incharge.

vii. Complete set of attested documents (as per check list) of proposed QC Incharge

previous approved QC Incharge in B.Sc. and Current requirement is M.Sc.

viii. Complete set of attested documents for 10 year experience.

Later on with reference to above shortcomings / deficiencies a reminder letter was issued on

7th

February, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976.

i. Complete set of attested documents of proposed QC Incharge holding degree in

M.S.C. (Chemistry) or Pharmacy and with relevant experience.

ii. Latest NOC of CRF.

iii. Approval letter of sections issued from CLB along with copy of approved L.O.P.

iv. Attested experience certificate of 10 years of proposed Production Incharge

according to Drugs (L,R&A) Rules, 1976.

v. Resignation letter of previously appointed Production Incharge.

vi. Resignation letter of Production Incharge Mr. RiazHusain from previous firm.

vii. Attested CNIC copy of proposed Production Incharge.

viii. Attested Appointment letter and Joining Report of Production Incharge.

ix. Undertaking by Production Incharge.

x. Prescribed Fee for change of Production Incharge Mr. Riaz Husain.

Later on with reference to above shortcomings / deficiencies a final reminder letter was issued on 27th

March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976.

i. Detail of premises including approved layout plan / Proof of Section from CLB.

ii. Nothing due certificate regarding CRF from STO (Updated).

iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge.

iv. Fee challan should be retained by STO (R&D), DRAP, Islamabad (Production

Incharge).

v. Provide name of approved Quality Control Incharge and Production Incharge. In

case of new nominees, provide complete set of documents for Proposed Quality

Control Incharge and Production Incharge with names as per check list.

vi. All documents should be duly attested.

Page 68 of 116

The firm has submitted their reply on 23rd

February, 2017 and 10th

April, 2017 which is evaluated and

still found following shortcomings / deficiencies:-

i. Detail of premises including approved layout plan / Proof of Section from CLB.

ii. Nothing due certificate regarding CRF from STO (Updated).

iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge.

iv. Complete Set of documents of proposed Quality Control Incharge and production

Incharge (as per check list)

Decision of Central Licensing Board in 254th

meeting.





application for renewal of DML No. 000168 by way of formulation of M/s Gaba Pharmaceutical

Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, may not be rejected by Central Licensing Board

or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


The Show Cause notice dated 22nd

June, 2017 was issued to the M/s Gaba Pharmaceutical

Laboratories, S-76, S.I.T.E, Maripur Road, Karachi.


January, 2018.

The reply of the firm is received on 24-01-2018 which is as under;

I would like to inform you that entire business of Gaba Pharmaceuical Laboratories has been shut

down/closed completely due to certain family issues among the partners. It is not out of place to

mention here that some litigation are also pending in the courts of law. Under these circumstances, we

are unabale to attend your scheduled meeting. It is therefore requested to grant minimum three months

time for personal appearance before the central licensing board. Your cooperation in this regard is

highly appreciated.

Decision of Central Licensing Board in 257th

meeting.

The Board considering the facts on the record and after thread bare deliberation decided to suspend

Drug Manufacturing Licence No. 000168 by way of formulation in the name of M/s Gaba

Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi under Section 41 of the Drugs

Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for

not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and

Advertising) Rules, 1976 till settlement of codal formalities.

Page 69 of 116

Case No. 34. M/S DANAS PHARMACEUTICALS (PVT) LTD., 312 INDUSTRIAL

TRIANGLE KAHUTA RAOD, ISLAMABAD CHANGE OF MANGEMENT –

VIOLATION OF SECTION 34 OF DRUGS ACT, 1976 THEREOF.

M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad Licence

No. 000569 by way of formulation was granted licence in 2005. The company/ firm informed for

change of Chief Executive vide letter No. Danas /L&A/2014 dated 08-07-2014. Some observations

were noted and conveyed to firm on 26th

December, 2014 and reminder to this effect was issued on

12January, 2015. The observations which were conveyed to the firm are as under:

i) It seems that management of the firm has been changed number of times without intimation

to Central Licensing Board. It is not clear that who has purchased the licensed premises of

M/S Danas Pharmaceuticals (Pvt) Ltd, DML No.000569 (Formulation) located at Plot #

312, Industrial Estate, Kahuta Triangle, Islamabad from Mr. Ansar Farooq, who was Chief

Executive Officer of the firm according to available record of Licensing Division, DRAP,

Islamabad.

ii) With respect to the deed of sale dated 09-09-2011 submitted by your firm, it has been

observed that one of the present Directors of your firm i.e Mr. Imran Khan S/o

Muhammad Khan holding CNIC # 3602-0489641-7 has purchased this licensed unit from

Mr. Rizwan Khan S/O Muhammad Khan holding CNIC # 36302-5064463-5. Mr. Rizwan

Khan was not the Director of the firm as per available record of Licensing Division DRAP

Islamabad and in any of Form 29 provided by your firm. Therefore you are required to

submit sale deed / agreement made between Mr. Ansar Farooq, previous CEO of the firm

& Mr. Rizwan Khan and to also submit copy of Form 29 issued and attested by SECP

wherein Mr. Rizwan Khan was appointed as Director of the firm and also for retirement /

resignation from directorship of the firm.

iii) You are also required to submit attested photocopy of Form-29 issued by SECP wherein

Mr. Usma Lahooti was appointed as director of the firm.

2. The firm replied that we are still waiting for the fresh Form—29 and annual return i.e Form-A

for the year 2014-15 from SECP, which is expected to receive with fortnight. Meanwhile Anti

Narcotics Force, Rawalpindi has also issued a letter on 26th

October, 2015 wherein they referred to

FIR 40/2011 ANF Police Station, Rawalpindi and directed to not to accept Form-A and 29 till

finalization of said case in Supreme Court of Pakistan.

3. Danas Pharmaceuticals, Islamabad has filled writ petition through Mr. Mohammad Mustafa

purported Chief Executive in the Islamabad High Court, Islamabad vide writ petition No. 1174/2016,

wherein above referred letter of ANF has been contested. The court has not yet granted any relief to

petitioner.Moreover, firm has been concealing information and changing their management time and

again without seeking approval from the Board as under:

Page 70 of 116

DETAILS OF THE DIRECTOR OF THE FIRM FROM THE TIME OF GRANT OF DML TO

TILL DATE

At time of grant of

first DML in year

2005. The name of

the Directors of the

firm on prescribed

Form 1 for

application for grant

of DML

(Page 87/Corr.) of

main volume

At the time of

submission of

renewal of

DML of the

firm dated 29-

03-2011

Form 29 issued

on 30-12-2012

(Page 50-

52/Corr.)

Form 29

issued on 31-

10-2013

(Page 53-

54/Corr.)

Form 29 issued

on 16-04-2014

(Page 48-

49/Corr.)

Form 29

issued on

02-07-

2014

(Page 45-

47/Corr.)

1. Mr. Ansar

Farooq

2. Mr. Muhammad

Naveed Akhtar

3. Mrs. Azra

Parveen

4. Mr. Nadeem

Ahmed Khan

5. Mrs. Mehreen

Nadeem

6. Mrs. Tahira

Tasneem

Mr. Ansar

Farooq CEO of

the firm.

1. Imran

Ahmed

Khan –

Appointed

2. Usman

Bashir -

Appointed

3. Najam-ul-

Ghafar-

Appointed

4. Tariq

Haneef Sole

proprietor

of Tariq

Hanif and

Co.

Chartered

Accountant-

Retired

Tariq Haneef

Sole

proprietor of

Tariq Hanif

and Co.

Chartered

Accountant-

re-appointed`

1. Mudasir

Farooq-

Appointed

2. Kaleem

Arshad -

Appointed

3. Usama

Lahooti -

Resigned

4. Fawad

Rasheed-

Retirement

Muhamm

ad

Mustafa

has been

appointed

by Board

of

Director

as Chief

Executiv

e Officer

upto the

conclusio

n of

AGM in

2015.

4. In the circumstance mentioned above, section 34 of the Drugs Act, 1976 and Rule 5(6)

of the Drugs (Licensing, Registering and Advertising) Rules, 1976 is not being complied. Any

contravention / illegality committed by M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle

Kahuta Raod, Islamabad would create trouble for the DRAP to nominate accused in the case.

DECISION.

5. The Board deliberated on the case matter in detail in the light of steps taken by the

Licensing Division and facts of the case decided to show-cause the company under Section 41 of the

Drugs Act, 1976 and Rule 12 of the Drug (Licensing, Registering and Advertising) Rules,1976 as to

why their Drug manufacturing Licence may not be cancelled or suspended for violation of Section 34

of the Drugs Act, 1976 and Rule 5 (6) of the Drug (Licensing, Registering and Advertising)

Rules,1976.

Action by Licensing Division

6. Accordingly, show cause notice was served to the firm through Chief Executive (claimant) and

Director (claimant).

Page 71 of 116

Reply by Mr. Muhammad Mustufa,

Managing Director & Chief Executive

7. Reply of Mr. Muhammad Mustufa

1. With due respects and apologies, aggrieved and resented with the observations

given and further issuance of show cause notice dt.02-03-2017 acknowledged by us dt.07-03-2017 in

the above referred meeting . In replying to show cause notice would like to bring the following points

for your kind consideration that justify if dully considered, will remove all the ambiguities and

issuance of un-warranted show-cause notice should be vacated .

i. That first of all, present management took the control of the company in 2014 by

purchasing shares at a juncture when it was at a “Crash situation”

ii. That with the restructuring, the present management team set a goal to reinvigorate

the image and business of the company which was tarnished / spoiled by the

misdeeds of erstwhile members. Through dedication and fairness the company is

gaining confidence in the business community and today IMS Data ranks it at #123

(listing of 2016). We are not just stopping here , rather we have set target to be

within top 100 companies by the end of current year.

iii. That currently, we are also proud to be one of the companies,chosen by the KPK

Government in its campaign to purchase quality drugs from the Market at

competitive prices.

iv. That with the staff strength of 50 peoples and revenue generation of forty millions,

In 2016 we are looking with 185 people and revenue generations two hundred

Eighty five Million plus per annum.

v. That is discussed earlier, In th transitional period of 2014,we took control of the

management/the undersigned being Chief Executive office of the Company

appointed in July 2014, and upon receipt of certified copy of Form-29 from SECP,

intimated the licensing Division vide letter No. Danas L/A/2014 dated 08-07-2014,

18-11-2014 and 24-11-2014 including the paid free Challan of Rs.50,000/- dt.18-

11-2014 for change of management (copy of letter enclosed herewith as Annexure-

A,B&C.)

vi. That besides, the share Holders and management Team, as mentioned in preceding

para, no change has been brought in the formation of the company , but re-elected

till 2019.Therefore, there exists no element of concealment from the licensing

Division, Whatsoever, on the part of the present Management has dully submitted

to your good office vide our letter dt.10-01-2017 dully acknowledged by you dt.10-

01-2017(Attached herewith certified copies of Form-29 and Form-A for the year

2016 for your kind perusal as Annexure-D)

vii. That the above fact clearly revealed that at the part of the present management there

is no concealment at all from the Licensing Division .

viii. That it is also pertinent to mention here that , we did queried the then Licensing

Division officer that since Januray,2014 we were continuously observing the name

of Mr. Imran Ahmed Khan the then C.E.O of the company not only signatory on all

documents related to Ministry /DRAP, but specifically with the Licensing Division

for submission of details of technical staff, layout plan, etc, for which we have seen

due acknowledgements from Licensing Division, including but not limited to

dealing with Area FID, DDG(E&M)/ Chairman QC for CGMP inspections, imports

of material (API’s) but no objection was ever raised upon the same. Therefore, we

requested the then Licensing Division to recheck/verify the record for change of

Page 72 of 116

management .However, despite assurance to do the needful, we had no reply or

response.

ix. That in view of our aforesaid observation, it is once again requested to re-check this

aspect as the same is needed to be rectified being an act done by the erstwhile

Management While dealing with the then members of Licensing Division.

x. It is also stated that if some illegality ,irregularity or concealment has been

committed by the previous Management between the period of 2011 up to july -

2014, the same is not attributable to us we have already submitted that we took

control of the affairs of the company in July 2014.

xi. That however, being the present custodian of the affairs of the company for the last

three years, we are extremely apologetic for the same and are ready to rectify any

error done / caused by the previous Management with the hope that the error

caused previously and prior to our inclusion in the Company may be condoned.

xii. That in edition to the aforesaid, through the subject Meeting, it has also been

observed by the Board that we promised to submit the certified copies of Form-29

for 2014 and 2015 but remained silent about the submission. It is submitted that the

same has been furnished to the licensing Division vide our letter

No.L&A/DANAS/SECP/01 & DANAS/L&A/2014.(copy of letters enclosed

herewith as Annexure-E)

xiii. That apart from above submission, your attention is also drawn towards our

meeting with the then Honourable Secretary Licensing Board Mr. Abdullah dt.22-

03-2016. In result of that meeting a detailed and elaborated /comprehensive

letter/reply explaining all the happenings/events and objections /observations in

chronological order since our inclusion in the affairs of the company in the year

2014 annexed with all necessary supportive documents including mentioned at

aforesaid para was re-submitted to your good office vide our letter dt.24-03-2016

duly acknowledged by the Licensing Division dt.25-03-2016 (copy of letter along

with all annexure enclosed herewith for your ready reference as Annexure-F)

xiv. That however, about the pending certified copies of Form-A (of present

management) for the year 2014 and 2015 have been dully submitted vide letter

dt.08-08-2016 acknowldged by your good office on dated 09-08-2016. (Copy of

letter enclosed herewith as Annexure-G).

xv. That regarding ANF’s letter dt. 26-10-2015 is concerned, it was about directions (in

our opinion beyond their legal scope) to our two main regulators i.e SECP and

DRAP i.e not to issue certified copies of Form-A and Form-29 for the year 2014

and 2015 for SECP and not to entertain the same by DRAP respectively.

xvi. That initially the issuance of certified copies of Forms A and 29 for the year

2014 and 2015 were g egretted by the SECP while acting upon the direction of the

ANF. That we have approached and explained our stance to SECP vide our letter

dated 19-11-2015. (Copy of letter enclosed herewith as Annexure-H).

xvii. That in this connection, we also approached and explained our stance to ANF

Authorities as well vide our letter dated 11-12-2015 and a copy of the same was

also submitted to the license Division vide our letter No.CEO/DP/01 dated 25-12-

2015. However, the ANF Authorities did not reply that letter. (Copy of letter

enclosed herewith as Annexure-I).

xviii. That to contest our statuary rights vis a vis management of the Company, we

were constrained to approach the Court of Law and filed a Constitutional Petition

bearing No. 1174/2015, titled “M/s Danas Pharmaceuticals (Pvt) Ltd. etc. Vs.

