India’s draft medical devices policy

Subject: Government Schemes

Section: Science

Context- The government is proposing a new policy to reduce India’s dependence on import of high-end medical devices.

Concept-

Key Provisions:

The proposed National Medical Devices Policy 2022 aims to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the challenges of the industry such as regulatory streamlining, skilling of human resources and lack of technology for high-end equipment and lack of appropriate infrastructure, through a coherent policy framework.
It also plans to facilitate an orderly growth of the sector, lifting local manufacturing and reducing imports to half over the next decade.
- Currently, nearly 80% of the medical devices used in the country are imported products, particularly high-end devices and medical equipment.
The draft policy envisages that by 2047, India will be one of the top five global manufacturing hubs in terms of value and technology for medical devices.

About Medical Devices and their Regulation in India:

The Medical Device Regulation Act of 2020 serves as the regulatory framework for medical devices.
Medical devices and IVDs are controlled by the Drug Controller General of India (DCGI), which is part of the Ministry of Health and Family Welfare’s Central Drugs Standard Control Organization (CDSCO).
The Drugs and Cosmetics Act, 1940 (“DCA”) governs the quality and safety of medical devices in India.
Only “notified medical devices” that are periodically notified by the government as “drugs” are covered by the DCA. These consists of 37 devices which Include:
- All devices, including an instrument, apparatus, appliance, implant, material, or other article, whether used alone or in combination, including software or an accessory, intended by their manufacturer to be used specially for human beings or animals.