India bars diabetes drug decades after U.S. ban

Wednesday, 29 October 2003, 08:00 Hrs
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NEW DELHI: India has finally banned the diabetes drug phenformin over two decades after its manufacture and sale was stopped in the U.S.

Phenformin is a synthetic oral hypoglycemic agent used to control maturity-onset diabetes. The drug was banned in the U.S. around 25 years ago after several cases were reported of it causing a unique type of toxicity - lactic acidosis.

Lactic acidosis is the build-up of lactic acid in the body.

While welcoming the ban on the drug, which was introduced in 1957, M.P. Agarwal of the Delhi Diabetic Forum said most qualified doctors in the country handling diabetic patients had stopped recommending its use at least four years ago.

"No qualified doctors have been prescribing phenformin for the last four to five years after having read widely circulated reports overseas about it leading to lactic acidosis, a dangerous condition, though it has not been reported in India," Agarwal told IANS.

Like phenformin, doctors in India are not recommending another diabetic drug, troglitazone, after reports of several fatalities in the West, Agarwal said.

On October 1 the Drugs Controller General of India (DCGI) issued a notification prohibiting the manufacture, sale or distribution of this drug as the "use of phenformin is likely to involve risk to human beings".

Mumbai-based USV Ltd is the only company that sells phenformin, under the brand name of DBI and DBI-TD. The sales figures of the company show that the offtake of the drug has been falling steadily over the last few years.

India is among the countries with a high incidence of diabetics. According to Agarwal, there are around 30 million confirmed cases.

Indians are rated as being highly vulnerable to diabetes and become afflicted at a relatively younger age than in the West, said Agarwal.

Last year the drugs technical advisory board of DCGI referred phenformin to a sub-committee for review. The committee did not favour banning the drug because cases of lactic acidosis due to the drug were not so common in India.

In a subsequent review, the DCGI decided to ban the drug in October 2002 but took a year to notify the decision.

The Indian Drug Manufacturers Association has supported the government move.

"The advisory committee of the DCGI has been functioning well. We support its move as it must have felt justified in addressing the anxieties of some quarter, though the drug is still being manufactured in some countries," said G. Wakankar, executive director of the association.

An official of the World Health Organisation (WHO) said the negative effects of phenformin were well known. "The ban will not cause any hardship in India as there already exists a good substitute without the ill effects of phenformin."

Source: IANS
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