The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has asked the Union health ministry to exclude the drugs meant for exports from its recent directive issued to the state drug licensing authorities to grant/renew drug licenses without endorsing brand names.

In a letter to the secretary, Ministry of health & family welfare, Pharmexcil has asked the health ministry to 'issue a clarification to the state licensing authorities that the recent directive (No. X.11011/1/2011-DFQC, dated 1.10.2012) may not be applied to products meant for exports'.

Pointing out the implications of the health ministry's directive on exports, Pharmexcil said that several overseas countries including developed countries, are granting product registrations for drugs by endorsing brand names as per their existing laws. In case, Indian drug regulatory authorities stop granting/renewing licenses with brand names, Indian exporters will be in a disadvantageous position.

They would not be able to market their products in established brand names over the years. They may not also be in a position to launch new products with brand names as drug registrations by overseas authorities would be based on drug licenses granted by Indian authorities. In view of the above, it would be seen that brand names are endorsed by overseas drug regulators based on licenses given by Indian drug regulators. In case, the Indian drug regulators stop endorsing the brand names for grant/renewal of products, the generic medicines established by Indian exporters over the past three decades would be significantly affected adversely. New product registrations in brand names would also be not possible, the Pharmexcil letter said.

Pharmexcil's COA member Bhavin Mehta said that there are about 3000 pharma exporters in the country and the companies are exporting drug formulations to almost all countries in the world. Most of the companies have established their markets with generic drugs sold in brand names. The state drug controllers have also issued COPP (certificate of pharma product) to WHO GMP compliant companies by endorsing brand names for each product. Accordingly, small and big pharma companies have registered the drugs in various countries in brand names. Even the drug regulatory authorities like USA, UK, Japan, Australia etc. have also granted product registrations to Indian companies in brand names.