A separate regulator is proposed for the sector under the Directorate General of Health Services. This would be a separate statutory body in the lines of Food Safety and Standards Authority of India (FSSAI). While this is likely to take a couple of years, there are plans to bring the medical devices under the jurisdiction of the Central Drugs Standard Control Organisation (CDSCO) for the time being, by creating a separate vertical for the same.
Industry sources indicate that they would prefer having a separate body to regulate medical devices.
The draft bill also proposes a penalty of up to Rs one crore on the manufacturers or importers for faulty medical devices having adverse impacts on patients. At present, there are no legal provisions for patient compensation.
India currently imports 80-90 per cent of medical devices of the $15 billion market.
Rajiv Nath, forum coordinator of Association of Indian Manufacturers of Medical Devices (AiMeD) said "The draft notifications recently issued by health ministry has notified all medical devices as 'medicines' under the Drugs Act from December 2019 but the roadmap being defined in the cover note does not detail migrating these to a separate 'Medical Devices Act' in due course as is long desired by Indian manufacturers and other stakeholders."
He added that this is causing huge confusion and apprehensions amongst domestic manufacturers who are awaiting with anxiety the details of a Draft Biomedical Devices Bill that Niti Aayog
is reportedly working on to address the regulatory vacuum & the national
concerns. "We are looking forward to being briefed on this by NITI Aayog," he said.
The government feels that the Ayushman Bharat has triggered an 'unprecedented demand' for medical devices and there is a need to regulate the sector effectively.