KERALA MEDICAL SERVICES CORPORATION LTD.,kmscl.kerala.gov.in/media/6f76ea00-Notice -complaints I_II.pdf · KERALA MEDICAL SERVICES CORPORATION LTD., (Dept. of Health & Family Welfare,

KERALA MEDICAL SERVICES CORPORATION LTD., (Dept. of Health & Family Welfare, Govt. of Kerala)

Thycaud P.O., Thiruvananthapuram-14 Tele Fax No : 0471-3045647,

0471-2337353, 0471-3045600 Email id : [email protected]

CIN : U24233KL2007SGC021616

Essential Drugs Section www.kmscl.kerala.gov.in No. KMSCL/DRG/117/2014(1) Date : 25/03/2015

NOTICE

Sub :- KMSCL – e-tender for Procurement of drugs & supplies for the year 2015-16 – Technical bid evaluation – complaints/ representations received – decision taken - published –reg.

Ref :- 1. E-tender Ref. No. KMSCL/DRGED/I&II/RC/2015/001 dated 08.01.2015

2. This office Notice No. KMSCL/DRG/117/2014(1) dated 20.02.2015

The complaints and suggestions received in response to the notices published

vide reference 2nd cited were examined in detail and decision taken on each

complaint/representation is published as tabulated below.

CATEGORY – I & II

(No: KMSCL/DRGED/I&II/RC/2015/001 DATED 08.01.2015)

Sl. No.

Nature of complaint/representation Decision

1. M/s. Labinduss Ltd has represented that,

i) They have already submitted notarized

copy of renewal certificate of SSI

registration (acknowledgement part II

which came into effect on 01.10.2014)

they have also submitted notarized copy

of their original SSI registration certificate

issued on 1984.

ii) Their formula of expectorant with CPM is

identical to the tendered item no-

D03009/12 (Cough Syrup).

Verified the online bid submitted by M/s.

Labindus Ltd and found that the

representation of the firm is genuine and

the SSI registration certificate of the firm

and the offer of Cough Syrup D03009/12

are accepted.

Sl. No.


2. A complaint has been received that the

formula of cough syrup quoted by M/s.

Biogenetic Drugs Pvt. Ltd is different from

tendered item and attached Market

Standing Certificate of the same uploaded

by M/s. Biogenetic Drugs Pvt. Ltd.

Verified the online bid submitted by

M/s. Biogenetic Drugs Pvt.Ltd and found

that the Market Standing Certificate

submitted is not as per tendered

specification. Hence offer of M/s.

Biogenetic Drugs Pvt. Ltd for D03009/12

(Cough Syrup) is rejected.

3. M/s. Wockhardt Limited has represented

that they have submitted Annexure VII

(details of manufacturing unit) along with

the online bid submission and furnished a

copy of the same.


Wockhardt Limited and found that their

representation is correct. Hence the offer

of the firm is accepted.

4. M/s.Wockhardt Limited has submitted i) Notary attested copy of renewed Product

Permission of Drug code D05003

(Dexamethasone Tab IP 0.5 mg) renewed

from 20.08.2014 to19.08.2019.

ii) Additional EMD for RS 26,250/- in the

form of DD (DD No. 453457 of SBI dtd.

25.02.2015) and requested to consider

their participation.

i) Offer of the firm for Drug code D05003

(Dexamethasone Tab IP 0.5 mg is

accepted.

ii) Additional EMD submitted is not

accepted and the selection of the

products will be as per 6.4.3 of tender.

Sl. No.


5. M/s. Eurolife Healthcare Pvt Ltd has

represented that their product is not

imported and Market Standing Certificate

Bill of Lading is not relevant to them and

submitted;

i) Copies of performance certificate issued

by Drugs Control Authorities for quoted

products.

ii) Performance statement duly notarized for

the items D02012 (Ciprofloxacin inj IP-

2mg/ml) & D15066 (Tobramycin Eye/ear

drops-0.3% v/v) and requested to consider

the documents.

i) Verified the online bid submitted by

M/s.Eurolife Healthcare Pvt Ltd and

found that there is no own

manufacturing license and sale license

in domestic market for D15066)

(Tobramycin Eye/Ear drops-0.3% v/v).

Hence the offer of the product is

rejected.

ii) Offer of M/s. Eurolife Healthcare Pvt

Ltd for D02012 (Ciprofloxacin inj IP-

2mg/ml) is accepted.

6. M/s. Swiss Parenterals Pvt. Ltd informed

that,

i) They are private limited company and

submitted Board Resolution for Power of

attorney and submitted in the online

tender.

ii) As per the validity certificate issued by the

Drugs Control Authorities, the license

shall continue to be in forced until the

orders are passed on the application

under the provisions of Drugs &

Cosmetics Act 1940.

iii) List of technical person in manufacturing

and testing were uploaded with site

master file of the firm which complete the

total details of their company in

manufacturing, testing& other activities.


