Commerce Ministry’s latest move augurs well for Indian medical devices industry

In what can be termed a major policy initiative to promote export of medical devices, the Union Commerce Ministry has recently brought in amendments to the list of export promotion councils, commodity boards and export development authorities, in the Foreign Trade Policy (FTP), 2023 to add the Export Promotion Council for Medical Devices (EPC-MD) to the list of export promotion councils. With this, the newly launched EPC-MD can issue Registration-Cum-Membership (RCMC) for items listed as falling under its jurisdiction.

In May this year, Union Health Minister Dr Mansukh Mandaviya had launched EPC-MD, which will boost the sagging morale of the medical devices industry in the country. The Commerce Ministry has approved the creation of a separate council for medical devices under the administrative control of the Department of Pharmaceuticals (DoP) in order to drive the growth of exports of the medical device sector.

The ministry issued a public notice announcing the amendments in Appendix 2T, which is the list of export promotion councils and other export authorities, of appendices and Aayog Niryat Forms of the FTP, 2023. This adds EPC-MD as a new entry at series number 38 in the appendix. The amendment also assigns a total of 151 medical devices for which the Council will be issuing RCMC. The list includes medicated cotton wool, bandages, sterile surgical catgut and similar sterile suture materials, pacifying preparations for x-ray examinations, diagnostic reagents designed to be administered to the patient, first-aid boxes and kits, rubber contraceptives for male and female, hot water bottles, ice bag, contraceptives based on hormones and spermicides, sacks and ages including cones, gloves, mittens, mitts-of a kind used for medical, surgical, dental or veterinary purposes, personal protective garments, syringes and needles, catheters, cannulae, stethoscopes, blood transfusion apparatus, acupuncture apparatus, parts and accessories of hearing aids, breathing appliances, clinical diapers, napkins and napkin liners for babies, electro-cardiographs, linear ultrasound scanner, magnetic resonance imaging apparatus, echo cardiograph, ophthalmic lasers, instrument and apparatus for measuring blood pressure, dialysis apparatus, endoscopes, baby incubators, defibrillators, laparoscopes and oxygen therapy apparatus.

The new council will be headquartered in the upcoming medical devices park common facility centre in Greater Noida. Its regional offices will be in AMTZ, Visakhapatnam, and Hyderabad. The regional office at Visakhapatnam is expected to be set up in one year and the office at Hyderabad by 2025.

The council’s administration and management will be through the Committee of Administration with elected and nominated members. The nominated members shall be from departments of Pharmaceuticals, Commerce, Promotion of Industry and Internal Trade (DPIIT), Ministry of Health and Family Welfare, Central Drugs Standard Control Organisation (CDSCO), CEOs or Managing Directors of major medical device clusters or parks, including the MD of Andhra Pradesh MedTech Zone and CEO of Hyderabad Pharma City. With an exclusive focus on the implementation of trade-related initiatives and easing of trade issues in the medical devices sector, the Council is being set up on the lines of Pharmaceuticals Export Promotion Council of India (Pharmexcil).

The new export promotion council will spur global market entry and will encourage domestic players to enhance quality standards and production capacity. India currently exports Rs 23,766 crore (2021-22) of medical devices up from previous year Rs 19,736 crore. However, while almost 80 per cent of the medical devices demand in the country is met through imports, the government and the medical devices industry are looking at various methods to improve domestic manufacturing and increase exports.

The government’s initiative in this regard is a welcome move as this strategic step will go a long way in accelerating exports of medical devices from India. It will definitely help exporters in promoting their products in international markets. Moreover, the EPC-MD will help bring in coordinated inter-ministerial policy measures for unleashing the huge export potential and investment potential of over Rs. 80,000 crore for manufacturing medical devices.