Health ministry proposes separate post for medical devices controller

Specific provision for recall of drugs and devices; penal provisions for substandard drugs

The Union health ministry has proposed the creation of a separate post for a drugs and medical devices controller general in India, under whom a separate wing of officials would operate as regulators for the medical devices sector, according to sources familiar with the development.

On Thursday, the Drugs Controller General of India (DCGI) convened a meeting in Delhi to deliberate on matters related to the draft New Drugs, Medical Devices and Cosmetics Bill, 2023, said people in the know.

Key features of the proposed Bill were discussed in the meeting. The ministry has recommended constituting medical devices officers independent of drug control officers and creation of medical devices testing laboratories and the appointment of medical devices testing officers, a source said. Business Standard has seen a copy of the presentation detailing these aspects.

The medical devices manufacturing lobby has been pressing for a separate Bill and a separate proposal for medical devices. It has also written to the ministry requesting a recall of the proposed Bill that is likely to be tabled in the monsoon session of the Parliament.

An industry source disclosed that the testing report of a medical devices testing officer would be considered conclusive evidence in any judicial matter. The source added: “Medical devices officers will have the power to inspect, take samples and so on, and can also seek police assistance as and when required.”

This apart, the proposed Bill recommends the establishment of a separate AYUSH board for drugs, cosmetics, and medical devices. It includes specific provisions for the recall of drugs and medical devices, as well as regulations pertaining to the power to prohibit or restrict the sale of drugs, cosmetics and medical devices through online channels.