Swiss Parenterals Pvt. Ltd and found that

representation of firm on point no i, ii &

iii are genuine and offer of the firm is

accepted.

Sl. No.


7. A complaint has been received that

i-a) M/s Indian Immunologicals Limited (IIL)

does not have a proper valid license

fulfilling the 3 years Manufacturing and

Marketing criteria.

i-b) The pack of 0.5 ml out of 1 ml for IM

use and 0.1 ml for ID use has been

totally suppressed.

i-c) This item does not have valid

endorsement on 26-H.

ii) In serial number 19, product permission

of M/s.Bharat Biotech International

Limited (BBIL) for drug Code

D21021/12 ,”along with 1ml diluent”

is inserted by hand.

iii) The product required by KMSCL has to

quantity for both IM or ID route of

administration with a final volume of

1ml dilution.

Verified the bids submitted by The Indian

Immunologicals Limited and M/s. Bharat

Biotech International Limited and found

the documents submitted by the bidders

are in order with respect to the tendered

product. Hence the complaint is rejected.

8. M/s. Intas Pharmaceuticals Ltd represented

that ,

i) Copy of Board Resolution since they are

being a Limited company,

ii) copy of all products Manufacturing

License & products permission and

requested to approve the same and

accept their tender

Verified the online bid and found that

the firm quoted for BP specification for

Drug code D17033 (Lorazepam Tab IP-

2mg) instead of tendered IP specification,

hence rejected.

For D 17022 the tendered specification is

Quetiapine Tab IP-50 mg whereas the

firm has offered SR Tab, hence rejected.

Sl. No.


For D17019 the tendered specification is

Sertraline Tab IP-50 mg whereas the firm

has offered USP, hence rejected.

For D21038, the tendered specification is

Voglibose Tab IP-0.2mg whereas firm

has not offered the same, hence rejected.

For D13056 (Prazosine Tab IP) the

tendered specification and offered

specification of firm is same and hence

accepted.

9. M/s. Aurolab represented that

i) License issued to Drug Code no-D15036

(Hydroxypropyl methyl Cellulose Eye

Drops-0.02) is for strength and its pack

size only, not for type of packing.

ii) Submitted copies of purchase orders of

KMSCL, Rajasthan Medical Services

Corporation Ltd, Directorate of Health,

Delhi Central procurement Agency for the

above item.

iii) Submitted details of Technical persons

engaged in manufacturing and testing.

Current supplier of the product -D15036

(Hydroxypropyl methyl Cellulose Eye

Drops-2ml) (PFS) with same

specification.

Representation of firm on point No-i), ii),

iii) are accepted.

10. M/s.Verve Human Care Laboratories

represented that the product permission for

Drug code D01023 (Fentanyl citrate inj IP

50mcg/ml) was enclosed with the original

uploaded technical bid at page no-12 in

“IP” only.

Verified the online bid submitted and

found that product permission for Drug

code D01023 (Fentanyl citrate inj IP

50mcg/ml) is enclosed in page No-12.

Hence accepted.

Sl. No.


11. M/s.Pharma Impex Laboratories Pvt.Ltd

represented that

i) Statutory authority in their state doesn’t

issue the Sales Tax Clearance Certificate

in various tenders and submitted the

documents from Directorate of

Commercial Taxes to this effect.

ii) Submitted a fresh GMP issued by

Directorate of Drugs Control valid up to

31/12/2017.

The representation furnished by M/s.

Pharma Impex Laboratories Pvt. Ltd is

examined and found genuine, hence

accepted.

12. M/s.Nestor Pharmaceuticals Ltd has

informed that they had attached drug

approval of D02013 (Gentamycin inj IP

80mg/2ml) on page No-50 of the online bid

submitted. They have also enclosed copies

of the same.

For D02013 the tendered specification is

Gentamycin inj IP 80mg/2ml, whereas

the firm has offered USP .Hence rejected.

13. Hindustan Laboratories has requested to

consider

i) the market standing certificate for Drug

code D13036 (Acetyl Salicylic Acid 150

mg) & D22004/12 (Vitamin multi tab-film

coated) against the certificate produced in

the online bid for Acetyl Salicylic Acid 300

mg and Vitamin multi tab-sugar coated

respectively as both are similar products

and requested to consider the same for

market standing certificate.

ii) Copies of purchase order from

Tamilnadu and product permission for

Acetyl Salicylic Acid Tab IP 150 mg and

The request of the firm has examined

and noted that the market standing

certificate submitted for different

products. Hence rejected.

Sl. No.


product permission for multi vitamin film

coated tablet were also produced.

