Regulation of medical devices: Draft Bill suggests separate expert group, check on online pharmacies

Regulation of medical devices: Draft Bill suggests separate expert group, check on online pharmacies

Subject : Governance

Section : Act

Context: 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
• 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.
• The draft Bill also proposes medical device testing centreson the lines of drug laboratories in states and at the central level
• the new Bill also proposes compulsory permission of the central licensing authority for clinical trials or clinical investigation of drugs and medical devices.
• 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.

Issues with epharmacy

• 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.
• they offer big discounts and the product is not always of quality