Govt soon to set up Export Promotion Council for Medical Devices

The Department of Commerce (DoC) has approved setting up a separate Export Promotion Council for the medical devices sector

The Health Master

December 9, 2022

321

Last Updated on January 9, 2024 by The Health Master

In an effort to initiate its actions towards setting up the Export Promotion Council for Medical Devices (EPC-MD), the Department of Pharmaceuticals (DoP) has designated an official from the Engineering Export Promotion Council (EEPC) India as the Officer on Special Duty (OSD).

The DoP said that it initiated necessary action towards establishing the EPC-MD, and has designated Pallavi Saha, joint director of EEPC India, as the OSD for the proposed council, to be the nodal officer of contact to carry out all the actions towards establishing the EPC-MD in consultation with the department.

The arrangement is till a regular functionary is appointed for the EPC-MD, it added.

Click for more on Export Promotion Council for Medical Devices

It may be noted that in September this year, the Department of Commerce (DoC) approved setting up a separate Export Promotion Council for the medical devices sector under the administrative control of the Department of Pharmaceuticals to help exporters promote their products in international markets.

The medical devices industry welcomed the move and the strategic step will go a long way in accelerating the exports of medical devices from India.

The DoC approves the creation of the EPC for medical devices with a one-time waiver of the condition in the guidelines on the subject, which requires the initial creation of an “Export Promotion Forum” before it is upgraded to an “Export Promotion Code.”

According to the approval, the Council will be headquartered in YEIDA, Greater Noida, Uttar Pradesh with regional offices in Andhra Pradesh (in AMTZ, Visakhapatnam) and Telangana (in Hyderabad).

The headquarters will be set up with initial funding of Rs 3 crore, in free office space of around 5,000 sq. ft area at the upcoming Medical Devices Park Common Facility Centre in Greater Noida, and required secretarial staff to run the Council.

The Regional Office at Visakhapatnam is expected to be set up in a period of one year, by the end of 2023, and the Regional Office at Hyderabad will be set up in a period of three years, by 2025.

The office space, manpower, and other requirements for the regional offices have to be fulfilled by the respective state governments, said an office memorandum from the DoC.

The Council’s administration and management will be through the Committee of Administration, which has elected and nominated members.

The nominated members shall be from the:

Department of Pharmaceuticals,
Department of Commerce,
Department for Promotion of Industry and Internal Trade (DPIIT),
Ministry of Health and Family Welfare,
Central Drugs Standard Control Organisation (CDSCO),
Chief Executive Officers or Managing Directors of major medical device clusters or parks especially, including the MD of Andhra Pradesh MedTech Zone and chief executive officer of Hyderabad Pharma City, etc.

The industry said that it is great news, a big boost to Indian medical device manufacturing. The long-sought and requested Medical Devices Export Promotion Council is finally sanctioned to be created under the aegis of the DoP, Government of India.

This strategic step will go a long way in accelerating the exports and manufacturing growth of the medical devices sector, they said.

Must read

Procedure to obtain license for manufacturing of Medical Devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Bags and its Testing

Medical Device Alert: Lists

Forms: Medical Devices

Schedules: Medical Devices

NABL 126: Specific criteria for calibration of Medical Devices