Question : Spurious and Expired Drugs

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether cases regarding circulation and marketing of spurious, substandard, expired and banned drugs being sold in Government Hospitals and in open market across the country have come to light;

(b) if so, the State/UT-wise number of such cases which came to light during each of the last three years and the current year and the number of such cases investigated and raided along with action taken by the Government against such persons and manufacturers;

(c) whether the present legal framework and manpower are adequate for monitoring and curbing the production/ marketing of such spurious and expired drugs, if so, the details thereof and if not, the reasons therefor; and

(d) the measures being taken by the Government to strengthen the present laws, infrastructure, manpower and monitoring system in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) & (b): In order to ensure the quality of drugs in the country, both the Central Drugs Standard Control Organisation (CDSCO) and the state drug regulators pick up a large number of samples of drugs from all over the country and have them tested and analysed in the laboratories of the Central and State Governments. In a few cases, the samples tested and analysed do not meet the prescribed standards. The details of the drugs that do not meet the standards are immediately notified by the Central or State regulator concerned. As per information received from State/UTs, the details of the cases of sub-standard, spurious/ adulterated drugs, number of prosecution launched etc. and action taken against the offender during last three years are enclosed as Annexure-I. Such data in respect of cases of expired drugs detected during the last three years is placed at Annexure-II.

(c) & (d): The Mashelkar Committee had recommended one inspector for 200 sales outlets and one inspector for 50 manufacturing units. Keeping in view the size of Indian Pharma Industry and the number of sales units, around 3200 Drug Inspectors are required both at the Central and State levels. The current strength of the drug regulatory personnel in the country is not sufficient to meet the requirement of ensuring quality, safety and efficacy of medical products. Keeping this in view, the Government has approved a scheme for strengthening the drug regulatory structures both in the Centre and in the States at a cost of Rs 1750 Crore. This includes provision of manpower, upgradation of existing laboratory infrastructure, establishment of new laboratories and provision of Information Technology services.

Further, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 1337 (E) dated 27.10.2017, making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government. Further, the licensed manufacturing premises shall be inspected jointly by the Drugs Inspectors of Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach.