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India admits to unapproved drug formulations in market

BMJ 2003; 326 doi: (Published 12 June 2003) Cite this as: BMJ 2003;326:1286
  1. Ganapati Mudur
  1. New Delhi

    The Indian government has admitted that drug formulations unapproved by India's drug regulatory agency and not evaluated for effectiveness are prescribed and sold across the country.

    The unprecedented admission from the health ministry emerged at a court hearing on nimesulide, a controversial non-steroidal anti-inflammatory drug prescribed in India to treat fever and pain (BMJ 2003;326:70).

    A group of lawyers in New Delhi called Social Jurist has filed a public interest lawsuit challenging the use of nimesulide among children. The group had also objected to unapproved combinations of nimesulide and other drugs, prescribed for use in adults, as illegal.

    Documents submitted to the court said …

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