Question : REGULATION ON MEDICAL DEVICES AND EQUIPMENT

(a) the norms and regulations laid down by the Government to maintain the safety and standards of medical devices and equipment in the country;

(b) whether instances of use of medical devices and equipment in an unregulated manner have been reported in the country;

(c) if so, the details thereof and the action taken by the Government thereon;

(d) whether the Government proposes to make separate provisions to regulate use of medical devices and equipment in the country; and

(e) if so, the details thereof?

THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a): Medical Devices notified under the Drugs and Cosmetics Act, 1940 are regulated as “Drugs” under the Drugs and Cosmetics Rules, 1945.

(b): No.

(c): Does not arise.

(d)&(e): The Drugs and Cosmetics (Amendment) Bill, 2013 has been introduced in the Rajya Sabha. It has a separate chapter on medical devices and has provisions to regulate their use in the Country.