EDEN IAS

DRAFT BILL 2022 SEEKS

UPSC CURRENT AFFAIRS | DRAFT BILL 2022 SEEKS TO REGULATE E-PHARMACIES AND MEDICAL DEVICES | 12TH JULY | BUSINESS STANDARD

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

This will close in 0 seconds