Drugs and Clinical Trials Rules, 2019

  • The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
  • 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 be applicable to all new drugs, ethics committee and investigational drugs applicable for human use, bioequivalence studies and clinical trial in India.

About New Rules

Objective:​ To change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
Coverage:​ These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
Application approval time:​ It has reduced the time for approving applications to30 days for drugs manufactured in India and 90 days for those developed outside the country. In case of no communication from Drugs Controller General of India(DCGI), the application will be deemed to have been approved.
Local clinical trial:​ 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 to be specified by the Drugs Controller General with the approval of the government.
Safety in clinical trial:​ The new rules will ensure patient safety, as they would been listed for trials with informed consent. The ethics committee will monitor the trialsand decide on the amount of compensation in cases of adverse events.

Existing Rules and Issues

  • Clinical trials in India are governed by the acts: Drugs and Cosmetics Act,1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970.
  • Prerequisites of conducting a clinical trial in India are: Permission from the Drugs Controller General, India (DCGI) Approval from respective Ethics Committee where the study is planned Mandatory registration on the ICMR maintained website

Location: Thiruvananthapuram, Kerala, India

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