Move to grant mfg licences in generic names faces objection from some States

Joseph Alexander, New DelhiMonday, September 24, 2012, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) is planning to change the concerned rules to grant manufacturing license of drug formulations in proper (generic) name only, but some States have raised apprehensions about the proposal.

It is learnt that some State licensing authorities have expressed reservation about the move, pointing out that the move may not be practical with regard to the products having multiple ingredients. To give licence only in the generic name can be feasible for single ingredient formulations.

However, if the same parameter was used for formulations with multiple ingredients, it may lead to large number of brands and would be difficult for the States to regulate the quality control, the States have reportedly informed the CDSCO.

As per the existing norms, at the time of the grant of the license for manufacture of a drug formulation by the State Licensing Authorities, the trade name / brand name, as submitted by the manufacturer, is endorsed by the licensing authority along with proper name of the product thereby giving legitimacy to market the drug under the brand or the trade name.

“Under Drugs & Cosmetics Rules, applications in various forms for grant/renewal of a licence to manufacture for sale or distribution of various categories of drugs as well as various forms for grant/renewal of such licenses require that the name of drug is specified. Such forms for application as well as grant/renewal of the Licenses do not require mentioning of any trade name/brand name. In case of drug formulation containing multiple ingredients, the licence should be granted under the name of categories of the products viz. 'Multivitamin Tablets/Capsule/Syrup', 'antioxidants, multivitamins and multi minerals tablets/capsule/syrup' etc. However, the composition of such product shall mention the name of ingredients as well as its strength,” sources said.

“It was noted that the grant of drugs manufacturing licenses under a trade or brand name is not in accordance to the spirit of the legislation and therefore it is proposed that manufacturing licenses for the drug formulations should be granted in proper/generic name only,” sources said.