BRIEF PROFILE Dr. Gyanendra Nath Singh (Dr. G ... -...

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BRIEF PROFILE

Dr. Gyanendra Nath Singh (Dr. G. N. Singh) M. Pharm., Ph.D., M.B.A. (U K)

Drugs Controller General India &

Secretary-cum-Scientific Director, IPC

Representation in various committees constituted by Govt. of India for protecting patient health

and safety in the country

Chairman - Drugs Consultative Committee, Ministry of Health and

Family Welfare, Govt. of India

Working Group of Pharmacovigilance Programme of India

Investigational New Drug approval committee

President - President, Indian Pharmaceutical Congress Association 2015

(IPCA)

Member - Drugs Technical Advisory Board, Ministry of Health and

Family Welfare, Govt. of India

National Pharmaceutical Pricing Authority, Govt. of India

Ayurveda Siddha Unani Drug Technical Board

(ASUDTAB), Department of Ayush, Ministry of Health and

Family Welfare, Government of India

Expert Core Committee of National List of Essential

Medicines, Govt. of India

Pharmacy Council of India, Govt of India, New Delhi

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Pharmacopoeia Commission for Indian Medicine (PCIM),

New Delhi

Jan Aushadhi Programme, Department of

Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt.

of India, New Delhi

National Institute of Pharmaceutical Educational

Research, Mohali, Punjab

Institutional Human Ethics Committee, National Institute of

Biologicals, Noida

The Appellate Committee, AICTE, New Delhi

Advisory Committee for Vaccinology , Jamia Hamdard

University, New Delhi

GLP Inspector -

President -

National GLP Compliance Monitoring Authority, Dept. of

Science and Technology, New Delhi

67th

Indian Pharmaceutical Congress, Mysore

Representation at international level in protection health and safety

World Health Organisation

(WHO) -

Member of the Expert Advisory Panel on International

Pharmacopoeia and Pharmaceutical Preparations

Editorial/Advisory Board - Newsletter, Pharmacovigilance Programme of India (PvPI)

Journal of Indian Chemical Society, Kolkata.

Indian Drugs, New Delhi.

Bulletin of Medico-Ethno-Botanical Research, New Delhi.

Honours and Awards -

To be conferred “U.P. Ratan Award” on 13th

September, 2015

“Sri Sri Anandmayee Sangh Award 2015” for supporting

patient safety and quality healthcare at Varanasi on August 9,

2015 with Partnership for Safe Medicines India.

“Dhanwantri Award for 2014” on 16th

November for

protecting Indian Tradition and Culture in the area of Health

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and Medicines by Akhil Bhartiya Vidhyat Parishad, Varanasi

Honoured for outstanding collaboration between Indian

Pharmacopoeia Commission and United State

Pharmacopoeia Convention from USP (USA), Sept 2011

Dr. P. D. Sethi Annual Award – 2010 for the best Research

Paper on Application of TLC/HPTLC in Pharma, Herbal and

Miscellaneous Analysis.

IDMA-APA PAC 2006 conferred “Award for Excellence in

Indian Pharmacopoeia Development” for the magnificent

contribution made to the discipline of Pharmaceutical Analysis

and Regulatory Affairs

Academic contribution

Advisor - Academic council/Senate member

Senate Member, Manipal University

Member, Academic Council, Banaras Hindu University,

Varanasi

Member Advisory Committee, JSS University, Mysore

Member Board of Academic Institutions Governing

Pharmacy Courses.

Advisor/External

examiner/Evaluator in

following Universities -

Delhi Institute of Pharmaceutical Sciences and Research

(DIPSAR), New Delhi

Jamia Hamdard, New Delhi

Rohtak University

Banaras Hindu University, Varanasi

Fellow Member - Fellow Institution of Chemists, Kolkata

Fellow, Indian Chemical Society, Kolkata

Fellow, Indian Institution of Chemists, Agra

Life Member, Mahamana Malaviya Mission

Research - Supervised various research projects leading to Doctorate and Post

graduate degree in Pharmaceutical sciences and the dissertation of

the same is submitted to universities for the award of the degree.

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Correspondence

(Office): Drugs Controller General (India)

Central Drugs Standard Control Organisation (CDSCO),

Ministry of Health & Family Welfare, Government of India,

FDA Bhavan, Kotla Road,

New Delhi-110002

Tel.: Offc.011-23236965, 23236976

Mobile: 9810379246

Fax: 011-23236973

Email: [email protected]

&

(Office): Secretary-cum-Scientific Director,

Indian Pharmacopoeia Commission,


Sector 23, Raj Nagar, Ghaziabad-201 002.

Tel.: Offc. 0120-2783392, 2783401

Mobile: +91 9810379246

Fax: 0120-2783311

Email: [email protected]

(Home): D-1, Type 5A, MS Flats,

Tilak Marg,

New Delhi-110001

Mobile: +91 9810379246

Email : [email protected]

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PROFILE

Dr. Gyanendra Nath Singh (Dr. G. N. Singh)

M. Pharm., Ph.D., M.B.A. (U K)

Drugs Controller General (I)

Central Drugs Standard Control Organisation (CDSCO)


New Delhi, India

&

Secretary-cum-Scientific Director

Indian Pharmacopoeia Commission


Sector 23, Raj Nagar, Ghaziabad, India

Date of Birth: 02-10-1959 Nationality: Indian

Correspondence:

D-1, Type 5A, MS Flats,

Tilak Marg, New Delhi-110001

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Mobile: +91 9810379246

Email : [email protected]

EDUCATIONAL QUALIFICATION:

o Have passed with first class having distinctions in major subjects.

S. No Examination Year University Major Subjects

1 Ph.D. 1983 -

1987

Banaras Hindu

University

Pharmaceutics

2 MBA 1997 -

1998

University of

Hull, U.K.

Human Resource Management,

Marketing, Strategic Management

3 o M. Pharm 1981-

1983

Banaras Hindu

University

Pharmaceutical Chemistry ,

Pharmcognosy, Advance

Pharmaceutical Analysis

4 o B. Pharm 1977-

1981

Banaras Hindu

University

Pharmaceutical Chemistry,

Pharmaceutics, Pharmcognosy,

Chemical Engineering,

Pharmaceutical Managent

5 o B.Sc.- I 1977 Banaras Hindu

University

English, Physics, Chemistry, Maths

6 o P.U.C. 1975 Banaras Hindu

University

English, Nepali, Physics, Chemistry,

Maths

7 o High

School

1973 U.P. Board English, Hindi, Maths, Biology,

Science

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WORK PROFILE:

S.No Designation Organisation Period

1 Drugs Controller General

(India)

[Additional Charge]

Central Drugs Standard Control

Organization (CDSCO),

Directorate General of Health Services,

Ministry of Health & Family Welfare, Govt.

of India

21st February 2012 to

Till date

2 Secretary-cum-Scientific

Director

Indian Pharmacopoeia Commission,

Ministry of Health & Family Welfare,

Govt. of India

1st September 2009 to

Till date

3 Director Ministry of Health and Family Welfare

Govt. of India

21st October 2002 to

31st October 2009

4 Manager

(R&D)

Formulation Unit, Indian Drugs &

Pharmaceuticals Limited (IDPL), Gurgaon

18th

September 2001 to

20th

October 2002

5 Dy. Manager

(FDRL)

Formulation Plant,

Indian Drugs & Pharmaceuticals Limited

(IDPL), Gurgaon

1st May 1995 to

17th

September 2001

6 Sr. Executive

(Research Development)

Corporate Office, Indian Drugs &

Pharmaceuticals Limited (IDPL)

24th

February 1992 to

30th

April 1995

7 Executive

(Formulation

Development)

Indian Drugs & Pharmaceuticals Limited

(IDPL),(A Govt. of India Under-taking)

21st August 1989 to

23rd

February 1992

8 Pool Officer Council of Scientific and Industrial Research

(CSIR),New Delhi

1st August 1988 to

20th

July 1989

9 Research

Associate

Institute of Technology, Banaras Hindu

University (BHU)

15th

June 1987 to

31st July 1988

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BRIEF WORK PROFILE:

1. National Drug Regulatory

From February, 2012 working as Drugs Controller General (India)

[Additional Charge] at Central Drugs Standard Control Organization

(CDSCO), Directorate General of Health Services, Ministry of Health &

Family Welfare, (Govt. of India). Discharging duties for Control and

regulation of Drugs and Pharmaceuticals Industry in India, Licensing and

Approval of New Drugs Biotherapeutics, Vaccines and FDCs, Clinical Trials

and Stem Cells Therapy Regulation and Update of Drugs & Cosmetics Act

1940 and rules there under.

As per the recommendation of Union Public Services Commission, joined as

Director, Central Indian Pharmacopoeia Laboratory (CIPL), a

subordinate office of the Directorate General of Health Services, Govt. of

India, (October 2002 to August 2009).

As per Gazette Notification of the Ministry of Health & Family Welfare,

Government of India, undersigned was declared as a Government

Analyst (2004 to 2008) at CIPL and discharged the responsibilities in

accordance with the provisions of the Drugs & Cosmetics Act, 1940, and

Rules, 1945 there under.

Discharged the duties of Appellate Laboratory in respect of condoms testing

as per provisions prescribed in Drugs and Cosmetics Rules, 1945.

More than 28 years of experience in Scientific Administration, Regulatory

Affairs, and Financial Management by virtue of working in Drugs Sector,

mainly in Formulation Development, Manufacturing, Quality Control and

Quality Assurance of Drugs.

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2. Quality and Safety of Drugs and Pharmaceuticals in Country

As Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission

(IPC):

Ensures timely publication of Indian Pharmacopoeia (IP) its addendum. IP is

produced by Indian Pharmacopoeia Commission (IPC), in fulfillment of the

requirement of Drugs & Cosmetics Act 1940 and Rules 1945 there under to

ensure Quality medicines to the public.

Promotes Rational use of medicines in the country, as Secretary-cum-

Scientific Director is responsible for timely publication of National Formulary

of India (NFI).

Monitors Safety of medicines in the country through ‘Pharmacovigilance

Programme of India (PvPI)’ and helps in regulatory decisions to CDSCO.

As DCG(I):

Ensures availability of quality and safety medicines to the public through

various regulatory approvals for manufacturing and marketing of drugs and

pharmaceuticals in the country.

3. Administrative

The Govt. of India constituted the Indian Pharmacopoeia Commission as an

Autonomous Body under the Ministry of Health and Family Welfare in year

2004, undersigned was assigned the duties of Secretary-cum-Scientific

Director from September 2009 to till date. As Chief Scientific and Executive

Officer of the Commission, the job profile includes providing overall direction

and leadership to the Commission in preparation of monographs for drugs and

formulations to be incorporated in the Indian Pharmacopoeia (IP). Bring out

Indian Pharmacopoeia and National Formulary of India on regular basis.

Maintain close coordination on issues related to Scientific, Technical and

Regulatory with National and International Bodies.

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As Head of the Office of Central Indian Pharmacopoeia Laboratory (CIPL),

Ghaziabad a subordinate office of the Directorate General of Health Services

from October 2002 to August 2009.

Held responsibility of Product Development, Personnel and Administration at

Plant level. Involved in Scientific and Administrative Management of

Formulation Development and HRM at IDPL Plant level at Indian Drugs &

Pharmaceuticals Limited (IDPL) A Govt. of India Under-taking company

from May 1975 to October 2002.

4. Research in Pharmaceuticals

Involved in research programmes in the area of physical pharmacy, and

Responsible for formulation development and research of new products

consisting of solid-dosage forms, parenterals and others as Research associate

and Pool officer (CSIR) at Banaras Hindu university (BHU) from June 1987

to July 1989. Also published the scientific findings in various indexed

scientific journals. At BHU, also involved in teaching of graduate and post

graduate pharmacy students.

Further extended the research activities in formulation of drugs and product

development at Research and Development (R&D) department of Indian

Drugs & Pharmaceuticals Limited (IDPL) A Govt. of India Under-taking

company as Executive and grown up to the level of Manager from August,

1989 to October 2002.

KEY ACHIVEMENTS

Established procedure for recommending payments for compensations in case

of injury/death during clinical trial through ‘Amendments in Drugs and

Cosmetics rule 1945 for safe guarding the rights, safety and well being of the

clinical trial subjects’.

Regular and timely publication of IP and its Addendum

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Ensuring availability of IP Reference Substances (IPRS) and Impurity

standards to fullfill the intended purpose of IP monographs

Indian Pharmacopoeial laboratory- WHO pre-qualified and NABL

accredited to ensure ISO:IEC 17025:2005

Regular and timely publication of National Formulary of India after three

decades

Effective administration of activities related to Pharmacovigilance

Programme of India (PvPI) which was recasted to Indian Pharmacopoeia

Commission (IPC) by the MoH&FW from All India Institute of Medical

Sciences, New Delhi. ADR of drugs are monitored throughout the country

including the drugs in National Health Programmes through ADR reporting

forms and helpline number: 18001803024. PvPI also works in close

collaboration with NRA and WHO.

ADDITIONAL APPOINTMENTS & ASSIGNMENTS

1. Membership/Representation in various committees constituted by Govt. of

India for protecting patient health and safety in the country

Chairman, Drugs Consultative Committee, Govt. of India

Chairman, Steering Committee, Pharmacovigilance Programme of India,

Ministry of Health and Family Welfare, Govt. of India

Chairman, Working Group, Pharmacovigilance Programme of India,

Ministry of Health and Family Welfare, Govt. of India

Member, Drugs Technical Advisory Board, Ministry of Health and Family

Welfare, Govt. of India

Member, Ayurveda Siddha Unani Drug Technical Board (ASUDTAB),

Department of Ayush, Ministry of Health and Family Welfare, Govt of India.

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Member, Drugs Consultative Committee, Ministry of Health and Family

Welfare, Govt. of India.

GLP Inspector, National GLP Compliance Monitoring Authority, Dept.

of Science and Technology, New Delhi.

Member, Expert Core Committee of National List of Essential Medicines,

Govt. of India

Member, Pharmacy Council of India, Govt of India, New Delhi

Member, Pharmacopoeia Commission for Indian Medicine (PCIM), New

Delhi

Member, Jan Aushadhi Programme, Department of Pharmaceuticals,

Ministry of Chemicals and Fertilizers, Govt. of India, New Delhi

Member, Institutional Human Ethics Committee, National Institute of

Biologicals, Noida

Member, of the Appellate Committee, AICTE, New Delhi

Member, Advisory Committee for Vaccinology , Jamia Hamdard

University, New Delhi

2. Membership/Representation in various committees at International level:

Dr. Singh has been selected by WHO, DG as a Member of the Expert

Advisory Panel on International Pharmacopoeia and Pharmaceutical

Preparations for a period of 4 years from June 2014.