14. M/s. Southern Union Pharmaceuticals

reported that, they offered BP Standards,

which is the latest standards for their two

products and also stated that BPC standards

have been replaced by IP/BP in the

provisions of the Drugs and Cosmetics Act

& Rules. It is also submitted that both

BPC & BP standards in respect of D14007

(Glycerin magsulf paste) and D15008

(Sodium bicarbonate ear drops) are

incidentally same and requested to accept

their offer for the above products with BP

standards which are similar to BPC.

The copies of BPC & BP enclosed for

reference.

Representation of M/s. Southern Union

Pharmaceuticals has examined and

found genuine. Hence offer for D14007

(Glycerin magsulf paste) and D15008

(Sodium bicarbonate ear drops) are

accepted.

15. M/s Ortin Laboratories Ltd represented

that,

i) they mistakenly entered code of Drug as

D13046 instead of D17038 and

requested to read the code as D17038:

(Clonazepam Tab IP-0.5mg)

ii) furnished revised Power of Attorney by

affixing photograph of authorized person

iii) Submitted copies of performance

statement annexure IV and requested to

accept their bid.

Verified the representation of M/s. Ortin

Laboratories Ltd on points no i, ii & iii

are found genuine. Hence accepted.

16. M/s. Ipca Laboratories Ltd represented that

i) The generic names of their quoted drugs

Verified the online bid and found that,

the market standing certificate for drug

Sl. No.


in brand names.

ii) They have already attached market

standing Certificate on online bid for the

two products and also attached copy of

the same for reference.

code D17022 (Quetiapine Tab IP-50 mg)

& D17059 (Zolpidem Tab IP-10 mg) is

not produced from the units where it is

licensed for manufacture. Hence rejected.

17. M/s Biochem Pharmaceutical Industries Ltd

submitted that

i) The copy of renewal license No.DD/139

& DD/140 in Form 26 valid from

11.01.2015 to 10.01.2020.

ii) The copy of renewal license No.DD/616

& DD/617 in Form 26 valid from

10.12.2014 to 09.12.2019 and produced

and informed that the renewal product

list is under renewal process of the

concerned authorities.

iii) The details of product permit and market

standing certificate for products D13013

(Atorvastatin Tab IP-10mg), D02031

(Azithromycin Tab IP- 500mg), D02075

(Levofloxacin Tab IP-500 mg) and

D02017 (OfloxacinTab IP- 200mg) were

uploaded in the online technical bid and

the copies of the same were attached.

iv) The documentary proof of loan license

for D02010 (Cefotaxime Sodium Inj IP-

250mg), and D02026 (Cefotaxime

Sodium Inj IP-1g) were enclosed as

additional document.

v) The bidder has not furnished the market

Product permits issued by the Drugs

Control Authorities to the loan licensee

(Zen Pharma Private Limited) for

D02010 (Cefotaxime Sodium Inj IP-

250mg), and D02026 (Cefotaxime

Sodium Inj IP-1g)are not submitted.

Hence offer of these products

manufactured from loan licensee (Zen

Pharma Private Limited) is rejected.

As the bidder has not furnished the

market standing certificate for D13061

(Telmisartan Tab IP-40mg, offer for the

item rejected.

Sl. No.


standing certificate for D13061(Telmisa

rtan Tab IP-40mg)

18. M/s. Unimark Remedies Ltd represented

that

i) Copy of application challan submitted to

the FDA, Joint Commissioner Nagpur

for renewal manufacturing license and

requested to accept their bid

Representation of M/s. Unimark

Remedies Ltd is genuine and offer of the

firm is accepted.

19. M/s. Gennova Biopharmaceuticals Ltd

represented that the copies of documents

notarized copy of original drug license, copy

of valid GMP certificate, copy of

performance statement and copy of power

of attorney, sale tax clearance certificate in

prescribed format, Balance sheet and

profit& Loss A/C statement upto Mar

2012,notarized documents WHO/GMP

certificate, notarized declaration on

submission of test report from NABL/Central

Drugs Laboratory, notarized details of

bankers of bidder and requested to consider

their bid for valuation.

Sale tax clearance certificate is not

submitted by M/s. Gennova

Biopharmaceuticals Ltd. Hence offer of

the firm is rejected.

20. M/s.Troikaa Pharmaceuticals Ltd

represented that notary attested copies of

Product permission of their products,

performance statement and manufacturing

and market standing certificate of their

quoted products and requested to consider

their bid for evaluation.

Bidder has submitted the product permit

for Drug code D13040 Amiodarone Inj

IP and Market standing certificate for

D29005 Noradrenaline Inj, hence offer

of these items are accepted.

