(a) whether a meeting was recently convened by his Ministry to deal with the menace of spurious drugs in the market;
(b) if so, the details thereof;
(c) the persons who had attended the meeting;
(d) the issues discussed in the meeting;
(e) the outcome thereof; and
(f) the steps taken/proposed to be taken by the Government to check the spurious drugs menace?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A. RAJA)
(a) & (b) Yes, Sir. Union Minister of Health & Family
Welfare had invited the representatives of pharmaceutical
industry on 27.1.2003 to have a general discussion on the
problem of spurious drugs as part of the various measures
taken to address this issue and to seek the active
participation of the industry to fight the menace of
manufacture and sale of spurious drugs.
(c) List of participants who attended the meeting is at
Annexure 1.
(d) & (e) The industry representatives expressed their
appreciation for the initiatives taken by the Government and
assured to extend all necessary cooperation. During the
discussion, a need was expressed for improved uniformity in
the enforcement strategies adopted by the State Governments
and for the adequacy of drug regulatory infrastructure etc.
Some industry representatives advocated adoption of packing
and labeling techniques which make it more difficult for the
antisocial elements to copy. A need for adequate police
assistance and speedy trials was also voiced.
(f) Since manufacture and sale of spurious drugs is a
clandestine activity indulged in by anti-social persons,
steps are taken from time to time by enforcement authorities
of the States to detect and unearth spurious/fake drugs in
the interstate commerce. Govt. of India has taken the
following steps :
(i) The Drugs Controller General (India) has advised
the State Drugs Controllers to take the following measures
for curbing the incidence of spurious drugs.
(a) Constitution/reactivation of the State Drug Advisory
Committee in which various State and industry associations
as well consumer associations should find representation.
(b) Establishment of separate intelligence-cum-legal
machinery with police assistance. Training should be
provided to selected officials of Drugs Control
Administration in the modalities of intelligence work,
prosecution etc in respect of spurious/counterfeit drugs.
(c) To ensure speedy analysis of drug samples by
establishing own state level drug testing facilities.
(d) State Drugs Control Authorities should be cautious
while approving licences for drug products to ensure that
`look-alike` products are not encouraged.
(e) To develop efficient communication facilities and recall procedures.
(f) Surveillance of suspected dealers.
(g) Engaging experienced counsel for fighting spurious drug cases
(h) Cooperation of pharmaceutical industry by regular interaction with them.
(i) Collection of survey samples under National Survey Quality Evaluation of Drugs (NSQED) Programme.
(ii) The Union Minster of Health & Family Welfare had
written on Oct 2002 to all the Chief Ministers
seeking their personal intervention to ensure that
adequate measures are taken in each State to deal
with this problem. Union Minister of Health &
Family Welfare also convened a meeting of the
Health Ministers and senior officials of 13 major
States of the country on 12.11.2002 to discuss
measures to ensure consorted action required to
check movement of spurious drugs in the country
and to involve all stakeholders, including pharma
industry, to curb the menace of manufacture and
marketing of spurious/fake medicines.
(iii) Union Ministry of Health & Family Welfare
constituted a Committee under the chairmanship of DGHS
to examine the extent of problem and suggest remedial
measures. Committee report has been submitted along
with its recommendation in July 2002. A copy of the
report of the committee constituted by the Government
of India to examine the issues concerning availability
of spurious drugs in the market and measures
recommended there of have been sent to all the State
Drugs Controllers for their implementation.
(iv) Government of India has set up an expert
committee on January 27, 2003 under the Chairmanship of
Dr. R.A. Mashalkar, DG, CSIR, Secy to Govt. of India to
look into various issues related to Drugs Control
administration including the matter of effectively
tackling the problem of spurious drugs.
(v) Central Government have taken steps to augment the
drugs testing facilities of State laboratories.
Strengthening information system through computer
networking is also under implementation.
Annexure I
List of Participants who attended the meeting conducted
by Union Minister of Health on 27th January, 2003 in
the Committee Room No. 249-A, Nirman Bhawan, New Delhi, regarding Spurious Drug.
Sl. No. Name Organization
1. Secretary (Health) Ministry of Health & F.W.
2. DGHS Ministry of Health & F.W.
3. Deepak Gupta, JS Ministry of Health & F.W.
4. Ashwini Kumar, Ministry of Health Drugs Controller General & F.W.
(India)
5. Dr. S.R. Gupta, JDC(I) Ministry of Health & F.W. 6. J. S. C haudhary, Dy. Dte. GHS Secretary
7 Y.R. Majundar President, IDMA
8. Dr. Ajit Dangi President, OPPI
9. Z.H. Charna OPPI 10. Dr. Vinay Nayak Cipla 11. Rajesh Jain Panacea Biotec 12. K. Shiv Kumar GSK 13. Hirindetr S. Sikka Nicolas & Piramal 14. R. Bala Torrent Pharma 15. Ramesh Subrahmanian Aventis Pharma 16. Vijay Karan Ex-Director, CBI 17. Sanjiv D. Kaul Ranbaxy 18. Dr. Adeep Bagati Ranbaxy 19. Ajay Sahni Wockhardt Ltd. 20. R.J. Khanna Wockhardt Ltd. 21. V.K. Chandrasekhan Dr. Reddy` Lab. 22. Arvind Vasudeva Dr. Reddy`s Lab. 23. N. S Yadav Dr. Reddy`s Lab. 24. A.S. Krishna Pfizer Ltd. 25. S.P. Sharma Bayer 26. R. Aggarwal Bayer 27. T.R. Grover Glenmark Pharma 28. S.B. Lal Themis Medicare Ltd. 29. Dr. Archna Ray Sun Pharma 30. P.H. Shroff Expert 31. Ulhas A.H. Joshi Gujarat Glass (Piramal Group) 32. Ankur Agarwal Gujarat Glass Pvt. Ltd. 33. S. Ramesh Associated Capsules Group 34. Ajit Singh, President President, Associated Capsules Group 35. Ashok Narain Director (PR) PIB 36. Brijesh Regal WHO Consultant to DCG(I) 37. G. Wakanker IDMA 38. S.K. Arya IDMA 39. N.R. Munjol IDMA
IDMA - Indian Drugs Manufacturers Association. IPA - Indian Pharmaceutical Alliance OPPI - Organisation of Pharmaceuticals Producers of India.