3. Member of the Editorial/Advisory Board:

Journal of Indian Chemical Society, Kolkata.

Indian Drugs, New Delhi.

Bulletin of Medico-Ethno-Botanical Research, New Delhi.

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Member Board of Academic Institutions Governing Pharmacy Courses.

4. Academic council/Senate member

Senate member, Manipal University

Member, Academic Council, Banaras Hindu University, Varanasi

Member Advisory Committee, JSS University, Mysore

5. Advisor/External examiner/Evaluator in following Universities

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New

Delhi

Jamia hamdard, New Delhi

Rohtak University

Banaras Hindu University, Varanasi

PUBLICATIONS IN SCIENTIFIC JOURNALS

Total number of research papers published 106, Publications details are appended below:-

1. Singh G.N., Singh V.P. and Gupta R.P. Colorimetric determination of

promethazine hydrochloride, Indian J. Pharm. Sci., 1984, 46(3), 125-125.

2. Singh G.N., Gupta R.P., Gulati R., and Srivastava A.K. Permeation study

of cholopromazine through poly dimethyl siloxane membrane, Indian J.

Pharm. Sci., 1984,46(4), 144-146.

3. Singh G.N., Gupta R.P., Gulati R., Effect of physico-chemical factors and

additives on permeation of Thioridazine hydrochloride through poly

dimethyl siloxane membrane, The Eastern Pharmacist, 1984, 27(320),

223-226.

4. Gupta R.P., Gulati R., Zutshi A., Singh G.N. Reaction mechanism and

colorimetric determination of phenothiazines with p-Dimethyl amino

benzaldehyde, Indian J. Pharm. Sci., 1984, 46(6), 216-218.

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5. Gupta R.P., Chandra S., Srivastava A.K., Singh O.N. and Singh G.N.

Colorimetric determination of Butaperazine dimeleate, The Eastern

pharmacist, 1985, 28(322), 135-136.

6. Gupta R.P., Singh G.N and Roy S.D. Role of isotopic dilution technique

in analytical and chemical assay of drugs. The pharmastudent, 1985-86,

23, 54-58.

7. Gupta R.P., Mandal M.K., Singh G.N. Adsorption interactions by

pharmaceutical ingredients. The Eastern Pharmacist, 1986, 29(334), 65-59.

8. Singh G.N. and Gupta R.P. Effect of solvents and additives on the

stability of drugs. Pharma Times, 1986, 18(7), 13-16.

9. Singh G.N., Gupta R.P. and Singh N.K. Drug absorption through

membranes. The Eastern Pharmacist, 1986, 29(243), 33-35.

10. Singh G.N. and Gupta R.P. Stability of Pharmaceuticals. The Eastern

Pharmacist, 1987, 30 (356), 85-89.

11. Singh G.N. and Gupta R.P. Adsorption characteristics of Norfloxacin to

pharmaceutical additives. Drug Dev. Ind. Phar., 1988, 14(13), 1845-1854.

12. Singh G.N., Gupta R.P. and Prakash P. Effect of ionic strength on the

stability of Norfloxacin. Pharmazie, 1988, 43, 134.

13. Singh G.N. and Gupta R.P. Effect of absorbents on permeation of

Norfloxacin. Pharmazie, 1988, 43, 699-700.

14. Singh G.N., Gupta R.P. and Gulati R. Invitro studies of Phenothiazines

with pharmaceutical ingredients. Indian Drugs, 1988, 25 (6), 235-241.

15. Singh G.N. and Gupta R.P. Role of antioxidants and preservatives on the

stability of drugs. The eastern pharmacist, 1988, 31 (365), 43-44.

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16. Singh G.N., Prakash P. and Gupta R.P. Effect of pH on the stability of

Butaperazine dimaleate solution in water, Indian J. Pharm. Sci., 1988,

50(2), 122-124.

17. Singh G.N. and Gupta R.P. Effect of pH on the stability of Norfloxacin.

The Eastern Pharmacist, 1988, 31 (365), 133-135.

18. Singh G.N. and Gupta R.P. Effect of ionic strength on the stability of

Butaperazibe. The Eastern pharmacist, 1988, 31 (366), 145-146.

19. Singh G.N. and Gupta R.P. Effect of solvent composition on the stability

of Butaperazine dimaleate. Indian J. Pharm. Sci., 1988, 50(4), 242-244.

20. Y.K. Aggarwal, B.E. Rao and Singh G.N. Studies on the diclofenac

sodium and determination in Pharmaceuticals, Journal of Pharma. and

Biomedical Analysis, 1991, 9(7), 101.

21. Y.K. Aggarwal, B.E. Rao, Singh G.N. New titrimetric methods for the

estimation of Diltiazem in dosage forms. Indian J.Pharm. Sci., 1991,

53(5), 214-216.

22. Y.K. Aggarwal, B.E. Rao, Singh G.N. Spectrophotometric determination

of Fortidine in pharmaceutical preparations. Journal of Pharmaceutical and

Biomedical Analysis. 1992, 10(7), 521-23.

23. Singh R. M., Ansari T. A., Jamil S., Kumar Y., Mathur S. C., Singh G. N.

Spectrophotometric Estimation of Rosuvastatin Calcium in Tablet

Formulation. Indian Drugs 2005, 42(4), 244-245.

24. Singh R. M., Ansari T. A., Jamil S., Mathur S. C., Shiv R., Singh G. N.

Determination of Etoricoxib in bulk drug and its dosage forms by RP-

HPLC. Indian Drugs 2005, 42(1), 56-58.

25. Singh R.M., Jamil S., Ansari T. A., Mathur S. C., Nivoria C. S., Pandey

M. K.,

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Singh G. N. Determination of Rosuvastatin Calcium in Pharmaceutical

Dosage Form by RP-HPLC Method. Indian Drugs, 2005, 42(2), 98-101.

26. Singh R.M., Ansari T.A., Jamil S., Kumar Y., Sharma D.K., Mathur S.C.,

Singh G.N. Spectrophotometric Method for the Estimation of Etoricoxib

in Formulation. Indian Drugs, 2005, 42(8), 535-536.

27. Singh R.M., Gupta S.K., Mathur S.C., Shiv R., Singh G.N. Quantitative

Determination of Thalidomide by Reverse Phase High Performance Liquid

Chromatography. J. Indian Council of Chemists, 2006, 22(2), 25-27.

28. Singh R.M., Mathur S.C., Shiv Raj, Singh G.N., Faisal M.S., Khar R.K.

RP-HPLC method for estimation of Modafinil in bulk drug. Indian Drugs,

2006, 43(6), 510-512.

29. Singh R.M., Khan H.R., Talegaonkar S., Mathur S.C., Singh G.N.

Spectrophotometric Determination of Repaglinide in Pharmaceutical

Dosage Form. J. Phamraceutical Research, 2006, 5(4), 111-112.

30. Singh R.M., Siddiqui A.A., Khar R.K., Mathur S.C., Shiv Raj, Singh G.N.

A Simple HPLC Method for Quantitative Determination of Nevirapine in

Tablet Dosage Form. J. Pharmaceutical Research, 2006, 5(4), 108-110.

