Although a month is nearing after the centre announced a ban on phenformin formulations, USV’s phenformin brands DBI and DBI-TD is freely available at the pharmacies across Mumbai and Navi Mumbai. Pharmabiz.com confirmed this after talking to several medical stores across Mumbai and Navi Mumbai. USV is the only company in the country manufacturing phenformin formulations. The ban has been effective since October 1, 2003.
Chemists said they have not received any intimation so far from associations like All India Organisation of Chemists and Druggists (AIOCD), Maharashtra State Chemists and Druggists Association (MSCDA) or Retail & Dispensing Chemists’ Association (RDCA) about the ban.
When contacted, highly placed officials representing AIOCD and MSCDA said neither the centre, DCGI nor USV has sent any direct or indirect communication about the ban on phenformin. “We are not aware of the ban. It is only after you called up that we have come to know about it,” said the AIOCD official. “Leave alone the centre, USV itself has not shown any accountability in notifying the associations about the ban or withdrawing its phenformin brands from the market,” said an official. Senior USV officials were not available for comment on the issue.
Phenformin was withdrawn from US market due to serious adverse reaction in 1971. The drug was found to be having serious chances of the patient developing lactic acidosis, a near fatal adverse effect. Only after conducting a year-long study on the drug that the government gave a positive nod for the ban.
As per ORG figures, USV brands were enjoying annual sales of around Rs 7 crore in the 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 World over, 188 of 191 WHO member countries barring India, Italy and Brazil have withdrawn the drug from their markets.