Mohali-based National Institute of Pharmaceutical Education and Research (NIPER), the premier institute having expertise in different fields related to pharma sector, is likely to work as the expert panel and recommend the standard input output norms (SION) under the foreign trade policy of the director general of foreign trade (DGFT), as desired by many pharma exporters for long.
Pharmaceutical Export Promotion Council (Pharmexcil), which had been asked by the DGFT to find out a technical panel for fixing the norms, is learnt to have zeroed on NIPER for the task on the grounds of the expertise it had and had sought comments in this regard.
The DGFT under the ministry of commerce and industry usually fixes and notifies standard input output norms for several bulk drug and formulations for the purpose of calculating entitlements under duty entitlement pass book scheme. These norms are notified based on the technical examination of manufacturing processes submitted by the applicant exporter for covered drugs.
However, of late some exporters have approached Pharmexcil and DGFT to fix and notify separate norms for export of some bulk drugs exported to regulated markets by following special processes without infringing patented processes. Based on the requests by the industry, the DGFT has asked Pharmexcil to suggest some organizations or experts who can give their technical comments and expertise for processing such applications.
Since the manufacturing processes in pharmaceutical sector would involve various product groups like drug intermediates, formulations. new drug delivery systems, herbal products etc, the Pharmexcil wanted some agency to take up the job. Hence, it has asked whether NIPER which has sufficient expertise could accept the responsibility for technical examination and recommendation to DGFT. Sources said the Pharmexcil was still waiting for a response from the NIPER and further steps would be initiated soon after it gets the reply.