Come April 1, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940, the ministry of health and family welfare said in a notification on Tuesday.
At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control.
The health ministry said the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex decision making body on technical matters related to drugs.
In a separate notification, the health ministry made some amendments to the Medical Devices Rules, 2017 (which was made public and suggestions were invited from stakeholders). This will be called Medical Devices (Amendment) Rules, 2020 and would also come in force from April 1.
It says that the medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). Such registration is voluntary for a period of 18 months, after which it will be mandatory.
The manufacturer of a medical device shall upload the information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO. Importers too will be required to do the same.
"Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints," the health ministry notification read. It can also cancel the license of a manufacturer if it finds lapses.
Further, it gives timelines for registration and regulation of devices. For low and moderate risk devices if is 30 months from date of commencement of the rules, while for moderate high risk and high risk devices it is a period of 42 months within which it would be brought under the new regulations.
According to healthcare activist group All India Drug Action Network's (AIDAN) Malini Aisola, "
Registration requirements for all devices is positive. Timeline for subjecting devices that will be duly notified as of April 1, ranges from 2.5 years to 3.5 years.So India has a loooongg wait before all its higher risk devices are regulated."
Meanwhile, the Industry lobby said that there is no formal assurance that the MoH will work with NITI Aayog on the draft Medical Devices Bill. "We are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non-conformity can be treated as a criminal offence by any Drug Inspector at his discretion and hauled before a court and there are no risk proportionate penalties," said Rajiv Nath of Association of Indian Medical Device Industry (AIMED).
He added that the industry has been seeking an assurance from MoH&FW that this is a temporary measure until the NITI Aayog drafted Bill to regulate Devices separately from Drugs becomes a separate Law.