Page 73 of 116

Federation of Pakistan etc”, pending adjudication before the Honourable Islamabad

High Court, Islamabad.

xix. That the above scenario has also been brought to your kind notice vide our letter

No. dated 13-04-2016 dully acknowledged by your good office dated 14-04-2016

(copy of letter enclosed herewith as Annexure-I).

xx. That after initial few hearings and arguments raised in the above refereed case, The

SECP admitted / felt their wrong footings on acting upon the directions of ANF’s

letter.

xxi. That therefore, during the pendency of the case, SECP has issued all the

pending certified copies of Form-A and Form-29 i.e for the year 2014, 2015 and

later for the year 2016.

xxii. That the same have been dully submitted to the licensing Division vide our

letter dated 08-08-2016 acknowledged by your good office dated 09-08-2016 and

for the year 2016 vide our letter dated 10-01-2017 dully acknowledged by you

dated 10-01-2017 (Attached herewith copies of letters alongwith certified copies of

Form-A and Form-29 enclosed herewith as Annexure-K and L).

xxiii. That although the same impugned letter in question contained direction for you

as well, but it is appreciated by saluting your wisdom that the Authority has not

aided any illegality on the Directions of ANF. We also appreciate this very fact that

the Authority has trusted in our words and acts and confided us. Therefore, keeping

in view of the stance, the Drug Regulatory Authority has been arrayed as Proforma

Respondent, as no relief has been sought against the Authority.

xxiv. Therefore, the undersigned while acting for and on behalf of the Company and

rest of the Sharre Holders / Management assures you that ever since our inclusion,

no illegality has ever been committed. However, the concerns raised by the Board

in the Meeting can only be attributable to the past Management.

xxv. That in the light of foregoing, we at present believe have no issues with our

main regulators i.e SECP or your good office. Further the main relief we were

looking for have already obtained.

2. That in the light of above submission, it would be crystal clealr that the present

management haven’s concealed anything from the competent authority, the main argument of

that licensing board meeting. Hence, otherwise, all other formalities are being fully complied

by us So, at this juncture, we can fairly say that there is no justification and plausible reason to

serve us a Show Cause Notice and it needs earnest reconciliation and revocation. Therefore

your early response to safeguard our valuable interests are dire needed, and the same shall also

be highly appreciated. Your precious time is also sought in furthereance of this communication

for a personal hearing and we hope to hear from you soon in this regard at your earliest

convenience.

3. He has also written an other letter where in he has made submission that we

further would like to inform you that in response to ANF’s letter No. dated 02-03-2017 a

comprehensive and well elaborated reply vide our letter dated 06-03-2017 has been dully

submitted to ANF Authorities. Acknowledgement to our above refered letter ANF authorities

is enclosed herewith for your kind perusal. We are looking forward to receive their appropriate

reply with in fortnight inshAllah. We are very much hopeful through that expected reply / letter

Page 74 of 116

our last issue pertaining to the directions given to SECP and your good office will also be

resolved amicably. You are also aware of the fact that regarding issue of management and

shares holding, we have already submitted up-to-date Form-A and Form-29 for the year 2016-

2019.

4. He has further responded through legal consel M/S AJURIS, Advocates &

Corporate Counsel, Islamabad, Where it is stated :-

i. We have been instructed by M/S Danas Pharmaceuticals (Pvt) Limited

(company ) and act for and on behalf of the Compnay and Mr.Mustafa/Chief

Exective Officer of the Company (Clients). This response is with refrence to

Show Cause Noted 02-03-2017 issued in the name of M/s Danas

Pharmaceuticals (Pvt) Limited .

ii. The Show Cause Notes alleges that the company has been concealing

information and changing their management without approval of Central

Licensing Borad in violation of section 34 of the Drugs Act,1976 read with

Rule 5(6) of the Drugs (L,R&A.) Rule,1976.Our client have been required

to show cause in writing within 15 days of issuance of the Show Cause

Notes as to why the Compnay’s Drug Manufacturing License No.000569

should not be cancelled or suspended .

iii. You will appreciate that our Clients have filed Writ Petition No.1174/2016

titled ‘M/s. Danas Pharmaceutics (Pvt.) Limited etc. vs. Federation of

Pakistan etc.’ (“Petition”) before the Honorable Islamabad High Court in

which notices have been served to the Drug Regulatory Authority of

Pakistan (“DRAP”). You will further appreciate that in the Petition our

Clients have impugned all letters of the Anti Narcotics Force that form the

foundation of the baseless allegations leveled against the Clients. Our

Clients have also filed an application for interim relief in the Petition, which

is pending adjudication before the Honorable Islamabad High Court.

iv. It is emphasized that during the pendency of the application for interim

relief, any adverse action against the Clients would be tantamount to

interference with the proceedings of the Honorable Islamabad High Court.

In this regard, reliance is placed on the case of Saifur Rehman Vs.

Muhammad Ayub and 2 others (1998 CLC 1872) which states “Needless

to point out that there is sound logic behind the proposition that a party to

the proceedings cannot, while an application for interim relief is bona fide

pending, blatantly so act as to pre-empt its lawful disposal because that, in

given set of circumstances, may amount to doing things calculated “to

interfere with or obstruct or interrupt or prejudice the process of law or the

Page 75 of 116

due course of a judicial proceeding” and thus fell within the mischief of

section 3 of the Contempt of Court Act, 1976.” Reliance is also placed on

the case of Arif Khan and 7 others Vs. Federation of Pakistan and others

(2002 CLC 601) which states that “There appears to be prima facie force in

the contention of Mr. K.M. Nadeem that while notices of a lis are issued to

the other side, the latter is expected to maintain a status guo.”

v. The basis of the SCN is a matter in dispute pending adjudication which is

ripe for final arguments and strong likelihood of success exists in favour of

the Clients. Any continuation of proceedings in pursuance of the SCN while

the Petition is pending may not only cause serious prejudice and loss to the

Clients it may also tantamount to interference with pending proceedings

before the Hononorable Islamabad High Court.

In view of the facts as stated and the law on the subject, you are requested to desist from

taking any coercive action against our Clients in relation to matters pending adjudication

before the Honorable Islamabad High Court. Your cooperation in this regard shall be highly

appreciated.

Reply by Mr. Usma Lahoti, Director.

8. Reply of Mr Usama Lahooti is as under:

1. It is submitted that I hold 66666.66 shares in Danas Pharmaceuticals (Pvt) Ltd.

Since 2012, which previously were held by Tahir-ul-Wadood Lahoti (my father) since 2007. I

alongwith shareholding was also the Director of the company, the title which I still hold as per

the record of Security Exchange commission of Pakistan (SECP), till date. Meanwhile a case

was registered against the company by ANF with regard to allotment of ephedrine to the

company. During the period 2012 to 2014 due to hectic commitment in the case and

subsequently the health issue of my father, which resulted into his CABG procedure, I

remained mostly busy there. During 2012, the then Chief Executive, illegally prepared Form

29 against me for removal from the Board of Director and submitted the same to the SECP.

The same was turned down by the SECP by declaring it as an illegal document prepared

contrary to the relevant rules spelled out in the Companies Ordinace 1984. After this I was re-

elected as director in 2013 by the company and my name was endorsed in the Form 29 of

2013.

2. During July, 2014, Mr. Imran Ahmad Khan resigned from the post of Chief

Exeuctive and Mr. Muhammad Mustafa, on the same date took over as Chief Executive. This

act was a gross irregularity of the companies Ordinance, 1984. I was neither informed nor

asked to vote, as per rights authorized to me by the Companies Ordinance, 1984.

Page 76 of 116

3. During the stay of my father in the company, he had loan an amount

approximately around 40 Million to the company at various stages, for various activities, from

his personal account. During last quarter of 2013 when the company was asked to pay back the

loan, they hesitated in one form or the other, saying that financial position of the company at

this point is not in a condition to pay back such a heavy loan. Since we were in dire need of the

money so the company was requested for grant of loan from the personal accounts of any of

the shareholder. This request was acceded to and a resolution was passed during the Board of

Director meeting held on 30th

January, 2014, wherein Mr. Muhammad Mustafa and Mr.

Mudassar Farooq agreed to give the loan amounting to 30.25 Millions against pledging of my

shares. For which as a guarantee I had given blank dated shares deed and resignation signed

and submitted the same to the company for keeping it as a pledged record. Contrary to the

agreement, Mr. Muhammad Mustafa fraudulently submitted my these documents to the SECP

for transfer of shares in his name. On getting this information about of his this malafide act I

immediately approached SECP for non transfer of my shares in anyone name without my

personal appearance.

4. Meanwhile, ANF had also frozen the shares of mine and my family through a

letter to SECP during December, 2012, February, 2015 and October, 2016. In the light of these

letters, SECP, paid no heed to fraudulently submitted documents for transfer of shares. After

having the knowledge about this act of Mr. Muhammad Mustafa, I initiated a correspondence

with the SECP mentioning about the irregularities taking place in the company, also

highlighted the illegal occupation of Mr. Muhammad Mustafa as Chief Executive of the

company. In response to my letter SECP gave me a comprehensive reply in February, 2016

mentioning therein that statutory documents of the company are frozen at the time of 2011 and

also clarified that Form 26 submitted by the company against me stands null and void after

being withdrawn by the company. Thereby confirming me back to the status of Director of the

company till date.

5. After having received detail reply from the SECP about the status of self

declared chief Executive by Mr. Muhammad Mustafa, I approached Drug Regulatory

Authority’s (DRAP), staring from Federal Inspector of Drugs, Chairman Quality Control,

Director Licensing, Director Quality Assurance and the Chief Executive Officer of the DRAP

through nth numbers of time. Similarly I had been corresponding through normal letters as

well as through legal notices with Mr. Muhammad Mustafa and Mudassar Farooq cautioning

them about all the illegalities being performed by them as per DRAP lay as well as, as per

Companies Ordinance, 1984 but unfortuneately nothing could put them right. Finally as a

result of my various personal meetings with Licensing Directorate Officials in DRAP resulted

in taking this case in the board meeting.

Page 77 of 116

6. To summarize the present management sitting in the company and

corresponding with DRAP is totally illegal and unauthorized. As per the record of SECP

according to the directions of ANF about freezing of assets. The only authorize Director is

myself which has been confirmed by the SECP through their letter of February, 2016. Since

the present management could not g et any headway from SECP through a marathon

correspondence by their counsel and even putting all kind of pressure on the Regulators of

SECP, finally they filed a writ petition No. 1174/2016 in Islamabad High Court, Islamabad. In

this petition, Mr. Muhammad Mustafa and party has made ANF, SECP and DRAP as the

respondents but have not made me or Ansar Farooq Ch. As respondents in the same petition.

The concern of the petitioners is evident from the court record that for the past more than 4

months, the petitioner’s counsel is seeking adjournment for the one reson or the other.

Moreover, the Honourable Islamabad High Court, Islamabad has not passed any restraining /

supporting order in favour of petitioner. The respondents ANF as well as SECP have submitted

their replies to the Islamabad High Court, Islamabad wherein they have clearly mentioned their

legal position about freezing of shares and making the same non transfereable in the SECP.

7. Just for record and for demand of justice, I am attaching copies of all letters sent

to SECP and their reply to me, letters / legal notices sent to Mr. Muhammad Mustafa and

Mudassar Farooq and copies of letter sent to FIDm CQC, DD Licensing, Director Licensing

and the CEO of DRAP, Going through these letters will give a clear idea that how much effort

I have put in to stand beside the law and knock each door to get the justice. The copies of reply

by ANF and SECP as respondents to the Islamabad High Court, Islamabad.

8. Keeping in view, the above brief history and seeing my efforts through

correspondence with Mr. Muhammad Mustafa, SECP and DRAP, I have no doubt in

conformingly mentoning that the management is illegal therefore, they should not be

entertained in seeking any approval, sanctions and any other facility from the DRAP. If the

company has to proceed on a legal way then all the correspondence reaching DRAP should

have my signature since I am the only legitimate director as per law. It is also submitted that as

per Drug Act relevant rules quoted in your show cause notice, I am being legitimate Director

be authorized to take on as Chief Executive of the company.

