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GOVERNMENT OF INDIA MINISTRY OF HEALTH & FAMILY WELFARE

DIRECTORATE GENERAL OF HEALTH SERVICES CENTRAL DRUGS STANDARD CONTROL ORGANISATION

CENTRAL DRUGS TESTING LABORATORY – MUMBAI Accredited By : NABL (ISO/IEC 17025:2005 in Chemical & Biological Testing) Certified For : IMS (ISO - 9001:2008; ISO - 14001:2004; OHSAS - 18001:2007)

ANNUAL REPORT 2015-2016

CENTRAL DRUGS TESTING LABORATORY–MUMBAI

Zonal FDA Bhavan, GMSD Compound, Belasis Road,

Mumbai Central, Mumbai-400 008.

Phone No.:022-23002309, 022-23002138

Fax : 022 - 23099240

Email: cdtlmumbai@cdsco.nic.in

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Introduction

Central Drugs Testing Laboratory (CDTL) - Mumbai is one of the

regulatory laboratory of the Ministry of Health & Family Welfare,

Government of India working under the administrative control of

the Drugs Controller General (India), CDSCO, DGHS.

CDTL was established in 1992 with an effort to cope better with

the testing of imported bulk and finished products.

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VISION

To be recognized globally for providing world class

testing facilities for safeguarding human and animal health by

establishing and reviewing quality objective at various levels

of the organization.

To safeguard and enhance public health by quality and

excellence in testing of drugs, cosmetics and medical devices.

To be a part of modern regulatory system in India to

protect public health by ensuring provision of safe, effective

and quality drugs and pharmaceuticals based on scientific

excellence accountable to both, the Government and the

public.

MISSION

To provide quality and effective analytical services achieved

through advanced testing in the area of drugs and

pharmaceuticals by dedicated and committed work force by

adhering core values of transparency, accountability,

efficiency, commitment, credibility and innovation.

To be a smart drugs testing laboratory equipped with

latest sophisticated equipments and having clean and

green eco-friendly environment.

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QUALITY POLICY

Central Drugs Testing Laboratory (Mumbai), committed to :

• Perform quality testing as per ISO/IEC 17025:2005 and

NABL guidelines to attain the highest proficiency and

unbiased testing of Drugs & Cosmetics & Medical Devices in

transparent, well documented and controlled environmental

conditions to attain proper justified quality results.

• Ensure that all laboratory personnel familiarize themselves

with quality documentation while implementing policies and

procedures in their work.

• Strive for continual improvement related to laboratory

functions through personnel involvement at all levels.

QUALITY OBJECTIVES

• To make all the laboratory staff aware to the requirements of

ISO/IEC 17025:2005 by conducting regular trainings and

interactions.

• To implement effective quality system in the laboratory.

• To ensure dependable and accurate testing facility.

• To operate in such an environment so that the test result

obtained is very close to the true result.

• To provide test results at the earliest and to the best

satisfaction.

• To update technical knowledge / skill of scientific / technical

staff by in- house and outside training.

• Regular participation in Proficiency testing and Inter

laboratory comparison programs.

• To provide proper & safe working environment to adopt

Good Laboratory Practices.

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Statutory & Other Major Functions of CDTL-Mumbai

• Analysis of Drugs and Pharmaceuticals, Cosmetics and Medical

Devices manufactured in the country.

• The Director, CDTL - Mumbai acts as “Appellate Authority” as

per Drugs & Cosmetics Act, 1940 for the testing of Copper T

and Tubal Rings (Intrauterine Contraceptive Device).

• Analysis of Import drugs & Cosmetics samples entering through

the port offices.

• Analysis of Registration samples for approval of site registration

as per GMP.

• Analysis of New Drugs to get license for manufacturing the

same.

• To undertake analytical research on standardization and

methodology of Drugs.

• Analysis of Drugs & Pharmaceutical formulations received as

Survey Samples from Central Drugs Standard Control

Organization and its Zonal Offices.

• Analysis of Drugs & Pharmaceutical formulations received as

National Survey sample from CDSCO or other offices under

Ministry of Health & Family Welfare.

• Imparting Training to Drugs Analysts deputed by the

Government laboratories from time to time.

• To act as sub-officials of IPC, to help in developing standards

both for Monographs and Reference Standards development

process for Indian Pharmacopoeia.

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OVERVIEW

The pharmaceutical industry is undergoing rapid changes and it has

become crucial to refine and sharpen our capabilities.

Together we are growing for tomorrow and beyond. We have

embarked upon an exciting journey at CDTL-Mumbai.

As we grow our capacity, capability and analytical research and

development expertise, the objective is to deliver results.

The year 2015 was very eventful for CDTL – Mumbai. Dr. Raman

Mohan Singh took over the charge as Director of this laboratory

from 07/05/2015. Earlier Mrs. M. M. Patel, SSO-I was Director in-

charge of this laboratory.

Our capable and committed employees and guidance of senior

officials are key drives in achieving our goals.

