The Maharashtra Food and Drug Administration will be directing USV Ltd to withdraw all stocks of phenformin formulations circulating in the market with immediate effect. Phenformin brands of the company are freely sold in retail shops in Mumbai and Navi Mumbai despite the ban order issued by the DCGI effective from October 1. Most of the retail chemists are unaware of the ban.

The state FDA will also be asking Maharashtra State Chemists and Druggists Association (MSCDA) to instruct its member wholesalers and retailers to stop sale of and return the remaining stocks of the drug to the company.

"It seems that USV and the trade bodies have not taken any serious steps regarding the ban. Both the parties would be dealt with strictly if the drug is not withdrawn immediately from the market," warned a senior official in Maharashtra FDA.

According to an official from MSCDA, various districts and chapters of the organization were intimated through with specific bulletins regarding the ban. "We will issue intimations to wholesalers and retailers again. We will act against those members whoa re not cooperating," he assured.

Phenformin was withdrawn from US market due to serious adverse reaction in 1971.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 World over, 188 of 191 WHO member countries barring India, Italy and Brazil have withdrawn the drug from their markets.