DoC, Pharmexcil discuss localization trends, concerns related to online CoPP during trade performance review

The Department of Commerce (DoC) and the Pharmaceuticals Export Promotion Council of India (Pharmexcil) have discussed localization trends, concerns related to implementation of online Certificate of Pharmaceutical Product (CoPP) and other trade issues during a recent DOC review meet on the trade performance of pharma and medical devices at Vanijya Bhawan, New Delhi.

Nitin Kumar Yadav, additional secretary, DoC chaired the 5th Review meeting on pharma and medical devices trade performance. The meeting was joined by Namit Joshi, chairman, Pharmexcil, Bhavin Mehta, vice chairman, Pharmexcil, Raja Bhanu, director general, Pharmexcil, Dr Vishal Rajgharia and Bharat Desai, Members of Committee of Administration (CoA), Pharmexcil.

Key concerns discussed included impact of localization on exports, emphasizing the need for a comprehensive strategy to monitor localization trends. The strategy will be a part of the study being conducted by the Centre for WTO Studies (CWTOS) engaged by the Department of Pharmaceuticals (DoP). A tentative deadline of one month to be considered, post which the feasibility of the study will be evaluated. Pharmexcil acknowledged the importance of tracking localization investments by Indian companies abroad and suggested using mission offices for better visibility.

While discussing regulatory issues, concerns were raised regarding the transition to an online system for issuing CoPP and the associated problems with the Centre for Development of Advanced Computing (C-DAC) portal. Clear turnaround time (TAT) for both applicants and issuing authorities was emphasized to avoid delays in exports. A meeting with the Central Drugs Standard Control Organisation (CDSCO) was suggested to address these issues and pre-existing industry’s issues. CDSCO urged exporters to bring their export related issues on an individual case-to-case basis.

A review of import trends revealed a significant increase in imports of human albumin. It was deliberated that the commodity is of essential category and mostly imported for government procurement and is not a cause of concern.

During the discussion, concerns regarding trade with Pakistan were raised, with a request for clarification on whether exports to Pakistan have been halted. It was clarified that at present the Directorate General of Foreign Trade (DGFT) Notification, regarding restriction on imports with Pakistan is in place and the notification is self-explanatory in itself. There is no other DGFT order with respect to exports to Pakistan. The need for a unified approach to address trade restrictions imposed by other countries, particularly in Africa, was also emphasized.

Delays in the renewal of written confirmations for active pharmaceutical ingredients (APIs) in Europe was discussed, with industry representatives highlighting the lengthy process and lack of clarity. The importance of aligning the CDSCO and industry expectations to streamline the renewal process was also highlighted.