Indian Regulators Moving Ahead with Medical Devices Bill

India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would separately define and regulate medical devices.

There are currently only 14 medical devices regulated by the Drug Controller General of India (DCGI); amending the Drugs and Cosmetics Act would bring all medical devices under regulation in India. The government’s proposed changes would establish a risk-based classification system for medical devices, as well as clinical trial protocols and conformity assessment procedures.

The Indian health ministry also plans to increase staff and infrastructure at the Central Drugs Standard Control Organization’s (CDSCO) medical device division to support expansion of the government’s regulatory scope.

Although a final version of proposed legislation is reportedly drafted, it remains unknown as to when the health ministry will submit the bill to Parliament for passage.

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