The Pharmaceutical Exports Promotion Council (Pharmexcil) has signed a Memorandum of Understanding (MoU) with the Indian chapter of Drug Information Association (DIA) to provide regulatory and technical expertise to the small and medium entrepreneurs (SMEs) in pharma industry on various issues related to exports.
The objective of the MoU is to establish collaboration and liaison between the council and the association to exchange information on regulatory and technical aspects and to organize joint programmes related to global drug registration, Good Manufacturing Practices (GMP) requirements and clinical research procedures, according to Pharmexcil sources.
The initiative is to support the SMEs to successfully operate in the exports market by keeping the latest developments in regulations and registration procedures in various countries, keeping the promotion of exports globally as its aim.
A growing number of regulations have been designed and imposed on healthcare product industries, worldwide. Failure to comply with requirements can delay the approval of pharmaceutical and medical device products resulting in loss to the sponsoring company. The regulatory affairs professionals have to keep themselves abreast of the rapidly changing regulatory and regulator science through training and knowledge sharing.
Though the major pharma exporters are capable of coordinating with the experts on the regulatory requirements of the importing nation, the SMEs have no such system or the wherewithal to keep the exports registration and regulatory requirements update. It is for such firms which will also contribute considerably to the nation's pharma exports, if adequate support is provided, the council and DIA will extend ready information and updates for exports to the destination countries, said the source.
Pharmexcil, under the aegis of Union Ministry of Commerce and Industry, has a membership base of about 3000 members and is administered by the committee of administration consisting of representatives from various sectors of pharma industry. The DIA, comprising experts in various fields of pharmaceutical and related industries, is an organisation working closely with regulatory bodies such as US FDA, EMEA, TGA, and other agencies globally on regulatory issues.