On March 19, 2019, the Union Ministry for Health and Family Welfare notified the new Drugs and Clinical Trials Rules, 20193 (the 'Rules') aiming to promote clinical research in the country via transparent and faster approvals process. The new rule will be applicable to all new drugs, ethics Committee and investigational new drugs intended for human use, clinical trial, and bioequivalence study. The new rules brings more clarity in terms of:

Clinical Trial of New drugs:

Clinical trial of indigenously developed drug: The Rules provide that any drug discovered in India, or research and development of the drug are being done in India, and which is proposed to be manufactured and marketed in the country, will be deemed approval for clinical trials within 30 working days by Central Licensing Authority (CLA). If no communication has been received from the CLA to applicant, the permission to conduct clinical trial shall be deemed to have been granted.

Clinical trial of Drug developed outside of India: For the clinical trial of drugs developed outside of India, which is already approved and marketed in a country, 90 working days is set as the limit for the CLA to respond. The validity of clinical trial approvals has been determined as two years for pharmaceutical companies to initiate a study, which is extendable by one year.

Post-trial access of new drug:

The Rules introduced the conditions for providing post-trial access of drugs to patients who require it for the first time. According to this the sponsor shall provide the investigational drug to the trial subject free of cost

  • if the clinical trial is being conducted for an indication for which no alternative therapy is available and the investigational new drug or new drug has been found to be beneficial to the trial subject by the investigator; and
  • if the trial subject or legal heir of such subject, as the case may be, has consented

Drug import for sale or distribution:

The Rules exempts local clinical trials for new drugs permitted to be imported for sale or distribution in India, to provide early access to patients to drugs already approved in the countries specified by the DCGI provided that –

  • if no major unexpected serious adverse events have been reported for the drug, and
  • where the applicant is agree to conduct Phase IV clinical trial to establish safety and effectiveness of such new drug, and
  • If the drug is indicated in life threatening or serious diseases or diseases of special relevance to Indian health scenario or for a condition which is unmet need in India such as XDR tuberculosis, hepatitis C, H1N1, dengue, malaria, HIV, or for the rare diseases for which drugs are not available or available at a high cost or if it is an orphan drug.

Compensation and monitoring:

The Rules aim to ensure patient safety in clinical trials via defining the process of informed consent, ethics committee, monitoring and compensation in cases of adverse events.

The Rules mandate that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator or till such time it is established that the injury is not related to the clinical trial.

Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General of India.

Orphan drugs:

For the first time, orphan drugs have been defined as a drug intended to treat conditions which affects not more than five lakh persons in India. In addition No fee shall be chargeable in respect of application for conduct of clinical trial for orphan drugs for rare diseases in India. Moreover, the Rules exempt local clinical trials for orphan drugs permitted to be imported for sale or distribution.


the Rules are comprehensive, well balanced policy and will improve the ethical and quality standards of clinical trials in the country, which will further benefit patients. The conditions of waiving local clinical trial under these Rules will help early access to drugs for patients in India. Where the deemed approval for clinical trials in 30 working days for indigenous drug will speed up the trial process and also encourage local drug development.


3 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==

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