Grant licences to generic drug names, not brand names, FDA told
The Union ministry of health and family welfare has issued a directive to the food and drug administration (FDA) to grant licences for drug formulation in its generic name instead of a brand name. Not happy with the new directive the FDA has written to the Union ministry seeking clarification on certain points.
It has pointed out that it will be a challenging task to keep check on drugs manufactured under different brand names with a common generic name since licences will be issued under generic names instead of a brand name.The Union ministry has issued the direction to all state licensing authorities under Section 33 (P) of the Drugs and Cosmetics Act 1940. It will hold good for renewal of licences as well. Salim Veljee, director of FDA, when contacted confirmed receiving the directive. While statutory direction prohibits use of brand names on licences, manufacturers will be free to use brand names on the drugs licensed under generic names.
The FDA which issues about 3,000-3,500 licences a year is worried about loss of revenue when the new directive comes into effect. "The manufacturer will not be required to pay for each brand of drug produced under a particular generic name," an FDA official wishing anonymity said.
The new directive is only for the domestic market and not for drugs meant for export. Arun Naik, member of Goa pharmaceutical manufacturers' association, said the FDA can always ask manufactures to provide information if more than one drug is produced under a generic name. The FDA is awaiting the Centre's reply. [TOI]