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Conducting Clinical Trials in India: Regulatory Guidelines


Clinical trials are research studies that are first performed in animals followed by humans, to check the safety of medical devices or new drugs. These clinical trials study is primarily funded by the pharmaceutical industry including the process of human testing (phase 1- phase 4). These clinical trial studies are performed in an academic centre with an academician as a principal investigator. The pharmaceutical companies provide the fund or sponsor these studies.

Clinical research studies aim to evaluate medical, surgical, and behaviour interventions. These are first checked on a small group of patients and if the results are successful then they are evaluated on a large group population. A clinical trial may also look at how to make life comfortable and better for people living with a life-threatening disease or any chronic ailment. When these trials are conducted on patients, the government must monitor the safe practice. No individuals should be harmed intentionally during these research trials.

Regulatory Authority

According to New Drugs and Clinical Trials Rules, 2019 (2019 CT Rules) and Handbook for Applicants & Reviewers of Clinical Trials of new drugs (January 2017) the Central Drug Standard Control Organisation (CDSCO) is the regulatory body responsible to monitor the clinical trial activities in India. Its equivalent counterparts elsewhere include the Food and Drug Administration (USA), Health Canada, and European Medical Agency. According to the 2019 CT Rules, the Drug Controller General of India (DCGI) heads CDSCO (Central Drug Standard Control Organisation. This organisation is responsible for granting permission for clinical trials that are conducted and monitoring its overall process. DCGI is regulated as Central Licensing Authority in the Indian regulation.

According to Relevant Sections for Regulatory Authority, Central Drug Standard Control Organisation (CDSCO) works under the Directorate General of Health Services (DGHS), which is a part of the Ministry of Health and Family Welfare (MOHFW). CDSCO has a major responsibility in approving new drugs, giving proper guidelines for conducting clinical trials, establishing certain sets of standards for drugs, supervising the quality of imported drugs, providing expert advice, and further coordinating with state authorities who regulate the manufacture, sale, and distribution of drugs. Apart from this, ICMR (Indian Council for Medical Research) is the top body that is responsible for the formulation, coordination, and promotion of biomedical research.

Regulatory Guidelines for Conduction of Clinical Trials in India

A clinical trial is the systematic study of a new drug and generates data for verifying and discovering

  1. The complete set of pharmacological properties (pharmacodynamics and pharmacokinetics) of drugs.
  2. To study the adverse effects related to drugs.
  3. To determine the safety and efficacy of new drugs

A new drug according to definition is one-

  1. which is not too significant in-country
  2. A drug that has already been approved but its doses and routes of administration are being changed or it’s being used for new indications.
  3. It’s approved for the market but its market use is for less than 4years.
  4. Vaccines
  5. Fixed-dose combination of two or more drugs, earlier used individually for certain claims, which are now proposed to be combined for the first time in a fixed ratio.
  6. Drugs made using Recombinant DNA Technology.

Conducting Clinical Trials-

The investigator must ensure that the trials are conducted as per the given mentioned guidelines-

  1.   In compliance with the protocol approved by ethical committees (EC) DCGI.
  2.   In compliance with GCP guidelines.
  3.   All applicable regulations

Regulation of Ethical Committees that approve the studies

 Investigators and Administrators of Academic Institutes should ensure that their Institutional Ethics Committees (IECs) are registered with the central licensing authority and the registration renewed at the end of 3 years. This is mandatory for Regulatory Clinical Trials. All clinical trials must be approved by Institutional Ethical Committees. If the IEC feels that there could be a potential overlap between the academic and regulatory purposes of the trial, they should notify the office of the DCGI. If the IEC does not hear from the DCGI within 30 days, it should be presumed that no permission is needed from the licensing authority.

Regulation of Clinical Trials with Clinical Trial Registry of India-

The Clinical Trials Registry of India is an online portal on which registration of clinical trials becomes mandatory in June 2009. It’s an online portal that allows the investigator-initiated and regulatory studies to be registered.

  1. Registration must be done before the first participant is enrolled
  2. Registration is important from a publication standpoint point as editors of many Biomedical Journals will not accept papers that have interventional studies not registered with a Clinical Trials Registry.

 Obtain a Consent of the participant

  1. A written consent form signed by all the participants must be given to the investigator
  2. An audiovisual recording of the consent must be hangover by the investigator in case of vulnerable participants (mental disability or any other problem).


With now a lot of research going on in the field of pharmaceutical sciences and medicine, a large number of drugs are being launched, the clinical trials testing is growing exponentially. India also promises one of the hottest destinations for clinical trials. India should bring strong and effective implementation in policies to perform these clinical trials with ease.

Also, to bring these policies under control India should devise policies and ensure implementation in legislative, Intellectual Property Rights structure, and regulatory issues. There is also a need to develop Clinical Research Organisations with adequate capacity and competency in carrying out research activities in compliance with ICH/GCP guidelines. Many new implementations and rules are set up for the proper regulation of the Indian Pharma Industry, the on;y thing required is its pharmacoeconomic balance and infrastructure monitoring.


Ritika Gupta

Ritika Gupta is an MPharm. graduate who is keen on spreading awareness about various unexplored medical fields through her writings.

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