The optimistic approach and spirit of our Director has helped in

enhancing our presence in the laboratory segment of Health

Ministry.

During the fiscal year 2015 we have taken strong initiatives

towards increasing sample output and reaching our near term

goals.

The laboratory is divided into two major divisions – Chemical &

Biological. The various sections functional under these divisions

are Wet Chemistry, Instrumentation, Analytical Research and

Development, Reference Standards, Sample Warden,

Microbiology, Medical Devices, Cosmetics and Quality Assurance.

“The best way to find yourself is to use yourself in the service of others. ----- Mahatma Gandhi

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Following are the milestones of this year.

1) Testing Performance Status : The laboratory received 7,476 samples in the fiscal year 2015-16

and 7,195 samples were reported. There is an exponential increase

in the sample out put which is depicted in the following bar graph.

2728 2774

59 1

23882774

64 1

23152538

72 4

74767195

3801

No. of Samples received No. of samples reported No. of samples declared asnot of standard quality

No. of samples declaredspurious / adulterated

Sample Status

2012-13 2013-14 2014-15 2015-16

Sr. No. Year No. of Samples

received

No. of samples reported

No. of samples declared as not of standard quality

No. of samples declared spurious /

adulterated

1 2012-13 2728 2774 59 1

2 2013-14 2388 2774 64 1

3 2014-15 2315 2538 72 4

4 2015-16 7476 7195 380 1

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2) Enhancing the output :

The staff is made aware of the need to focus on the results of its

work and strive hard to account better, offering clarity regarding

the value and impact of our work. Steps are taken based on facts

and designed to increase our goals.

Measures taken to enhance the sample output:

Rigorous training and seminars given to the fresh candidates

so that the Quality of work is assured.

New instruments like Dissolution Apparatus (5nos.), HPLC

systems (4 Nos.), pH meters(4 Nos.), Disintegration Test

Apparatus (4 Nos.)were installed to speed up the analysis.

Extended working hours implemented along with night

schedules on instrumental analysis for output enhancement.

Laboratory has been working on Saturdays & Public

Holidays to contribute more working hours.

Biometric attendance system introduced to enhance the

punctuality of the employees.

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3) National Drug Survey Samples :

Working in CDTL is about setting standards where quality of

service is given utmost importance. The laboratory was entrusted

with the job of analysing samples of National Drug Survey

Samples routed through NIB, Noida and the number of samples

received were 5797. The staff and officers have taken every single

effort for speedy analysis of the molecules allotted to the

laboratory.

The Ministry supported this venture by sanctioning 35 more

contractual posts, (25 recruited in July 2015 and 10 in December

2015). These includes 25 Bench Chemists and 05 Supporting Staff

who have worked upto March 2016 in the laboratory.

The support of contractuals further strengthened the laboratory.

Their addition has significantly enhanced the output of the

laboratory.

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4) Training Programmes :

Anticipating challenges and taking steps rightly was a milestone.

The staff is geared up for best performance.

The existing senior staff participated in training seminar schedule

and lectures were imparted on various topics. The senior experts of

the pharma field were also invited for Guest lecture on the related

topics.

a) In – house training :

Regular Technical Training Programme on various Instrumental

Techniques and analytical methods were conducted to update the

staff in their theoretical knowledge and were beneficial to

Contractual staff to be familiar with instruments.

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Total 28 training programmes conducted in this period as per

training schedule. Details of which are as follows.

Sr.

No.

Date Name & Designation

of the speaker

Name of the Topic

1. 29/07/2015 Dr. M. Vijay Kumar,

SSA

Basic chromatography &

HPLC/Column chemistry

2. 30/07/2015 Reverse / Normal / Ion

Exchange chromatography

3. 31/07/2015 Method development &

Validation

4. 04/08/2015 Smt. S. S. Parikh, JSA Ultra-Violet Spectroscopy &

Disintegration Test

5. 10/08/2015 Smt. S. S. Kaisare,

SSA

Good Laboratory Practices

6. 11/08/2015 Shri. Arun. K.

Nagarkar, JSA

TLC/HPTLC & its

Applications

7. Basics & Ethics of

Chromatography

8. 14/08/2015 Dr.Anantha Rama G,

JSA

Dissolution Testing &

Calibration

9. 18/08/2015 Smt. A. S. Nandi,

JSA

Microbiological Limit Tests

10. 21/08/2015 Shri. AmolAkash,

JSA

A brief Introduction on

“Bacterial Endotoxin Test”

11. 25/08/2015 Smt. Smita George

JSA

Sterility testing and clean room

area concept

12. 28/08/2015 Smt. A. S. Paranjpe,

SSA

Infrared Spectophotometry

(FTIR)

13. 02/09/2015 Smt.S. A. Navaratne,

SSA

Polarimetry& Moisture content

14. 05/09/2015 Smt. H.H.

