First Indian Bill that Creates a Distinction Between Drugs and Medical Devices

The Drug and Cosmetics Bill will enable the medical device makers to serve the needs of Indian patients in a better way. This bill is currently waiting for its passage in the Indian Parliament. AdvaMed, an association of medical device manufacturers that provides 40 percent of the medical technology said that currently out of the 14,000 types of medical devices that exist, only 22 are on the government’s list and even these are treated as drugs.

The Bill is historic because it creates a distinction between drugs and medical devices for the first time in India’s legislative history.

"We believe that by establishing an appropriate regulatory framework for medical devices, it will enable industry to better address the needs of Indian patients," said Sanjay Banerjee, Chair of AdvaMed India.

"The obfuscation of the two categories in India has created ambiguity about safety standards and quality control, and limited the ability of the medical device industry to address issues of access, availability, affordability and safety," it said in a statement.

The body said that the Bill is a benchmark legislation as it outlines a regulatory system that is appropriate for medical devices and is broadly harmonized with international regulations.

"It will ensure quality of medical devices, patient safety and remove bottlenecks to easy availability. It will grow domestic manufacturing capacity, allow domestic industry to compete globally and incentivize international industry to invest and ’Make in India’," it said.

First introduced in the Rajya Sabha in 2013, the Bill has since then gone through several revisions under the Health Ministry which has also organized a series of consultations to ensure that the amendments address all concerns adequately.

Source-PTI