Last Updated on October 12, 2021 by The Health Master
The medical devices industry has urged the Central government to frame a separate Act for medical devices sector in the country, similar to the introduction of Food Safety and Standards Act (FSSAI) for the food industry.
Asking the government to frame a separate Act at the earliest in order to help the medical devices industry grow better and innovate faster, Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD) said that the current approach of keeping the Medical Devices Law under the drug regulations is restricting the industry in various levels as both are different in nature.
“We seek earliest passage of a Separate Medical Device Law as done for FSSAI in food, that is reasonable and implementable for our products as medical devices are not medicines,” Nath sought in a letter to Union minister of health and family welfare Mansukh Mandaviya recently.
“We are opposed to a piecemeal approach of amendment of the Drugs & Cosmetics Act by giving a separate chapter of Medical Devices with shared punitive and penal criminal actions as for Drugs,” he added.
The draft bill by Niti Aayog needs to be pursued as the shifting stand of the ministry of health and family welfare creates unpredictability that negatively impacts much needed investments in medical devices.
These issues need to be discussed before finalising the Bill. The existing rules need to be transplanted into the new Act. The advantages of a separate Act will be that there will be less criminal action, most offences can be decriminalised which cannot be done in the pharmaceutical industry. When both medical devices and pharmaceuticals are treated under the same Act, this is a constraint to the industry, he added.
Innovation on medical devices is happening so fast and the CDSCO and the government needs to have a different mindset on that. But if they do that, the pharmaceutical industry and the regulators will not allow that. It is a different requirement for engineering. Like innovation in the automobile industry is different from that in food, which again, is different from drugs.
According to earlier reports, Niti Aayog almost two years back proposed a move to bring all the medical devices under a single regulatory framework and have a separate Medical Devices Administration. The aim for the Medical Devices Bill was to bring in ease of doing business and treat medical devices as separate from drugs.
Currently, the medical devices are regulated under the Medical Devices Rule, 2017, under the Drugs and Cosmetics Act, 1940 and the drug regulator is going ahead with its plans to move the medical devices into a licence regime in a phased manner. The drug regulator has classified almost all the medical devices into four categories based on the risk involved.
According to the government’s plan, the medical devices regulatory process starts with voluntary registration, which began in April, 2020, which will move to compulsory registration, for Class A and B products, starting from October 1, 2021 and Class B and C it will start from October 1, 2022. All the classes will eventually move to the licensing regime one year from there.