10 June 2015 | News | By BioSpectrum Bureau
DoP issues National Medical Device Policy 2015
An autonomous body 'National Medical Device Authority (NMDA) is to be created under DoP
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.
According to the new draft, an autonomous body 'National Medical Device Authority (NMDA) is to be created under DoP. The Authority shall provide a single window mechanism to the industry with an objective of promotion of the industry to make the country not only self-reliant but also a global hub of production and innovation in medical devices. It will be responsible for setting up and managing, through appropriate corporate body/SPV, Medical Device Mega Parks of various specialization in the vicinity of center of excellence.
The government on the recommendations of NMDA, subject to availability of Budgetary resources may provide incentives like preference in govt. procurement for indigenously manufactured devices, low cost funding like interest subsidy to MSME, concessional power tariff for upto 5-10 years, provide seed capital, viability gap funding and co-fund start-up projects, incentivize and promote exports in the sector etc for both Greenfield and Brownfield units.
Medical device testing centers to be set up preferably in the PPP mode. Also, the medical devices may be included as a separate entry in the list of commodities controlled under the Essential Commodities Act.