Compensation for drug trial injuries in India

Clinical trials are an essential part of drug development and drug trial injuries are often inevitable. An investigational drug trial may lead to untoward side effects or injuries called adverse events (AEs) and serious adverse events (SAEs) or adverse drug reactions (ADRs). An adverse event may be relatively minor in the form of bruises or vomiting or major such as organ damage and temporary physical disability, or catastrophic injuries leading to permanent disability or death. Injuries may be psychological, emotional, social or economic and may require only acute or emergency care or long-term medical care.

SAEs are untoward medical occurrences during clinical trials, associated with death, prolonged hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defects or otherwise life-threatening conditions. An adverse event may be unexpected or suspected. An unexpected ADR is an AE that is not consistent with the applicable and available product information as per the investigator’s brochure (IB) or prescribing information, e.g. the IB mentions hepatitis as a suspected AE and the subject develops hepatic encephalopathy, or the IB mentions urticaria and the subject develops anaphylaxis.

Regulatory framework

The regulation of Indian clinical trial injuries is based on a “no-fault approach”, in accordance with schedule Y of the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, Indian Good Clinical Practice Guidelines and the Indian Council of Medical Research (ICMR) Ethical Guidelines for Biomedical Research on Human Participants, 2000. The principles enunciated in the ICMR guidelines are in consonance with guideline 19 of the Council for International Organizations of Medical Sciences and the World Medical Association’s Declaration of Helsinki.

Dr Rachna Bharadwaj is an associate at Krishna & Saurastri Associates and an advocate registered with the Bar Council of India.