Government proposes Drug, Medical Devices, and Cosmetics Bill-2022

Context

Recently, the Union government has proposed the New Drugs, Medical Devices and Cosmetics Bill, 2022.

Key-highlights of the Draft Bill

• "Definition for medical devices: The Bill introduced a separate definition for medical devices, which includes-
  • All types of diagnostic equipment and its software.
  • Implants and devices for assistance with disabilities.
  • Life support system.
  • Instruments used for disinfection, and any kits. 
    

• It made a provision for the creation of a ‘medical devices technical advisory board’.
  • This board will include medical professionals, and also people with technical knowledge of the devices. 
  • Officials from the Health Ministry, 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 will be part of the Advisory board. 
• Testing Centres: The Draft Bill also proposes medical device testing centers in states and at the central level.
• Mandatory permission: The Bill has stated that clinical trials or clinical investigations of drugs and medical devices will need compulsory permission from the central licensing authority.
• Compensation: The Bill highlighted that medical management and compensation have to be provided to persons who are injured while participating in clinical trials. 
  • In case of death, the legal heir of the participant should be awarded compensation.
• The Bill also recognized the issue of e-pharmacies; it stated that the Union government would come up with rules and regulations to regulate the online sale of drugs.
  • The Union Government would come up with new sets of rules for online pharmacies.