India may soon expand the list of medical devices on which price controls can be imposed. A technical advisory body of the Central government, Drugs Technical Advisory Board (DTAB), has recommended that the list of such medical devices should include all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment and X-Ray machines.
Once these medical devices and other high end equipments come under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, it can be deemed as drugs for the purpose of price control under the Drugs (Price Control) Order issued under the Essential Commodities Act, 1955.
The medical devices that are already in this list are cardiac stents, syringes, needles, perfusion sets, HIV diagnostic kits, heart valves, orthopedic implants, blood component bags, etc.
The DTAB, in its meeting held on May 16, also agreed to the proposal for enabling NABL accredited laboratories or any hospital accredited by national accreditation board for hospitals and health care providers (NABH) for issuing performance evaluation report under Medical Devices Rules, 2017 to harmonize the requirements at par with the international rules.
"We have been seeking regulations of commonly used medical electronic equipment to ensure patients safety and we are glad that the Health ministry is now experimenting with this and planning to notify six medical electronic equipment and all implantable medical devices," Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), said.
According to him, the move is necessary to restrict import of pre-owned medical equipment and address patient safety concerns like lack of calibration for accuracy and radiation etc. While clubbing medical devices in the company of drugs can be a short term arrangement, it cannot work long term and the characteristics of medicines and engineering products are entirely different, he says. "Long term solution is a separate Medical Devices Act to house the Medical Devices Rules and regulate all medical devices at one go in a phased manner with a defined transition period," he adds.
The Medical Devices Rules, 2017 which came into effect early this year is in conformity with the Global Harmonisation Task Force (GHTF) framework and best international practices.
It classifies medical devices on the basis of associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk).
The rules also seek to evolve a culture of self-compliance by manufacturers of medical devices and, hence low risk Class A category are accorded manufacturing licences without prior audit of manufacturing site. While the manufacturer will get a license on the basis of self-certification of compliance with, there will be a post approval audit of manufacturing site to ascertain the conformance level. The central authority regulate the high and moderate high risk devices which the low risk ones are handled by state licensing agencies.