Following the Union health ministries suspension order for the import or manufacture of the controversial diabetes drug rosiglitazone and its fixed dose combinations with other drugs in the country with immediate effect, the Maharashtra Food and Drug Administration (FDA) has gone a step further and sent notification to the wholesalers and retailers to recall the drug from the market.

P R Uttarwar, joint commissioner, Maha FDA informed that their office sent in the notification to recall on the same day they had received the order from DCGI's office for suspension of manufacturing of the drug. “It is imminent that rosiglitazone would be soon banned under section 26A of the drugs and cosmetics act. Suspension of the manufacturing license was just a step before completely prohibiting the manufacturing of the drug. Thus recalling the drugs would be the most obvious thing to do since its should not be consumed by patients any more.”

The Maha FDA has directed all the joint commissioners in the state ie Nagpur, Aurangabad, Amravati, Nashik, Thane, Pune and Mumbai to recall all the drugs and its fixed dose combinations with other drugs from the market with immediate effect. After receiving the orders the respective offices have already started the recalling process through out the state.

According to Hemant Koshia, commissioner, Gujarat State Food and Drug Control Administration (FDCA), in Gujarat almost 57 product license was given to 17 manufacturers with different strengths and names to manufacture rosiglitazone and its fixed dose combinations with other drugs in the state. He informed, “We have sent the order to all the manufacturers in the state to immediately suspend the work, though we have not send any orders for recall of the drugs that are already in the market. We are waiting for the government notification as soon as its in we will do the needful.”

A decision to suspend the import or manufacture rosiglitazone was issued by the ministry in respect of continued marketing of rosiglitazone in the country in view of its ban in Europe and restricted use in US. Since the continued use of rosiglitazone would lead to more cardiovascular events and adverse effects on lipid profile, it is expected that in the public interest the DCGI's office may soon expedient the process by prohibiting the manufacture, sale or distribution of rosiglitazone by notification in the official Gazette.

Rosiglitazone and its formulations as single drug or as FOG are being marketed in the country as anti-diabetic drugs. Rosiglitazone is sold by GSK and its generic versions are manufactured in the country by Sun Pharmaceuticals, Dr Reddy’s Laboratories and Torrent Pharmaceuticals, among 30 other manufacturers. GSK sells the drug as Avandia overseas and Windia in India.