The ministry of commerce and industry has mooted a much larger role for the Pharma Export Promotion Council (Pharmexcil) in addition to its existing functions. The ministry wants pharmexcil to add on responsibilities in the sphere of regulatory research and marketing initiatives that can help domestic pharma units access markets of various countries, enhance pool of trained professionals in pharma industry by playing a pro-active role in education among other activities.
Currently Pharmexcil, a body set up by the commerce ministry with representation from the industry is assigned the responsibility of facilitating export promotion in the pharma sector. The export council is entrusted with the task of issuing registration-cum-membership certificate (RCMC) apart from organizing trade related meetings in India and abroad. Additionally, it makes suggestions to the government on policy issues related to pharma exports.
The ministry now wants Pharmexcil to create an umbrella regulatory services arm within its ambit so that small and medium enterprises (SMEs) wouldn?t have to liaise with the local governments of various countries independently for drug registration. Such a cooperative setup could act as a nodal point to register products of different companies in the destination country on a shared cost basis so that pharma industry can avoid duplication of resources. It is prohibitively expensive to undertake drug registration at individual firm level (specially SMEs) as requisite skills are generally not available to many firms. A regulatory affairs support cell in Pharmexcil that offers consultancy on regulatory matters with respect to various countries would go a long way in solving regulatory issues of SMEs which have invested heavily in manufacturing but are finding it difficult to economically register and reach various markets.
?Learning the skill set and regulatory compliance issues for each and every country across the world are prohibitively expensive for an SME. The services of the regulatory desk would be made available to member firms of Pharmexcil.? says a recent report by the commerce ministry.