Talapatadur, JSA

Titrimetric methods of

Analysis

15. 10/09/2015 Dr. Raman Mohan

Singh, Director

Role of IPC for Quality

Medicines

16. 10/09/2015 Smt. S. U. Warde,

SSO-II, Microbiology

NABL accreditation and its

requirements

17. 15/09/2015 Smt. M. M.Mathure,

JSA

Limit Tests (Heavy Metals,

As, Chlorides, Sulphates, Iron

& Lead)

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Sr.

No.

Date Name & Designation

of the speaker

Name of the Topic

18. 16/09/2015 Smt. A. V. Bandre,

JSA

Potentiometric Titrations

19. 22/09/2015 Shri. AshishYenkar,

JSA

Microbiological Assay of

Antibiotics

20. 01/10/2015 Smt. M. M. Patel,

SSO-I, Chemistry

Central Drug Regulatory

System / D & C Act

21. 05/02/2016 Dr. M. V. Kumar,

SSA

HPLC Method Development

for Drugs & formulations

22. 19/02/2016 Shri. Ashok Kumar,

JSA

Research Article on Sildenafil

&Tadalafil in capsule

formulation

23. 26/02/2016 Smt. S. A. Navaratne,

SSA

Handling of Reagents &

Reference Substances

24. 07/03/2016 Smt.S. S.Kaisare, SSA Quality Management System

25. 11/03/2016 Smt. A. S. Paranjpe,

SSA

Requirement of Raw Data

Documentation.

26. 28/03/2016 Smt. S. U. Warde,

SSO-II, Microbiology

Awareness of ISO/IEC

17025:2005

27. 29/03/2016 Smt. S. U. Warde,

SSO-II, Microbiology

Awareness of ISO/IEC

17025:2005&NABl

accreditation

28. 30/03/2016 Smt. S. U. Warde,

SSO-II, Microbiology

Awareness of ISO/IEC

17025:2005 &NABl

accreditation

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b) Training / Seminar – by Guest Speakers :

Sr.

No.

Date Name of the speaker Name of the Topic

1. 11/09/2015 Dr. Sanjay Poman,

Merck

HPLC Column Chemistry &

Applications

2. 16/12/2015 Dr. PrakashDiwan

Lead NABL Assessor

Overview of NABL Accreditation

3. 28/12/2015 Dr. N. Singh Analytical Method Development for

Chemical, UV-Vis & HPLC

Technique

4. 11/01/2016 Dr. Gopa Ghosh GLP and Practical tips on Speedy

Quality Testing

5. 11/01/2016 Dr. K. V. Jogi History of CDTL and Process in

making CDTL one of the leading

laboratories.

6. 16/03/2016 Dr. J. G.Mhalas NABL Pre-assessment Audit

Briefing

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c) Out – Door Trainings &Seminars :

Technical and administrative staff also nominated for attending

training and other related seminars to them as follows :

1. Workshop on Laboratory Data Integrity held at Mayfair Banquets,

Worli, Mumbai on 08/05/2015 organised by IDMA, Mumbai.

Attended by :Smt S. U. Warde, SSO-II

2. International Seminar IPHEX - 2015 held at Bombay Exhibition

Centre, Mumbai organised by Pharmaxceil from 13/05/2015 to

15/05/2015.

Attended by : Smt S. A. Paranjpe, SSA,Smt S. S. Kaisare, SSA

3. Training on Total Uncertainty Measurement held on 14/05/2015 at

IDEMI, Mumbai.

Attended by : Dr. M. Vijay Kumar SSA, Smt S. A. Navaratne SSA,

Smt S. S. Parikh JSA, Dr. Anantha Rama. G JSA

4. Training at IPC Ghaziabad on 18/05/2015 and 19/05/2015 toget

acquainted with NABL proceedings and guidance.

Attended by :Smt S. S. Kaisare SSA, Smt S. A. Navaratne, SSA

5. One day meeting with Dr. Ronald Piervincenzi, Chief Executive

Officer, United States Pharmacopoeia at IDMA, Mumbai on

05/06/2015 along with other Pharma Stakeholders.

Attended by :Smt M. M. Patel SSO-I, Smt S. U. Warde SSO-II

6. Meeting on “Single Window Project - Follow up meeting regarding CRCL Lab module Extension” to DCG(I) and Textile Committee reg.

on 20/08/2015 at Textile Committee, Prabha Devi, Mumbai.

Attended by :Smt M. M. Patel SSO-I

7. Workshop for HPLC/UPLC/LC-MS users at Ghatkopar on

29/09/2015organised by Waters (I) Ltd.

Attended by :Dr. M. Vijay Kumar, SSA, Dr. Anantha Rama G. JSA,

Shri Ashok Kumar, JSA

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8. One day workshop on “Awareness of IP and Indian Pharmacopoeia

Reference standard (IPRS) ’’at Pharmacy & Technology management,

NMIMS, Vileparle, Mumbaion 07/10/2015 organised by IPC and

Pharmexcil.