9. In response to para 3 of your show cause notice dated 02-03-2017, I hereby

confirm that Mr. Tahir-ul-Wadood Lahoti will like to be heard by the Central Licensing Board

on the date of its assembly in person. You are requested to intimate about the date and venue of

Board Meeting at Cell No. 0332-5555532 and 0316-5555532

Page 78 of 116

Proceedings Central Licensing Board in 254th

meeting

9. Mr. Osama Lahooti, Director (claimant) or his representative could not appear before the

Board.

10. Mr. Muhammad Mustafa, Chief Executive (Claimant), Mr. Muhammad Mudassir and Ahmad

Junaid Advocate appeared before the Board. They pleaded their case reiterated the facts already

submitted in reply to the Showcause Notice and set of documents presented before the Board. During

the pleadings they apprised the Board that till March, 2016 Security and Exchange Commission of

Pakistan has been issuing Form-29 and has been refusing to issue Shareholdings. They also apprised

the Board that they have signed a “Sale Deed” with Mr Osama Lahooti while “Transfer Deed” is

signed without date of execution. They also apprised the Board that they have contested against the

letter of the ANF in the Islamabad High Court, Islamabad through Constitutional Petition bearing No.

1174/2015 whereby Drug regulatory Authority of Pakistan was directed not to accept Form-A and

Form 29. A number of hearings has been held and no relief to the plaintiff has been awarded by the

Honourable Court and no restraining orders are passed by the Honourable High Court.

Decision of the Central Licensing Board in 254th

meeting

11. The Board after hearing the one party decided to defer the case for giving final opportunity of

personal hearing to the Mr. Osama Lahooti in the next meeting of the Board.

12. After 254th

meeting of the Central Licenisng Board Mr. Muhammad Mustafa through his legal

counsel M/s Ahmed Junaid Advocate addressed to Secretary Central Licensing Board has alleged as

under:

i. that he have acted on for and on behalf of M/s Danas Pharmaceuticals (Pvt)

Limited (the Company) and this refers to the hearing dated 15-06-2017, under Show Cause

Notice dated 02-03-2017. With regard to the same, you are being conveyed utmost

disappointment on behalf of the Company, as serious observations and concerns causing

grievance to the Company have been made/found during the course of the subject Meeting. It

has been explicitly observed/witnessed that, you had deliberately kept the Respectable

Members of CLB in dark, regarding certain aspects of our case, which are validly and legally

favoring the Renewal of License. Further, in a deliberate and blatant manner, you have

concealed from the minutes of CLB meeting the very aspect/fact that the present management

(those who are reflecting from the updated/later/recent Form-29 issued from the SECP) are the

legitimate sole owners of total 200,000 shares of the Company out of which 133,334 (66.67%)

shareholding (an absolute majority) in the company holds PERFECT TITLE, and only 66,666

(33.33%) shares with the freezing status by ANF Authorities. The said aspect was supported by

documentary evidences/facts as has been submitted by the Company from time to time in your

good office.You have not only deliberately concealed from the respectable members of the

CLB but also from the minutes of CLB meeting the fact that the company has been submitting

Page 79 of 116

all forms A and Forms 29 since 2014, which do not reflect Mr. Lahooti as Director of the

company.

ii. You have also deliberately concealed from the respectable members of the

CLB, but also not recorded in the minutes of CLB meeting the contents of letter dated 10-01-

2017, wherein you were informed by the company that as per relevant provisions of governing

law i.e. companies ordinance, 1984, through elections in the AGM of the company, as was due

in October, 2016, the present Management has been elected for the period of next three years

i.e. for the term 2016-2019, which do not reflect Mr. Lahooti as Director of the Company for

the said term.

iii The company and its present Management in therefore highly indignant and in

deep dejection, which further observing the unacceptable/unwarranted biasness on the part of

the Secretary Licensing Board, as it has been witnessed beyond and shadow of doubt that you

have reflected a mindset to deteriorate the very interests of the company, as you have brushed

aside the contents of reply to the show cause Notice, which was mainly rebutting the alleged

concealment of change of Management. Through the said reply it has been maintained that it

was committed/ mis-doing of the then Management, however you only discussed, to our

understanding supported mostly the allegations leveled by Mr. Usama Lahoti against the

present management of the company.

iv Therefore, being the stake holders of the situations, they therefore, hold right to

query us with expectations of an immediate/without any delay response from your side.

Needless to state that you and us are fortified by the provisions of the Drugs Act, 1976 and

Drugs (Licensing, Registration and Advertising) Rules, 1976, for the purpose of renewal of

license. Without prejudice, it seems to us that we have sat to argue/defend the so-called and

irrelevant concerns of an outgoing share holder and previous director of the company i.e. Mr.

Lahooti. Therefore, in view of the same, please clarify that haven’t you created a norm/history

that the Central Licensing Board is also authorized to turn its ears to any complaint, if raised

and agitated regarding the title of share holdings or any dispute, if raised thereon? Or you are

broadening the scope of the aforesaid legislations by acting as a Judge of your own cause?

Please, write to us that which provision of the said laws warrants you to travel beyond the

scope of your permitted authority.

v To the best of their knowledge and understanding, if you could prove otherwise,

our perusal of the aforesaid laws reveals that renewal of license of a company is only

dependent to what is required under Rule-5 thereof and also disclosure of mandatory

information i.e. name of management only, as required to be placed through Form-1-A.

Therefore, if you are privy to any other piece of legislation, which does warrant you to arbitrate

and adjudicate any correspondence/complaint as a judge, whereby a previous share holder has

Page 80 of 116

raised any objection regarding transfer of shares, or his directorship, then you are requested to

share the said law with us as well.

vi. You are also reminded that during the hearing of show Cause Notice, we have

referred to plethora of decisions given by the Central Licensing Board’s Meetings, wherein the

Board while renewing the License/Change of management has only resorted to Form-29 of the

company which the company has been dully submitting since 2014. We are also keen to know

that what made you convinced to contradict and deviate from the previous decisions

passed/taken by the Board, whereby the Licenses have been renewed on the basis of the

information available through Form-29, issued by the SECP.

vii All the aforesaid events and those out of our previous hearing, transpire beyond

any shadow of doubt that you have taken steps ahead to facilitate the concern of Mr. Lahooti

and that too in such a manner that you forget to follow the law governing your ambit and

preview/authority. This is also to state that the Show Cause Notice only levels an allegation of

concealment on our part, which we clarified and rebutted through convincing/tangible and

reliable evidence.

viii Knowingly well that you are not empowered to do so under the law, but to our

extreme astonishment, we are unable to understand as to what personal interests/fringe

benefits, or simply what urgency was existing on your part that made you to adjudicate upon.

We are also unable to understand, what exactly barred you that even you didn’t even bother to

make it part of show cause notice or call an explanation/justification/from the company prior to

discussion in the CLB, which you are under an obligation to. But rather, you seem completely

biased to the Company, whereas it should not be based on personal grievances, rather it is

about legal proceedings against a legally licensed company and the company and its present

management owe all its rights and reservations, but given your

KNOWINGLY/DELIBERATELYRENDERING AN UNJUST

JUDGMENT/FAVORITISM/NEPOTISM in favour OF AN ALIEN TO THE PRESENT

MANAGEMENT, YOU EVEN have given him another opportunity of hearing to fulfill his

suspicious plans. Although Show Cause Notice was very clear and candid that if nobody

appears, the decision with made ex-parte.

ix As matter of fact, you must understand that this is the licensed company duly licensed

under Drugs(Licensing, Registration and Advertising) Rules, 1976, in particular you are

dealing with, and not merely the Shareholder of the Company and this is THE COMPNAY

which takes full responsibility of th records and documents attached with or contents declared

thereof submitted through statuary documents/ forms from time to time dully certified by the

SECP, wherein your role is mere an employee and the law applicable on the subject make you

a PUBLIC SERVANT, who as the custodian of law, is not only required to maintain the norms

Page 81 of 116

of justice and equity, but is expected to deal with the affairs fo the Companies without any

fear, favour or nepotism.

x That although you are not in your legal capacity to play the role of an

adjudicator under various provisions and sections of the Drugs (Licensing, Registration and

Advertising) Rules, 1976 as we have every reason to believe that you have acted in excess of

your legal jurisdiction. It was your moral but definitely a legal obligation to first enquire the

stand of the Company by sharing the documents/claim submitted by Mr. Lahooti, and in the

light of that submissions you should have questioned us or ask any reply after testimonial of

the evidences, heard/seen from both end.

xi. It is also strange that you have failed to advice Mr. Usama Lahooti that SECP under the

preview of various PROVISIONS of Companies Ordinance 1984, i.e. Section-76, Section 152

and Section-290, DRAP is not the competent Authority to adjudicate such matters but only

Civil Court has jurisdiction to adjudicate thereon. Further, if any Shareholder is aggrieved of

omission of his name from the register of Share Holders, it is only for the Company Judge of

High Court to decide and adjudicate the said issue/matter under Section-152 of the Companies

Ordinance, 1984. On the contrary by agitating this matter in the CLB, you have rendered him

favour, which is highly unbecoming of a man of your stature.

xii Even worse than this, you seem to favor/show fidelity to Mr. Usama Lahooti, as

YOU deliberately concealed our letters written a year ago dated 21-03-2016 and 24-03-2016

from the CLB in the hearing, wherein we have explicitly explained/clarified/informed your

good office that Mr. Lahooti was removed from directorship of the company in year, 2012 and

was never re-instate or re-elected by the board of the company, you not only turned a deaf ear

to our aforesaid letters, but miserably failed to convey our advice to Mr. Lahooti that DRAP is

not competent forum to adjudicate upon his grievance, if any.

xiii Further, you have deliberately concealed from the Respectable Members of

CLB that the Company has submitted the dully certified Form-29 dated 04-10-2012 issued by

SECP wherein Mr. Lahooti having tendered his willful resignation from the said office on 19-

09-2012, in lieu of his forced removal from the directorship through Board Resolution passed

by the then management and by the vast majority of the shared holders on 19-09-2012 (copy of

the said resolution is re-enclosed for your kind perusal and understanding) the same was duly

acknowledged by him on 05-12-2012. Afterwards he was never restored neither re-appointed

nor elected by the company since 2012 copy of Form-29 dated 04-10-2012 (Fresh copy of the

said Form-29 dated 04-10-2012 re-attested and re-certified on dated 14-07-2017 by SECP is

enclosed herewith for your kind perusal and understanding) .

xiv We have already reached to the conclusion that having your sympathies for him,

Mr. Usama has been knitting a plan against the Company and its Management, and having got

your illegal support, while playing a dubious role, you mysteriously portrayed this whole

Page 82 of 116

matter suspicious in front of CLB, by referring to a Form-29 dated 31-10-2013, wherein Mr.

Usama is shown re-elected as Director till 2016, as becoming a part and parcel of Mr.

Lahooti’s intrigue thinking you kept a dreadful and criminal silence at your part of

justification, to the fact that the said form-29 is not issued/certified by the SECP.

xv We have strong apprehension about accepting/entertaining of the said Form,

though knowingly well that the same has no legal sanctity and is a sheer violation of your

lawful duty, rather we consider it the mischief/misconduct on your part while acting as the

Secretary Licensing Board. The said act of yours in unfathomable and incomprehensible to the

company and its management and needs immediate clarification/legal footing, if any, from

your side. At the same time, we reserve the right to question the validity of the said Form in the

court of law.

xvi Further, you have also deliberately concealed from the respectable members of CLB

that the company has been submitting all Form A and Forms 29 since 2014, which don not

reflect Mr. Lahooti as Director of Company.Let the company make it very clear that the

aforesaid on your part is your acts of duality and it further give rise to a simple question

about your conduct and your impartiality as The Secretary Licensing Board.

xvii. It is hard to understand that, what made you to sit and act as a judge and term

Mr. Usama’s so-called complaint a Dispute. This leads to the conclusion that either you are

unable to understand the scope of your duties inside the Central Licensing Board, or you

are acting in flagrant disregard of the same. Therefore, to justify your part, we shall also await

to see, when you will write a letter to Mr. Usama clearly stating therein that he should

approach the appropriate forum, if he has any objection of the transactions inside the Company

OR OTHERWISE WE SHOULD BE CALLED UPON WHEN HE WILL BE HEARD IN

THE UP COMING MEETING OF CLB TO COUNTER HIS CLAIMS/DOCUMENTS. And

in case, you fail to do so, it will lead to the conclusion, as drawn aforesaid, that you are acting

hands in gloves with Mr. Usama under the garb of his evil designs coupled with your personal

interests.

xviii You must be already privy to the fact that we have issued a letter dated 21-03-

2016 in the name of Mr. Usama Lahooti to withdraw from his evil designs or at-least approach

the Court of law against us to prove the same. You are also therefore, as we consider the same

malicious and unproductive attempts and futile efforts on your part, advised to forthwith

withdraw your un-lawful objection/arbitration or else, we shall be within our rights to hold you

answerable before the Courts of law to prove your legal standings and footings, and in case of

your failure to prove the same, you shall also be liable to face our claim of damages.

xix. We have also seen that during the hearing of show cause notice you told us

that letter dated 26-10-2015 written by ANF has tied your hands and you have expressed

your inability to acknowledge the change of Management due to the same, But more

Page 83 of 116

surprisingly, for un-known reason you had deliberately concealed from the minutes of

CLB in dark about ANF’s letter dated 30-05-2017 in which ANF’s Authorities have

shown their inability to respond to their earlier letter dated 26-10-2015, as the matter is

prejudice before the Honourable Islamabad High Court, which raises a very serious

question that if ANF’s Authorities couldn’t stand to their stance, how you could react to

the same? (Copy of the said letter is enclosed herewith for your kind perusal and

understanding)

xx. But even to settle this issue, when you were asked to give us the same in writing

that enable us to place the same before the Honourable Court to get directions thereof, you

simply flare up and used abusive language with Representative of the Company, who came to

your office for the letter. The company and its management reserve right to place on record of

the appropriate forum, the recorded/documented version of your conduct, as you have shown

to the company’s representative.

xxi. You are further directed, as well as required, through this communication to

forthwith and in any case within FIVE DAYS of receipt of the instant letter, do the needful

done, as required through preceding paras, failing which we reserve our rights and, therefore,

shall be at liberty to initiate legal proceedings against you. In that eventuality, this is to inform

you further, that we might feel obligated to divulge to the Court of Law or any other

competent forum to secure our rights. Looking forward to hear from you soon.


13. Mr. Osama Lahooti has been called for personal hearing.


meeting

14. The Secretary, Central Licensing Board separated himself from the proceedings of the case in

the light of allegations from legal counsel of Mr. Muhammad Mustafa as reproduced at para 12 above

and went out of the Committee Room. The honourbale members of the Board brought him back and

posed confidence on him being Secretary of the Central Licensing Board. The Board also condemned

in stronger terms the contents of the letter written by legal counsel of Mr. Muhammad Mustafa. The

Board also reiterated that decision taken and recorded in minutes are taken by the Board and not by

any individual and allegations leveled against the Secretary, Central Licensing Board are baseless and

of infected mind. The observers on the Board also condemned the contents of the letter written by

legal counsel of Mr. Muhammad Mustafa in stronger terms.

15. Col. (R) Tahir ul Wudood Lahooti father of Mr Osama Lahooti appeared before the Board as

representative of Mr Osama Lahooti. He contended that:

i. I, hold 33% shares of the company till date.

ii. I am the legitimate director of the company till date as clarified by the SECP during their

letters.

iii. All documents submitted by Mr. Muhammad Mustafa to your office against my share

holding and directorship are false, fabricated and have been turned down by the SECP,

being the regulator of private limited companies as per the Company Ordinance, 1984.

Page 84 of 116

iv. Since July 2014 onward, every activity took place in the company related to purchases,

obtaining sanctions from DRAP related to the active and inactive materials are illegal and

also are in total violations of Drug Act.

v. All relevant restrictions imposed by the Anti Narcotics Force (ANF) have also been

communicated to your office since October, 2015 which clearly directs that sharing

capacity of mine cannot be changed.

vi. I have been communicating with all relevant offices in the Drug Regulatory Authority,

Pakistan starting from FID, CQC, DDG Licensing, Director Licensing and the CEO of

DRAP.

vii. Mr. Mustafa and party have not been able to prove their legal position in front of all legal

Regulators.

viii. Restriction imposed by the ANF on transfer of my shares have been communicated to all

the concerned regulators since October, 2015.

ix. I definitely have apprehension about illegal activities in the company which may harm me,

being a director, and not being a part of management physically.

x. Drug Act paras quoted in the show cause notice if read and viewed, it allows the board to

handover the management to me being the legitimate director in all legal documents.

xi. If the DRAP accepts the direction of ANF conveyed then it must accept my shares holding

and directorship. Similarly if DRAP and the Licensing Board do not accept the ANF

direction then it must be conveyed to me in clear words so as enabling me to approach the

appropriate forum regarding this decision of Drugs Licensing Board.

The Board after hearing the versions of both Parties, is of the unanimous view that the dispute

between the Parties is regarding the share holding of the Company i.e M/s Danas Pharmaceuticals

(Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad which is purely of civil nature and not

within the mandate and jurisdiction of the Board. The Parties therefore, may be advised to have it

resolved from the Court of competent jurisdiction.

Meanwhile, since the important question before the Board is that who will be responsible for any

irregularity / illegality during the time the question of ownership is resolved by the Court. It was

resolved that the Secretary Licensing Board, may write a letter to Anti Narcotics Force, in reference to

their last received letter stating therein that the Board has received an application from one of the

Parties, who has allegedly acquired the major share holding in the Company and same has been

endorsed by the Securities and Exchange Commission of Pakistan (SECP), but the Board is unable to

process their application due to the impeding instructions issued by the Anti Narcotics Force vide their

letter No. F. 2 (132) Assets/ANF/IR/2011-4143 dated 26th

October, 2015, F. 2 (132)

Assets/ANF/IR/2011-4143 dated 02 March, 2017. Therefore, ANF, may advise the Board the course

of action required to be taken in this regard.

Compliance of the Licensing Division.

In the light of decision of Central Licensing Board in its 255th

meeting, a letter dated 2nd

October,

2017 was written to Anti Narcotic Force for seeking their advice that the whether the request of Mr.

Mohammad Mustafa, Chief Executive (Claimant) may be entertained for change of management.

Page 85 of 116

Reply of the ANF dated 8th

November, 2017.

1. It is intimated that quota was allocated in the name of company which is nominated through its

administration in case FIR No.40/2011 PS ANF Rawalpindi.

2. It is further intimated that the matter is sub-judice before the Honourable Islamabad High

Court and learned CNS Court, Islamabad. Moreover, proceedings for freezing the shares of

Usama Lahoti in CNS Court Islamabad have been initiated in which next date of hearing is 15-

11-2017.

3. Forgoing in view it is advised that no action regarding transfer of shares / change of

administration be taken till finalization of above said case, please.

Reply of the ANF dated 13th

December, 2017.

1. Assets inquiry of all stakeholders in case FIR No.40/2011, State Vs Ansar Farooq etc. PS

ANF Rawalpindi is under process.

2. Apropos, it is requested that any adverse order may not be passed or any such process may

not be initiated prejudiced to the right of company / persons to conduct business till

finalization of the inquiry, please.


meeting

The Board considered the replies received from ANF Rawalpindi which is law enforcement agency.

ANF Rawalpindi has advised that no action regarding transfer of shares / change of administration be

taken till finalization of above said case and any adverse order may not be passed or any such process

may not be initiated prejudiced to the right of company / persons to conduct business till finalization

of the inquiry. The Board therefore decided to pend the case till decision by the court of the competent

jurisdiction on the subject matter.

Case No. 35. M/S CALIPH PHARMACEUTICALS (PVT) LTD., PLOT NO.17, SPECIAL

INDUSTRIAL ZONE (EPZ), RISALPUR – VIOLATION OF RULE 5(2A) OF

DRUGS (L,R&A) RULES, 1976.

Case Background

M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur submitted the application for renewal of DML

No. 000748 by way of formulation on 17-07-2017 for the period of 13-08-2017 to 12-08-2022, which

was well on time. After evaluation of the renewal application of the firm, a letter for completion of

application for renewal of DML was issued for following shortcomings: -

i. Fee of Rs.50,000/- alongwith requisite documents for approval of change in

management, but the management seems to have been changed as under;


Memorandum and Article of

Association (Page 33/Corr –

main file)


Form-1A (Page 8/Corr) dated

14-07-2017

i. Mr. Mumtaz Ali

ii. Mrs. Lal Zari

iii. Mr. Farman Ali

i. Mr. Muhammad Azmat Ali

ii. Mr. Amjad Ali Zeb

Page 86 of 116

ii. Attested copy of approval letter(s) of all the approved section(s) has not been

attached

Proposed QC Incharge (Mr. Naseer Ahmed).

iii. Complete set of attested documents as per check list.

iv. Fee challan of Rs.5,000/- for approval of change of QC Incharge.

With reference to above letter, the firm submitted some shortcoming documents. Upon

evaluation, Licensing Division issued final reminder with following shortcomings;

i. Attested copy of Form-29 and Form-A of SECP showing the detail of previous

management, has not been attached.

ii. Approval letter(s) of all licensed section(s), has not been attached.

iii. Resignation letter of previously appointed QC Incharge.

With reference to above final reminder, the firm submitted some shortcoming documents.

Upon evaluation, following shortcoming has still been observed;

i. Attested copy of section approval letter(s) has not been provided.


meeting



(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule 5(2A)

of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for

renewal of DML No. 000748 by way of formulation of M/s Caliph Pharmaceuticals (Pvt) Ltd.

Risalpur not be rejected by Central Licensing Board.

Case No.36 M/S GENERA PHARMACEUTICALS, PLOT NO. 244, STREET NO. 8, I-9/2,

INDUSTRIAL AREA, ISLAMABAD – VIOLATION OF RULE 5(2A) OF

DRUGS (L,R&A) RULES, 1976.

Case Background

M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad submitted

the application for renewal of DML No. 000448 by way of (Formulation) on 27-04-2015 for the

period of 29-04-2015 to 28-04-2020, as due date of renewal of said DML was 28-04-2015.


renewal of DML was issued for following shortcomings: -

i. Form “C” from registrar of firm.

ii. Partnership deed, attested copies of CNICs of all partners.

iii. Declaration regarding change of management from last renewal.

iv. Proof of sections approved by the Central Licensing Board.

v. Approved copy of layout plan.

vi. Nothing due certificate regarding CRF from STO.

With reference to above letter, the firm submitted some documents. Upon evaluation, a final reminder

with following shortcomings was issued to the firm;

i. Form “C” from registrar of firm.

ii. Partnership deed, attested copies of CNICs of all partners.

iii. Declaration regarding change of management from last renewal.

iv. Proof of sections approved by the Central Licensing Board.

v. Approved copy of layout plan.

Page 87 of 116

vi. Nothing due certificate regarding CRF from STO.

vii. Documents of proposed Quality Control Incharge (Mr. Hashim)

With reference to above letter, it is mentioned that as per available record of Licensing Division, no

correspondence received in respect to shortcomings in application for renewal of DML of the firm.


meeting





application for renewal of DML No. 000448 by way of formulation of M/s Genera Pharmaceuticals,

Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad may not be rejected by Central Licensing

Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.

Case No.37 M/S EG PHARMACEUTICALS, 13-A, INDUSTRIAL TRIANGLE, KAHUTA

ROAD, ISLAMABAD – VIOLATION OF RULE 16 OF DRUGS (L,R&A)

RULES, 1976.

Case Background

M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad wherein the firm has

submitted the application for change of technical staff (Production Incharge) dated 17-11-2015.

After evaluation of the change of technical staff application of the firm, a letter for completion of

application for change of technical staff was issued for following shortcomings: -

1. Clear readable and attested copy of CNIC of appointee.

2. Job acceptance letter by the appointee.

3. Approval letter of earlier approved Production Manager.

4. Resignation letter of the previous approved Production Manager.

5. Undertaking as whole time employee from the Firm’s higher authority.

6. Detail experience of 10 years for Production Manager according to the Section (16)

of Drugs Licensing Registering & Advertising Rules, 1976.

The firm submitted reply but the same was incomplete and reminder was issued to the firm with

following shortcomings:-

1. Job acceptance letter by the appointee.

2. Approval letter of earlier approved Production Manager.

3. Resignation letter of the previous approved Production Manager.

4. Undertaking as whole time employee from the Firm.

5. Detail experience certificate as under Drugs Licensing Registering & Advertising

Rules, 1976 (not less then 10 years).

6. All documents attested as per check list.

The firm submitted reply but the same was incomplete and final reminder was issued to the firm with

following shortcoming;

1. Relevant experience of proposed Production Incharge is less than 10 years.

As per record of Licensing Division, no reply has been received from the firm in response to above

mentioned final reminder. It is also submitted that the proposed Production Incharge has resigned from

the firm dated 30-11-2017 and firm has not submitted documents for approval of new Production

Incharge.

Page 88 of 116


meeting





application for renewal of DML No. 000752 by way of formulation of M/s EG Pharmaceuticals, 13-A,

Industrial Triangle, Kahuta Road, Islamabad may not be rejected by Central Licensing Board or their

Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.

