Question : USE OF BANNED SUBSTANDARD INGREDIENTS BY DRUG MANUFACTURERS

(a) whether a large number of medicine manufacturing units are using banned/substandard ingredients in the country;

(b) if so, the details thereof;

(c) the number of such cases came to the notice of the Government during the last three years, State-wise;

(d) the action taken against them;

(e) the steps taken by the Government to check these unlawful activities;

(f) whether the Government propose to set up a Drug Regulatory Authority to monitor the drug industry; and

(g) if so, the details thereof?

THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI K. RAHMAN KHAN)

(a)to (e):Ministry of Health and Family Welfare has not received any such information/complaint that a large number of medicine manufacturing units are using banned/substandard ingredients in the country. The manufacture of drugs is licensed and regulated by respective State Drug Control Authority in India. The active ingredients as well as excipients used in the manufacture of drug formulations are required to be tested by every manufacturer as per prescribed specifications before releasing the drug in the market.

(f) and (g): A Drug Regulatory Mechanism already exists in the country. Drug industry in every state is monitored by the respective Drug Control Authority.