31. Singh R. M., Khan R.,H., Talegaonkar S., Mathur S.C., Shiv Raj, Singh

G.N. A Simple HPLC Method for Quantification of Repaglinide in Tablet

Dosage Form. Indian Drugs, 2007, 44(6), 428-433.

32. Singh P., Bajpai M., Prakash O., Matur S.C., Singh R.M., Tiwari R.,

Singh G.N. Quantitative determination of Piperine in Piper longum

powder through High Performance Thin Layer Chromatography. J.

Pharmaceutical Research, 2007, 6(3), 170-172.

33. Om Prakash, Singh R.M., Mathur S.C., Singh G.N. Quantification of

Gallic acid by HPLC and Antioxidant activity of Amla fruits. J.


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34. Goel A., Goel R., Singh G.N., Ahmad F.J., Singh R.M., Jain G.K.

Development and Validation of a stability indicating HPTLC method for

analysis of 3-Acetyl-11-Keto-β-Boswellic acid in herbal extract and

nanoparticles formulation. Acta Chromatographia 2008, 20(3), 495-509.

35. Yadav A., Singh R. M., Mathur S. C., Kumar S., Prakash O., Singh G.N.

Simultaneous estimation and validation of Domperidone and Paracetamol

by RP-HPLC method in bulk and its dosage form. Pharmabit, 2008, 17(1),

83-86.

36. Madan S., Singh G.N., Kumar Y., Kohli K., Singh R.M., Mir S. R.,

Ahmed S. A new Flavanone from Flemingia strobilifera (Linn.) R.BR. and

its antimicrobial activity. Tropical journal of Pharmaceutical Research,

2008, 7(1), 921-927.

37. Prakash O., Singh G.N., Singh R. M., Mathur S. C., Bajpai M., Yadav S.

Determination of Bacoside A by HPTLC in Bacopa monnieri extract.

International J. Green Pharmacy, 2008, July-Sep, 173-175.

38. Prakash O., Singh G. N., Singh R. M., Mathur S. C., Bajpai M., Yadav S.

Protective effect of BCEZ, a herbal formulation against

carbontetrachloride induced hepatotoxicity. International J. Pharmacology,

2008, 4(4), 282-286.

39. Singh P., Bajpai M., Prakash O., Tiwari R., Mathur S.C., Singh R.M.,

Singh G.N. High Performance Thin Layer Chromatographic method for

the determination of Cinnamadehyde in Cinnamomum bark powder. J.

Natural Remedies, 2008, 8(2), 179-182.

40. Ganesh B., Pathak D.P., Singh R.M., Mathur S.C., Kumar S., Prakash

O., Singh G.N. High Performance liquid chromatographic method for the

determination of Trandolapril in bulk drug and tablet dosage forms. J.


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41. Singh R. M., Gupta P., Khosla P., Mathur S. C., Singh G. N. Formulation

and Evaluation of Ethyl Cellulose Coated Nimesulide Microcapsules:

Influence of Solvents. Indian Drugs 2008, 45(5), 370-375.

42. Prakash O., Singh R.M., Pandey M., Mathur S.C., Raj S., Singh G.N.

Development and Estimation of a Liquid Chromatographic Method for

Fexofenadine HCl in Tablets. Indian Drugs 2008, 45(2), 149-152.

43. Madan S., Ahmad S., Singh G.N., Kumar Y., Kohli K. and Singh R.M.

Chemical and Biological Properties of Stevia rebaudiana, Hamdard

Medicus, 2008, 51(4), 30-47.

44. P.K Saini, R.M Singh, C.L Jain, S.C Mathur and G.N Singh. A sensitive

and selective RP-HPLC method for the determination of Lamivudine and

Stavudine in tablets. Journal of Pharmacy Research, 2009, 2(10), 1598-

1600.

45. Saini P. K., Jain C. L., Singh R. M., Mathur S. C., Singh G. N., Naslam

M. A simple and sensitive HPTLC method for simultaneous determination

of Abacavir sulphate and Lamivudine in pharmaceutical dosage form.

Journal of Pharmaceutical Research, 2009, 8(4), 187-191.

46. P. K. Saini, C. L. Jain, R. M. Singh, S. C. Mathur, G. N. Singh, M.

Naslam. Development and validation of a HPLC method for the

simultaneous analysis of Abacavir sulphate and Lamivudine in combined

tablet dosage forms. Pharmabit, 2009, 20(2), 97-105.

47. Saini P. K., Jain C. L., Singh R. M., Mathur S. C., Singh G. N. Reverse

Phase-Ultra Performance Liquid Chromatographic (UPLC) Method for

determination and validation of Irinotecan Hydrochloride in Bulk and its

Injection Dosage Form. The Indian Pharmacist, 2009, 8(83), 55-58.

48. Saini P. K., Khan S., Prakash O., Singh R. M., Mathur S. C., Singh G. N.,

Khar R. K. Simultaneous Determination of Simvastatin and Ezetimibe by

RP-HPLC Method in Tablet Dosage Form. Pharmabit, 2009, 19(1), 65-68.

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49. P. K. Saini, C. L. Jain, R. M. Singh, S. C. Mathur, G. N. Singh, S. Tuteja,

U.K. Singh. Simultaneous Determination of Lamivudine and Zidovudine

by HPTLC Method in Tablet Dosage Form. Pharmabit, 2009, 19(1), 25-

28.

50. P.K. Saini, C.L. Jain, R.M. Singh, S.C. Mathur, G.N. Singh. Rapid and

Sensitive RP-Ultra Performance Liquid Chromatography (UPLC) Method

for Estimation and Validation of Paclitaxel in Bulk and its Injection

Dosage Form. Pharmabit, 2009, 20(2), 143-147.

51. Yadav Alok, Singh R. M., Mathur S. C., Saini P.K., Prakash O., Singh

G.N. Simultaneous HPTLC method for estimation of Domperidone and

Paracetamol in bulk and its tablet dosage forms. Journal of Planar

Chromatography, 2009, 22(6), 421- 424.

52. Jain V.K., Vats A.R., Singh R.M., Mathur S.C., Kumar S., Sharma D.K.,

Prakash O., Singh G.N. Development and validation of HPLC method for

the determination of Donepezil hydrochloride in bulk and tablet dosage

form. Indian Drugs, 2009, 46 (6), 65-68.

53. Saini P.K., Jain C.L., Singh R.M., Mathur S.C. and Singh G.N.

Development of a simple HPLC method for the quantitation of

Artemisinin in Artemisia Annua Herb. J. Pharm. Res. 2009, 8(1), 16-18.

54. Madan S., Singh G.N., Kumar Y., Kohli K., Singh R.M., Prakash O.

Isoflavonoids from Flemingia strobilifera (L) R.Br. Roots. Acta Poloniae

Pharmaceutica, 2009, 66(3), 297-303.

55. Prakash O., Singh G.N., Singh R.M., Madan S., Mathur S.C. Study of the

interactions of herbal extracts in combination against the free radical

scavenging activity. Pharmaceutical Biology, 2009, 47(8), 729-733.

