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Drug regulatory officials giving the nod for sale of Unapproved drug formulations in India

In a recent court hearing over nimesulide, a controversial non-steroidal anti-inflammatory drug prescribed in India to treat // fever and pain the health ministry admitted that drug formulations unapproved by India’s drug regulatory agency and not evaluated for effectiveness are prescribed and sold across the country.

Social Jurist, a group of lawyers in New Delhi had 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. The documents they submitted to the court indicated that dozens of unapproved formulations of nimesulide combined with various other drugs, such as analgesics, anti-allergy drugs, muscle relaxants, and other non-steroidal anti-inflammatory drugs, remain unapproved however are still available in the market.

The drugs controller general of India has however blamed the states’ drug regulatory officials for issuing manufacturing licences despite the absence of marketing approvals from the central health ministry. The drugs controller’s office has also stated that they have asked a panel of experts to examine whether nine of the fixed dose combinations suggested by the social Jurist are in fact available in the market.

Dr Reddys’s Laboratories one of India’s leading makers of nimesulide have announced that they have stopped making four combinations of nimesulide and explained its decision as part of rationalising its nimesulide strateg.

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