New Medical Devices Bill to Bring Increased Accessibility and Affordability for Patients

The Indian government has recently passed a new Medical Devices Bill that aims to make medical devices more accessible and affordable for patients. The bill was passed by the Indian parliament in December 2019 and received presidential assent in March 2020.

The primary objective of the bill is to regulate medical devices by ensuring their quality, safety, and efficacy. The bill also provides for the establishment of a National Medical Devices Authority (NMDA), which will act as the regulatory body for medical devices in India.

One of the key features of the bill is the inclusion of medical devices under the purview of the Drugs and Cosmetics Act, 1940 (DCA). This means that medical devices will now be regulated and approved in a similar manner to drugs and cosmetics. The bill also provides for the creation of a separate chapter for medical devices in the DCA.

In addition to the above, the bill also aims to bring about greater transparency in the pricing of medical devices. The NMDA will be responsible for monitoring and regulating the prices of medical devices, and all manufacturers and importers of medical devices will be required to declare the maximum retail price of their products.

The bill also introduces provisions for the recall of medical devices in case of defects, harm, or unsafe conditions. The NMDA will have the power to issue directives to manufacturers and importers for the recall of medical devices, and failure to comply with such directives will attract penalties.

Another important provision of the bill is the establishment of a Medical Devices Technical Advisory Board (MDTAB). The MDTAB will be responsible for advising the NMDA on technical matters related to the regulation of medical devices.

The new Medical Devices Bill is a welcome move towards making medical devices more accessible and affordable for patients in India. The inclusion of medical devices under the DCA and the creation of the NMDA and MDTAB will ensure that medical devices are regulated in a manner that ensures their quality, safety, and efficacy.

The bill will also bring about greater transparency in the pricing of medical devices and ensure that patients are not exploited by unscrupulous manufacturers and importers. Overall, the bill is a positive step towards making healthcare more accessible and affordable for the people of India.