India admits to unapproved drug formulations in market

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 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.

"We have some absurd, irrational combinations," said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities India, a journal that tracks pharmaceutical products. "For instance, combinations of nimesulide and diclofenac—you won’t find such fixed dose combinations elsewhere," he said.

The drugs controller general of India has blamed states’ drug regulatory officials for issuing manufacturing licences despite the absence of marketing approvals from the central health ministry. In an affidavit the drugs controller’s office said it had asked a panel of experts to examine whether nine of these fixed dose combinations could be justified.

The drugs’ controller said the expert panel had already declared that combinations of nimesulide with paracetamol and with the muscle relaxants tizanidine and chlorzoxazone (muscle relaxants) may "continue to be marketed." The drugs’ controller also said that state authorities have been asked to adhere strictly to drug rules and not give licences to unapproved combinations.

"We have a strange situation where the government concedes that formulations out in the market for many years have yet to be evaluated," said Dr Gulhati. Some doctors have long criticised India’s drug companies for flooding the market with bad combinations.

Dr Gulhati said that over 70 unapproved combinations are sold under several hundred brand names. These include combinations of antibiotics that could contribute to the emergence of drug resistant organisms.

The drug controller’s decision to allow the use of nimesulide in children has also come under attack, with some paediatricians criticising the manner in which the regulatory authorities evaluated the drug.

Explaining the decision to continue with the use of nimesulide in children, the drugs controller provided statements from the Indian Academy of Pediatrics and personal opinions of several practising doctors that there was no justification to impose a ban on nimesulide.

But paediatricians allege that medical opinion is being influenced by drug companies. Only Italy, India, and Brazil allow the use of nimesulide in children.

"In the past, unscientific data generated by drug companies has been passed off as studies that establish the safety of this drug," said Dr Sanjiv Lewin, associate professor of paediatrics and clinical ethics at the St John’s Medical College Hospital, Bangalore.

Last month one of India’s leading makers of nimesulide, Dr Reddys’s Laboratories, announced that it had stopped making four combinations of nimesulide. The company explained its decision as part of rationalising its nimesulide strategy.

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India admits to unapproved drug formulations in market

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