National Medical Devices Promotion Council

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It took complete one years to set up National Medical Devices Promotion Council, after its initial announcement by then Minister of Commerce & Industry Mr Suresh Prabhu during 4th WHO Global Forum Meet on Medical Devices, at Andhra Pradesh Medtech Zone, in Vishakhapatnam. It will be headed by Secretary, Department for Promotion of Industry & Internal Trade (GOI). Now the Council is scheduled to hold its 1st meeting on January 14, wherein apart from Secretary DPIIT, there are 27 other members in the Council including NITI Aayog Adviser, senior officials from health ministry, National Pharmaceutical Pricing Authority (NPPA), MSME, Department of Biotechnology and representations from various stakeholders including industry associations. The agenda of the meeting would be deliberations on creation of regulatory structure for medical devices, considering the representations and grievances from the industry, discussion on trade margin rationalization and tariff protection for devices. Government intends to support the medical device industry in order to promote India as manufacturing hub for low priced quality products, like pharma sector.

Medical Devices Industry plays a critical role in the healthcare ecosystem. The manufacturing and trade in MDI is growing steadily which includes a wide range of products owing to increasing non-communicable diseases and hospitalization. Although the industry has been growing in double digits but is predominantly import-driven with imports accounting for over 70 % of the domestic market.

The mandate of this council would be creating an ecosystem by policy interventions to promote local manufacturing of quality medical devices so that India can reduce its imports from other countries and can generate revenue from exports of quality devices. Medical devices market in India is estimated to be $7 billion approx. Currently, US is the largest exporter of medical devices to India, constituting one-fifth of the total, Germany, China, Singapore and the Netherlands are among other major suppliers.

National Medical Devices Promotion Council will have the following objectives and activities :

  1. Act as a facilitating and promotion & developmental body for the Indian MDI.
  2. Hold periodic seminars, workshops and all related networking activities to garner views of the industry and understand best global practices in the sector and  deliberate on various parameters for inclusion in the industrial and trade policies in   medical devices.
  3. Identify redundant processes and render technical assistance to the agencies and departments concerned to simplify the approval processes involved in medical device industry promotion & development.
  4. Enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector.
  5. Support dissemination and documentation of international norms and standards for medical devices, by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of understanding of regulatory and non regulatory needs of the industry.
  6. Drive a robust  and dynamic Preferential Market Access (PMA) policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in imports; while ensuring pro-active monitoring of public procurement notices across India to ensure compliance with PMA guidelines of DPIIT and DoP.
  7. Undertake validation of Limited Liability Partnerships (LLPs) and other such entities within MDI sector, which add value to the industry strength in manufacturing to gain foothold for new entrants.
  8. Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector, including trade interventions for related markets.

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