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Spice of the Month
- GS 2 ||Governance || Adminstrative Bodies || Regulatory
Why in News?
- The government is planning to set up a National Medical Devices Promotion Council under the Department of Industrial Policy and Promotion (DIPP) in the Ministry of Commerce and Industry.
- The announcement was made on the occasion of the 4th WHO Global Forum on Medical Devices at Andhra Pradesh Medtech Zone in Vishakhapatnam.
National Medical Devices Promotion Council
- The proposed national council, headed by the Secretary, DIPP, would achieve convergence as medical devices were covered under various Ministries and departments.
- Apart from the concerned departments, it will also have representatives from the healthcare industry and quality control
- Andhra Pradesh MedTech Zone, Visakhapatnam, will provide technical support to the Council.
National Medical Devices Promotion Council (NMDPC) Objectives and Activities:
- Act as a facilitating, promotional & developmental body of MDI (Medical Devise Industry)
- Identify redundant processes and render technical assistance to the agencies and departments concerned to simplify the approval processes involved in the medical device industry promotion & development.
- Support the dissemination and documentation of international norms and standards for medical devices by capturing the best practices in the global market.
- Rise to international level of understanding of regulatory and non regulatory needs of the industry.
- 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 DIPP and DoP.
- 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.
- Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector.
- The manufacturing and trade in MDI(Medical Devise Industry) are growing steadily in double digits. However, it is largely import driven with imports accounting for over 65 percent of the domestic market.
- The setting-up of the Council will spur domestic manufacturing in this sector as Indian companies and startups have started moving towards creating innovative product
Challenges for Medical Device industry in India
- Low Penetration – The per capita medical device spending of USD 3, compared to USD 7 in China and USD 42 in Russia is significantly low.
- Lack of Accessibility – The Indian healthcare system is inadequate, inefficient, and unevenly distributed. 69% of the Indian population live in rural areas, while 73% of qualified consulting doctors reside in urban areas. Eight percent of qualified doctors are in rural areas, and the remaining 19% is in semi-rural areas.
- Inadequate regulatory systems- Nonalignment with global standards and the lack of quality product testing infrastructure are issues that hinder sectoral progress.
- Real estate prices and high capital costs limit the growth of delivery infrastructure.
- Insufficient attention by policymakers and a complex tax regime are also responsible for the sector’s underdevelopment.
- The lack of a comprehensive policy and focus to develop the healthcare eco-system.
- The limited attractiveness of India as a destination for medical devices due to uncertain regulations and pricing environment, unavailability of skilled resources, and ease of doing business compared to other comparable destinations in Asia.
- Lack of innovation and customization resulting in fewer options available to the patients.
Additional Information-The Medical Devices Industry in India
- The Medical Devices industry in India has steadily grown and is valued at more than $5 billion.
- As per industry estimates, the Indian medical devices market will grow to USD 50 billion by 2025.
- Currently, India is counted among the top 20 global medical devices market and is the 4th largest medical devices market in Asia after Japan, China, and South Korea.
- Up to 100% Foreign Direct Investment is permitted in Medical devices through the automatic route
- NMDPC(National Medical Devices Promotion Council) -Composition, objectives and functions.
- Significance and the need for the NMDPC.