Manufacturing Policy

National Medical Device Authority (NMDA)

Institutional Framework:

• Medical device testing centers to be set up preferably in the PPP mode - Common medical device testing facilities can be set up by government in major medical device manufacturing hubs to facilitate testing/ evaluation of medical devices. Recurring expense can be borne by the industry.

• Designate “Centres of Excellence” (CoE) for supporting product development and validation- The centers having existing requisite facilities and expertise for different categories of medical devices (Example: Department of Electronics and Information Technology (DEITY), Bureau of Indian Standards (BIS), Indian Institute of Technology, Madras (IIT-M), Indian Institute of Technology, Delhi (IIT-D), Indian Institute of Science, Bangalore (IISc-B), Central Institute of Plastics Engineering (CIPET), Defence Research and Development Organization (DRDO). These Centres of Excellence would support:

• Product development - design and prototyping

• Validation and certification of the medical use of devices

• Adopt, implement and advocate policies on efficacy and safety testing

• Strengthen a Made in India marking (BIS) specific to Medical devices in line With International standards like CE and FDA

• Set up a Skill Development Committee under National Medical Devices Authority with representatives from Medical devices industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC), which would:

1. Identify skill gaps and reduce shortages

2. Design curriculum and explore possibilities for on-line/ elearning modules to meet specific requirement of medical device segment

3. The committee would engage with HSSC affiliated Vocational Training Providers as well as potential ITIs, Polytechnic and other institutes for skill development

4. Set up satellite training campus around manufacturing hubs for skill upgrading

5. Liaise across the Medical devices industry for job placements.

6. Provide counseling to candidates seeking skill development and address issues like student loan, scholarships, job placements etc.

• Since the medical devices sector is highly innovation and technology intensive, it is recommended to create a system where Industry may place/ make available their IP in noncore activities available to the exchange which may help technological up-gradation of the sector.

• Set up/ promote Incubation centers through appropriate incentive structure/ cost sharing. Such centers would address gaps in capabilities within R&D infrastructure, testing calibration etc.

Affordability:

• Separate price control for medical devices- The medical devices may be included as separate entry in the list of commodities controlled under the Essential Commodities Act.

• The Government may announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by notifying a separate Medical Devices Prices Control Order (MDPCO).

• A separate division may be created in National Pharmaceuticals Pricing Authority for pricing of the devices by suitably amending the resolution constituting NPPA.

Implementation:

In the first phase, the Department of Pharmaceuticals will within six months, bring a detailed proposal for creation of the National Medical Devices Authority with vision, mission, objectives, constitution, Head Quarters and likely budgetary allocation for appraisal and approval of the competent authority.

The Department of Pharmaceuticals will come up with separate proposals for amending the Essential Commodities Act, amending the scope of functions of NPPA, and the National Medical Devices Pricing Policy.

Department of Pharmaceuticals has invited comments / suggestions on the draft National Medical Device Policy - 2015 which is uploaded on their website, www.pharmaceuticals.gov.in

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