India's Leading Healthcare & Pharma Companies 2023

52 | India’s Leading Healthcare & Pharma Companies 2023 [ OVERVIEW OF INDIA MEDICAL DEVICES SECTOR ] KEY GOVERNMENT INITIATIVES FOR MEDICAL DEVICES INDUSTRY To boost investments in the sector the government has initiated development of medical devices clusters & parks. Also, 100% FDI is permitted through automatic route since 2014. The Medical Devices Rules, 2017 provide regulatory framework for the entire spectrumof medical devices in terms of quality, safety, and efficacy. Besides, the National Pharmaceutical Pricing Authority has enhanced price monitoring of essential medical devices like stents, oxygen concentrators, and other point of care devices. In addition to these policy measures, the recent government initiatives are as mentioned. Na t i o n a l Me d i c a l De v i c e Policy 2022: National Medical Device Pol icy 2022 has been drafted to place the sector on high growth path. The key focus areas of the policy are quality standards & safety of the devices, regulatory streamlining, building competitiveness through fiscal and financial support, infrastructure development, facilitating R&D, human resource development, awareness creat ion & brand positioning. Production Linked Incentive (PLI ) scheme for medi cal devices: The tenure of PLI scheme for medical devices is fromFY21 to FY28 with total financial outlay of INR 34.2 bn. The scheme covers four target segments of medical devices Cancer care/radiotherapy Radiology & imaging medical devices and nuclear imaging An e s t h e t i c s & c a r d i o - respiratory Implants Out of 42 applications received, 21 applicants have been approved with committed investment of INR 10.6 bn and expected employment generation of around 6 thousand employees. As of September 2022, 13 projects have already been commissioned. Reconstitution of National Medical Devices Promotion Council: In August 2022, the Na t i on a l Med i c a l De v i c e s P r o m o t i o n C o u n c i l w a s r econ s t i t u t ed a s an i n t e r - depar tmental counc i l whi ch comprises of stakeholders from government and industry and provides a platform to discuss and resolve various regulatory issues. Set up of Export Promotion Council for Medical Devices: In September 2022, a separate Export Promotion Council (EPC) for Medical Devices has been set up under the administrative control of Department of Pharmaceuticals. Measures to improve access o f med i ca l dev i ces : The government has made available 240 types of surgical supplies in over 8.5 thousand Jan Aushadhi Kendras at affordable prices under the Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana. Measures taken under the Union Budget FY’24: The budget proposed dedicated mul t idiscipl inary courses for medi ca l dev i ces in ex i s t ing institutions to ensure availability of skilled manpower. Further, the budget has allocated INR 2 bn in FY24 for medical devices park and INR 1 bn under PLI scheme for domestic manufacturing of medical devices. Dun & Bradstreet