The Department of Pharmaceuticals (DoP) has issued the draft National Medical Device Policy-2015, for strengthening the 'Make in India' drive in medical device sector by reducing the dependence on imports and setting up a strong base for medical devices especially those having critical implications in terms of affordability and availability for patients.
As per the draft policy, an autonomous body 'National Medical Device Authority' (NMDA) will be created which will provide a single window mechanism to the industry with an objective of promotion of the medical device industry to make the country not only self reliant but also a global hub of production and innovation in medical devices. The authority will be responsible for setting up and managing, through appropriate corporate body/SPV, Medical Devices Mega Parks of approximately 500 hectares and above, of various specialisations in the vicinity of Centres of Excellence.
The NMDA will create benchmarks as per international best practices and update all the stakeholders on global development, besides developing knowledge networks with partners from industry. It will identify and prevent creation of unnecessary and unjustified technical barriers to trade especially by new or changing technical regulations; support and prepare indigenous businesses to face competition, access foreign markets, and find new business partners abroad; search, collect, collate and analyse relevant data; and promote, co-ordinate and issue guidelines for the development of risk assessment methodologies and monitor, conduct and forward messages on the risks associated with medical devices to the central government, state governments and other enforcement agencies.
As per the draft policy, incentives will be given to both Greenfield and Brownfield units such as preference in government procurement for medical devices which are being manufactured in India with an additional preference for medical devices manufactured under MSME sector; R&D by agencies like ICMR, DBT, CSIR, DIETY & DoP should be supported and coordinated through the single window facilitating body; low cost funding like interest subsidy to MSME; and concessional power tariff for up to 5-10 years.
Other incentives include seed capital, viability gap funding and co-fund start-up projects; support for commercialization of innovations; provide longer term view (10 years window) for 200 per cent weighted tax deduction on approved expenditure on R&D as the gestation period in high is this industry; tax and duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment; and minimum/ zero duty on the import of raw materials and manufacturing equipments for production of medical devices.