Bill makes distinction between drugs and medical devices:

A medical device makers body today said that the Drug and Cosmetics Bill which is awaiting passage in Parliament will enable the industry to serve the needs of Indian patients in a better way.
AdvaMed, an association of medical device manufacturers that provides 40 per cent 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 body noted that currently, 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 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 harmonised 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 incentivise 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 organised a series of consultations to ensure that the amendments address all concerns adequately.