GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
LOK SABHA
UNSTARRED QUESTION NO: 2721
ANSWERED ON:12.03.2010
SALE OF BANNED MEDICINES
(a) whether a large number of medicines are being sold in the country which are banned in other countries because of their adverse side effect on health;
(b) if so, the details thereof and the reasons therefor;
(c) whether Drug Technical Advisory Board (DTAB) is examining the matter;
(d) if so, the names of the medicines which are under examination indicating the name of their manufacturers; and
(e) the time by which a final decision is likely to be taken to ban the use of such drugs in the country?
ANSWER
(a) to (c): The Drug Technical Advisory Board (DTAB), a statutory body under the Drugs and Cosmetics Act examines the safety issues related to continued marketing of certain drug formulations, in context of current knowledge, which have been withdrawn/restricted in some other countries. Certain drugs or formulations withdrawn in one or some countries are continued to be marketed in India after examination by the Expert Committees set-up under DTAB, and wherever necessary, restrictions are imposed on their use for certain indications only. These are based on the risk assessment process which includes disease pattern in the country, indications and dosage of the drug permitted, availability of safe substitutes and overall safety profile of the drug.
(d) & (e): Safety issues of continued marketing of certain drug formulations such as nimesulide, Gatifloxacin, Tegaserod, rosiglitazone etc, in context of current knowledge, which have been withdrawn / restricted in some other countries are under examination by Drug Technical Advisory Board (DTAB). Details of companies who are manufacturing these drugs are not available with Central Drugs Standard Control Organisation (CDSCO) as the manufacturing licence is granted by State Licencing Authority. However as per available information nimesulide is marketed by Dr.Reddys Labs, Piramal Lifesciences, Alembic etc., Gatifloxacin by Aristo Pharma, Torrent Pharm, Piramal, Cipla Ltd etc., Tegaserod by Emcure, Torrent, Intas etc., rosiglitazone by Dr. Reddys, Torrent, Emcure, Cipla etc.