Case No. 38 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S TAGMA

PHARMA (PVT) LTD, 12.5-KM, RAIWIND ROAD, LAHORE

M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore had applied for renewal

of DML No. 000414 by way of formulation on 14-07-2015 for the period of 06-08-2015 to 05-08-

2020.The application for the renewal of DML of the firm was evaluated and a letter for following



1. Duly attested details of management.

2. Form-29.

3. Proof of all sections.

4. CNIC copies of management.

5. Attested details of qualified persons.

6. Undertaking regarding correct details.

The firm submitted documents on 29-09-2015 but following documents were still

deficient /short and Final Reminder was issued on 21-07-2017 to the firm with following

shortcomings: -

1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of



3. Detail of Premises with Proof of CLB approved sections.

4. Approval letter of Production Incharge and Quality Control Incharge, if any

change then provide set of documents for proposed Production Incharge and

Quality Control (as per check list) along with prescribe fee of Rs. 10,000/-


The firm submitted documents on 01-08-2017 in reply to Final Reminder. Upon Evaluation

following shortcoming has been observed and application for renewal of DML is still incomplete






Page 89 of 116

Now the Division of Budget and Account has forwarded Nothing due certificate regarding CRF from

STO (Updated) and following documents shortcomings:






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application for renewal of DML No. 000414 by way of formulation of M/s Tagma Pharma (Pvt) Ltd,

12.5-Km, Raiwind Road, Lahore may not be rejected by Central Licensing Board or their Drug


Case No. 39 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S SYMANS

PHARMACEUTICALS (PVT) LTD, 10-KM, SHEIKHUPURA ROAD, LAHORE

M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore had applied

for renewal of DML No. 000323 by way of formulation on 16-09-2015 for the period of 19-10-2015 to

18-10-2020.The application for the renewal of DML of the firm was evaluated and a letter for

following shortcomings / deficiencies was issued to the firm on 26-07-2016 under Rule 5{2A} of

Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. Form 29- from S.E.C.P along with copies of CNIC and any change in management

/ Directors / Owners

2. Approval Layout plan of premises (Copy)

3. Proof of licensed sections from CLB

4. Approval letter of technical staff

5. Nothing due certificate for CRF


deficient /short and same were conveyed to the firm Reminder-I letter issued on 28-12-2016.

1. Attested documents of renewal as per form 1A.

2. Proposed technical staff documents as per check list.

3. Approval Layout plan of premises (Copy).

4. Proof of licensed sections from CLB.


Page 90 of 116

The firm submitted documents on 30-01-2017 in reply to Reminder-I but following

documents were still deficient /short and Final Reminder was issued on 06-02-2017 to the firm with

following shortcomings: -

1. Attested documents of renewal as per form 1A.

2. Proposed technical staff documents as per check list.

3. Approval Layout plan of premises (Copy).



The firm submitted documents on 28-02-2017 in reply to Final Reminder. Upon Evaluation

following shortcoming has been observed and application for renewal of DML is still incomplete

1. Approval letter of proposed Quality Control Incharge, if any change then provide set of

documents for Proposed Quality Control Incharge (as per check list) along with

prescribe fee.

2. Approved master Layout plan of premises (Copy).


4. Updated nothing due certificate regarding CRF from STO.



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application for renewal of DML No. 000323 by way of formulation of M/s Symans Pharmaceuticals

(Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board or their

Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.

Case No. 40 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SHAFI

TEXTILE CORPORATION, 608-B, SMALL INDUSTRIAL ESTATE,

SARGODHA ROAD, FAISALABAD

M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road,

Faisalabad had applied for renewal of DML No. 000436 by way of formulation on 22-10-2014 for the

period of 07-09-2014 to 06-09-2019.The application for the renewal of DML of the firm was

evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 16-02-2017

under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule

1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- =

(45x5000).

Page 91 of 116

2. There is change in management of the firm, so proper application along with

challan fee of Rs. 50,000/-.

3. Proof of licensed section from CLB /Approved layout plan.



The firm did not submit their reply. Final Reminder was issued on 08-06-2017 to the firm

with following shortcomings: -

1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule

1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- =

(45x5000).

2. There is change in management of the firm, so proper application along with

challan fee of Rs. 50,000/-.

3. Proof of licensed section from CLB /Approved layout plan.



The firm has not submitted the above mentioned documents till date and application for

renewal of DML is still incomplete


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application for renewal of DML No. 000436 by way of formulation of M/s Shafi Textile Corporation,

608-B, Small Industrial Estate, Sargodha Road, Faisalabad may not be rejected by Central Licensing

Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.

Case No. 41 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S MASFA

INDUSTRIES (PVT) LTD, 17-KM, SHEIKHUPURA ROAD, LAHORE

M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore had applied for

renewal of DML No. 000713 by way of formulation on 13-07-2016 for the period of 15-06-2016 to

14-06-2021.The application for the renewal of DML of the firm was evaluated and a letter for

following shortcomings / deficiencies was issued to the firm on 19-09-2016:-

1. The application of renewal of DML is 30 days late.

2. Detail of management ate previous renewal of DML and latest management at

present renewal of DML.

3. Proof of sections approved by CLB.

4. Approval letter of Production Incharge and Quality Control Incharge.

Page 92 of 116

5. Updated Nothing due certificate for CRF from STO (R&D) DRAP, Islamabad.


deficient /short and Final Reminder was issued to the firm on 10-07-2017 for completion of

application.

1. You were asked to submit late surcharge fee for DML renewal

i.e.30*5,000=150,000/- However Statistical Officer of DRAP endorsed for Rs.134,

970/- you are required to submit remaining Rs. 15,030/- in DRAP account.

2. Attested Form-29 from S.E.C.P. (Latest 2017 and at time of grant of DML (2011) if

any change in management then fee for change in management/Director.

3. Nothing due certificate of C.R.F. from S.T.O DRAP.

The firm submitted documents on 28-08 -2017 in reply to Final Reminder but

application for renewal of DML is short of following documents as of today:

1. Nothing due certificate of C.R.F. from S.T.O DRAP.


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(Licensing, Registering and Advertising) Rules, 1976 as to why the DML No. 000713 by way of

formulation of M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore may not be

suspended under Rule 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 till

settlement of Central Research Fund.

Case No. 42 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S BAXTER

PHARMACEUTICALS, KARACHI

M/s Baxter Pharmaceuticals, A-1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway,

Karachi had applied for renewal of DML No. 000700 by way of formulation on 28-01-2016 for the

period of 25-02-2016 to 24-02-2021.The application for the renewal of DML of the firm was

evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 07-11-2016

under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i. Form 1-A.

ii. Class(es) of Drugs.

iii. Dosage form(s) of Drugs.

iv. Name of Drug(s) registered.

v. Name of Proprietor/Director alongwith attested CNIC copies.

vi. Detail of Premises including approved L.O.P.

vii. Detail of Section-wise equipments/machinery.

viii. Detail of Technical Staff.

Page 93 of 116

ix. Latest N.O.C. of C.R.F.

The firm did not submit their reply. A Reminder-I was issued on 24-04-2017 to the firm

with following shortcomings: -

1. Form 1-A,

2. Class(es) of Drugs.

3. Dosage form(s) of Drugs.

4. Name of Drug(s) registered.

5. Name of Proprietor / Director along with CNIC copies

6. Detail of premises including approved layout plan / Proof of Sections from CLB.

7. Detail of Section-wise equipments/machinery.


9. Provide name of approved Quality Control Incharge and Production Incharge. In case

of new nominees, provide complete set of documents for Proposed Quality Control

Incharge and Production Incharge with names as (per check list) along with prescribe

fee.


The firm did not submit their reply. Final Reminder was issued on 19-06-2017 to the firm for

above mentioned documents.

The firm has submitted the requisite documents. Upon evaluation, following documents are

still found to be short and application for renewal of DML is still incomplete;

1. Prescribed fee for change of management.

2. NOC from previous management.


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application for renewal of DML No. 000700 by way of formulation of M/s Baxter Pharmaceuticals, A-

1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway, Karachi may not be rejected by Central

Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central

Licensing Board.

Case No. 43 CANCELLATION OF DRUG MANUFACTURING LICENSE NO. (000663)

(FORMULATION) OF M/S AL-AJU COTTON INDUSTRIES MIR PUR KHAS

SINDH.

The case was presented before the Board as under:-

The brief background of the case is as under: -

Federal Inspector of Drugs Dr. Najam-us-Saquib visited M/s Al-Aju Cotton Industries

on 28th June 2013 wherein the FID had reported that there was no production activity underway and

premises were found closed. He had further informed that letters and reminders to the firms were

issued but no reply from the firm was received. The neighboring person informed that there was no

production activity since long and said premises alongwith other surrounding land had been purchased

Page 94 of 116

by another person namely Mr. Amjad Memon. On contact to Mr. Amjad Memon he had confirmed

that he had purchased the whole land and he did not know about running a pharmaceutical unit, nor he

was interested in the same. The FID had recommended for cancellation of Drug Manufacturing

License of M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh. Accordingly the case was placed in

233rd

meeting of CLB held on 30th

& 31st December 2013.

Decision of CLB taken in 233rd

meeting held on 30-31 December, 2013.

The Board in light of inspection report of area FID and after thorough discussion and

deliberations decided to issue Show Cause notice to M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh

and called the firm for personal hearing in next meeting before cancellation of DML. Board further

decided to collect the DML and Inspection Book through area FID.

Accordingly, Show Cause notice was issued to the firm and the firm was also called for personal

hearing in the 234th

meeting of CLB. The firm did not respond to the show cause notice. The case was

again placed before the Board in its 234th

meeting held on 27-02-2014 however firm also failed to

appear for personal hearing despite of issuance of letter for the same.

Decision of CLB taken in 234th

meeting of CLB held on 27-02-2014

The Board after thorough discussion / deliberations and facts on grounds considered and

deferred the case for final opportunity of personal hearing and collection of DML and inspection book

through Area FID before suspension / cancellation of DML.

3. Accordingly, the decision was conveyed to the firm for final opportunity of personal

hearing and a letter was also issued to area FID to collect the DML and inspection book. But no

response received from area FID and firm. Accordingly the case was once again presented in 235th

meeting of CLB held on 15th

May 2014 for consideration/decision.

Decision of CLB

The Board after thorough discussion/deliberation and facts on ground decided to defer

the case for report of area FID.

No report from area FID. In the light of aforesaid decision is received till date.


meeting

The Board considering the facts on the record and after thread bare deliberation decided to give final

opportunity to area Federal Inspector of Drugs for updated report for perusal of the Board.

Case No. 44 RENEWAL OF DRUG MANUFACTURING LICENSE NO. (000684)

(FORMULATION) OF M/S BRAND PHARMA INTERNATIONAL, K-105,

PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI

M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi was issued the

License No. 000684 (Formulation) on 10-05-2010 and due date of renewal of License was 09-05-

2015. It is pertinent to mention that Rule 5 (6) of Drug (L, R & A) Rule, 1976 states “if an application

of renewal is made after the expiry of the period of validity of License but within 60 days of expiry, the

License shall continue in force on payment of additional surcharge of Rs. 5,000/- per day the

application is delayed and thereafter until orders are passed on such application”. But in this case the

Page 95 of 116

application for renewal of DML for the period 10-05-2015 to 09-05-2020 has not been received till

date. Therefore, DML No. 000684 (Formulation) M/s Brand Pharma International, K-105, Phase-II,

S.I.T.E, Super Highway, Karachi is no more valid.


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(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 of the

Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why DML No. 000684 by way of

formulation of M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi

may not be declared cancelled.

Case No. 45 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S DOSACO

LABORATORIES, 9.2-KM, SHEIKHUPURA ROAD, LAHORE.

M/s Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore. had applied for renewal

of DML No. 000094 by way of formulation on 12-04-2016 for the period of 19-04-2016 to 18-04-

2021.The application for the renewal of DML of the firm was evaluated and a letter for following

shortcomings / deficiencies was issued to the firm on 04-10-2016:-

1. Classes of Drugs

2. Dosage forms of drugs

3. Detail of management previous renewal of DML and lattes management present

renewal of DML.

4. Proof of Section from CLB

5. Approval letter of Production Incharge and QC Incharge


The firm submitted documents of Mr. Yasir Khan for approval as Production Incharge on 13-12-2016

but did not respond to shortcomings to Licensing Division’s letter issued on 04-10-2016. Application

for approval of Production Incharge was evaluated and firm was communicated following deficient

documents in the application vide letter issued on 28-12-2016:-

1. Job acceptance letter by the appointee

2. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 (Not less than 10 year).

3. Resignation / retirement of earlier Production Incharge.

4. Resignation or termination letter of appointee from the previous firm / promotion

letter / transfer letter from the same firm.

5. Undertaking as whole time employee


Page 96 of 116

The firm did not submitted documents and Final Reminder was issued to the firm on

19-06-2017 for completion of application.

1. Classes of Drugs

2. Dosage forms of drugs

3. Detail of management previous renewal of DML and lattes management present

renewal of DML.

4. Proof of Section from CLB

5. Approval letter of QC Incharge

6. Noting due certificate regarding CRF from STO (Updated).

7. Job acceptance letter by the appointee (Production Incharge)

8. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 of Production Incharge (Not less than 10 year).

9. Resignation / retirement of earlier Production Incharge.

10. Resignation or termination letter of appointee from the previous firm / promotion

letter / transfer letter from the same firm (Production Incharge).

11. Undertaking as whole time employee on stamp paper (Production Incharge)


The firm submitted documents on 13-09-2017 is reply to Final Reminder for renewal of

DML. Upon evaluation following shortcomings has been observed in the application for renewal of

DML is still incomplete:

i. Nothing due certificate regarding CRF form STO, DRAP, Islamabad

(Update).

ii. Proof of sections approved by Central Licensing Board.

iii. CNIC copy, academic degrees and Registration Certificate of appointee are

not duly attested.

iv. Resignation/ retirement letter of earlier Production Incharge is not

provided.

v. Experience certificates is less than 10 years as per submitted documents of

the firm. Total experience of Proposed Production Incharge is

approximately 9 years and 03 months.

vi. There is change in management of the firm. The detail of which is as

under:

Management as

per Form-1A at

the time of

renewal of DML

for tenure 19-04-

2006 to 18-04-

2011

Management as

per Form-1A at

the time of

renewal of

DML for tenure

19-04-2011 to

18-04-2016

Management as

per Form-1A at

the time of

renewal of DML

for tenure 19-04-

2016 to 18-04-

2021

Current Status

Page 97 of 116

i. Mr.