For Drug code D13016 (Dopamine HCL

Inj IP)the product permit submitted by

the firm is USP. Hence rejected as per

Sl. No.


clause 6.5.6 of tender.

21. M/s.Corona Remedies Pvt.Ltd informed

that, they are the manufacture of the

product D20037 (Ursodeoxycholic Acid tab)

for IP as per tender and requested to

consider their product

For Drug code D20037 (Ursodeoxycholic

Acid tab) the product permit submitted

by the firm is USP. Hence rejected as per

clause 6.5.6 of tender.

22. M/s.Sangrose Laboratories Pvt. Ltd. has

submitted notarized copy of Drug

manufacturing license and product

permission

For drug code D09003 (Acyclovir cream

IP) and D14031 (Clobetasol Propionate

cream IP) the bidder has submitted

product permit in IP monograph. Hence

offer of the above products is accepted.

23 M/s.Cipla Ltd, has submitted the notarized

copies of license for Drug code D17033

(Lorazepam Tab IP-2mg) and copy of

certificate dtd 05.06.2014 issued by the

licensing authority in respect to the change

in claim of pharmacopeia standards of

earlier approved monographs to the

presently approved IP-2014.

Notarized copy of product permit to

manufacture Drug code D17033

(Lorazepam Tab IP-2mg)is not furnished

hence rejected.

24. M/s.Kwality Pharmaceuticals Pvt. Ltd has

submitted attested copy of WHO-GMP

Certificate, GMP Certificate, GLP

Certificate, Product approvals of quoted

items and requested to approve the sections

have rejected on factory inspection

conducted during 2012-13.They have also

submitted clarifications and additional

document against the observations

The offer of the firm for small volume

Parenteral preparations only accepted as

per clause 5.2.12.

i) The firm has submitted product

permission for Naloxone HCL Inj IP

and hence accepted.

ii) For Drug code D17034 – (Lorazepam

Inj IP- 2MG/ML),the offered

Sl. No.


published in the notice dtd 20.02.2015. specification in online tender was for

BP and hence rejected.

iii For Drug code D20014 -

(Ondansetron Inj IP-2mg/ml) the

offered specification in online tender

was for USP. The firm has submitted

product permission for Ondansetron

Inj IP 2mg/ml. Hence accepted.

iv) Verified the online bid submitted and

found that product permission for

Dicyclomine HCL Inj IP-10mg/ml-2ml

amp is available in page no-146 of

the bid. Hence accepted.

v) The product permission for the

product For Drug code D04011-

Propofol Inj IP- 1% w/v 50ml is not

authenticate and hence offer of the

product is rejected.

vi) The bidder has represented that

Suxamethonium Chloride is the

synonym of Succinyl Choline chloride

and hence the offer for Succinyl

Choline chloride Inj is accepted.

vii) For tendered specification for Drug

code D01009 Paracetamol Inj

150mg/2ml,the bidder has offered

Paracetamol 150mg/ml. Hence offer

of the product is rejected.

viii) Verified the specification of Drug

code D04018 (Lignocaine 2% With

Sl. No.


adrenaline Inj) in the online bid

submitted by the bidder and found

that the specification of product

tendered matches with the

specification in the product approval

and the offer of product is accepted.

ix) For Drug code D17034 – (Lorazepam

Inj IP- 2MG/ML) and

D13040(Amiodarone Inj IP),the


was for BP. The firm has not

submitted any clarification in this

regard and hence the offer of these

products is rejected.

x) For Drug code D04023 – (Atracurium

Besylate inj IP)and D16007

(Magnesium Sulphate Inj IP) the


was for USP. The firm has not

submitted any clarification in this

regard and hence offer of these


25. M/s.Vivek Pharmachem(India) Limited

represented that

on subsequent renewal of the drug license,

the items have been renewed for IP

standards.

It is requested to accept USP standards for

Drug code D02027 instead of IP standards

and they will supply Moxifloxacine eye

Verified the online bid submitted by

M/s.Vivek Pharmachem (India) Limited

and noted that the drugs controller has

specified in the product list of Drug codes

D02055, D02010, D02026, D02034

D02020 that “approved as USP now in

IP”. Since the bidder has not produced

individual product permit of the above

Sl. No.


drops in IP standards only. items in IP monograph, the offer of the

above products are rejected.

The firm has not submitted product

approval of D15041-Moxifloxacin eye

Drops and D02027 –Vancomycin Hydro

chloride Inj IP and hence offer of these


26. M/s.Ciron Drugs Pharmaceuticals Pvt.Ltd

vide letter dtd 25/02/2015 has represented

that the product permit of the items were

uploaded on the online bid the

nomenclature of the items were different

which they have corrected and furnished as

additional document.

i) For Drug code D04023 – (Atracurium

Besylate inj IP) the offered

specification in online tender was for

USP. The offer of the product is

rejected as per clause 6.5.6.

ii) For D17013- Fluphenazine

Decanonate Inj IP 1ml Amp) &

D22017- Calcium Carbonate Tab IP

the offered specification in online

tender were for BP. The offer of these

products is rejected as per clause

6.5.6.

iii) For Drug code D12019- (Low

Molecular Weight Heparin Inj.

