The Drugs Controller General of India has banned the manufacture, sale and distribution of Phenformin formulations for human use in the country. With the ban, USV Ltd, the only company in India to manufacture the formulations, will have to withdraw its DBI and DBI-TD brands from the market.
The government notification banning the drug has come exactly after one year of the authorities reportedly deciding to prohibit the use of the drug in the country.
The centre has said that it is satisfied that better alternatives to the drug formulations containing phenformin are now available and felt it necessary to ban the drug with effect from October 1, 2003.
Curiously, most of the countries where phenformin used to be marketed had felt the need for banning the drug for the very same reason several decades ago. The drug was withdrawn from US market due to serious adverse reaction 32 years back. The American overview of the drug, at the time of their decision to ban its consumption in 1971 was that "phenformin is no longer indicated for diabetes or any other condition. There is no situation in which clinical benefit derived from phenformin out weighs the risk of therapy".
Phenformin, an anti-diabetic drug discovered in 1957 was found to be having serious chances of the patient developing lactic acidosis, a near fatal adverse effect. A large American study conducted in 1970 found that it was causing 250% more deaths due to cardiovascular diseases than those who were not taking phenformin. At the same time, another drug called metformin belong to the same class of drugs was introduced in the market and found to be more effective and significantly safer and also competitively priced. It is known that the presence of a much better alternative was the reason for the US decision.
The outcry against the continuing presence of the drug in India began just three years ago, with the editorial of a medical publication pointing out that the drug should have been banned decades ago. The media campaigns that followed ensured that the matter was taken up at the Drugs Technical Advisory Board (DTAB) meeting held in 2001. The sub-committee set up by DTAB 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".
If reports quoting ORG figures are to be taken seriously, the USV brands were enjoying annual sales of around Rs 7 crore in Year 2000 and about 10,000 patients were consuming the drug annually when the issue came to light. World over, 188 of 191 WHO member countries had withdrawn the drug by that time. India along with Italy and Brazil were the only nations who continued to manufacture and market the drug.
The drug continued to be in the market with full approval for another year until the authorities announced in October 2002 that they have decided to ban the drug due to "reports of side-effects and presence of better alternatives". Another year passed by before the final notification, sealing the fate of the drug in the country, came in place.
Industry observers feel that the government has been "pro-active" enough to give sufficient time for USV to build up an alternative (and safe) brand containing metformin to replace its phenformin brands. USV manufactures anti-diabetic formulation containing metformin under the brand name "Glycomet".
It is known that the annual sale of Glycomet is currently just over Rs 12 crore and its sale is increasing by 11% annually. The total sale of DBI and DBI-TD is Rs 4.2 crore and the sale is going down by 17% annually.