The Pharmaceutical Export Promotion Council (Pharmexcil) has urged the Commerce Ministry to commence a drive for bringing in uniformity in regulations relating to production, marketing and distribution of drugs and pharmaceuticals among partner countries. This will be one of the key pre-requisites to the free trade agreements (FTA) and closer economic partnership arrangements (CEPA).

The council called for synchronization of rules to facilitate trade growth since regulations particularly those binding labelling requirements varied in different countries under the FTA regime.

Pharmexcil also put forward a number of suggestions to the Commerce Ministry in this regard. It felt that only products with value addition of not less than 40 per cent is included in such agreements.

It also urged the Government to look into the possibilities of preferential treatment for production registration and regulation between CEPA and FTA countries, according to Pharmexcil officials.

Other measures suggested by the body included mandatory certificate of origin and physical verification and approval of manufacturing facilities by competent authorities to ensure quality.

"The certificates of origin must be duly endorsed through chamber of commerce or Indian Mission. Dossier for every product should be made a pre-requisite and stringent quality control certification with registration fee made mandatory," according to the council official.
Pharmexcil has called for a cut in the current transaction costs besides a provision of exemption from Value Added Tax as against periodical refund with respect to export transactions contemplated in VAT regulations.

While stating that the Drugs Price Control order has lost its relevance, the Council expressed reservation over the move to expand the span of drugs under price control. It wanted effective price monitoring to replace micro-management of price movement of drugs through rigid price control.

"Drug prices being lowest in India act as a stumbling block for higher realizations in export markets of developed and some developing countries. Besides, any attempt to augment the production capacities involves a lot of additional investment," the Council noted.