Attended by :Shri A. K. Nagarkar JSA, Shri S. K. Singh JSA,

Smt. S. G. ChithilapillyJSA ,Shri P. P. Thakur JLA

Bench Chemists :Shri. A. R. Chaurasia,Smt. S.D.Shriyan,

Ms. N. V. Kocharekar,Smt. SobiaMohd. Abdul Ghani

Data Entry Operator :Smt. S. Yadav, Ms. A. Desai, Shri.K. Avhad,

Shri. S. S. Shirke

9. 18th IDMA-APA,PAC Seminar on Quality and Compliance Global

Expectations, organised by IDMA and APA held at Sofetil at BKC

Mumbai from 09/10/2015 to 10/10/2015

Attended by :Smt S. S. Parikh, JSA, Smt. H. H. Talapadtur, JSA,

Shri M. Dange, Bench Chemist

10. Training programme on "NABL accreditation as per ISO/IEC

17025:2005”organised by Indian Pharmacopoeia Commission,

Ghaziabad from12/10/2015 to 15/10/2015 held at IPC, Ghaziabad.

Attended by :Smt. M. M. Patel SSO-I, Smt. S. U. Warde SSO-II,

Dr. M. Vijay Kumar SSA.

11. SPDS Course III on Dissolutions Science on the topic “Dissolution

and Bioavailability - fundamentals and applications of IVIVC” at

SciTech Centre, Mumbai on 19/10/2015 and 20/10/2015.

Attended by : Smt. M. M. Mathure, JSA, Shri S. D. Yadav, JLA,

Ms. Priyanka Kori, Bench Chemist

12. Seminar of Waters Corporate at Andheri on 06/11/2015

Attended by : Dr. M. Vijay Kumar, SSA

13. Seminar of USP India PE course on “Development and

Validation of Dissolution Procedure” held at Andheri, Mumbai on

14/11/2015 and15/11/2015 organised by USP, India.

Attended by :Shri. Ashok Kumar, JSA

Bench Chemists :Shri. Bhushan B. Sonawane, Smt .Sobia Mohd.

Abdul Ghani, Smt. Priyanka Gondhale.

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14. 67th Indian Pharmaceutical Congress – “Healthy India – Swasth

Bharat” 2015 held at JSS University Mysuru from 19/12/2015 to

21/12/2015organised by IPCA.

Attended by : Dr. Anantha Rama. G JSA, Shri. Shrawan Kumar Singh,

JSA, Shri. Amol Akash, JSA, Shri. Ashish Yenkar, JSA

15. Attended Hindi Sammelan at Mumbai on 17/02/2016 and 18/02/2016.

Attended by :Shri. Shrawan Kumar Singh, JSA, Shri. Santosh.B. Doke,

LDC

16. One Day USP dietary Supplements workshop in collaboration with

Pharmexcil at Hotel Courtyard - Marriot, Mumbai on 25/02/2016

Attended by : Bench Chemist : Smt. Sobia Mohd. Abdul Ghani,

Shri. Anand Patil

17. One day hands-on training programme on Implementation of

Personal Information system (PIS) under General administration

Module at Zones/Sub-Zones/Port Office/Labs of CDSCO under e-

Governance on 29/02/2016

Attended by :Shri. Santosh B. Doke, LDC.

18. Two days USP PE course on “Pharmaceutical Waters” at Mirage

Hotel, Mumbai on 21/03/2016 and22/03/2016.

Attended by :Smt S. S. Kaisare, SSA, Shri. AmolAkash, JSA

Bench Chemist : Ms. Shriyan. Saraswati.Dasappa,

19. One day workshop on “HPLC/UPLC/LCMS Seminar and Demo of

Q Da Mass Detector” by Waters India Pvt. Ltd. at Presidential Plaza,

Mumbai on 10/03/2016.

Attended by :Shri. S. K. Singh, JSA ,Shri. H.P. Magar, SLA

20. Training of Public Financial Management System on 15/03/2016 at

Ballard Estate, Mumbai.

Attended by :Smt. S. S. Chindarkar, UDC, Smt. S. R. Rajangali, LDC

21. Seminar on Agilent Technologies Optimize Your Lab Productivity

on 18/03/2016 at Hotel United – 21 Thane.

Attended by :Shri A. K. Nagarkar, JSA, Smt. Harshada. H. Talapadatur,

JSA

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5) Meetings attended by Dr. Raman Mohan Singh, Director :

1. First meeting to review the matters related to all the Central Drugs

Testing Laboratories at CDSCO, Head Quarters, FDA Bhavan,

New Delhi on 15/05/2015 and 16/05/2015.

2. Deputed for IP related work at IPC by the DCG(I) from 18/05/2015 to

22/05/2015.

3. Attended LSW 2nd Meeting along with JS(Regulatory) and DCG(I)

with stakeholders regarding Clinical Trials and Biologicals at

Mumbai on 30/05/2015.