D04021- Vecuronium, Bromide Inj. IP

10mg and D04020- Vecuronium

Bromide Inj. IP 4mg, the Official

Monograph has not specified in their

product approval. The offer of these

products is rejected as per clause

6.5.6.

iii) For Drug code D02027- Vancomycin

Hydrochloride Inj. IP), the offered

Sl. No.


specification in online tender was for

USP. The offer of the product is


iv) For Drug code D15030- Flurbiprofen

Eye Drops IP, D17020- Olanzapine

Tab IP 5mg, D09001- Acyclovir Inj,

D15035- Hydroxy Propyl Methyl

Cellulose Eye Drops, D16021-

Oxytocin Inj IP, D15024-

Ciprofloxacin + Dexamethasone Ear

Drops, - Ipratropium Nebulising

Solution (Respiratory solution),

D20015- Lactulose Syrup (Solution

USP), D16007- Magnesium Sulphate

Inj IP, D13028- Nitroglycerin Inj,

D03001- Theophylline And

Etophylline Inj, D14023/12- Sisomicin

Cream, D15052- Prednisolone Acetate

Eye/Ear Drops, D15066- Tobramycin

Eye/Ear Drops, D13031/12-

Amlodipine Tab IP 5mg &

D13032/12- Enalapril Maleate Tab IP

the firm has uploaded the product

permits for the tendered specification

in the online bid. Hence offer of these

products is accepted.

v) For Drug code D17016- Olanzapine

Tab IP 10mg & D07008- Phenytoin

Sodium Inj IP the product permit has

been submitted. Hence accepted.

Sl. No.


vi) For Drug code D01009- Paracetamol

Inj 150mg/ 2ml, 2mlAmp the product

permit submitted is for Paracetamol Inj

150mg/ 1ml, hence rejected.

vii) For Drug code D15021- Brimonidine

Eye Drops the product permit

submitted is for export purpose only

and hence rejected.

viii) For Drug code D15008- Sodium

Bicarbonate Ear Drops BPC the

product permit submitted is for

Sodium Bicarbonate Ear Drops BP.

Offer of the product is accepted.

27. M/s.Theon Pharmaceuticals Ltd has

informed that,

i) Monograph specification of item no-

D20037, D21038 was earlier under USP

and as per amendment of IP Monograph

2014 the same has come under IP. They

have confirmed that in case of approval

they will supply the above items under IP

specification only.

ii) It is confirmed that they have offered item

at serial no-67 as per tender having Drug

Code D02055 (Cefixime Tab IP-200 mg)

and the difference happened in the list of

items quoted (annexure-II) was due to

typographical error .

i) The monograph specification for the

item offered by M/s.Theon

Pharmaceuticals Ltd for Drug code

"D20037, Ursodeoxycholic Acid Tab,

300 mg", is USP and Monograph is

not specified for "D21038, Voglibose

Tab, 0.2mg" instead of tendered

specification of IP. The offer of the

product is rejected as per clause 6.5.6.

ii) The representation that they have

offered item at serial no-67 as per

tender having Drug Code D02055

(Cefixime Tab IP-200 mg). The firm

has submitted product permit for

Cefixime tab USP. The offer of the


Sl. No.


28. M/s. United Biotech (P) Ltd informed that

i) Drug code D02049 is same as tendered

item-Acyclovir 250mg.

ii) As per IP 2014, Dopamine HCL

inj.40mg/ml is described as a Dry

Powder/Lyophilized injection filled in

sealed container whereas they

manufacturing Dopamine HCL

Inj.40mg/ml in liquid form, The active

pharmaceutical ingredient of Dopamine

HCl inj. 40mg/ml is manufactured as per

IP specifications and requested to

consider their bid.

i) The drug code offered in Sl.No.3

(D02049) in the list of items quoted

(Annexure II) does not match with the

drug name tendered. In the

clarification furnished by the firm also

the Drug code and drug name does

not match. Hence offer of the Sl.No.3

in the list of items quoted (Annexure

II) is rejected.

ii) The representation of the bidder in

point no ii is not as per tender

specification. Hence offer for

Dopamine HCl inj. 40mg/ml is

rejected.

