User:Bluerasberry/clinical trial injuries in India

Clinical trial injuries in India including any harm which come to research participants in India as a result of their participation in clinical trials. Harms include problems which a participant reports, and serious adverse events, and death.

Swasthya Adhikar Manch v. Union of India
During Swasthya Adhikar Manch v. Union of India, the Supreme Court of India examined what happens when a research participant dies in a way related to their participation in a clinical trial. That examination found that the research organizers may pay the family of the deceased. When the researchers offer money, they offer widely varying amounts without explanation of why sometimes they offer less or more. The court considered whether this different treatment to different people was discriminatory or inappropriate. One consequence of that court case was the establishment of Rule 122 DAB, which is a government regulation in Drugs and Cosmetics Rules, 1945. This rule gives direction to companies conducting clinical research for how to compensate research participants in the case of injury.

Rule 122 DAB describes that an ethics committee formed by the Drugs Controller General of India should describe the money amounts required as payment in case of death. The

An academic commentator asked many questions about how the changes would affect academic research, and requested that the government answer questions from researchers and include them in the development of documentation. A legal commentator remarked that this change is likely to make India a safer and more attractive place for foreign research investment in clinical trials.

Clinical trial regulations typically through familiar government channels which clearly indicate when they take effect. The government issued Rule 122 DAB in an unusual way, and consequently, at the time of its publication there was uncertainty about when and how it would roll out. The Indian Society for Clinical Research was among those asking for clarity and the opportunity for public comment.

Society
A 2014 survey of clinical trials proposed at a small set of hospitals found that while some had insurance, none had insurance which would fully cover payments to research participants as a result of death.

Payment


In August 2012 the Central Drugs Standard Control Organization presented a formula for calculating the compensation which a researcher should pay if a research participant has an injury in a clinical trial.

On 18 November 2012 the Drugs Controller General of India issued a new legal rule that if any research participant dies related to a clinical trial then the organizer must pay compensation.

Other
Activist Rahul Verma filled an RTI to All India Institute of Medical Sciences, New Delhi following reports that researchers there were keeping some children for long periods of time and turning away admissions for other children.