4. Meeting at IPC, Ghaziabad on 22/07/2015 regarding “Agenda of next

SB meeting of IPC and recruitment of Pharmacopoeial Associates” at Zonal Office of IPC at Mumbai.

5. Meetings to discuss at CDSCO, Head Quarters, FDA Bhavan, New Delhi

and at Ministry of Health & Family Welfare, Nirman Bhavan, New

Delhi to discuss the administrative matters.

6. 48thDrugs Consultative Committee (DCC) meeting at FDA Bhawan,

New Delhi on 24/7/2015 called by DCG(I) Office, CDSCO, Head

Quarters.

7. The 31st Scientific Body Meeting of IPC at Malviya Bhawan, New

Delhi on 25/07/2015.

8. “ISPEYPEP conference on Supplier Quality Management” as Guest

of Honour at JW Marriot, Mumbai on 01/08/2015.

9. Meeting attended along with Mrs. M. M. Patel at Textile Committee,

Prabha Devi, Mumbai on “Single Window Project Follow up meeting

regarding CRCL Lab Module extension to DCG(I) and Textile

Committeereg.” on 20/08/2015.

10. The meeting called by DCG(I) at FDA Bhawan, CDSCO Head Quarters,

New Delhi of all Directors& CDSCO official for “Efficient running the

drugs testing laboratory in the country” on 08/09/2015.

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11. The meeting at FDA Bhawan, called by DCG(I) “ to discuss the issues

related to proper and timely utilisation of funds sanctioned by the

cabinet committee on economic affairs to CDSCO during 12th Five

Year plan on 14/09/2015

12. Attended the IP working group meeting held on 15/09/2015 and

16/09/2015 as Expert to review the IP related work.

13. Attended WHO - Regional meeting for promoting cooperation for

Regulation in Trade of Medicinal Products at WHO-SEARO New

Delhi on 21/09/2015 and 22/09/2015.

14. Attended as auditor “Audit for Gap analysis of RDTL

requirements under 12th Five Year Plan at RDTL-Chandigarh “ on

23/09/2015 as instructed by CDSCO, Head Quarters.

15. 49th Meeting of the Drugs Consultative Committee at FICCI

Auditorium New Delhi on 16/10/2015, called by DCG(I), CDSCO, Head

Quarters.

16. The meeting under the Chairmanship of Joint Secretary (Regulatory) to

“Review the status of test / analysis of drugs samples of all Central /

Karnataka State Govt. Drugs testing labs and related issues” at

Nirman Bhawan, New Delhi on 17/10/2015.

17. The meeting for discussion on “Implementation of FCTC Article 9&

10 in relation to tobacco testing laboratories and analysis of

Smokeless Tobacco (SLTs) at DGHS, Nirman Bhawan, New Delhi held

under the chairmanship of Addl. DGHS on 19/10/2015.

18. The first meeting of “IPRS Review Committee of IPC“ as its member

held at Indian Pharmacopoeia Commission, Ghaziabad on 29/10/2015.

19. The meeting for review of recruitment rules of Central Drugs

Laboratory at FDA Bhawan, New Delhi on 30/10/2015.

20. The"38th Annual meeting of the National Pharmaco vigilance

Centres Participating in the World Health Organization (WHO)

Programme for International Drug Monitoring" on 4/11/2015 to

6/11/2015 at the Grand New Delhi organised by PVPI-NCC of IPC,

Ghaziabad.

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21. Meeting for administrative matter discussion and for amendments in

existing Recruitment Rules of CDTL, Mumbai at CDSCO, Head

quarters, New Delhi on 23/11/2015.

22. The Technical Specification review meeting on 24.11.2015 at HLL Life

care Limited, Noida.

23. Meeting of BIS-PCD-21 regarding standards of plastic containers at

Manak Bhavan, New Delhi on 13/12/2015.

24. “IPC - general Chapter Review Meeting“ at CDTL - Mumbai on

22/12/2015

25. Attended the meeting of New Monographs in 8th edition on Indian

Pharmacopoeia (IP-2018) held at IPC, Ghaziabad on 27/01/2016.

26. Attended the “Review meeting of National Drugs Survey Testing”

held on 02.02.2016 at National Institute of Biologicals, Noida.

27. Attended the meeting at NTCP, DGHS, Nirman bhavan, New Delhi on

15/02/2016 regarding the renovation of Regional National Tobacco

Testing Laboratory at CDTL, Mumbai.

28. Attended the meeting called by Addl. D. G. To “ discuss to the

Memorandum of Understanding (MOU) for the National Tobacco

Testing Laboratories ”at Nirman Bhawan, New Delhi” on 29/02/2016.

29. Attended the “27th Meeting of BIS Cosmetics Sectional Committee,

PCD 19 and its Subcommittee” held on 04.03.2016 at BIS Auditorium,

New Delhi.

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6) Seminar, workshop attended / as Faculty / to deliver Lecture/ or Presentation by Dr. Raman Mohan Singh, Director :

1. Presentation on “Indian Pharmacopoeia - A Book of Global

Standards” in IPHEX - 2015 organised by Pharmaxcel on 14/05/2015 at

Bombay Exhibition Centre Mumbai.

