Question : NATIONAL DRUG AUTHORITY AND LENTIN COMMISSION

(a) the progress with regard to the formation and functioning of the National Drug Authority;

(b) whether stringent measures have been taken to stop production, prescription and sales of unethical and hazardous drugs;

(c) if so, the details in this regard;

(d) whether the Lentin Commission have been set up;

(e) if so, the details thereof alongwith the terms of reference and the recommendations made by the Commission;

(f) whether the said recommendations have been implemented by the Government; and

(g) if not, the reasons therefor?

THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A. RAJA)

(a): The Govt. of India, Ministry of Health & Family Welfare have set up an Expert Committee under the Chairmanship of Dr. R.A. Mashelkar, Director General, CSIR, to look into the various issues of drug control and give its recommendations. One of terms of reference is to recommend new structure for the Drug Regulatory System in the country including setting up of National Drug Authority.

(b)&(c): The Drugs and Cosmetics Act, 1940 was amended in 1982 to prohibit the manufacture and sale of drugs considered harmful or irrational by the Govt. of India throughout the country. The formulations reported to be unethical, hazardous or irrational are examined by the Drugs Technical Advisory Board through its expert committees and the formulation considered harmful or irrational are prohibited throughout the country though a Gazette Notification. 74 categories of drug formulations have since been prohibited.

(d) to (g): The Lentin Commission was set up by Govt. of Maharashtra in 1986 and it submitted its report to the State Govt. for its consideration.