29. M/s.Nanz Med Science Pharma(P) Ltd

informed vide letter dtd 25/02/2015 that,

i) The firm is quoted for the item Silver

Sulphadiazine cream 1% w/w is USP is

recently included in IP as per

addendum of Dec 2014.It is mandatory

on the part of the manufacturer to adopt

Indian Pharmacopeia within specified

period from the date of inclusion though

the manufacturing permission may be in

any other pharmacopeia.

ii) Submitted copy of market standing

certificate

iii) Submitted notary attested copy of

power of attorney and requested to

consider their bid

i) For Drug code "D14001 – Silver

Sulphadiazine Cream IP 1% w/w

100gm & "D14001/12 – Silver

Sulphadiazine Cream IP 1% w/w

500gm the offered specification in

online tender was for USP. The offer

of these products is rejected as per

clause 6.5.6.

ii) Offer for Povidone Iodine Scrub,

Povidone Iodine Solution IP-500 ml

bottle and 5ml, Gamma Benzene

Hexa Chloride Solution, Benzyl

Benzoate Application IP-100 ml

bottle, Whitfield's Ointment IP-15

gm, Povidone Iodine Ointment USP-

25 gm tube are accepted.

Sl. No.


iii) Notary attested copy of power of

attorney accepted.

30. M/s. Valence Healthcare submitted the

following clarification/ documents.

Product Permissions showing the bidder can

market all the items in the bid.

Current market standing Certificate of

products,

Certificate of sale tax submission Audited

balance sheet, Profit& loss A/c for last 3 yrs

and requested to consider the bid.

The bidder has not furnished the market

standing certificate issued by the licensing

authority to prove 3 years Market

Standing of D21028 - Glimepiride Tab IP

1 mg" and "D21032/12 - Glimepiride Tab

IP 2mg". Hence offer of these products is

rejected.

For drug code D14031-Clobetasole

Propionate Cream IP 0.05% the offered

specification is for USP and for drug code

D20033-Pantoprazole Tab IP 40mg the

product offered has no official

monograph and hence offer of these


The offer for drug codes D02055

Cefixime Tab IP 200mg & D02057-

Cefpodoxime Proxetil Tab IP 200mg are

for Dispersible Tablets and the offer for

drug code D20032- Ondansetron Tab IP

4mg is for Orally Disintegrating Tablets

IP. As the offered specification of the

above products differ from that of

tendered, offer of these products is

rejected.

31. M/s. Mercury Laboratories Limited informed

that

i) For Drug code D12014 (Tranexamic

Acid Tab IP) the offered specification

Sl. No.


i) Drug license for drug code-D12014

(Tranexamic Acid Tab IP) was taken

during 2003 and at that time the item

was not monograph IP and the license

was renewed up to 31/12/2016. They will

renew the license in IP from 01.01.2017

however they would be in a position to

manufacture and supply the item in IP

monograph.

ii) As regards D-20012(Bisacodyl Tab IP-

5mg), and D01002 (Paracetamol Tab IP-

500mg), they argued that the WPCs filed

by them in Hon. High court have been

disposed after final hearing counsel of

Corporation and the above drug do not

existed as blacklisted item and the

Corporation have to accept the verdict of

the Hon. High court of Kerala setting

aside the blacklisting orders.

in online tender was for BP. The offer

of these products is rejected as per

clause 6.5.6.

ii) D01002 - Paracetamol Tab IP 500

mg. and D20012 - Bisacodyl Tab IP 5

mg. were blacklisted by the

Corporation upto 31.03.2016 due to

Not of Standard Quality of the same

firm supplied in previous years. Hence

the offer for Paracetamol Tab IP 500

mg. and Bisacodyl Tab IP 5 mg. is

rejected as per clause 5.2.7 of the

tender

32. M/s.Samarth Life Sciences Private Limited

has furnished the following documents

i) Power of Attorney with attached

photograph

ii) Annual turnover statement in prescribed

format

iii) It is informed that they have not quote

rates for D04023 (Atracurium Besylate

inj IP-10mg/ml) and D22016 (Iron

Sucrose inj USP-100mg elemental

iron/5,ml) which erroneously appeared

i & ii) The documents noted in Point no

i & ii are accepted.

iii) The offer of the products D04023

(Atracurium Besylate inj IP-10mg/ml)

and D22016 (Iron Sucrose inj USP-

100mg elemental iron/5,ml) is

rejected based on the representation

of the bidder.

Sl. No.


in the technical bid and the total EMD

of these products is published as

shortage in notice dtd 20.02.2015

33. M/s.Glenmark Pharmaceuticals has

informed that they had submitted copy of

WHO GMP Certificate of their loan licensee

M/s. Biodeal Pharmaceuticals Pvt. Ltd. for

item with drug code D14010. They resubmit

the document.