2. Delivered lecture as Faculty on “Role of IP for Quality Medicines” in

4thTraining Programme for Analysts of Central and States Laboratories

at IPC, Ghaziabad on 15/09/2015.

3. Delivered lecture on “Role of IP for Quality Medicines” as Faculty at

“One day workshop on awareness of IP and IPRS” organised by IPC

and Pharmexcil at NMIMS, Mumbai on 07/10/2015.

4. Attended inaugural function of “18th IDMA-APA, PAC on Quality

and Compliance : Global Expectation at Safitel, BKC , Mumbai on

08/10/2015.

5. Delivered the lecture as a speaker “ in ITEC International Training

Programme sponsored by External Affairs Ministry, Govt. Of India at

NIPER, Mohali, Chandigarh on 28/10/2015 attended by ASEAN

countries Regulators and Laboratory Staff.

6. Attended Launching of “Organ donation by Ministry of Health &

Family Welfare Ministry at Vigyan Bhavan” New Delhi on 27/11/2015.

7. Attended 67th Indian Pharmaceutical Congress 2015 held at Mysuru

from 19/12/2015 to 21/12/2015 as chairman of one scientific session.

8. Attended One day seminar as Chairman of one session, on “Role of

Academics, Pharmaceutical Industry and IT Sector in promoting

India’s Health Sector” organised by CDSCO, West zone Mumbai in

Collaboration with IPC, Ghaziabad at CSIR – NCL, Pune on 07/01/2016.

9. Attended One day Workshop on “Emerging Needs and Regulations of

Phyto pharmaceuticals” at Zonal FDA Bhavan, Mumbai organised by

BIRAC-CDSA-DST and CDSCO, Mumbai on 12/01/2016.

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10. As Faculty and given a lecture on “Requirements of GLP for

Inspection” in a one month Training Programme for Drugs Inspectors at

NIB, Noida organised by CDSCO, Head Quarters on 22/01/2016.

Addressing during seminar on “Role of Academics, Pharmaceutical

Industry and IT Sector in promoting India’s Health Sector”

on 07.01.2016.

7) International visit / Meeting attended Attended ISO/TC-217 15thmeeting at Dubai from 07/12/2015 to 11/12/2015

as a member of delegation from BIS-PCD- 19 representing India.

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8) Monthly Review Meetings and Management Review Meetings Monthly review meetings were conducted to motivate the staff and

also keep them aware of the laboratory goals. These meetings also

help the management in knowing the grievances of the staff and

find a solution. The targets for the month and any short falls to

achieve the same are also discussed during these meetings.

Management Review Meetings (MRM) also takes place two times

in a month to review the progress made and to discuss future

targets with Senior Technical Officials and Administrative

officials. Action to be taken and progress of last meeting minutes

also discussed in the MRM.

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9) Analytical Research and Development :

The Analytical Research & Development department generates

new ideas to enrich the knowledge base. It helps to sort out the

problems faced in related analytical methodology.

The senior officials encourage research activities and the analysts

have put in extra efforts for method development of drug

combinations.

An RPHPLC method for simultaneous estimation of Sildenafil

citrate and Tadalafil in capsule dosage form was developed.

10) Preparation of Internal Working Standards :

The laboratory has taken up the work of preparing Internal

Working Standards of appropriate quality. 13 Working Standards

have been standardised in this period.

Assessment of the suitability for use is carried out. Identification,

LOD/Water, Purity are some of the criteria covered for which the

drug is certified as working standard.

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11) NABL (ISO/IEC 17025:2005) accreditation :

Another milestone of 2015 is that CDTL – Mumbai has applied for

NABL accreditation in October 2015. The Accreditation is

considered as the first essential step for facilitating mutual

acceptance of test results and measurement data. The pre-

assessment of NABL was successfully faced by CDTL-Mumbai on

16.03.16.

12) Integrated Management System :

In order to strengthen the organisation value and gain global

recognition the laboratory is geared up to acquire certification of

IMS(ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007).

The senior staff of CDTL - Mumbai was trained for Integrated

Management System for ISO-9001:2008 & ISO 14001:2004 and

OHSAS 18001:2007. The training was conducted on 22/12/2015 to

24/12/2015 through Nutan Quality System Consultancy.

13) Eco friendly Premises :

As a citizen everybody must grow a social responsibility to

maintain an eco-friendly life and that will go down the generations

to save our Mother Earth. Gardening work started already to make

the premises more green. The laboratory started horticulture as an

art and designing the plants. The STP plant is also an additional

feature in encouraging eco friendly premises and good

environmental conditions.

