Banned drugs "sold freely" in India

22 July 2007

The Drug Controller General of India, M Venkateswarlu, has followed up a recent tightening of drug clinical regulations (Marketletter July 9) with a program to collect 50,000 drug samples from across the country to identify the scale of counterfeiting in India, Livemint.com reports. Mr Venkateswarlu said the initiative will "give us a statistical and realistic estimate of the problem" of fake medicines. A recently-published European Commission report claimed that India is the top source of counterfeit drugs to the region, ahead of the United Arab Emirates and China.

An additional problem is the market for drugs that have been banned in other parts of the world but remain on sale in India, despite the efforts of the DCGI, according to the Times of India. Among the 11 drugs mentioned in the report is US health care giant Johnson & Johnson's gastroesophageal drug Propulsid (cisapride), which was withdrawn in 2000 (Marketletter July 18, 2005), after reports of 80 heart-related deaths and 341 injuries among patients taking the medication in the USA.

Another, furazolidone, an antibiotic used to treat infectious diarrhea, was previously marketed by the UK's Shire Healthcare. A third, the non-steroidal anti-inflammatory nimesulide, is under review by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) due to concerns over serious liver problems (Marketletter June 4). India-based generic drugmakers Dr Reddy's Laboratories and Nicholas Piramel ceased production of some nimesulide products in 2003.

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