GMP Certificate M/s. Biodeal

Pharmaceuticals Pvt Ltd submitted in

online bid was valid upto 07.12.2013

only. The firm has submitted the same

valid upto 09.04.2016. Hence accepted.

34. The following complaints were received by

email dtd 25/02/2015

i) M/s. Akkums Drugs and Pharmaceuticals

Ltd has not submitted Annexure IV for

drug code D13031/12

ii) In the online bid of Ciron Drugs and

Pharmaceuticals Pvt. Ltd they quoted for

a) D22006 (Ferrous Sulphate Tab IP

200mg) product permission in BP

and for Export only

b) D13013(Atorvastatin Tab IP 10mg) –

product permission is dated

17.04.2012 (3 years not completed)

c) D15021(Brimonidine Eye Drop) –

Permission dated 02.11.2012 and for

Export

d) D01004 (Diclofenac Sodium Tab IP-

50mg)- The permission is not granted

as Gastro Resistant.

iii) The date of first batch is not clear in

annexure IV and is mentioned as year

i) Verified the online bid submitted and

found that M/s.Akkums Drugs and

Pharmaceuticals Ltd has not

submitted Annexure IV for drug code

D13031/12 and hence offer of the


ii) Verified the online bid submitted by

Ciron Drugs and Pharmaceuticals

Pvt.Ltd and found that the offer for

drug code D22006 Ferrous Sulphate

Tab IP 200mg is of BP specification

and hence rejected as per clause

6.5.6.

The firm has submitted certificate

issued by the licensing authority to

prove 3 year market standing

certificate of D13013 (Atorvastatin

Tab IP 10mg. Hence the complaint is

rejected.

The product approval furnished for

D15021 (Brimonidine Eye Drop) is

Sl. No.


2011 -12 only for D13033 Metoprolol

tab IP 50mg offered by Intas

Pharmaceuticals Ltd.

for export purpose only. Hence offer

of the product is rejected.

The product permit for D01004

(Diclofenac Sodium Tab IP-

50mg)specifies that the product is

enteric-coated and the bidder has

submitted Market standing certificate


prove 3 years market standing

certificate. Hence complaint on the

above product is rejected.

iii) M/s. Intas Pharmaceuticals Ltd. has

submitted Market standing certificate


prove 5 years market standing for the

product D13033 (Metoprolol tab IP

50mg). Hence complaint on the

above product is rejected.

35 Complaints were received that the following

firms were blacklisted by the other Govt

Procurement agencies.

i). M/s Medipol Pharmaceuticals India Pvt.

Ltd was blacklisted by Tamilnadu

Medical Services corporation Ltd upto

20.10.2019 due to the supply of spurious

drug.

ii). Biogenetic Drugs Pvt Ltd- Rajasthan

Medical Services Corporation Ltd. has

blacklisted Paracetamol syrup IP.

iii). Unicure India Ltd-Betamethasone

Verified the complaint received and

found genuine and the following decision

were taken.

i) The bid quoted by M/s.Medipol

Pharmaceuticals India Pvt. Ltd. is

rejected as per clause 5.2.7

ii) The offer of Biogenetic Drugs Pvt Ltd

for D01003 Paracetamol Syrup/

Suspension IP-125 mg and Unicure

India Ltd for D14009/12

Betamethasone Valerate Cream IP is


Sl. No.


Valerate ointment IP was blacklisted by

Tamilnadu Medical Services corporation

Ltd upto 30.09.2016 due to the supply

of Not of Standard Quality drug.

36. Complaints were received that

i) No batch detail in the year of 2013-14

was furnished for D02004 Amoxycillin

Cap IP 250mg, D02005-Amoxycillin Cap

IP 500mg by The Pharmaceuticals &

Chemicals Travancore Pvt Ltd.

ii) D13024 Acetyl Salicylic Acid Tab IP

75mg offered by Hindustan Laboratories

The permission not granted as Gastro

Resistant.

iii) In Annexure IV for all the products, the

date of first batch is not clear, it is

mentioned as year 11-12,12-13 &13-14

only and date is not mentioned by Intas

Pharmaceuticals Ltd.

iv) Ravian Life sciences Pvt. Ltd. has not

furnished no old permission for

D13031/12 Amlodipine Tab IP 5mg F/C

and the permission is not of E/C and

Gastro Resistant for D01004 Diclofenec

Sodium Tab IP 50mg.

v) M/s Biogenetic Drugs Pvt. Ltd, has

renewed the License in the year 2010 but

they have taken all the product

permission as per the date mentioned

Verified the online bid submitted by the

bidders and found that

i) The Pharmaceuticals & Chemicals

Travancore Pvt Ltd has furnished

batch manufacturing details for 2011-

12(5 batches) and 2012-13(5 batches)

for D02004 Amoxycillin Cap IP

250mg, D02005-Amoxycillin Cap IP

500mg and complies with clause 5.2.4

and hence complaint on the same is

rejected.

ii) Hindustan Laboratories has offered

Aspirin delayed release Tab USP

instead of tendered D13024 Acetyl

Salicylic Acid Tab IP 75mg.Hence

offer of the product is rejected as per

clause 6.5.6.

iii) Verified the complaint in point no-3

and noted that Intas Pharmaceuticals

Ltd has submitted required details of 5

batches of items manufactured during

the last 3 years, hence the complaint

on the same is rejected.

iv) The complaint raised against M/s.