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14) Gap analysis :

Team appointed to carry out Gap analysis of existing infrastructure

In terms of both physical & human venues and planned

infrastructure in order to upgrade the testing capacity of analysis,

10000 samples per annum. The team examined and analysed

requirements for expansion/ up gradation of CDTL-Mumbai under

the 12th five year plan. A meeting for the purpose was held on

24/09/2015 at CDTL, Mumbai by the team appointed by Head

Quarters which submitted its report to the higher authority for

further action in the matter.

26

15) Budget :

Total budget sanctioned for the year 2015-2016 was Rs. 8,21,00

(thousands) which was utilised judiciously to upgrade the

laboratory facilities as follows :

Sub Head

Budget

Provision

During the

year

2015-16

(Rs. In

Thousands)

Total

Expenditure

2015 - 2016

Progressive

Exp.

March -

2016

Balance as

on March –

2016

PLAN PLAN PLAN PLAN

Salary 3,20,00 4,55,937 2,97,81,716 22,18,284

Wages 5,00 40,334 4,63,475 36,525

OT 0 0 0 0

MT 5,00 34,579 2,95,885 2,04,115

TE 6,00 2,08,673 5,91,938 8,062

OE 1,80,00 9,04,862 1,79,91,511 8,489

PUB 5,00 6,410 4,92,576 7,424

S&M 85,00 9,49,462 84,96,839 3,161

M/W 3,00 1,15,390 2,97,297 2,703

PS 70,00 6,55,575 69,23,489 76,511

OC 5,00 9,202 4,99,710 290

M&E 1,37,00 48,12,033 82,03,472 54,96,528

TOTAL 8,21,00 81,92,457 7,40,37,908 80,62,092

27

ACHIEVEMENTS

1) Participation in Testing of National Drug Survey Samples :

With the additional staff and sophisticated equipments, the

laboratory was able to discharge its responsibilities of testing

of samples in a more effective and efficient manner in the

shortest period. The laboratory participated in the testing of

Drug Samples received (about 6000) through NIB under

National Drug Survey to identify Spurious and Not of

Standard Quality drugs moving in Indian Market.

2) New Recruitments and Enhancement of Testing Capacity:

The major achievement is to increase the capacity of quality

testing to more than 7000 samples per annum. 30 New Bench

Chemists were employed in the laboratory during this period

for helping in testing National Drug survey Samples of Drug

Safety India through NIB, Noida. With recruitment of

additional Bench Chemists, time limit for analysis of life

saving drugs have decreased. Their addition has significantly

enhanced the output of the laboratory and further strengthened

it.

3) Enhancement of Instrument facility :

In addition to the existing instruments, new instruments like

5 Nos. of Dissolution Apparatus, 4 Nos. of HPLC systems,

Polarimeter, Water System, pH meters, Disintegration Test

Apparatus, Potentiometric Titrator, Bacteriological Incubators

were purchased to speed up the analysis.

4) Trainings and Seminars :

In house Seminars and Training Programmes are organized to

enhance and update the knowledge of the staff. With a view to

encourage and boost their confidence to discharge their

28

functions more efficiently, we provide the opportunities to

work with almost all instruments. The laboratory encourages

the staff to attend seminars and trainings of other organizations

to cope up with latest developments in the Pharma Sector and

Laboratory Instruments. Experts and professionals from

Pharma Sector are invited as faculties to deliver lectures to

enhance the technical skill of our staff and to improve their

skill in scientific and R & D sphere.

5) Accreditations :

Another milestone of 2015 is that CDTL – Mumbai has applied

for NABL accreditation in October 2015. The Accreditation is

considered as the first essential step for facilitating mutual

acceptance of test results and measurement data. The pre-

assessment of NABL was successfully faced by CDTL-

Mumbai on 16.03.16.

6) Revenue Generation :

The laboratory is now generating revenue in the form of testing

fee for Registration Samples for analysis. Charges for the tests

of these samples are collected as per Drugs & Cosmetics Act

and deposited in Government of India account. The revenue

generated from October - 2015 to March – 2016 (06 months)

in the fiscal year is Rs.9,76,610/-which is a major

achievement.

7) Biometric Attendance :

The laboratory has introduced Aadhar Enabled Biometric

Attendance System from June 2015 to enhance the punctuality

of employees.

29

Other Activities

INDEPENDENCE DAY CELEBRATION This year Independence day was an exceptional and special day

for CDTL. The office of Central Drugs Testing Laboratory,

Mumbai has celebrated the 69th Independence day of India at

9.30 am on 15th August 2015 at the office premises of Zonal

FDA Bhavan, GMSD compound, with much enthusiasm at the

instance of Dr. Raman Mohan Singh, Director (CDTL). The

national flag was hoisted by Dr. Raman Mohan Singh, Director,

CDTL along with other guest officers viz. Dr. K. Bangarurajan,

DDC(I) and Dr. S. Sudhakar, CMO & GMSD I/C followed by

National Anthem. In order to make the function grand success,

80% of officers/staff (including contractual staff) from the office

of central drugs Testing Laboratory, Mumbai Dy. Drugs

Controller, CDSCO, WZ Office had attended the ceremony. The

staff expressed their individual views towards future progress

and achievement in the interest of nation and celebrated by

singing patriotic songs.

