Question : CENTRAL DRUGS STANDARD CONTROL ORGANISATION

(a) whether there is sufficient number of personnel including drug inspectors in the office of the Central Drugs Standard Control Organization (CDSCO) to regulate and enforce various provisions regarding quality of drugs and drug trials in the country;

(b) if so, the details thereof indicating the number of such personnel working in CDSCO against their sanctioned strength;

(c) if not, the reasons therefor alongwith the corrective measures taken/proposed to be taken by the Government in this regard;

(d) the number of complaints including those of unethical drug trials received in CDSCO during the last three years and the current year so far; and

(e) the action taken/proposed to be taken by the Government thereon?

THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a) to (c): There has been shortage of regulatory staff, including drug inspectors, in the past in the Central Drugs Standard Control Organization (CDSCO) for regulating and enforcing various provisions regarding quality of drugs and drug trials entrusted to it under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 made thereunder. However, 216 posts in various grade were created during 2008-2009 taking the total sanctioned strength from 111 to 327. Against these sanctioned posts, 119 regularly appointed and the rest contractual personnel are taking care of the essential functioning of the organisation. Creation of posts and filling of vacant / newly sanctioned are parts of the overall process of strengthening of drug control mechanism and is a continuous and ongoing process.

(d) & (e): A statement giving the details of the cases investigated and action taken thereon is annexed.