SYLLABUS SECTION: GS III (HEALTH ISSUES)
WHY IN THE NEWS?
Recently, Union Health Ministry has released the draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’ that seeks for the first time to regulate e-pharmacies.
KEY HIGHLIGHTS OF DRAFT BILL 2022 SEEKS:
- It seeks to replace Drugs and Cosmetics Act of 1940 while laying down,
- Strict regulatory guidelines to keep pace with changing needs and technology.
- India is among top 20 markets for medical devices worldwide and it is expect to reach US$ 50 billion in 2025 ($10 billion in 2020).
- New definitions for clinical trial, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug and import spurious drugs, among others.
- Medical device testing centres will be establish on the lines of drug laboratories in states and at central level.
- Online pharmacies and medical devices will be regulates in DRAFT BILL 2022 SEEKS.
- Permission of central licensing authority for clinical trials/investigation of drugs and medical devices.
- A separate Drugs Technical Advisory Board and Medical Devices Technical Advisory Board to give suggestions.
- Allows Centre to waive requirement of conducting clinical investigation for manufacture or import of a new medical device in public interest.
- Penalties such as imprisonment and compensation in case of injury or death during clinical trials for drugs.
- A scientific research board for supporting development of innovative drugs of Ayurveda, Siddha, Sowa-Rigpa, Unani and homoeopathy will be establish.
Read more: UPSC CURRENT AFFAIRS
SOURCE: BUSINESS STANDARD