AdvaMed, an association of medical device manufacturers that provides 40 percent of the medical technology used across the world is eagerly awaiting the passage of the Drug & Cosmetics Bill in the monsoon session starting on July 21. This Bill, for the first time, recognises medical devices as a crucial and distinct pillar of India’s healthcare system.
For decades, the medical device industry has gone unrecognised in India. Currently, of the 14000 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.
Mr. Sanjay Banerjee, Chair of AdvaMed India said, “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.”
First introduced in the Rajya Sabha in 2013, the Bill has since then gone through several revisions under the aegis of the current Health Ministry. The ministry has organised a series of consultations with other departments, industry and civil society to ensure that the amendments address all concerns adequately.
The nascent medical devices sector entered the limelight last year with Prime Minister Modi calling out to medical device manufacturers to ‘Make in India’, and the Department of Industrial Policy and Promotion (DIPP) opening up the sector to 100 percent automatic foreign direct investment.
Mr. Vibhav Garg, Vice Chair of AdvaMed India said, “We are heartened by this government’s focus on tackling India’s growing non-communicable disease burden by recognising the role of medical devices. We expect the Bill to help translate the government’s intent into action by creating the right environment for investment, innovation and local manufacture.’
AdvaMed believes that the Bill is a benchmark legislation because 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, and therefore 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’.
