Monday, 15 June 2015

INDIA - Draft National Medical Device Policy-2015 -Department of Pharmaceuticals

On June 03, 2015, the Department of Pharmaceuticals (DoP) has issued the draft of the National Medical Device Policy-2015 delineating the objective, responsibilities, initiatives, framework and implementation of  the “National Medical Device Authority (NMDA)” and invited comments from stakeholders by June 30, 2015.

The objective of the National Medical Device Policy is to strengthen the 'Make in India' drive in the medical device sector by reducing dependence on imports and setting up a strong base for medical devices in terms of affordability and availability for patients.

Following are the highlights of the Policy:

  1. An autonomous body, "National Medical Device Authority"(NMDA), to be created under the DoP which shall: 
    • 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;
    • promote networking of national and international organizations within and outside India with the aim of facilitating scientific co-operation, coordination of activities, exchange of information, implementation of joint projects and exchange of expertise;
    • take all such steps to ensure that the public, medical professionals and interested parties receive rapid, reliable, objective and comprehensive information through appropriate methods and means.
  2. The Government on the recommendations of NMDA, subject to availability of Budgetary resources, may consider the following incentives for both Greenfield and Brownfield units:
    • Preference in government procurement may be considered for medical devices which are being manufactured in India with an additional preference for medical devices manufactured under the MSME sector.
    • R&D by agencies like ICMR, DBT, CSIR, DIETY & DoP should be supported/ coordinated through the single window facilitating body.
    • Low cost funding like interest subsidy to MSME
    • Concessional power tariff for up to 5-10 years
    • Provide seed capital, viability gap funding and co-fund start-up projects
    • Provide longer term view (10 years window) for 200% weighted tax deduction on approved expenditure on R&D as the gestation period is high in this industry.
    • Tax/ duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment
    • Minimum/ zero duty on the import of raw materials and manufacturing equipment for production of medical devices.
    • Restrictions on import of second hand diagnostic equipment/ tools
    • Higher taxes after 5-7 years of usage for imported second hand devices
  3. Institutional framework:
    • 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).
    • To create a system where Industry may place/make available their IP in non-core activities available to the exchange which may help technological up-gradation of the sector.
  4. Affordability:
    • The medical devices may be included as a 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 the National Pharmaceuticals Pricing Authority for pricing of the devices by suitably amending the resolution constituting NPPA.

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