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, commented, “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 percent of the Asia-Pacific medical devices market in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 7 percent 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 concluded, “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.”