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 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
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.
- 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.
- 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.
- In case of no communication from Drugs Controller General of India, the
application will be deemed to have been approved.
- Drug Controller General of India will decide the compensation in cases
of death and permanent disability or other injury to a trial subject.
- 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.