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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,
Ministry of Health & Family Welfare, Government of India,
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)
Ministry of Health & Family Welfare, Government of India,
New Delhi, India
&
Secretary-cum-Scientific Director
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare, Government of India,
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
7/32
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.
Pharmaceutical Research, 2007, 6(3), 161-162.
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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.
Pharmaceutical Research, 2008, 7(3), 145-147.
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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.
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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.
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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.
One Week Residential Training Programme for Indian Drugs Regulators and
Government Analysts of States/UTs and CDSCO - “Risk Based Inspections
of Manufacturing Facilities” from 23.05.2016 to 28.05.2016 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” 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
34/32
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
One day Training Programme for Indian Drugs Regulators and Government
Analysts of States/UTs and CDSCO on “RISK BASED INSPECTIONS OF THE
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MANUFATURING FACILITIES from 23rd
May 2016 to 28th
May 2016 on 27th
May 2016 – 65 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 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
………………….