Indian trade regulator allows medical device EPC to issue export certificates

In a bid to ensure uninterrupted medical device exports and streamlined customs processes, the Directorate General of Foreign Trade (DGFT), under the Union Ministry of Commerce & Industry, has issued a directive allowing the Export Promotion Council for Medical Devices to issue Registration-Cum-Membership Certificates (RCMC).

Medical device manufacturers can currently be members of various Export Promotion Councils (EPCs), such as the Engineering Export Promotion Council (EEPC), the Pharmaceuticals Export Promotion Council of India (Pharmexcil), and the Federation of Indian Export Organisations (FIEO). They can obtain their RCMC from any of these EPCs.

The new directive now also includes the EPC for Medical Devices as an authorized body to issue RCMCs. Previously, the EPC for Medical Devices was not allowed to issue RCMCs because it was not functioning. “Now that it is going to become functional, the government is announcing a transition system to ensure that, once the EPC for Medical Devices is staffed and fully operational, it will take over the role of issuing RCMCs for medical device exporters,” said a senior government official.

Detailed in Public Notice dated June 23, 2023, this directive addresses key challenges hindering medical device exporters from obtaining RCMCs crucial for availing export benefits under the Remission of Duties and Taxes on Exported Products (RODTEP) scheme.

Central to the new directive is the inclusion of the Export Promotion Council (EPC) for Medical Devices in Appendix 2T of the Foreign Trade Policy (FTP) 2023 that empowers the EPC for Medical Devices to issue RCMCs for specific items, providing an additional streamline to the existing apparatus. Importantly, RCMCs issued by the Engineering Export Promotion Council of India (EEPC India) will remain valid until their scheduled expiry, ensuring continuity during the transition period, indicated the directive reviewed by Business Today.

However, despite this forward-thinking measure, the EPC for Medical Devices is not yet fully operational or integrated into DGFT’s Common Digital Platform for RCMC issuance, creating temporary logistical challenges for exporters.

To circumvent these issues, the DGFT has temporarily authorized EEPC India and other relevant EPCs to continue issuing RCMCs for medical devices. This pragmatic stopgap is designed to alleviate delays and ensure that exporters can promptly obtain the necessary certifications for customs clearance and export benefits.

EEPC India, a premier organization in trade and investment promotion for the engineering sector, is well-positioned to assist, given its extensive membership of over 12,000, including numerous SMEs. Customs authorities have been directed to accept RCMCs issued by EEPC India and other pertinent EPCs until the EPC for Medical Devices is fully operational, the official said.

Association of Indian Medical Device Industry (AIMED) has been advocating for this initiative to enhance India’s global brand presence and offer sector-specific focus and support to Indian manufacturers. “The DGFT’s action is welcomed as it addresses transition challenges until the Medical Devices EPC becomes fully operational. As outlined in the National Medical Devices Policy 2023, the Medical Devices EPC plays a crucial role among the six key strategies to establish India as a manufacturing hub for medical devices,” said Rajiv Nath, Forum Coordinator, AIMED.

“The Indian medical devices industry has seen exports rise significantly, reaching approximately $668.9 million for the year 2022-23, growing by 65%. This places India after Germany and China in terms of export volume, highlighting the industry’s commitment to quality and its emerging global leadership,” said Rajiv Chhibber, Vice President, External Affairs at Sahajanand Medical Technologies Ltd on the sidelines of the launch edition of India Health Expo, organised by Informa Markets in India.

“India’s medical device industry, currently valued at $11 billion (Rs 91,300 crores), is growing at an annualised rate of 18-20%, highlighting its rapid expansion and global competitiveness. It is projected to reach $50 billion (Rs 4,150,000 crores) by 2030 and over $250 billion (Rs 20,750,000 crores) by 2047,” Chhibber said.

Source: bt Business Today