30

Seminar/Lecture of Dr. Prakash V. Diwan

To encourage and motivate the staff a lecture cum seminar was

conducted at CDTL-Mumbai, Seminar Hall on 16/12/2015 to

enlighten the staff regarding NABL accreditation by Dr.

Prakash V. Diwan, Former President, IPS, Former Project

Director, NIPER Hyderabad and Technical Advisor to IPC-

Ghaziabad.

Dr. Diwan’s lecture was highly motivating. The presentation

was imparted in two parts. The first half was an inspirational

speech on “Attitude a Key to Success” which was an eye

opener. The speech highlighted the importance of “Positive

Attitude” in the daily life for success.

The second part of Dr. Diwan’s lecture emphasised on the

overview of NABL and ISO/IEC 17025:2005. The clauses of

ISO were discussed and the staff was briefed on Integrated

Management System. His motivation will definitely enhance

the spirit of CDTL personnel towards achieving our motto

“DOING WELL AND DOING GOOD”.

31

FOUNDATION DAY CELEBRATION AT CDTL – MUMBAI We in CDTL took pride and pleasure in celebrating our Foundation

day on 11th January, 2016. On this day a puja was arranged to

embark the beginning of the new year followed by a workshop cum

lecture sessions by our guests – Ex-Director (I/c) Dr. K. V. Jogi, &

Ex. Director (I/c) Dr. (Mrs.) Gopa Ghosh. Their presence on this

auspicious day was a boost for all the employees.

Dr. Gopa Ghosh gave a presentation on GLP & Practical tips on

speedy quality testing. She emphasized the need of implementation

of quality management system and Good Laboratory Practices. The

intent was to ensure reliable generation and verification of all data

establishing confidence in the integrity of the data. The next lecture

was given by Dr, K.V. Jogi. He traced the history of CDTL and its

foundation, and reflected on how far it has come. It was heart

warming and compassionate for the senior staff to reminisce the old

days. After the striking lectures mementos were given to the guests

and they were felicitated. During the felicitation Dr. Raman Mohan

Singh gave special credit to all team members who have really

worked hard in this process to make CDTL-Mumbai one of the

leading laboratories. He said that the laboratory has to go a long

way & we can achieve our common goal.

32

Republic Day Celebrations :

The laboratory celebrated the 67th Republic Day at 9.30 am

on 26th January 2016 at the office premises of Zonal FDA

Bhavan, GMSD compound, with much fanfare The national

flag was hoisted by Smt. M. M. Patel SSO-I, CDTL along

with the guest officer Dr. S. Sudhakar, CMO & GMSD I/C

followed by National Anthem. The staff expressed their

individual views towards future progress and achievement in

the interest of nation.

Visit of Drugs Controller General (India): Dr. G. N. Singh, DCG(I) addressing the CDTL & CDSCO,

West Zone staff on 13.05.2016

33

Visit of Additional Secretary: Shri. K. B. Aggarwal, Additional Secretary accompanied by

Dr. S. Eeswara Reddy, Joint Drug Controller (I) visited on

23/01/2016.Mr.Aggarwal started the session by asking the

staff to introduce themselves. He insisted on giving ideal

output and practically possible output from instruments. His

emphasis was on the maximum utilisation of man power and

instruments as both are very significant in increasing the

analysis capacity of the laboratory. The staff discussed their

grievances with him regarding upgradation, promotional posts

etc. He advised the officials to prepare a statistical report on

output of each instrument depending on the time required for

analysis of each sample molecule. He ended the session by

motivating the staff to strengthen the visibility of the

laboratory and work ahead to expose it as MODEL

LABORATORY.

34

FUTURE PLANS :

Renovation of Microbiology Division and expansion of clean

room area.

To add two more floors on the existing building for expansion

and to develop Cosmetics and Medical Devices Section and

storage facility at the basement.

The laboratory is looking forward for final audit of NABL

(ISO/IEC17025:2005) Accreditation The laboratory is

committed for IMS (ISO 9001:2008, ISO 14001:2004 &

OHSAS 18001:2007) certification.

To establish the E – governance system in official day to day

work and to have online receipt and reporting system for

testing reports through SUGAM Portal.

Plan to establish a Training Cell and Analytical Research

Centre to enhance the efficiency and effectiveness of the

laboratory.

With a view to promote eco – friendly premises through green

environment, we plan to increase the plantation to make the

campus clean and green.

Propose installation of Solar System to minimize the

consumption of electricity.

Setting up of Regional National Tobacco Testing Laboratory

(RNTTL) under National Tobacco Control Programme

(NTCP) of DGHS, Ministry of Health & Family Welfare as

directed by DGHS.

We in CDTL have a strong track of creating and delivering

values. Our journey is characterized by our ability to pursue

our goals with conviction

We try to remain true to our commitment, to our objectives

and policies.