The office of the Drugs Controller General of India (DCGI) has found fault with the recent notification issued by the health ministry banning the manufacture, sale and distribution of Phenformin formulations for human use in the country. The DCGI officials have said that the notification, which banned the drug with immediate effect (from October 1, the date of notification itself), was technically flawed.

They pointed out that the notification did not follow the normal practice of allowing some time to the manufacturers to withdraw the drugs from the market while announcing the ban. The particular notification has not given any time to the companies to withdraw their products. A fresh notification, rectifying the mistake will now have to be issued, they said. The officials were not able to pinpoint the section from where the error must have occurred. Senior officials also feigned ignorance when asked about the time frame that was originally supposed to be given to the companies while notifying the ban. The officials could only say that "something has gone wrong in the process" of preparing the notification.

Whatever be the case, the gazette notification would continue to have the legal validity unless a fresh one supersedes the present one. Further there is no provision in the Drugs and Cosmetics Act that prevents the ministry from issuing a notification that can come to effect the same day. Ministry officials were not available for comments.

USV Ltd is the only company in India to manufacture the formulations. With the ban, the company will have to withdraw its DBI and DBI-TD brands from the market.

Phenformin, an anti-diabetic drug discovered in 1957 is banned in almost all countries across the world after it was found to be having serious chances of the patient developing lactic acidosis, a near fatal adverse effect. World over, 188 of 191 WHO member countries have withdrawn the drug. With India also joining the list, Italy and Brazil are the only nations who continue to manufacture and market the drug, it is learnt.