Medico-Legal Regulation Of Clinical Trials In IndiaMedical innovation, research and development are a necessary arm for the health care sector and medical advancement helps in securing public health and also to reduce the effects of deadly diseases. What is the meaning of term “clinical trial”? Clinical Trial is a term used to define research in the field of medicine, wherein new tests and experiments are conducted with an objective of identifying its potential benefits and risks on human body along with its capacity to treat a particular health condition. People, usually marginalized people, volunteer for these tests on them in light of monetary or other benefits provided to them. Pharmaceutical companies may conduct trials of some dangerous chemicals on the innocent participants, can conduct the process in an unhygienic condition leading to infections, can suppress the trial results or even manipulate the vulnerable population like youth to take a risky trial. This in some instances has also led to increasing deaths amongst the younger population. Laws attempt to regulate the conditions of these participants of clinical trials as they are in a position of being exploited.
Can a research laboratory undertake clinical trials without any accountability? The answer is NO. Clinical trials in India are heavily regulated to ensure ethical and safe conduct of tests. However, this position was achieved after the Swasthya Adhikar Manch v. Union of India case of 2013. Swasthya Adhikar Manch was an NGO which filed a Public Interest Litigation (“PIL”) in light of several deaths that were happening at the medical trial sites. They alleged that the clinical and bio-medical trial regime is undertaking certain unregulated actions which are affecting the lives of innocent participants. They also claimed that certain entities were undertaking trials without procuring proper licenses from the authorities and were also not providing sufficient care, remedies or compensations to the affected participants. As a result, the Supreme Court pronounced a judgement through which the fate of clinical trials in India underwent a make-over which shall be discuss in detail during the course of this article.
Regulatory Framework
Drugs and Cosmetics Act, 1940 along with Drugs and Cosmetics Rules, 1945 have been the pillars of medico-legal regulation of the pharmaceutical industry in India which dealt with manufacturing and distribution of drugs and excluded the regulation of clinical trials per se. The regulatory body which oversaw the application of these laws was the Central Drugs Standard Control Organization (“CDSCO”). However, in 1988, Schedule Y was added in these rules which became instrumental in regulating clinical trials in India. This marked the introduction of ethical accountability in clinical trials.
Schedule Y was later amended in 2005 which made it more efficient in terms of “Good Clinical Practices”. A separate set of Good Clinical Practices Guidelines for Clinical Research in India have also been introduced by CDSCO to regulate the scientific clinical trials in India. Despite the existence of certain deficiencies, the law consisting of Drugs and Cosmetics Act and Rules governed the clinical trials in India for a long period of time, before the judgement in the Swasthya Adhikar Manch case in 2013. In this case, the Supreme Court pointed out all the lacunas in the law like – participant protection, sponsor responsibility, regulated compensation mechanism etc. It also posed a strict regulatory oversight responsibility on the Drug Controller General of India. Not only this, Indian Council of Medical Research (“ICMR”) also provides for certain guidelines to regulate clinical trials and ethical standards for the same.
Later, in 2019, a new legislation came in the name of – New Drugs and Clinical Trials Rules, 2019 governed by Central Licensing Authority and State Licensing Authorities. It attempted to replace Schedule Y and underwent its first amendment in 2024. It attempted to provide for –
- Formulation of Ethics Committee
- Compensation and insurance provisions for the participants
- Time-bound approval mechanism
- Mandatory registration of Contract Research Organizations (“CROs”)
- Safety monitoring methods like compulsory audit requirements
Usually, pharmaceutical companies outsource the research and development operation to a third-party organization referred to as the CRO. They are responsible to take market approval for the drug under contention. A CRO may perform functions such as project management, data management, clinical studies, post-marketing surveillance, etc. The relationship between a CRO and a pharmaceutical company is regulated by an agreement known as – Clinical Trial Agreement.
The mandatory formation and registration of an Ethics Committee helps in self-regulation of the methods of the clinical trials as all the processes to be undertaken are required to be approved by the Ethics Committee before its conduct. The committee is required to consist of one Chairman, who shall be usually from outside the organization to ensure independence. Along with that, at least one medical scientist, one woman, one legal expert, social scientist, community member and one theologian are to be included in the Ethic Committee for its efficient and legally sound operation. The registration of the Ethics Committees is provided for a period of five years, after which they should apply for the renewal of the registration with the authorities. The position which the Ethics Committees hold is a very important one as they are the primary source of overseeing ethical conduct of the clinical trials and to decide compensation if anything goes south.
Global Legal Framework of Clinical Trials
The pharma companies are capable of exploiting the interests of clinical trial participants by not disclosing the potential side effects of a clinical trial. This is where the concept of informed consent came into picture. Apart from India, there are other jurisdictions which have a well settled regulatory framework for the clinical trials. In the United States of America, the Food and Drug Administration regulates clinical trials under Federal Food, Drug and Cosmetic Act. There are specific provisions for informed consent, good clinical practices, reporting of adverse events etc. which help in navigating unethical and exploitative practices.
In China, Article 26 of the Law of the People's Republic of China on Medical Practitioners provides for prior approvals of the hospital and the patients to be taken by physicians before undertaking any experimental treatments. Although there has been no specific legislation for the human participants, Article 29 of Drug Administrative Law of the People's Republic of China that the doses to be administered for any purpose shall be submitted before the authorities and be approved before undertaking the process.
United Kingdom is regarded as one of the best regulated when it comes to clinical trials. There, the Medicines and Healthcare Products Regulatory Agency oversees the clinical trials and approvals. They keep a check on applications for clinical trials, good manufacturing practices, good clinical practices, safety of medicines, assessing post-marketing safety reports etc. Now, there is a new code which has been developed to regulate the whole process of clinical trials which is known as Guidance on Changes to the Clinical Trials Regulations.
The legal framework of clinical trials in India has seen its growth over the years. This shows the agility of the law and its ability to stay relevant with the passing time. That being said, still the laws in India surrounding clinical trials are not at their best. They lack strong enforcement. Despite the provision of ethical accountability, still it is observed that clinical research is breaching the ethical threshold. To make enforceable impact of these regulations, it is important to provide for stringent penal provisions for its oversight. License revocation and heavy penalties can be charged for ethical breach of conduct or any denial in payment of requisite compensation to the victim participants. This action will instil a sense of deterrence amongst the pharma companies conducting mass clinical trials leading to eventual exploitation of the needy.
Author: Adv. Varun Singh, Founder, Foresight law Offices India. Views are personal.