56. Madan S., Singh G.N., Kumar Y., Kohli K., Singh R.M., Prakash O.

Phytochemical Analysis and Free-Radical Scavenging activity of

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Flacourtia Indica (Burm.F.) Merr, Journal of Pharmaceutical Research,

2009, 8(2), 81-84.

57. Madan S, Pannakal S.T, Ganapaty S., Singh G.N., Kumar Y. Flacourtin, a

phenolic glucoside from Flacourtia indica. Natural Product

Communications, 2009, 4(3), 381-384.

58. P.K. Saini, R.M.Singh, C.L. Jain, S.C.Mathur, and G.N. Singh.

Development and Validation of RP-HPLC method for estimation of

Efavirenz in bulk and in tablet dosage forms. Journal of Pharmaceutical

Research, 2010, 9(2), 87-89.

59. Singh R.M., Saini P.K., Mathur S.C., Singh G.N. and Kumar Santosh.

Application of High Performance Liquid Chromatography to the

Determination and Validation of Levodopa in Methanolic extract of

Mucuna utilis. International Journal of Green Pharmacy, 2010, 4(3), 156-

158.

60. Saini P.K., Jain C.L., Singh R.M., Mathur S.C. and Singh G.N.

Quantification of Vinorelbine in Bulk Drug and its Injection Dosage Form

by RP-UPLC Method. The Indian Pharmacist, July 2010, 50-55.

61. Saini P. K., Jain C. L., Singh R.M., Mathur S. C. and Singh G. N.

Development and validation of Spectrophotometric method for estimation

of Emtricitabine in bulk and capsule dosage form. The Indian Pharmacist,

August 2010, 61-64.

62. P. K. Saini, C. L. Jain, R.M. Singh, S. C. Mathur, G. N. Singh. A Rapid

and Sensitive RP-UPLC Method for Simultaneous Determination of

Zidovudine, Lamivudine and Nevirapine in Tablet Dosage Form. Journal

of Pharmaceutical Research, 2010, 9(2), 56-59.

63. Saini P. K., Jain C. L., Singh R. M., Mathur S. C., Singh G. N., Khar R.

K., and Hafeez A. Simultaneous Quantification of Artemether and

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Lumefantrine in Tablet Dosage Form by RP-HPLC Method. Indian Drugs,

2010, 47(4), 32-35.

64. P.K. Saini, R.M. Singh, S.C. Mathur, G.N. Singh, C.L. Jain, R.K. Khar,

and Abdul Hafeez. A Simple and Sensitive HPTLC Method for

Quantitative Analysis of Artemether and Lumefantrine in Tablets. Journal

of Planar Chromatography, 2010, 23(2), 119-122.

65. B. Lal, S. C. Mathur, R. M. Singh, P. K. Saini, O. Prakash, G. N. Singh.

Development and Validation of a RP-HPLC method for estimation of

Montelukast Sodium in Bulk and in Tablet Dosage Form. Indian J. Pharm.

Sci., 2010, 72(2), 235-237.

66. Saini P. K., Singh R. M, Jain C. L., Mathur S. C., Singh G. N., Tuteja S.,

Singh U.K., and Prakash O. Simultaneous estimation of Lamivudine and

Zidovudine in combined dosage form using RPLC method. Indian Drugs,

2010, 47(2), 23-26.

67. Shailendra Singh, U.K. Singh, G.N. Singh, R.M. Singh, S.C. Mathur, D.

K. Sharma, P. K. Saini, Alok Yadav, Deepak Duggal, Vishal Gupta A

Simple and Sensitive HPTLC Method for Quantitative Analysis of

Prulifloxacin in Tablets. Pharmabit, 2010, 21(1), 59-64.

68. P.K. Saini, C.L. Jain, R.M. Singh, S.C. Mathur, G.N. Singh. Development

and Validation of RP-Ultra Performance Liquid Chromatographic (UPLC)

Method for Quantification of Topotecan Hydrochloride in Bulk and its

Injection Dosage Form. Indian J. Pharma. Sci., 2010, 72(4): 494-497.

69. Madan S., Singh G.N., Kumar Y. and Kohli K. Phytochemical analysis

and free-radical scavenging activity of Flemingia strobilifera (Linn) R.Br.

Research Journal of Pharmaceutical Biological and Chemical Sciences,

2010, 1(4), 183-190.

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70. P. K. Saini, R.M Singh, C.L Jain, S.C Mathur and G.N. Singh.

Quantification of Vinorelbine in bulk and injection dosage form by

Spectrophotometric method. Pharmbit, Vol. XXII, No.2, July-Dec 2010.

71. Vishal Gupta, R.M. Singh, P.K. Saini, S.C. Mathur, and G.N. Singh.

Development and Validation of Gemifloxacin by RP-HPLC Method in

Tablet Dosage Forms The Indian Pharmacist, May 2011, 55-59.

72. R.M. Singh, P.K. Saini, C.L. Jain, S.C. Mathur, and G.N. Singh.

Estimation of Efavirenz in Bulk and Tablet Dosage form by HPTLC. The

Indian Pharmacist, 2011, 9(8), 69-74.

73. Pandey M.K., Singh G.N., Sharma R.K. and Lata Sneh. Physicochemical

Standardization of Andrographis paniculata(Nees): An Ayurvedic Drug.

International Journal of Pharmaceutical Research & Development, 2011,

3(6), 81-89.

74. Pandey M.K., Singh G.N., Sharma R.K. and Lata Sneh. Antibacterial

activity of Eclipta alba (L.) Hassk. Journal of Applied Pharmaceutical

Science, 2011, 1(7), 104-107.

75. Pandey M.K., Singh G.N., Sharma R.K. and Lata Sneh. Evaluation of

Antibacterial activity of Andrographis paniculata against Human

Pathogens. Inventi Rapid: Ethnopharmacology, 2011, 4.

76. Manoj Kumar Pandey, G.N.Singh, Rajeev Kr Sharma and Sneh Lata,

Evalution of Herbal Formulation (Tablet) containing Kalmegh as a Singh

Herb, International Journal of Biomedical Research and

Analysis,2(5):Sept- Oct. 2011; 26-30.

77. S. Singh, U. K. Singh, R. M. Singh, G. N. Singh, S. C. Mathur, P. K.

Saini, A. Yadav, V. Gupta and D. Duggal. Development and Validation of

a RP-HPLC Method for Estimation of Prulifloxacin in Tablet Dosage

Form. IJPS. Oct 2011, 73(5): 577-579.

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78. Kalaiselvan V, Viyayakumar A, Suresh Kumar K, Singh G.N.

Lycopene’s effects on health and diseases. Natural medicine Journal.

Available on line, dated 16/2/11.

79. Iftekar H Md, Kalaiselvan V, Singh G.N. Efficacy and safety of

Vildagliptin in the management of type 2 diabetes mellitus. Indian J

Pharmacy Practice 2012; 5(4):8-15

80. Kalaiselvan V, Jai Prakash, Singh G.N. Pharmacovigilance Programme of

India. Archives of Pharmacy Practice 2012;3(3):229-232.

81. V. Kalaiselvan, SK Gupta, SS Agrawal, S. Srivastava, R Saxena, Singh

G.N. Effect of topical administration of ‘Triphala’ in the prevention of

galactose induced cataract in rats. International Journal of Chemical and

Pharmaceutical Research 2012; 1(1):20-25

82. Kalaiselvan V, Hemant S, Singh G.N. Quality standards for

antiretrovirals in Indian Pharmacopoeia. Drug Information Journal 2012;

DOI: 10.1177/00928615

83. Prakash J, Singh G.N. Indian Pharmacopoeia Commission-Letter to

editor. The Indian Pharmacist. Oct 2012; 16-17.

