Clinical Trial and its legality in India

Author- Abhishek Sinha, B.B.A. LL.B. (IVth Year), ICFAI University, Dehradun


India being the land of Unani and Ayurveda Medicines, it is a prominent gospel that long-established systems of medicines always played a significant role in meeting the health care needs of the world. India in the past few years have witnessed a huge rise in outsourcing of clinical trials from developed countries to developing countries by intercontinental pharmaceutical companies.[1]

Research studies that involve human beings and multiple tests and treatments are conducted on them and evaluation is done to see their effects on human health outcomes. These research studies aim to evaluate medical, surgical or behavioural interventions. These ways are found out to be the most effective that a new medical treatment, like a new drug or medical diet or device, is prudent and effectual. Clinical trial aims to make life better for a human being living with a life-threatening disease or a chronic health problem[2].

Phases of Clinical Trials

Phase I

  • In the first phase, the experimental medicine or treatment is tested on a healthy clique (at least 2 subjects) by the Researchers in clinical pharmacology and has the essential facilities to closely study the subject.
  • To find the correct dosages to be given, side effects and safety of the drug or treatment[3].
  • Documents required-

–        Male fertility study

–        Allergenicity / Hypersensitivity test

–        Photo-allergy or dermal photo-toxicity test

–        Systemic toxicity studies

–        In-vitro genotoxicity tests

Phase II

  • In the second phase, The experimental medicine or treatment is tested on a larger group of human beings (10 to 20) compared to Phase I.
  • This aims to collect preliminary information and to see whether it’s effective on the subject or not[4].
  • Documents required-

–        Summary of the non-clinical safety information

–        In-vivo genotoxicity tests

–        Repeat dose systemic toxicity studies

–        Segment 2 reproductive or developmental toxicity study

Phase III

  • The experimental medicine or treatment is given to large groups of people and in different countries and different dosages.
  • If the trial results turn out to be positive then FDA approves the experimental drug or device[5].
  • Documents required-

–        For Phase III Clinical Trials- the non-clinical safety data’s summary (listed above) is provided which is already submitted while getting the permissions for Phase I and II trials, with relevant references.

–        In this case of an application for directly initiating a Phase III trial – complete details of the non-clinical safety data needed for obtaining the permissions for Phase I and II trials, as per the list provided above must be provided.

–        To support the duration of proposed human exposure, repeat-dose systemic toxicity studies of appropriate duration is done.

–        Reproductive/developmental toxicity studies

–        Segment I (women of child-bearing age) and Segment III (for medicines to be given to pregnant women)

–        Carcinogenicity studies (medicine is going to be used for more than 6 months).

Phase IV

  • After approval of the FDA, drugs takes place in the trial of phase IV and now its effectiveness and safety are monitored in huge populations[6].

Laws related to Clinical Trials:

The Drugs & Cosmetics Act, 1940

All facets of drugs and cosmetics concerning their import, manufacture, distribution and sale are governed by the Drugs and Cosmetics Act, 1940.

Inherent enabling powers for regulating the clinical trials are given under the Act[7].

Licensing for sale, import, distribution and manufacture of drugs and cosmetics.

Qualified persons can only manufacture, distribute and sell drugs and cosmetics.

To prevent substandard drugs, presumably for maintaining high standards of medical treatment.

Ayurvedic, Siddha and Unani drugs manufacture and sale are regulated.

To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.

New drugs and clinical trials rules, 2019

It incorporates the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 1964 as amended in 2013 (Helsinki Declaration).

It layout a logical and methodical procedure, as one would expect from science. These rules assume that everyone in the ecosystem making a decision will be led by science, evidence and facts.

Aims to promote clinical research

Reduced the time for approving applications; 30 days for drugs manufactured in India and 90 days for drugs manufactured outside India.

Compensation shall be given to the people who dies or suffers from permanent disability during a clinical trial.

Removed regulations on a test conducted on animals.

Indian Medical Council Act, 1956

It was passed to uniformly regulate the medical education/profession in India.

All clinical trials in India should follow the ICMR guidelines of 2000[8].The Clinical trial can be initiated only (i) after approval of the Drugs Controller General (India) [DCG(I)], (ii) approval from the respective Ethics Committee and (iii) mandatory registration on website53 being maintained by ICMR before the enrolment of the first trial participant for the clinical trial[9].


  1. In the case of Swasthya Adhikar Manch v. Union of India, the government was criticized by Justice R. M. Lodha and H. L. Gokhale for its inaction in repressing clinical trials wherein the penniless and destitute, especially juveniles, tribals and Dalits were being used as subjects and treated as guinea pigs.
  • In the case of Rahul Dutta v. Union of India, the Hon’ble court held that there was a prima facie violation of Article 21 of the Constitution which guarantees the fundamental right to the human subjects and the court considered awarding damages to the subject. Court took strict action against the pharmaceutical companies for causing the deaths of subjects who were not knowing that they were being used as guinea pigs.


The clinical trials are organized to establish the efficacy and safety of the new drug before it is introduced in the market for use of humans on a large level. Some fundamental obligations of the State are strength and health of the subjects are not abused and to improve public health. Under the umbrella of clinical trials undesirable and injurious activities shall be rigidly controlled. Being an emerging country, India needs to advertise a strong culture of research and development in the health sector. The Supreme Court has raised a voice to protect helpless citizens from being exploited as guinea pigs for clinical trials. Court’s one of the important contributions has been that it has tried to awaken the role players who had gone under hibernation.

[1] Salla Sariola, Roger Jeffery, Amar Jesani & Gerard Porter (2019) How Civil Society Organisations Changed the Regulation of Clinical Trials in India, Science as Culture, 28:2, 200-222, DOI: 10.1080/09505431.2018.1493449

[2] WHO, Clinical Trials (2020),

[3] Clinical Trials in India: A Way Towards Impoverishment?, (2017) 11 NSLR 1

4 Inadequacies of Clinical Trial Regulations in India, (2012) 5 NUJS L Rev 379

[5] Clinical Trials in India, (2006) 5 Law Rev GLC 103

[6] FDA, What are the different types of Clinical Research? (Apr. 01, 2018),

[7] Clinical Drug Trials in India: Need for Regulatory Reform, (2016) 6 SCC J-20

[8] Clinical Trials in India: Emerging Legal and Ethical Issues, 3-5 RMLNLUJ (2011-2013) 19

9 Clinical Trials in India: A Way Towards Impoverishment?, (2017) 11 NSLR 1