Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India.
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| - Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India. (en)
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| - Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India. Various government agencies and laws regulate clinical trials. The Drugs Controller General of India grants approval for clinical trials and is the top level authority which specifically oversees clinical trials. The Drugs Controller is a part of the Central Drugs Standard Control Organisation and answers to that organization. Both of those organizations answer the Ministry of Health and Family Welfare as the highest level government agency overseeing everything related to medicine and health. The Indian Council of Medical Research governs the professional and ethical behavior of the doctors and scientists. The Pharmacovigilance Program of India tracks reports of harm from the use of drugs. Outside of the central government, each state has its own regional regulatory agencies with some input into governing trials. Since the early 2000s there have been international discussions from science, medicine, and business sectors which observed that India is both an attractive and challenging place to conduct medical research. Favorable characteristics of India included that there are many trained workers including health professionals, there is a large and diverse population, and that the cost of research is relatively low in India in comparison to other countries capable of doing research. Challenging characteristics include lack of research capacity, evolving and uncertain government regulatory infrastructure, diversity of languages, and the need for a culture of research participant confidentiality. In the years around 2010 there were various scandals in media and popular discussion in which companies conducted clinical trials in unethical ways. There were many discussions raising many complaints, including that researchers were not getting informed consent from research participants, and that the medical research was dismissing high rates of injury and death among research participants. Following the 2013 case Swasthya Adhikar Manch v. Union of India in the Supreme Court of India, various government agencies reformed their regulations to make clinical trials more ethical. There have been many changes with various responses. Among the responses, some say that the clinical trials are safer for participants, and others say that the new rules favor large domestic and international companies over other stakeholders. (en)
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