Go For Inerim Report

MASHELKAR COMMITTEE FOR
REVIEW OF DRUGS REGULATORY SYSTEM
IN INDIA

1. The Pharmaceutical industry represents one of the India’s strength. It has been growing annually at the rate of over 10% for the last decade and currently occupies the fourth position in the world in terms of volume. The industry has moved from being an importer of every formulation in the fifties to one that has assumed prestige in terms of its exports today. As the number of drugs, as well as their volumes, keep increasing, the issue of quality will assume permanent importance. Across the globe, countries are adopting rigorous drugs quality control systems and enforcement mechanisms to avoid sub-standard/spurious drugs in their respective markets.

2. Supreme Court of India, the National Human Rights Commission and the Standing Committee of Parliament have time and again recommended improving the drug regulatory system. The new Pharmaceutical Policy approved by the Cabinet recently addresses these quality concerns. The Haathi Committee had earlier recommended the setting up of a National Drug Authority. The Mashelkar Committee on Pharmaceutical Research and Development had recommended the Establishment of a First Class Drug Regulatory infrastructure.

3. There has not been a comprehensive review of the Drugs & Cosmetics Act 1940 since its enactment, although Rules have been amended from time to time to keep them up to date. There is also a national concern regarding the problem of spurious drugs. It is important to see all the issues in an integrated manner.

4. The Government of India has, therefore, decided to set up an Expert Committee which will look into all these issues with the following Terms of Reference.

1. Recommend a new structure for the Drug Regulatory System in the country including the setting up of a National Drug Authority.
2. Recommend measures to strengthen the drug regulatory infrastructure in Centre and States.
3. Evaluate the extent of the problem of spurious and sub-standard drugs and recommend measures required to deal with this problem effectively.
4. Recommend changes required in the Drugs and Cosmetics Act, 1940 as well as in judicial procedure related to offences committed under this Act.
5. Recommend steps to be taken by the Pharmaceutical Industry and Pharmacy Association to tackle the problem of spurious drugs.
6. Consider and advise on any other issue incidental to the above.
7. Devise road maps for implementation of all recommended measures.

COMPOSITION OF EXPERT COMMITTEE

1. Dr. S.P. Agarwal, DGHS
2. Representatives (JS Level officers) of Department of Chemicals & Petro Chemicals, Ministry of Home and Ministry of Law. Joint Secretary I/C drugs, Department of Health.
3. Health Secretaries / Drug controllers of the States of Karnataka, West Bengal, Maharashtra, Delhi, Bihar and Madhya Pradesh.
4. Presidents of the following Associations :

5. Eminent lawyer; Sri Amarendra Sharan, Sr. Adovcate, Supreme Court, 105 New Chamber Block, Supreme Court, Bhagwan Das Road, New Delhi

6. Shri Julius Rebeiro, Ex-Advisor to Governor.

7. Shri Vijay Karan, Ex Commissioner; Delhi Police

8. Representative of Consumers: Shri Bijon Mishra, Vice Chairman, Consumer Coordination Council.

9. Eminent Scientist – Dr. M.D. Nair

The Committee will have the freedom to co-opt 2-3 eminent scientist who can make contribution in this field. The committee may also invite anybody as a Special Invitee.

The Committee will also take into consideration reports of Committees set up earlier.

The Committee would also examine the best international practices which could be comparable to India.

The Committee should submit its report within six months.

TA/DA of official members will be borne by their respective offices. TA/DA to non-official members (S.No. 5 to 9 above), co-opted members and special invitees will be paid in accordance with SR 190 and further instructions as contained in Appendix – 2 to Part-II of FRSR.

The expenditure involved will be met out of the sanctioned budget under Demand No. 42, Major Head 2210, 08104-Drugs Control (Minor Head), 02 CDSCO (Plan) for the year 2002-03.

This issues with the concurrence of Finance Division vide Dy. No. C-721/IFD dated 27.1.2003