Govt. notifies new rules for drugs, clinical trials

Note4Students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Drugs and Clinical Trials Rules, 2019

Mains level:  Measures for ethical clinical trials of medicines in India


News

  • The Union Health Ministry has notified the Drugs and Clinical Trials Rules, 2019 aimed at promoting clinical research in the country.

Drugs and Clinical Trials Rules, 2019

  • The rules will apply to all new drugs, investigational new drugs for human use, clinical trials, bio-equivalence studies and ethics committees.
  • The rules has reduced time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  • Also, in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.
  • As per the new rule, the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries (EU, U.K., Australia, Japan and U.S.) specified by the Drugs Controller General with the approval of the government.
  • The new rules will ensure patient safety and an ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.
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