Muhammad

Firdous.

ii. Mr.

Muhammad

Yaqoob Butt

and Others.

Not Provided i. Mr. Nadeem

Firdous.

ii. Mr. Abu

Obaida Butt &

Others.

i. Mr. Nadeem

Firdous.

ii. Mr. Umar

Butt


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application for renewal of DML No. 000094 by way of formulation of M/s Dosaco Laboratories, 9.2-

Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board or their Drug


Case No.46 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S

MEDIPAK LTD,132/1 INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE.

The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a

case No. 19/2016 is filed before Hon’ble Drug Court, Quetta in respect of M/S Medipak Ltd,132/1

Industrial Estate, Kot Lakhpat, Lahore. Accused are wasting time of Hon’ble Court by adopting

delaying tactics.. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to cancel the Drug

Manufacturing Licence of said firm.

Meanwhile, M/s Medipak Ltd, 132-Industrial Estate, Kot Lakhpat, Lahore, wherein firm has submitted

a copy of orders dated 29-11-2017 of Hon’ble High Court Balochistan, Quetta wherein The Hon’ble

High Court suspended the directions of Drug Court, Balochistan Quetta till next date of hearing i.e,

20th

December, 2017.


meeting

The Board considering the facts on the record and after thread bare deliberation decided to seek

updated status from the firm regarding the case and accordingly communicated to the Honourable

Drug Court.

Case No. 47. CONSIDERATION OF BIOCHEMISTS FOR APPROVAL AS QUALITY

CONTROL INCHARGE.

Case Background

Mr. Jehangir Alam was proposed as Quality Control Incharge by the M/s Pak Risen

Pharmaceuticals, Hattar but application was rejected by the Licensing Division on the basis that he

does not fulfill the requirement of Rule 16(e) of Drugs (L,R&A) Rules, 1976 in terms of qualification

as he holds the degree of BS (Hons) in Biochemistry.

Page 98 of 116

Now, Mr. Jehangir Alam, Assistant Quality Control Manager, M/s Pak Risen

Pharmaceuticals, Hattar has requested to consider Biochemists for approval as Quality Control

Incharge as under;

“It is stated with great concern that I am a Biochemist and I am associated with

Pharmaceutical Industry for about 10 years. I have worked as Quality Control

Incharge (DRA approved) for about 04 years. Recently I have applied for the post of

Quality Control Incharge from PakRisen Pharmaceuticals but my case was declared

rejected as I was found deficient on Rule 16(e) of Drug Act 1976 (i.e degree of

Biochemistry was not considered as a branch of chemistry).

I have discussed this matter with honorable Dr. Manzoor Bozdar Sahib and Shaikh

Faqeer Muhammad Sahib and they both respectable dignities directed me to consult

HEC for a clarification note on Biochemistry as a branch of chemistry So, I did

accordingly and submitted my application to HEC.

The panel of curriculum board immediately responded in positive and declared Bio-

chemistry a one of the main five branches of chemistry and more over they (HEC)

enquired my need for this clarification so I wrote about the rules of DRAP 16(e). They

had gone through my case in detail and released a detail clarification note on

“Biochemistry as one of the main branch of chemistry”. (Copy of Declaration note

attached)

Honorable sir, I am working as assistant quality control manger despite of all my

experience of pharmaceutical laboratory. Our biochemist friends of India and

Philippines are working as quality control Incharge without any objection in their

respective authorities.

We request honorable DRAP to consider (Biochemists) for Quality Control Incharge.

The course outline of biochemistry suggests that it is the most closest and appropriate

branch of chemistry for pharmaceutical laboratory.”

CLARIFICATION BY HEC

“It is hereby to inform you that your case was forwarded to our expert for

comments/reply. The reply from expert is reproduced below;

i. Biochemistry is one of the five branches of Chemistry.

ii. Pharmacology is the branch of Biochemistry.

iii. Physical Chemistry and two subjects of organic Chemistry were taught

compulsory in BS Biochemistry and are evident from the mark sheet of applicant.

iv. Subject of analytical techniques was taught in the degree under heading

Biochemical Techniques in which Homogenization, Centrifugation,

Spectrophotometry, Chromatography, Gas Chromatography, HPLC, IR, Atomic

Absorption, Electrophoresis and other chemical techniques are extensively

studies using chemical, pharmaceutical and biological samples.

v. Other techniques like density, viscosity, pH and titrations and drug quantity

determinations are the part of studies in the degree.

vi. That BS Biochemistry fulfill the requirement of Rule 16(e) of Drugs (Licensing,

Registering and Advertising) Rules, 1976 in terms of qualification.

Therefore, based on the above observations, it is to informed that Biochemistry is a

branch of Chemistry and falls in domain of Chemistry under Drugs Rule 1976.”


meeting

Deferred for detailed working regarding the subject being taught in different Universities.

Page 99 of 116

Case No.48 APPROVAL OF MASTER LAYOUT PLAN / AUTHENTICATION /

REGULARIZATION OF EXISTING FACILITY, DRUG

MANUFACTURING LICENSE NO.000379 (FORMULATION) OF M/S

MUNAWAR PHARMA (PVT) LTD, LAHORE

M/s Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore, DML No. 000379 (Formulation),

has applied for regularization of layout plan of running facility for their following existing sections

which were licensed before the promulgation of S.R.O. 470/98 dated 15th

May 1998 when approval of

layout plan was not mandatory: -

Regularization / Authentication / Amendment of Already existing Sections.

1. Tablet (General) Section. 2. Liquid (General) Section.

3. Liquid Injection (General) Section. 4. Capsule (Cephalosporin) Section


(Cephalosporin) Section

6. Capsule (Penicillin) Section


(Penicillin) Section

8. Tablet (Psychotropic) Section

9. Injection (Psychotropic) Section 10. Quality Control Laboratory

Accordingly, layout plan of firm was approved/regularized/authenticated and following panel was

constituted to verify the above sections of firm as per approved layout plan.

1. Dr. Ikrarm-ul-Haq, Member Central Licensing Board.

2. Prof. Dr. Muhammad Jamshed, Dean Faculty of Pharmacy, University of Central

Punjab, Lahore.

3. Mr. Asim Rauf, Deputy Director General (E&M), DRAP, Lahore.

4. Hafiz Muhammad Jawad Ali, Federal Inspector of Drugs, Lahore-V.

Accordingly, Panel has inspected the premises and verified the above mentioned section.

Recommendations: -

The Panel of inspectors endorsed the regularization of the above mentioned section to M/s

Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore


meeting

The Board approved the regularization of Layout Plan as per recommendations of the members of the

panel.

Page 100 of 116

QUALITY ASSURANCE CASES

Item No. I. Resumption of DML

Case No. i. M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad. Background of the case:

Dr. Abdur Rashid, Additional Director (QA&LT) along-with Syed Hakim Masood, Area FID, Karachi conducted inspection of the firm M/s Alkemy Pharmaceutical, Hyderabad on 16.11.2016 in connection to Quality Control letter dated 27.05.2016, wherein the firm was found in manufacturing and sale of sub-standard drug Azofin suspension, Kemycone suspension and to verify GMP compliance / production activities of the firm. 2. The panel noticed number of critical observations, which need urgent attention and rectification. The observations includes:-

i. No traceability of Raw Materials was available. No proper records were available. No thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.

ii. Dispensing Areas needs renovation and additional calibrated weighing balance required.

iii. Old silverson mixers are rusted/old and required to be placed with new ones.

iv. Storage tanks required to be replaced with new ones.

v. Floor, walls and ceiling are cracked/old and needs overall, renovation required.

vi. The rodents and insects can enter from drainage in the production of syrup section and so requires better drainage system.

vii. Vessels need to be replaced.

viii. Liquid filling machine is old and rusty and must be replaced with semi- automatic filling machine with conveyor belt.

ix. Water System needs to be upgraded with new one.

x. Batch Manufacturing instructions were missing from batch manufacturing records.

xi. Iron racks are required to be placed in the warehouse. Iron and plastic pellets maybe further added in the warehouse and wooden pellets should be removed from the area.

xii. There are no racks in the finished goods store and medicines are placed on the floor. Few wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation.

xiii. Dust can enter from the open exhaust, therefore an exhaust is required.

xiv. There is overall need to upgrade the facility in the chemical and microbiological sections of the QC laboratory. No HPLC is available, so one HPLC may be provided.

xv. There is lacking of proper log book of the equipments, calibration, and validation of the analytical methods.

xvi. Viscometer is no more available to measure the viscosity of suspension.

xvii. In microbiological section, autoclave, colony counter and refrigerator are no more available. It is recommended to provide the same.

Page 101 of 116

xviii. The qualified person in chemical and microbiological section needs training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training.

xix. Qualified persons documents were submitted in 2013, but have not been approved by the concerned division.

xx. Packaging materials and labels are not properly stored and documented.

The panel concluded that:- The observations were discussed with the management and

the management of the firm voluntarily stopped production in the liquid syrup section for maintenance and renovation. The panel recommended to issue a show cause notice for Liquid Section and personal hearing be given to the representative of the firm for cancellation and suspension of DML. Action taken by DRAP: Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017. Reply by the firm: The firm vide letter dated 17.01.2017 submitted reply, requested that the facility has been maintained and requested for the constitution of the panel to visit the firm and to provide opportunity for personal hearing. Proceedings of the 252nd Meeting of CLB

The Board was informed by the Deputy Director (QA) that the samples of Azofin Suspension and Kemycone Suspension were declared as of substandard quality by the Central Drugs Laboratory, Karachi. Accordingly the case was placed in 258th meeting of Registration Board held on 25th and 26th April, 2016. The Registration Board constituted panel of experts comprising of Dr. Abdur Rashid, Additional Director (QA&LT) and Syed Hakim Masood, Area FID to conduct PSI. The panel conducted inspection of the firm on 16.11.2016 and observed gross violations in Liquid syrup Section. Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017. The firm was served letter for personal hearing on 08.03.2017. Mr. Faraz Ahad Shaikh, Managing Director and Mr. Asif Najeeb Laghari, QC In-charge appeared before the Board. Managing Director inform the Board that they voluntarily stop the production in liquid section. He added that the observations noted by the panel have been rectified and they are ready for inspection. The Board inquired regarding availability of FTIR, Viscometer and Polarimeter in the Quality Control Lab. The QC In-charge replied in negative. The Board took serious notice of non-availability of most important equipments used for testing of liquid products, in QC Lab. Decision of the 252nd Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 16.11.2016, casual attitude of the firm towards GMP compliance in liquid syrup section, the Board decided to:-

i. Suspend the Drug Manufacturing License of liquid syrup section of the firm M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Karachi, for a period of 03 months under section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (LR&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB.

ii. Conduct panel cGMP inspection of the firm on approved format under

Schedule B-II of Drugs (LR&A) Rules, 1976, after submission of compliance report by the firm, by the following members:-

Syed Muid Ahmad, Member CLB Dr. Abdur Rashid, Additional Director (QA&LT), Islamabad.

Page 102 of 116

Syed Hakim Masood, Area FID, Hyderabad / Karachi

iii. The Board also decided to direct the panel to submit brief report in tabulated form identifying the previous observations and the current status with clear and candid recommendations.

iv. The report shall be presented in the meeting of Central Licensing Board for

perusal and approval.

Updated Status:

Decision of the 252nd meeting of CLB was conveyed to the firm M/s Alkemy Pharmaceutical, Hyderabad on 24.04.2017 after approval of the minutes of the meeting. Suspension of DML period of the firm has been expired on 23.07.2017.

In compliance to decision of 252nd Meeting of CLB the panel conducted inspection of the firm on 26.07.2017 and forward the report to Division of QA&LT on 14.11.2017. The panel submitted detailed inspection report as under:-

S# Observations noticed on Panel inspection conducted on 26.07.2017

1 No traceability of Raw Materials was available. No proper records were available. No thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.

Firm has initiated record keeping in respective ledgers. Installed calibrated thermometer and hygrometer with available records for previous month and current month.

2 Dispensing Areas needs renovation and additional calibrated weighing balance required.

Dispensing area has been upgraded and calibrated weighing balance is now provided.

3 Old silverson mixers are rusted/old and required to be placed with new ones.

New silver sons mixer has been installed

4 Storage tanks required to be replaced with new ones.

New storage tanks have been installed

5 Floor, walls and ceiling are cracked/old and needs overall, renovation required.

Flooring has been improved with preventable backflow drainage sieve.

6 The rodents and insects can enter from drainage in the production of syrup section and so requires better drainage system.

Drainage lines have been improved with preventable backflow drainage sieve.

7 Vessels need to be replaced. Complied with replacement with new ones

8 Liquid filling machine is old and rusty and must be replaced with semi- automatic filling machine with conveyor belt.

Filling machine has been repaired and semi automatic capping machine with the conveyor belt has been installed.

9 Water System needs to be upgraded with new one.

Renovated the water system. Some new S.S. Lines has been provided where

Page 103 of 116

required.