84. Prakash J, Nirmal Geetika, Pandey MK, Singh G.N. Antidiabetic

activities of selected medicinal plants and their status in Indian

Pharmacopoeia. Pharmabit. Jan-June 2013.

85. Meenakshi Dahiya, Nidhi Dubey, Prabha Singh, Singh G. N. Method

development and validation of testosterone in muscle by using LC-MS/MS

in positive ESI mode. Indian Journal of Chemistry, vol. 52B, April 2013,

pp 573-578.

86. Ashish Chauhan, Pradeep Arora, Alok Yadav, R. M. Singh, D. K. Sharma,

S.C. Mathur, Singh G.N. Development and Validation of HPTLC Method

for the Estimation of Ondansetron Hydrochloride in Bulk Drug and Tablet

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Dosage Forms Journal of Pharmaceutical Research Vol. 12, No. 2, April-

June 2013: 61-65.

87. R. M. Singh, L. Kumar, P. Arora, S.C. Mathur, P.K. Saini, R.M. Singh,

Singh G.N. Method Development and Validation for the Quantitative

Estimation of Eslicarbazepine Acetate by RP-HPLC in Bulk Drug and

Tablet Dosage Form. Indian J. Pharma. Sci., 2013, 75(6): 736-739.

88. Sahu S., Singh R. M, Mathur S. C., Sharma D. K., Saini P.K., Duggal D,

Tyagi V. and Singh G.N. Forced Degradation Study of Eletriptan by

Using Ultra High Performance Liquid Chromatography (UHPLC).Indian

Drugs 50(07) July 2013.

89. Arora P. K., Chauhan A., Duggal D., Saini P. K., Mathur S. C., Singh R.

M. and Singh G.N. Development and Validation of RP-HPLC Method for

Determination of Zolmitriptan in Bulk Drug and Tablet Dosage Form.

INDIAN DRUGS 50(08) August 2013.

90. Meenakshi Dahiya, Nidhi Dubey, Prabha Singh, Singh G. N.

Development and validation of LC-MS/MS method to determine the

residue of veterinary drugs ivermectin, doramectin and moxidectin in

milk, Indian Journal of Chemistry, vol. 52B, October 2013, pp 1313-1317.

91. Singhal M, Amin S, Dhal C, Kukrety A, Chauhan A, Singh RM, Saini PK,

Mathur SC, Singh G.N. Development and Validation of RP-HPLC

Method for the Determination of Candesartan Cilexetil in Bulk Drug and

Tablet Dosage Form. Indian Drugs, 51(05) May 2014.

92. Kalaiselvan V, Jai Prakash, Kalaivani M, Singh G.N. Quality Standards

and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia

and National Formulary of India. Therapeutic Innovation & Regulatory

Sciences, 2014; 48 (3): 386-392.

25/32

93. Prasad T, Kalaiselvan V, Jai P, Surinder S, Singh G.N. Weight gain in

association with insulin use- an analysis of individual case safety reports

in Indian database. Pharmacovigilance, 2014; 2(1):doi10.4172.

94. Kalaiselvan V, Sakshi G, Prasad T, Gupta SK, Singh G.N. Spontaneous

reporting of adverse drug reactions in geriatric patients in India. National

Journal of Physiology, Pharmacy & Pharmacology, 2014;4(3): [Online

first]

95. Nasiruddin Ahmad Farooqui, Akalanka Dey, T.S. Easwari and G. N.

Singh. Antibacterial Potential of Nimbolide from Azadirachta Indica.

International Journal of Pharmacy and Pharmaceutical Sciences, ISSN-

0975-1491, Vol. 6, Issue 5, 2014.

96. Kalaiselvan V., Jai Prakash, Kalaivani M and G. N. Singh. Quality

Standards and Current Status of Ophthalmic Formulations in Indian

Pharmacopoeia and National Formulary of India. Official Journal of DIA

– Therapeutic Innovation and Regulatory Science. ISSN: 2168-4790,

Volume 48, Number 3, May 2014.

97. Shruti Rastogi, M. Kalaivani, Amandeep K Bhatia, Jai Prakash, G.N.

Singh. Implementing the principle of the 3Rs through the Indian

Pharmacopoeia. Therapeutic Innovations and Regulatory Science. DOI:

10.1177/2168479015572371

98. Anurag S Rathore, Renu Jain, M. Kalaivani, Gunjan Narula, G.N. Singh.

Setting standards for Biotech therapeutics in India. BioPharm

International. 2014;11(27):35-40.

99. Singhal M, Amin S, Kukrety A, Chauhan A, Tiwari V, Singh RM, Saini

PK, Mathur SC, Singh G.N. Development and Validation of RP- UPLC

Method using Experimental Design Approach for Simultaneous

Estimation of Candesartan Cilexetil and Chlorthalidone. Indian Drugs,

51(11), November 2014.

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100. Shruti Rastogi, Amandeep K Bhatia, Ashish Kushwaha, Manoj K Pandey,

Alok Sharma, Jai Prakash, G.N. Singh. Development and Validation of a

Liquid Chromatography Method for Determination of Embelin in Crude

Extract of Embelia ribes. Asian Journal of Biomedical and Pharmaceutical

Science. 2014; 4(36): 9-13.

101. Anuj Prakash, Anil K Teotia, Javed A. Farooqi and G. N. Singh. Forced

Degradation Study of Lamivudine under the Scope of Genotoxic Impurity.

World Journal of Pharmacy and Pharmaceutical Sciences, 2015, 4(06):

1032-1041.

102. Anuj Prakash, Utpal nandi, Anil K Teotia, javed A. Farooqi and G.N.

Singh. Forced Degradation Study of Emtricitabine for Evaluation of

Genotoxic Impurity in Active Pharmaceutical Ingredient’s (API) Shelf

Life. World Journal of Pharmacy and Pharmaceutical Sciences, 2015,

4(07):1909-1919.

103. Chauhan A, Arora P.K, Nagpal R, Duggal D, Kukrety A, Saini P.K.,

Mathur S.C., Singh R.M. and Singh G.N. New Sensitive UV

Spectrophotometric Methods for Simultaneous Estimation of Zidovudine

and Lamivudine in Fixed Dose Combination. Indian Drugs 52(03),

February 2015.

104. Faraat Alia, G. N. Singh, P. L. Sahu , Anuj Prakash , Manish Trivedi,

Tanzeel A. Khan. Stability-Indicating RP-HPLC Method Development for

The Estimation of Pantoprazole Sodium in Tablet Dosage Form. World

Journal of Pharmacy and Pharmaceutical Sciences. Volume 4, Issue 08,

2015, 1145-1152.

105. Faraat Ali, G. N. Singh, P. L. Sahu, Dr. Robin Kumar, Ms. Manisha

Trivedi. Development and Validation of Analytical Method for the

estimation of Ceftaroline Fosamil in bulk and Pharmaceutical Dosage

form by RP-HPLC. World Journal of Pharmacy and Pharmaceutical

Sciences. Volume 4, Issue 08, 2015, 929-938.