Ravian Life sciences Pvt Ltd has

Sl. No.


above as additional products which

shows that the products quoted were not

in continuation.

examined and found genuine and

hence the offer for D13031/12

Amlodipine Tab IP 5mg and

Diclofenec Sodium Tab IP 50mg is

rejected.

v) Verified the online bid submitted by

M/s Biogenetic Drugs Pvt. Ltd and

found that the firm has produced

certificate issued by the licensing

authority to prove 3 years market

standing for the offered products.

Hence the complaint on the same is

rejected.

37. Complaints were received that

i) Ratnamani Healthcare Pvt. Ltd. has not

submitted market standing certificate for

D08001 Albendazole Tab 400Mg,

D02031- Azithromycin Tab 500Mg and

D03024 Salbutamol Syrup.

ii) Cadila Healthcare Limited has not

submitted market standing certificate for

D06015 N-Acetyl Cysteine Tab.

iii) NIRMA Limited has mentioned only 4

batches in annexure IV of D04004

Lignocaine HCL Inj.

iv) M/s.CIPLA Ltd has not submitted market

standing certificate for D13023

Clopidogrel Tab 75Mg.

v) Samarath Life sciences mentioned only

i) Verified the online bid submitted by

M/s. Ratnamani Healthcare Pvt Ltd

and found that the bidder has not

furnished Market standing certificate

for D08001 Albendazole Tab 400Mg,

D02031- Azithromycin Tab 500Mg

and D03024 Salbutamol Syrup and

hence the offer of these products is

rejected.

ii) Verified the online bid submitted by

M/s. Cadila Healthcare Limited and

found that the bidder has not

furnished Market standing certificate

for D06015 N-Acetyl Cysteine Tab

and hence the offer of these products

is rejected.

Sl. No.


4 batches in annexure IV of D06015 N-

Acetyl Cysteine Tab.

vi) Glaxo India Limited has not submitted

market standing certificate for D08001

Albendazole Tab 400Mg , D05010

Cetrizine Tab 10Mg,and D20002

Ranitidine Tab 150Mg.

vii) Cipla Ltd, United Biotech has submitted

Product Permission for Vancomycin

Intravenous Infusion IP for the tendered

specification of Vancomycin Inj IP.

viii) Swiss Parenterals Ltd has submitted


HCL Inj USP for the tendered

specification of Vancomycin Inj IP.

iii) Verified the online bid submitted by

M/s. NIRMA Limited and found that

the details of only 4 batches were

mentioned in annexure IV of D04004

Lignocaine HCL Inj and hence the

offer of the item is rejected.

iv) Verified the online bid submitted by

M/s. Cipla Limited and found that

the bidder has not furnished Market

standing certificate for for D13023

Clopidogrel Tab 75Mg. and hence

the offer of this product is rejected.

v) Verified the online bid submitted by

M/s. Samarath Life sciences and

found that the details of only 4

batches were mentioned in

annexure IV of D06015 N-Acetyl

Cysteine Tab and hence the offer of

the item is rejected.

vi) Verified the online bid submitted by

M/s. Glaxo India Limited and found

that the bidder has not furnished

Market standing certificate for

D08001 Albendazole Tab 400Mg,

D05010 Cetrizine Tab 10Mg, and

hence offer of these products is

rejected. The market standing

certificate for Tab Ranitidine 150mg

was uploaded by the bidder along the

online bid hence complaint in this

Sl. No.


regard is rejected.

vii) Vancomycin Inj is official in Indian

Pharmacopoeia as Vancomycin

Intravenous Infusion IP. Hence

complaints in this regard against

Cipla Ltd and United Biotech are

rejected.

viii) Swiss Parenterals Ltd has submitted


HCL Inj USP and hence the offer of

the product is rejected as per clause

6.5.6.

Sd/-

MANAGING DIRECTOR

(TENDER INVITING AUTHORITY)

Documents

KERALA MEDICAL SERVICES CORPORATION LTD.,kmscl.kerala.gov.in/media/6f76ea00-Notice -complaints I_II.pdf · KERALA MEDICAL SERVICES CORPORATION LTD., (Dept. of Health & Family Welfare,