10 Batch Manufacturing instructions were missing from batch manufacturing records.

Documentation is found improved management was further advised to adhere GDP.

11 Iron racks are required to be placed in the warehouse. Iron and plastic pellets maybe further added in the warehouse and wooden pellets should be removed from the area.

Wooden pallets have been replaced with plastic pallets. Racking system is seen in the raw material store.

12 xii. There are no racks in the finished goods store and medicines are placed on the floor. Few wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation.

Renovated the area. Plastic pallets have been provided. Racking system is still in process.

13 Dust can enter from the open exhaust, therefore an exhaust is required.

Open exhaust has been closed. HVAC system installed in liquid manufacturing area which is observed functional.

14 There is overall need to upgrade the facility in the chemical and microbiological sections of the QC laboratory. No HPLC is available, so one HPLC may be provided.

HPLC seen installed at the time of inspection. QC system seen / observed upgraded.

15 There is lacking of proper log book of the equipments, calibration, and validation of the analytical methods.

Log book / sheets seen implemented.

16 Viscometer is no more available to measure the viscosity of suspension.

Viscometer provided

17 In microbiological section, autoclave, colony counter and refrigerator are no more available. It is recommended to provide the same.

Autoclave, refrigerator have been provided. Colony counter is in purchase process.

18 The qualified person in chemical and microbiological section needs training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training.

Initiated. It is suggested that training program should remain continued.

19 Qualified persons documents were submitted in 2013, but have not been approved by the concerned division.

Receiving in DRAP regarding approval of qualified personnel where presented.

20 Packaging materials and labels are not properly stored and documented.

Packing material inventory is now being managed in this area.

Page 104 of 116

Recommendations of the panel

“The panel appreciated the improvements under taken by the firm. Keeping in view the commitment for continuous improvement, people met and area visited the panel recommends resumption of production in syrup section of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad”.

Proceedings of the 257th Meeting of CLB

The Deputy Director (QA) presented panel report of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad conducted on 26.07.2017 in compliance to the decision of the 252nd Meeting of CLB. Decision of the 257th Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 26.07.2017 decided to resume the DML of Liquid Syrup Section of the firm M/s Alkemy Pharma, Hyderabad alongwith resumption of production in the Liquid Syrup Section.

Page 105 of 116

Case No. ii. M/s Rex Pharmaceuticals, Karachi

Background of the case

Inspection of the firm M/s Rex Pharmaceutical Pakistan, Karachi was conducted on

06.03.2013 by Mr. Abdul Rasool Sheikh, FID, Karachi. During inspection the FID pointed out

a number of serious/critical shortcomings in all sections. Accordingly showcause notice/stop

production order was issued on 23.04.2013. The case was presented before CLB in its 232nd

meeting held on 29&30th July 2013. The Board had decided as under:-

i) The case was deferred by Central Licensing Board till its next meeting as per

your request that the Director of the firm had gone to Saudi Arabia for performing Umrah and requested to defer the case till next meeting of CLB.

ii) The production will remain stopped / suspended till the final approval for

resumption of production by the Central Licensing Board. 2. The case was again presented before the 233rd Meeting of CLB, wherein the CLB had

decided as under:-

“After thorough discussion and deliberations, considering the background of the case and facts on record, Board unanimously decided to suspend the DML of the firm for period of three months under Rule 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976. The Board further decided to issue show cause notice and personal hearing to the firm and advised for market survey of production manufactured by firm.”

3. The decision of the CLB was conveyed to the firm on 24.02.2014.The firm vide letter No. Nil dated 02.04.2014 replied that they have removed all the shortcomings and ready for inspection. The Area FID visited the firm on 18.11.2014 and recommended for cancellation of DML. The case was placed before the CLB in its 245th Meeting held on 30.12.2015. Proceedings of the 245th Meeting of CLB:

The firm was provided opportunity of personal hearing before the Board, but no representative appeared before the CLB, on behalf of firm. The Board showed displeasure on such non serious attitude of the company. Decision of 245th Meeting of CLB:

The Board after thorough discussion, keeping in view the available record, observations of the FID in its inspection conducted on 06.03.2013, track record and non serious attitude of the firm, and report of the FID dated 18.11.2014 which categorically stated that “The DML of the firm may be cancelled in larger public interest”, has decided to suspend the DML of the firm M/s Rex Pharmaceuticals Pakistan, Karachi for a period of 06 months, under Rule 12 of the Drugs (LR&A) Rules, 1976. 4. The decision of the CLB was conveyed to the firm on 09.02.2016.

Page 106 of 116

Inspection conducted by Area FID, Karachi on 06.01.2017

Mr. Abdul Rasool Shaikh, FID, Karachi vide letter dated 24.01.2017 informed that the firm was inspected on 06.01.2017 and found non-operational, no one was there except watchman who told that factory is closed since 2011 and owners are reported to be living in USA now days. Based on the current conditions of the firm it is recommended that their DML by way of formulation may be cancelled in larger public interest. Proceedings of the 252nd Meeting of CLB

The Board was informed by the Deputy Director (QA) that the firm was served letter for personal hearing on 08.03.2017 and the area FID was also informed to send the letter to the firm. But no representative of the firm appeared before the Board for personal hearing under section 41 under the Drug Act 1976, read with rule 12 of the Drugs (L, R & A) Rules 1976.

Decision of the 252nd Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the Federal Inspector of Drugs in its letter dated 24.01.2017, in which the FID recommended to cancel the DML of the firm in the larger public interest, casual attitude of the firm towards GMP compliance, track record of the firm and nonappearance of representatives of the firm before the Board to defend the case, the Board decided to cancel the Drug Manufacturing License of the firm M/s Rex Pharmaceutical Pakistan, Karachi, under Section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (L,R&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB. 5. Decision of the CLB was conveyed to the firm and quarter concerned on 15.03.2017. Decision of Appellate Board in its 147th Meeting

M/s Rex Pharmaceutical Pakistan, Karachi filed an appeal against the decision of the CLB regarding cancellation of DML. The case was considered in 147th meeting of the Appellate Board held on 28.08.2017, wherein the appellate board decided to suspend the operation of impugned order of CLB dated 15.03.2017 communicated on 24.04.2017 and remand the appeal back to the CLB. The appellate board constituted a panel of following panel to inspect the premises of the appellant who shall submit its report within 30 days from the date of communication:-

a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. Syed Muied Ahmed, Expert in Manufacturing, Karachi

The report of the panel will be placed before the CLB in its forthcoming meeting. Meanwhile the production of the firm will remain suspended till recommendations by the panel for the resumption of production and approval thereof by the CLB. Panel inspection on the decision of the Appellate Board:-

The panel inspected the firm on 12.12.2017 and noticed following observation which

still needs rectification:-

General:- Layout of the facility was approved by DRAP in 1997. Panel noticed number of

changes in the facility as compared to the approved layout of 1997.

Page 107 of 116

Dry Powder injectables (Cephalosporin) There was not status labeling for clean down quarantine and passed material storage

areas There was not air conditioning in cold store area. No temperature monitoring or recording in raw material stores area No designated area for material sampling. No provision of HVAC in change room and main corridor of ceph manufacturing area No HVAC in vial washing room Plain water, deionized water and distilled water lines were provided in the vial washing

room but no status labeling on these lines. No provision was seen for water for injection loop in vial washing room Dry heat sterilizer and autoclave installed in washing room were very old and no

evidence was available for their qualification / validation Magenhelic gauge outside the sterile vial filling area showed zero pressure, meaning

there was no pressure differential in the room. Dry powder vial filling line was very old and no evidence of qualification / validation. No temperature monitoring in finished goods store area.

Liquid injectables (ampoule) section

Common change room for liquid injectable and cephalosporin dry powder injectable sections. Male and female staff enter and come out of both the above sections through the same change room.

No proper change room for ampoule washing room No proper HVAC in ampoule washing room Ampoule washing machine was very old and almost manual. No clarity on quality of water used for ampoule washing. No provision was seen for

water injection loop in ampoule filling machine. No manometer installed to demonstrate air pressure differential in ampoule filling

room. No connection of water for injection loop in ampoule manufacturing area. No mixer for

making solutions. No means for pressure filtration of solutions. Autoclave for filled ampoule sterilization was very old and no evidence of qualification

/ validation. No provision for ampoule leak testing.

Veterinary injectables section

Clean down and quarantine area is common No temperature control in raw material store. No sampling and dispensing booth No status label on water lines No filter assembly was available for filtration of injectable solutions. No laminar flow on injectable filling machine No HVAC in sterile cool down area and vial washing area. No autoclave was available in veterinary injectable area

Eye drop section:

No proper change facility for sterile eye drop section No HVAC in washing area No status labeling on water lines No filter assembly for eye drop solution filtration. One old filling machine was installed in a room, without any provision for stopper

inserting and capping. No laminar flow on filling machine.

Page 108 of 116

Eye ointment section There was no equipment in ointment manufacturing No service lines or drain lines in the room There was not any room for ointment filling and no filling machine was available.

Dry powder (cephalosporin)

No status labeling in stores No HVAC in change room HVAC was not working in powder mixing room Cephalosporin powder filling room is next to non-cephalosporin tablet compression

room and non-ceph tablet coating room with a door in between. Chances of cross contamination were evident.

No provision of bottle cleaning No dust control or extraction in powder filling area. A blister cutting and a strip cutting machine were lying in a small room. Both were very

old and looking out of order. An old capsule filling machine was lying in a small room in cephalosporin area.

Oral liquids section

HVAC supply and return duct were on the same wall of the liquid filling room. Therefore chances of quality air not reaching to the other end of the room

No transfer pump or filtration assembly seen in the liquid manufacturing room. Tablet section

No positive or negative air pressure differential in tablet compression rooms. Entry to one table compression room is through another tablet compression room;

therefore chances of cross contamination. Solvent coating is carried out in open pans. No exhaust system for solvent vapors. No proper HVAC ducting. Supply and return on the same wall. Granulation area very noisy due to air coming from the air supply duct. Seems

problem in air balancing. No positive or negative air pressure differential in granulation room. Veterinary oral liquid & powder section.

No proper manufacturing vessel in liquid manufacturing area. No proper liquid filling machine. Powder blender was available in one room but not powder filling machine. No exhaust system or air pressure differential were available.

The panel further concluded and recommended that:- The panel observed a number of shortcomings in building, production machinery, HVAC system, documentation etc. Therefore, based on the areas inspected, the people met and documents reviewed and considering the findings of inspection the panel recommends that the Drug Manufacturing License may be granted to M/s Rex Pharmaceuticals Pakistan, Karachi, for two sections only namely Oral Liquids and Tablet (after addressing the observations in this report). Proceedings of the 257th Meeting of CLB

The Deputy Director (QA) presented report of the panel in compliance to decision of 147th Meeting of Appellate Board.

Page 109 of 116

Decision of the 257th Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 12.12.2017 decided to

1. Re-inspect the firm M/s Rex Pharmaceutical Pakistan, Karachi by following panel

of experts, constituted by the Appellate Board in its 147th Meeting:-

a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. Syed Muied Ahmed, Expert in Manufacturing, Karachi

2. The panel shall submit the detailed report alongwith rectification status of the

observations in the Tablet Section and Liquid Syrup Section noted by the panel in its report dated 12.12.2017. Further more the panel will also submit detailed report regarding the quality control laboratory and storage facilities of the firm. The report shall be placed in the forthcoming meeting of Central Licensing Board for consideration.

Page 110 of 116

Quality Control Cases

Case No. 01:

Subject: - Manufacturing and Sale of Unregistered Drug Product-PregEase Tablets Batch

No.15021 by M/s Zestech Sciences, Karachi for ICI Pakistan, Karachi F. No. 4-

07/2015- (QC)

The FID-II, Karachi Mrs. Muneeza Khan inspected the premises of M/s ICI Pakistan Limited

5- West Wharf Road Karachi on 19-03-2015 and took the sample of Tab Preg Ease Batch No.15021

manufactured by M/s Zestech Sciences Karachi. The sample was sent to the Federal Government

Analyst, CDL Karachi for test/analysis purpose. However, the Federal Government Analyst, CDL,

Karachi vide his test report No. KQ.102/2015 dated 13-05-2015 declared the said drug product preg-

Ease tablets Batch No.15021 manufactured by M/s Zestech Sciences, Karachi for ICI Pakistan,

Karachi as Un-registered drug product under the Drug Act, 1976.

The result of CDL test Report

Remarks:-

“The label of the sample claims “Natural Nutritional Supplement to help calm nausea &

jkvomiting of pregnancy (NVP) vitamin B6 and calcium have been identified as allopathic ingredients.

Hence, the sample is declared as un Registered Drug product under the Drug Act 1976”

2 The FID-II served the explanation letter on 26th

May 2015 to the firm M/s ICI Pakistan Ltd

Karachi and M/s Zestech Sciences Karachi to explain their position. In reply to the FID explanation

M/s Zestech Sciences Karachi requested for Appellate testing of drug in question under the provision

of Drugs Act 1976 on 30th June 2015. The sample was sent to the Appellate Laboratory NIH

Islamabad. The Appellate Laboratory has also declared the sample of said drug product as of

substandard quality vide its test report No. 027-MNHRS/2015 dated 02nd

November 2015 along with

remarks mentioning the sample unregistered and unlicensed.

