The Union Health ministry has released the new draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’ that separately defines medical devices, makes provision for constitution of a separate expert group on medical devices, and calls for setting up of central and state medical device-testing laboratories on the lines of the network of drug-testing laboratories. The draft Bill also suggests that the Central government formulate rules for regulating online pharmacies.
The government has sought comments, objections, and suggestions on the draft Bill over the next 45 days.
The draft Bill has separate definition for medical devices that bring under its ambit diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits. The previous 1940 Act regulated the medical devices as one of the four categories of “drugs”.
But the Bill doesn’t stop at just defining medical devices, it makes provision for creation of a ‘medical devices technical advisory board’ on the lines of the existing drugs technical advisory board. This board will not only include medical professionals, but also people with technical knowledge of the devices. Other than officials from the Health ministry, the board will also include people from the department of atomic energy, department of science and technology, ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology.
So far, decisions regarding medical devices were taken by the drugs technical advisory board that was not necessarily equipped to understand the engineering aspects of the device, according to the people working in the field.
“We are disappointed that the aspirations of a separate Act for medical devices have not been addressed. On the positive side, we are pleased to find the proposal of a separate Board, which was a long-pending demand,” said Rajiv Nath of the Association of Indian Medical Devices Industry (AiMeD).
The draft Bill also proposes medical device testing centres on the lines of drug laboratories in states and at the central level.
Other than bringing in provisions for medical devices, the new Bill also proposes compulsory permission of the central licensing authority for clinical trials or clinical investigation of drugs and medical devices. Although companies at present also have to seek permission from the apex drug regulator to conduct trials, it was never mentioned in the previous law.
The draft Bill states medical management and compensation has to be provided to persons who are injured while participating in such trials. And, in case of death, the legal heir of the participant should be awarded the compensation.
The Bill also touches upon the contentious issue of e-pharmacies, which drug store owners say are hard to regulate. “Many do not have a licence and just sell drugs that are available with other licensed stockists. They offer online consultations and just prescribe medicines, which are not always a transparent mechanism. If you ask for the highly regulated MTb drug, you will probably get it. In addition, they offer big discounts and the product is not always of quality,” said JS Shinde, president, All India Chemists and Druggists Association (AIOCD).
The draft Bill also specifically states that the Central government must come up with rules to regulate online sale of drugs and for online pharmacies to operate “in accordance with a licence or permission issued”.