Govt. notifies new rules for drugs, clinical trials

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Health and Family Welfare Ministry have notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.

Key Facts:

  • The new rules will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
  • These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
  •  It has reduced the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  •  The rules stated that in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.

Source:The Hindu

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