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106. Shruti Rastogi, Manoj Kumar Pandey, Jai Prakash, Alok Sharma,G.N.

Singh. Veterinary herbal medicines in India. Pharmacognosy reviews.

2015, Volume 9, issue 18, 155-163.

Communicated:

107. Dhal C, Ahmed FJ, Chauhan A, Jyothi M, Singh RM, Saini PK, Mathur

SC, Singh G.N. Optimized Approach for Quantitative Estimation of

Doxycycline Hyclate and Curcumin Simultaneously by RP-HPLC Method

in Bulk Drug and Pharmaceutical Sample. Communicated to Journal of

Pharmaceutical & Biomedical Analysis.

108. Dhal C, Ahmed FJ, Tiwari V, Singh RM, Saini PK, Mathur SC, Singh

GN. Optimization of RP-HPLC Method by Central Composite Design For

the Validation and Estimation of Doxycycline Hyclate in Bulk Drug and

Formulations. Communicated to Indian Drugs.

109. Singh R.M., Mathur S.C., Prakash O., Singh G.N., Aggarwal A., Murali

B.M, Deepak., Katiyar C.K. Development of Pharmacopoeial monographs

on selected Indian Medicinal Plants for Indian Pharmacopoeia.

Communicated to Indian Pharmacist.

110. Singh R. M., Singh G.N., Mathur S. C., Sharma D. K., Prakash Om.

HPLC method for determination of Enalapril Maleate in bulk drug.

Communicated to The Pharma Review.

111. Prakash O., Singh G.N., Singh R.M., Mathur S.C., Madan S. Quantitation

of Principal Phenolic Phytochemcals and Antioxidant activities of three

Indian medicinal plants. Communicated to Food Chemistry.

112. Kumar Anil, Annapuvana M. M., Singh R. M., Mathur S. C., Sanjay

Kumar, Prakash O., Singh G.N. Simultaneous estimation of Omeprazole

and Domperidone in bulk and its dosage form by High Performance

Liquid Chromatography. Communicated to Pharmabit.

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113. Anuj Prakash, Anil K Teotia, Javed A. Farooqi and G.N. Singh. Forced

Degradation Study of Abacavir Sulphate under the Scope of Genotoxic

Impurity. Indian Journal of Chemistry-Section B, 2015.

114. Anil Kumar, Annapuvana M. M., Singh R. M., Mathur S. C., Sanjay

Kumar, Prakash Om, Singh G.N. A new HPTLC method for

quantification of Domperidone and Omeprazole in Bulk and Capsule

Dosage Forms. Communicated to J. Planar Chromatography.

115. Neha S. Arora, Kanchan Kohli and G.N. Singh. Cadmium, Lead, Arsenic

and Mercury detection and validation by Inductive Couple Plasma-Mass

Spectroscopy in different cultivars of Mango (Mangifera Indica) fruit pulp.

Communicated to Journal of Pharmaceutical Research.

116. Patel B., Pandey M., Rajput P., Jaiprakash, and Singh G.N. A Novel RP-

HPLC Method for the Estimation of Topiramate in Tablet Dosage Form

by Derivatization Technique using PDA Detector. Communicated to The

Journal of AOAC International.

117. M. Kalaivani, Shruti Rastogi, V Kalaiselvan, G. N. Singh. Adverse

reactions after Hepatitis B vaccination: A data analysis of spontaneous

reports from Pharmacovigilance programme of India, Drugs - Real World

Outcomes.

INTERNATIONAL PARTICIPATION:

Participated in various National/ International Conferences/ Seminars/ Symposia and are

as follows,

1988

Rapporteur at First Asian Conference on Pharmaceutical Education,

Research and Drug Industry at National University of Singapore, 1988.

Co-Chairperson in First World Congress on Oriental Medicines and Yoga,

Bangkok, 1988.

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2010

Speaker – International perspectives – Pharmacopoeias, at International

Conference organized by the European Directorate for the Quality of

Medicines & Health Care (EDQM), Council of Europe, 14th

- 15th October

2010 held at Prague, Czech Republic.

Represented India in the 4th

Joint Chinese Pharmacopoeia (ChP) – USP at

International Symposium on Drug Standards and Quality Control (October 21

– 22, 2010) Hangzhou – China.

2011

Participated WHO, Geneva as representative of Indian Pharmacopoeia

Commission for consultation on specifications for Medicines and Quality

Control Laboratory issues, 14th

July, 2011 and also attended briefing on issues

related to International Pharmacopoeia, WHO, Geneva, 15th

July, 2011.

Represented India in 1st Global Summit of Pharmacopoeias, Beijing,

China 17 -18th

November, 2011.

2012

International Meeting of World Pharmacopoeias 29th

February to 2nd

March, 2012 WHO, Geneva.

The International World of Pharmacopoeia: Now and in Future “Good

Pharmacopoeial Practices” from 7th

to 10th

October, 2012 at

Amsterdam, Netherland.

International Conference on Drug Regulatory Authorities from 22nd

October to 24th

October, 2012 at Swiss Tallin Conference Centre, Estonia.

2013

WHO Meeting on “New Medicines, Quality Control and Laboratory

Standards” from 12th

to 14th

June, 2013 at WHO, Geneva.

Meeting on “Biopharma and Healthcare” on 21st June, 2013 at

Massachusetts, USA.

WHO Meeting on “Interchangeability of Multisource Products” as

temporary adviser from 6th

to 7th

July, 2013 at Copenhagen, Denmark.

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5th

European Union – Indian Joint Working Group meeting on

Pharmaceuticals, Biotech Products and Medical Devices from 22nd

to 25th

September, 2013.

Sino-Indian Entrepreneurs Partnering Conference from 5th

to 10th

November, 2013 at Beijing, China.

State regulation of medical products and medical devices – PharmMed

Obrashenie-2014, Moscow, Russia from 29th

to 31st October, 2013.

2014

Asia Pacific Leaders Malaria Alliance (APLMA) Access to Quality Medicines

and other Technologies Taskforce (AQMTF) meeting from 12th – 13

th March,

2014, Sydney, Australia.

Third International meeting of World Pharmacopoeias and MHRA

Conference from 10th

to 11th

April 2014, London (UK).

Asia Pacific Leaders Malaria Alliance (APLMA) Access to Quality

Medicines and other Technologies Taskforce (AQMTF) - Regulators Sub

Group meeting from 15th

to 16th

May, 2014, Bangkok, Thailand.

“Malaria Medicines Regulators” group’s 2nd

meeting on the “Access to

Quality Medicines and other Technologies Task Force (AQMTF)” at

Manila, Philippines from 07th

to 11th

June, 2014.

Visited Strasbourg, France as part of Trade Delegation Pharmexcil from 05th

to 10th

October, 2014.

Steering committee meeting on SSFFC of Member States Mechanism,

Geneva from 29th

October to 01 November, 2014, Geneva, Switzerland.

2015

Visited Paris, France & Brussels, Belgium as a part of Trade delegation of

Ministry of Commerce from 18th

to 22st March 2015. Attended the meeting

with ANSM French Regulatory Authority and European Commission

(EC) on M/s GVK issues.

Attended the V International World Pharmacopoeia Summit and USP

Convection Meeting from 18th

to 26th

April, 2015, Washington, USA

“CPhI Worldwide” as part of delegation of the Department of Commerce

led by Commerce Secretary from 12th

- 15th October, 2015, Madrid, Spain.

