New Delhi: Government think tank Niti Aayog and the health ministry have arrived at a consensus on the Medical Devices Bill, according to sources, ending months of wrangling over several issues, including what will encourage domestic manufacturing.
Sources told that the final draft of the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, proposes that medical devices should be regulated by a separate division under the Central Drugs Standard Control Organisation (CDSCO).
“All stakeholders have arrived at a consensus over the bill and we will soon make a presentation before the PMO (Prime Minister’s Office) for their approval,” one of the people cited earlier told ET, requesting not to be named.
The division that will monitor medical devices will be headed by a technical expert, and there will be no separate regulator, as conceptualised by the Aayog earlier.
Besides, the regulation of the devices will be under a separate Act and not under the Drugs and Cosmetics Act, 1940, as was being pushed by the health ministry.
This follows several rounds of discussions over the last few months to resolve the impasse created by the Aayog and the ministry pushing their own prescriptions.
A consensus was arrived at after the PMO intervened, given the urgency to push domestic manufacturing of medical devices in a big way to bring down costs as well as reduce imports.
However, the decision to use IIT labs for certification of these devices, as well as ensuring that certification is of global standards and there is no need for dual certification, would be taken up at a later stage once the Bill is passed by Parliament, the person cited earlier told ET.
The ministry will soon move a cabinet note on this. After approval, the Bill will be tabled in Parliament.
The CDSCO, under the health ministry, regulates the safety, efficacy and quality of notified medical devices under the provisions of the Drugs and Cosmetics Act, 1940, and Rules made there under.
However, this has been a bone of contention between the ministry and the Aayog, with the latter being of the view that drugs and devices are two different things and cannot be regulated by a drug expert.
Currently, only 23 categories of medical devices are regulated in India under the Drugs and Cosmetics Act.
The health ministry had recently notified that all medical devices will be brought under regulation in a phased manner. It has proposed seven categories of devices intended for use in human beings or animals, categorising them as drugs with effect from December 1, 2019.
Ultrasound equipment would be under the category of drugs from November 1, 2020.
At over $15 billion, India’s medical devices market is the fourth largest in Asia after Japan, China and South Korea, and is projected to grow to $50 billion by 2025. India imports 80% of its medical devices.