Medical Devices Bill to offer an improved regulatory framework for doing business in India, says GlobalData

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India’s recent move to propose an improved regulatory framework under the new Medical Devices (Safety, Effectiveness, and Innovation) Bill will improve the ease of doing business by providing a sound environment for innovation and approval of medical devices in the country, says GlobalData, a leading data and analytics company.

The Ministry of Health and Family Welfare (MoHFW) and Niti Aayog reached an agreement on establishing a separate regulatory body for medical devices sold in the Indian markets. The government also plans to include top technical institutions of India, such as the Indian Institutes of Technology (IITs), by utilizing their world-class laboratories, to help set benchmarks and safety guidelines for providing certifications to medical devices.

Abhinav Purwar, Medical Devices Analyst at GlobalData, comments: “Governments decision to involve IITs clearly indicates that it is aiming to achieve global standards with the help of the new bill and to make India a hub of Medical Device manufacturing. This will provide the desired momentum to take the ‘Make in India’ initiative forward.”

GlobalData’s research reveals that the Indian medical devices market accounted for more than 14% of the Asia-Pacific medical devices market in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 7% through 2025.

The proposed regulatory framework will focus on the safety, efficiency and quality of medical devices, and will be operating under the Central Drugs Standard Control Organization (CDSCO), further enhancing its expertise to regulate safety and efficacy of medical devices. As compared to the current scenario where only 23 categories of medical devices are regulated, the Health ministry plans to cover all the medical devices sold under the new bill.

Purwar concludes: “A strong and independent regulatory framework is needed to promote domestic manufacturing and to reduce dependence on imported devices. The Medical Devices Bill will provide domestic manufacturers a level playing field to compete with multinationals. This will help local manufacturers to produce a variety of innovative medical devices for domestic market and exports.”

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