31/32

2016

Drugs Chemicals & Associated Technologies (DCAT) and meetings with US

FDA and US Pharmacopoeia from 14th

– 17th

March, 2016, New York &

Washington DC, USA.

WHO Annual meeting of interim network for promoting cooperation for

regulation of medical products in SEA Region during 17 – 18 August, 2016,

Bangkok, Thailand

7th

International Meeting of World Pharmacopoeias 12 – 15 September, 2016

Osaka and Tokyo, Japan.

WORKSHOPS ORGANISED

WHO-IPC Collaborative workshop-cum-Symposium on “Challenges and

Opportunities in compliance of current standards prescribed in IP 2010” on

8th

-9th

December 2010 at IPC, Ghaziabad.

WHO-IPC Collaborative workshop-cum-Symposium on “Role of IP in

improving quality of medicines” on 7th

-8th

April 2011 at IMTech, Chandigarh.

WHO-IPC Collaborative workshop-cum-Symposium for Govt. Analyst on

implementation of IP standards on 26th

-27th

May 2011 at CDTL, Mumbai.

WHO-IPC Collaborative workshop-cum-Symposium on “ Role of NFI in

rational use of medicines” on 2nd

-3rd

November 2011.

WHO-IPC Collaborative workshop-cum-Symposium on “Good laboratory

practices: Concept to implementation” on 23rd

-24th

November 2011 at IPC,

Ghaziabad.

Actively participated in publication of “Guidance manual for compliance of

Indian Pharmacopoeia (IP)” by IPC in collaboration with CDSCO and WHO-

Country Office for India.

BOOKS PUBLISHED

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“Guidance manual for compliance of Indian Pharmacopoeia (IP)” published

by The Indian Pharmacopoeia Commission in collaboration with CDSCO and

WHO-India, 2012.

“Guidance document for spontaneous adverse drug reaction reporting”

Published by The Indian Pharmacopoeia Commission [National Coordination

Centre-Pharmacovigilance Programme of India (PvPI)], 2014.

MEMBERSHIP OF PROFESSIONAL BODIES

Fellow Member, Institution of Chemists

Fellow Member, Indian Council of Chemists

Life Member, Indian Pharmaceutical Association

Life Member, Indian Pharmaceutical Graduate Association

Life Member, Indian Hospital Pharmacist Association

Life Member, Potash Research Institute of India

OTHER ACTIVITIES

Passed 'C' Certificate of NCC.

Passed Certificate and Diploma Courses in Yoga.

Published more than 106 research papers in Journal National and

International repute.

Tech) from prestigious Institutes/ Universities.

Empanelled as an Expert Member- WHO, UNIDO in Pharmaceutical

discipline.

Workshops/Training programmes conducted by Central Drugs Standard

Control Organisation (CDSCO) during last one year for Drug Regulators are as

follows:

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Good Manufacturing Practices Training Workshop for Central & Drug

Regulators from 16th & 17th November, 2015 at Ahmedabad for 93

participants and from 19th & 20th November, 2015 at Bangalore for 100

participants

Advance GCP Workshop training for Drugs Inspectors facilitated by USFDA

from 21st – 23rd April, 2016 for 60 participants.

Three week Training Programme - Investigation Techniques and Launching

of Prosecution 28.03.2016 to 14.04.2016 at National Institute of Biologicals,

Noida.

One Week Residential Training Programme for Indian Drugs Regulators and

Government Analysts of States/UTs and CDSCO - “Risk Based Inspections

of Manufacturing Facilities” at 09.05.2016 to 14.05.2016 at National Institute

of Biologicals, Noida.



of Manufacturing Facilities” from 23.05.2016 to 28.05.2016 at National

Institute of Biologicals, Noida.



of Manufacturing Facilities” from 11.07.2016 to 16.07.2016 at National

Institute of Biologicals, Noida

Workshops conducted by CDSCO in co-ordination with WHO:

CDSCO Advanced Training on Evaluation of CMC Module III of CTD and

Inspection of vaccines manufacturing as per cGMP norms from 14th to 17th June

2016 at KASAULI

WHO - CDSCO International Workshop on Good Regulatory Practices for

National Regulatory Authorities and WHO-CDSCO International Dissemination

and Training Workshop on Drug Safety-Introduction to the WHO Surveillance

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and monitoring system for Sub-Standard, Spurious, Falsely Labelled, Falsified

and Counterfeit medical products from 20th to 22nd July 2016 at New Delhi

WHO Advanced in-country workshop on Good Manufacturing Practices (GMP)

regulatory inspection using the Quality Risk Management Approach for Drugs Inspectors

of Central and States from 8th to 12th August, 2016 at Hyderabad.

Workshops/Training programmes conducted by Indian Pharmacopoeia

Commission (IPC), Ghaziabad during last one year for Drug Regulators are

as follows:

Training Programme for New Promoted Assistant Drug controllers (ADC) of

Central Drug Standard Control Organization (CDSCO) for Strengthening of

National Regulatory Authority (NRA) from 01/06/2015 to 12/06/2015 – 14

participants

4th

Training Programme on for Regulators on Various Analytical Instruments &

Techniques for Government Drugs Analysts/ Bench Chemists and Scientific

Officers from 07/09/2015 to 01/10/2015 – 35 participants

One Day Workshop for stakeholders on Awareness Programme of Indian

Pharmacopoeia and Indian Pharmacopoeia-. Reference Standard on 7th

October,

2015 at Mumbai – 180 participants.

Training Programme on ISO 17025:2005 For Central and State Drugs Testing

Laboratories to get NABL accreditation from 12/10/2015 to 15/10/2015- 33

participants

Second Training Programme on ISO 17025:2005 For Central And State Drugs

Testing Laboratories to get NABL accreditation from 30/11/2015 to 03/12/2015

– 24 participants

Third Training Programme on ISO 17025:2005 to get NABL accreditation For

Central And State Drugs Testing Laboratories from 02/02/2016 to 05/02/2016 –

26 participants

One day Training Programme for Indian Drugs Regulators and Government

Analysts of States/UTs and CDSCO on “RISK BASED INSPECTIONS OF THE

MANUFATURING FACILITIES from 09th May 2016 to 14th May 2016 on 13th

May, 2016 – 75 participants



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MANUFATURING FACILITIES from 23rd

May 2016 to 28th

May 2016 on 27th

May 2016 – 65 participants



MANUFATURING FACILITIES from 11th

July 2016 to 16th

July 2016 on 15th

July 2016 – 60 participants

5th

Training Programme on Various Analytical Instruments & Techniques for

Government Drugs Analysts from 05th

April 2016 to 5th

May 2016 – 35

participants

6th

Training Programme on Various Analytical Instruments & Techniques for

Government Drugs Analysts from 12th

July 2016 to 12th

August 2016 – 25

participants

3rd

One Day Workshop for stakeholders on Awareness Programme of Indian

Pharmacopoeia and Indian Pharmacopoeia-. Reference Standard on 07th

July

2016at Mumbai – 190 participants

At International level - Technical study tour of Quality Analysts of Medicine

Control Laboratory of Central Joint Laboratory of Mongolia at Indian

Pharmacopoeia Commission, Ghaziabad from 16th November 2015 to 27

th November

2015 – 06 participants

………………….

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