Doctrine Of Instrumentality

Under Article 12 of Indian Constitution the term "Instrumentality or Agency" of state is given upon incessant judicial interpretation by the courts. There are certain tests which need to be fulfilled before being recognized as the instrument of the state. It is possible that the instrumentalities or agencies may not be a branch of a government department, but when there is a violation of fundamental Rights, they shall be construed as a state under the definition

e.g., government companies and public undertakings.

Article 21 of Constitution of India states about the "Protection of Life and Personal Liberty ". It states that no person shall be deprived of his life or personal liberty except according to procedure established by law. This fundamental Right is available to every person, citizens and foreigners alike. This implies that this Right has been provided against the State only. State here includes not just the government, but also, government departments, local bodies, the Legislatures, etc.

Article 3 of Universal Declaration of Human Rights states that everyone has the Right to life, liberty and security of person.

In Rahul Dutta v. Union of India and Swasthya Adhikar Manch, Courts have stated that the untimely death of trial participants is a gross violation of the fundamental Right to life guaranteed under Article 21 of the Indian Constitution . In India, to fill the gap in the fundamental Right to compensation, the apex court has found the monetary way to expiate the abuse of the human Rights.

The Supreme Court in Rudal Shah v. State of Bihar, for the very first time laid down the principle that compensation can be given in the cases where any fundamental Right of an individual has been injured and that the higher courts have the authority to do so by using the writ jurisdiction and evolved the principle of compensatory jurisprudence.

Declaration Of Helenski Regarding Compensation

The statement of compensation for clinical trial participants has been put forward clearly in the 2013 version of the "Declaration of Helsinki" adopted in 1964 by the World Medical Association which states that "appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured."

Indian Statutory About Compensation

The Indian law for clinical trials, i.e., the Schedule Y[8] 2005 had clearly stated that informed consent form (ICF) must include the compensation procedure as an essential part in the document. The Indian Council of Medical Research guidelines as well as Indian GCP guidelines advocate provision of compensation to trial participants for any kind of injury/temporary or permanent disability.

In case of death, their dependents are entitled to material compensation. The Drug Controller General of India (DCGI) has previously directed that the clause clearly mentioning that any trial injury or death and medical care will be compensated by sponsor must be included in ICFs.

Swasthya Adhikar Manch, Indore Vs. Union Of India And Other

An NGO (Swasthya Adhikar Manch) filed PIL in the Supreme Court of India. The litigation raised an objection to informed consent procedure in clinical trials and compensation delivered to trial participants for injury and death. In India, by the year 2005–2012, there were a total of 2868 deaths of trial participants, out of which only 89 deaths were found to be related to trial.

Compensation was paid to 86 participants as relative of three participants could not be traced. The amount of compensation paid ranged from 55,000 to 4,200,000 rupees and its assessment was not based on any objectively defined guideline/formula but was decided according to the best judgment of Ethics Committees and/or the sponsor/investigator. The Supreme Court of India considering this issue directed the government to bring regulation and mechanism to ensure the safety of clinical trial participants.

Another PIL, Kalpana Mehta v. Union of India was filed after the death of seven tribal girls during clinical trials of Human Papilloma Virus vaccination in Andhra Pradesh and Gujarat. In both cases, the court applauded the efforts of various NGOs for bringing such gross violation of fundamental and human Rights to the attention of the court. Despite this, due to the lackadaisical approach of the government and the DCGI, the Court has not reached a final decision in both the cases yet.

Provision For Compensation

As per the order of court, government made a three-tier system for the approval of clinical trials and amended the Drugs and Cosmetics Rule 1945 to ensure the safety of participants. There were consecutively three gazette notifications by the Ministry of Health to put 17 Indian Medical Association vs Medical Council Of India on 25 March, 2013 amendments for clinical trial-related injury and death, conduct of clinical trials, and registration of Ethics Committee on January 30, 2013, February 1, 2013, and February 8, 2013. The provision of compensation was notified by inserting a new rule 122 DAB entitled, "Compensation in case of injury or death during clinical trial."

As a Result of Supreme Court's multiple orders, the government introduced the 'New Drugs and Clinical Trials Rules, 2019' in order to promote a more transparent clinical research process and provide compensation for the victims of clinical trial.

1. The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
2. New rules have reduced the time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
3. In case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.
4. Drug Controller General of India will decide the compensation in cases of death and permanent disability or other injury to a trial subject.
5. 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 specified by the Drugs Controller General with the approval of the government.