NITI Aayog Proposes Single Regime For Medical Devices, Penalty For Faulty Products: Report

New Delhi, 19 Dec 2019:

The NITI Aayog, on December 18, has suggested a single regulatory regime to oversee medical devices and a separate four-division Medical Devices Administration (MDA) to improve ease of doing business in the sector, the Business Standard reported.

The MDA would function parallel to the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services (DGHS), the proposal states.

It would likely employ 700 in permanent posts for four separate divisions — health and safety, conformity assessment, enforcement, and laboratories and medical devices testing, it added.

Besides this, the requirement for manufacturing licences to register devices or acquire conformance certificates would be waived.

The changes have been put forth in the draft Medical Devices Bill, which is expected to be notified within the next six months, the paper noted. A window of 12-36 months would be given for existing medical devices to adhere to the new Act, once it comes into force.

The bill also proposes a penalty of up to Rs 1 crore in cases where importers or manufacturers sell faulty medical devices, where a patient’s identity is revealed or if a product is launched without obtaining a certificate of conformance, the Economic Times reported.

The penalty, plus three years imprisonment, was suggested for fraudulently acquired conformance certificates, the ET report added.

Other proposals in the draft include a National Register of Medical Devices, presently governed by the Drugs and Cosmetics Act, 1940; mandatory registration of all devices and compliance certificates by the regulator, mandatory for manufacturers and importers to get unique identification (UID) number for their devices.