India bans diabetic drug, 32 years late

Three decades after it was banned in the US, the Drugs Controller General, India (DCGI) has taken note of negative reports on the anti-diabe...

Three decades after it was banned in the US, the Drugs Controller General, India (DCGI) has taken note of negative reports on the anti-diabetic drug phenformin, and banned it for use in the country.

The DCGI issued a gazette notification on October 1, 2003 prohibiting the ‘‘manufacture, sale or distribution’’ of this drug. In its order, the Government notified that ‘‘the use of phenformin is likely to involve risk to human beings.’’

The decision was announced by the DCGI in October 2002 but it took the Government one year to notify it.

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Phenformin was invented in 1957 and introduced in the world market. In 1970, an American study found that the drug was causing 250 per cent more deaths due to cardiovascular diseases. ‘‘It was also found to be responsible for development of lactic acidosis, a near-fatal adverse effect,’’ said Dr C.M. Gulati, WHO expert and editor of Monthly Index of Medical Specialities.

Concluding that ‘‘there is no situation in which clinical benefit derived from phenformin outweighs the risk of therapy,’’ the drug was withdrawn in the US in 1971. Subsequently, it was withdrawn from 188 of the 191 WHO member countries. Apart from India, Brazil and Italy are the two other countries where the drug is manufactured.

In India, USV Limited, Mumbai is the only company which sells it under the brandname of DBI and DBI-TD. Its annual sale in 2,000 was around Rs 7 crore and an estimated 10,000 patients consumed it. As per ORG figures, the sales have fallen and the total sale of DBI and DBI-TD is Rs 4.2 crore and is going down by 17 per cent annually. The adverse effects of the drugs were highlighted in December 2000 and at a June 21, 2001 meeting of the Drugs Technical Advisory Board (DTAB), phenformin was referred to a sub-committee for review. The committee concluded that there was ‘‘no reason to ban the drug because cases of lactic acidosis due to the drug were not that common in India.’’

The decision gave a fresh lease of life to the drug. ‘‘It is well known that there is no adverse drug reporting system worth the name in India. It is a very vague argument,’’ said Dr Gulati.