The result of Appellate Laboratory:-

Assay:- Stated Found Limit Percentage

Vitamin B6 2mg/tab 1.903mg/tab 90-110% 95.14%

Folic Acid 400mcg/tab 415.68mcg/tab 90-110% 103.92%

Calcium 124.1mg/tab 11.18mg/tab 90-110% 9.018%

Does not comply with manufacturer’s specification.

The FID-II Karachi furnished the names of responsible accused persons in his report are as

under:-

Mr. Ahsan Feroz Proprietor

Page 111 of 116

Mr. Mumtaz Ali Khan Production Incharge

Mr. Ejaz Ahmad Paracha QC Manager

Recommendations of FID:-

“Based on the above submission and Lab reports it can easily be concluded that the drug Preg Ease

tablets is un registered un-licensed and Sub-Standard product hence sheer violation of Section 23 &27

of Drugs Act 1976 by the manufacturer M/s Zestech Sciences Plot No. 47/23, Korangi Industrial area

Karachi based on the violations committed by the firm it is concluded that the contents of case may be

kept on the agenda of upcoming meeting of CLB for permission of prosecution against the firm or the

contents may be sent to Director OTC & Herbal for his comments in the light of the SRO 412”.

The show cause notices were issued to the above named accused persons offering them opportunity of

personal hearing before the Central Licensing Board before its 249th

meeting held on 29-08-2016. The

Firm had submitted the reply of show cause notice. The case was accordingly placed before the CLB

in its 249th

meeting held 29th

August 2016.

Decision of 249th

meeting of CLB

The Board deferred the case due to paucity of time.

The said accused persons were called for personal hearing.

Proceedings:-

Mr. Ahson Feroze appeared before the Central Licensing Board in its 250th

meeting held 27th

October

2016 and pleaded their case and informed that he is the Managing Director of M/s Zestech Sciences

Karachi and M/s Maple Pharmaceuticals Karachi. He was accompanied by Mr. Saeed Khan who

informed that he looks the matters of

Regulatory affairs of both firms M/s Maple Pharmaceuticals Karachi and M/s Zestech Sciences,

Karachi. Mr. Ahson Feroze claimed that their firm (M/s Zestech Sciences Karachi) had not received

the copy of test report of Appellate Lab NIH Islamabad and said that the FID had picked three

products out of which two were cleared by CDL, Karachi. He informed that their firm has got the

enlistment while products were applied to Division of Health & OTC, DRAP, Islamabad.

Decision:-

The Board after detailed discussion, deliberation and keeping in view the facts of the case the Board

decided as under:-

1. To direct the concerned FID Karachi, to re investigate the case by including M/s ICI,

Karachi from where the samples were picked for test/analysis as the subject drugs were

stocked for sale in the premises of M/s ICI Karachi. The Board directed the FID to

submit the complete case after fulfilling codal formalities with provisions of law and

along with clear and candid recommendations.

2. The Board directed the Quality Control Section to get the status of enlistment of the firm

M/s Zestech Science Karachi and product (Tablet Preg Ease) from the Division of Health

& OTC, DRAP, Islamabad along with the comments on both laboratories test reports.

Page 112 of 116

As per decision of the Central Licensing Board Federal Inspector of Drugs Karachi (Mrs.

Muneeza Khan) and Deputy Director Health OTC, DRAP Islamabad was requested to

implement the decision of Central Licensing Board.

In compliance of decision of Central Licensing Board:

1. The Deputy Director Health & OTC, DRAP, Islamabad replied vide letter No.F.08-24/2016-

DD (Health &OTC) dated 23rd

December 2016 wherein he informed that the said firm was

enlisted as manufacturer of Softgel capsules Hardgel capsule Tablet, Oral Liquid, Cream

Ointment and Sachet dosage forms in 7th

meeting of Enlistment Evaluation committee held on

01-02-2016. The products of M/s Zestech Sciences are under evaluation and till to date no

product have been enlisted for market authorization.

2. The area FID Karachi vide letter No.MK-33-43/2015-FID-II(K) dated 27th

April, 2017,

informed that she picked the samples from the premises of ICI Pakistan Limited 5- West

Wharf Road Karachi.

She further submitted that based on information and Laboratory reports it can easily be concluded that

the drug PregEase is un-registered and substandard drug/ product, hence M/s ICI Pakistan

violated the section 23(1)(a)(v) & 23(1)(a)(vii), which is punishable under section 27 of the

Drugs Act 1976. She recommended that M/s ICI Pakistan Ltd: may be prosecuted in the drug

Court of Sindh Karachi.

Current Status of the Case:

The case was placed before CLB in its 254th

meeting held on 15th

June 2017. The Board decided the

case as under:

Decision:

“The Board deliberated on the facts presented above and decided to defer the case till

completion of all codal formalities including the Showcause Notice is required to be served to M/s

ICI Pakistan Limited 5- West Wharf Road Karachi with clear and candid recommendations for the

consideration of the board.”

As per decision of CLB the show cause notice was issued to the M/S ICI Pakistan Ltd: Karachi dated

07-07-2017, but no response has been received till to date.

Proceedings and Decision of 257th

Meeting of CLB:

Central Licensing Board was informed that M/s. ICI Pakistan failed to respond the show cause

notice issued to them. After threadbare evaluation decided that the views/ comments of the Health &

OTC Division/ EEC shall be obtained on the subject matter before taking any decision.

Page 113 of 116

Case No. 02:

Subject: Seizure of un registered Drugs under Section 18(1) of the Drug Act 1976.

The FID Lahore Mr. Syed Zia Husnain visited the premises of M/s Mahmood

Pharmacy S-77-R/85/C, Jail Road, opposite Services Hospital Lahore on 26th

August, 2016. The FID

forwarded the case to the Director, QA&LT, DRAP, Islamabad vide letter No.12406/2016-DRAP (L-

V) dated 29th

August, 2016.

At the time of raid Mr. Sana ullah S/o Muhammad Suleman R/o H. No.05 St. No.05, mohallah

Amin park Ravi road Lahore who is manger was present. Mr. Atif Ejaz S/o Ejaz pervaz R/o 67/C

Punjab Co-operative housing Society, defense Lahore (Qualified person as per drug sale license ) was

gone for jumma prayer as informed by the manager Mr. Daud Tareen s/o Muhammad Aslam Tareen

R/o B-42, GOR-III Shadman, Lahore (Proprietor) was absent.

The FID Lahore seized the following drugs on form-2 under section 18 (1) (f) of Drug Act,

1976:

S. No. Name Of

Product(s)

Batch/Lot

No.

Mfg

Data

Exp.

Date

Manufactured

by

Quantity

01. Marevan

5mg

Tablets

A520518 11-15 05-18 Mfd By. GSK

(Detail address

not mentioned

in English)

(13)

Thirteen

jars

02. Marevan

5mg

Tablets

A521058 03-16 09-16 -do- (11)

Eleven

jars

03. Marevan

5mg

Tablets

A520917 02-16 08-18 -do- (04) Four

jars

04. Marevan

5mg

Tablets

A520916 02-16 08-18 -do- (15)

Fifteen

jars

05. Marevan

5mg

Tablets

A520917 02-16 08-18 -do- (03)

Three

jars

06. Centrum

Silver

M25939 - Sep-17

Marked by.

Pfizer

Madison,

NJ07940 USA

2015 Pfizer Inc

Made in

Canada

(03)

Three

Packs

07. Centrum

Silver

M87735 - Dec-17 2014 Pfizer Inc

Made in

Canada

(02) Two

Packs

08. Centrum

Silver

N43989 - 01-18 2014 Pfizer Inc

marked by M/s

Pfizer

Madison,

NJ07940

(02) Two

Jars

Page 114 of 116

09. Colomycin

Injection

11393 10-2014 10-2017 M/s Forest

Laboratories

UK, Ltd,

Whiddon

Valley,

Branstaple,

North Devon

Ex 32 8NS,

United

Kingdom.

02

Packs×10

Vials

10. Viagra

100mg

Tablets

MALL

19990544G

Dec-

2013

01-Apr-

2018

Mfd by.

Brooklyn, Ne

Packed by:

Pfizer Ply Ltd,

Australia

(03)

Three

Packs×

06

Tablets

11. Cialis

20mg

Tablets

Control No.

0674654099

-

April-

04/2018

Made in USA (02) Two

Packs×

03

Tablets

12. Centrum

Tablets

M877733 - Dec-17 Mfd. Pfizer

Inc. Canada

(02)

Packs

13. Neurobion

Injection

213371 12-2015 112017 Mfd. Merck

kGaA,

Darmstadt,

Germany

(03)

Three

Packs

14. Pirfenex

200mg

Tablets

BA60218 Dec-15 Nov-17 Mfd. Cipla

Malpur, Solan

173205 India

(01) One

Pack

The FID seized these unregistered drugs in contravention to section 23 of Drugs Act,

1976 and also contravention to DRAP Act, 2012 and the room was locked and sealed under section 18

(i) (h) of Drugs Act, 1976.

Samples of drugs which were available in sufficient quantities were also sent to Federal

Government Analyst for test/ analysis.

The details of test/analysis results of said drugs by Federal Government Analyst, Central

Drug Laboratory are as under:-

S.No. Test Report No.&

date

Name of Drug

with batch No.

Mfg by Remarks of CDL

1. Test Report No.

R.LHR.403/2016 dated

01-11-2016

Marevan 5mg

Tablets Batch

No.A521058

M/s GSK Declared

Unregistered report

no.R.LHR.403/2016

dated 01-11-2016

Page 115 of 116

2. Test Report No.


01-11-2016

Centrum Sliver

Batch

No.M30477

M/s Pfizer

Inch,

Canada

Declared

Unregistered report

no.R.LHR.404/2016

dated 01-11-2016

3. Test Report No.


02-11-2016

Cialis 20mg

Batch

No.0674654099

M/s GSK Declared

Unregistered test

report no.

R.LHR.405/2016

dated 02-11-2016

4. Test Report No.


02-11-2016

Pirfenex Tablets

Batch

No.BA60218

M/s Cipla

Ltd India

Drug is not included

in any

Pharmacopoeia, test

report no.

R.LHR.406/2016,

dated 02-11-2016

The FID requested to allow to keep the safe custody of the seized drugs mentioned on

Form-2 under Section 19(5) of the Drug Act 1976 as the firm is involved in illegal and unregistered

manufacturing of drugs.

Permission of safe custody of the stock was granted to the FID on 16th

September 2016.

Meanwhile M/s Mehmood Pharmacy S-77-R/85/C, Jail Road Opposite Services Hospital Lahore filed

application in the Drug Court, Lahore in connection with case under reference. On the order of Drug

Court Lahore, premises (room) under reference was de-sealed on 17-11-2016.

Recommendations of FID

Since the sale and stock of un registered drugs in prohibited under section 23 (1) and section A(1)

(a)(vii) of schedule II of Drugs Regulatory Authority of Pakistan Act 2012 which is punishable under

section 27(1) (A) of the Drug Act 1976 and schedule III of DRAP Act 2012 . sale of un registered

drug is cognizable offence under section 30(2) of the Drug Act 1976 and schedule IV(1) (a) of Drug

regulatory authority of Pakistan Act 2012. As pharmacy is not explaining their position in response to

the letters of FID. The FID further informed that all four reports of Federal Government Analyst have

also been received, therefore under the explained circumstances mentioned above case is being

forwarded under section 19(7) of Drugs Act 1976 and section 7 of schedule V of Drugs Regulatory

Authority of Pakistan Act 2012 to seek further orders of central licensing Board as to action to be

taken against the following accused persons in respect of contravention of Drug Act 1976 and Drug

Regulatory Authority of Pakistan Act 2012.

The Show cause notice was issued to the following accused persons on 25th

January 2017.

Page 116 of 116

M/s. Mehmood Pharmacy S-77-R/85/C,

Jail road, Opposite Services Hospital,

Lahore.

Mr. Sana Ullah S/O M Suleman

House No. 05, Street No.05

Mohellah Amin Park Ravi Road, Lahore

Mr. Atif Ejaz S/O Ejaz Perves R/O67/C

Punjab Co-Operative Housing Society

Defense Lahore.

Mr. Daud Tareen S/O M Aslam Tareen R/O

B-42, GOR-III, Shadman, Lahore

(Proprietor).

However, the accused persons had not submitted the reply of the show cause notice.

Current Status:

The Names of the accused persons alongwith CNIC nos., contact nos. and copy of Drug Sale

License have been received from the FID in response of the decision of 252nd

Meeting of the Central

Licensing Board.

Proceedings and Decision of 257th

Meeting of CLB:

After detailed evaluation and discussion the Central Licensing Board decided to issue show

cause notice to the following accused persons:

i. M/s. Mehmood Pharmacy

S-77-R/85/C, Jail Road,

Opposite Services Hospital, Lahore through its Proprietor

ii. Mr. Sana Ullah S/O M Suleman

House No. 05, Street No.05

Mohellah Amin Park Ravi Road, Lahore.

iii. Mr. Atif Ejaz S/O Ejaz Perves R/O67/C

Punjab Co-Operative Housing Society Defense,

Lahore.

iv. Mr. Daud Tareen S/O M Aslam Tareen R/O

B-42, GOR-III, Shadman, Lahore

(Proprietor).

and called for personal hearing in the upcoming meeting of the Central Licensing Board.

The meeting ended with the vote of thanks to and by the chair.