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[1] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India.[2]
Flowchart of Clinical Trials in 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.[3] The Drugs Controller is a part of the Central Drugs Standard Control Organisation and answers to that organization.[3] 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.[3] 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.[4] 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.[4] 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.[4]
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.[5] 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.
^Indian Council of Medical Research (2017). "National Ethical Guidelines for Biomedical and Health Research involving Human Participants" (PDF). Indian Council of Medical Research.
^"Extraordinary" (PDF), The Gazette of India (in Hindi and English), New Delhi: Ministry of Housing and Urban Affairs, 19 March 2019
^ abcGogtay, NJ; Ravi, R; Thatte, UM (March 2017). "Regulatory requirements for clinical trials in India: What academicians need to know". Indian Journal of Anaesthesia. 61 (3): 192–199. doi:10.4103/ija.IJA_143_17. PMC 5372399. PMID 28405032.
^ abcCite error: The named reference Perkovic 2012 was invoked but never defined (see the help page).
^Parishwad, Rajesh (25 January 2013). "Indian supreme court's anger over unregulated clinical trials". Chemistry World. Royal Society of Chemistry.
and 23 Related for: Clinical trials in India information
Clinicaltrials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical...
Clinicaltrials on ayurveda refers to any clinicaltrials done on ayurvedic treatment. Ayurveda is a traditional medicine system inIndia and like other...
Republic of Korea ClinicalTrials.gov ClinicalTrials Information System (CTIS), European Medicines Agency ClinicalTrials Registry - India (CTRI) Cuban Public...
approach to pharmacovigilance: The case of India as a growing hub of global clinicaltrials". Research in Social & Administrative Pharmacy. 15 (1): 109–113...
of India through the Department of Health Research, Ministry of Health and Family Welfare. In 2007, the organization established the ClinicalTrials Registry...
activities related to medical research, particularly clinicaltrials. Clinical research associates work in various settings, such as pharmaceutical companies...
concluded in April 2021. In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinicaltrials. A total...
A 2014 article in the Indian Journal of Pharmacology praised The Hindu's ongoing journalism and critique of clinicaltrialsinIndia. On 7 October 2019...
the incidence of vitamin A deficiency in children by 24%. In two separate randomized clinicaltrialsinIndia, eating iron- and zinc- biofortified pearl...
is under trials. In May 2021, Drugs Controller General of India (DCGI) approved clinicaltrialsin the age group of 2 to 18 years. The trials are conducted...
review and challenges inIndia" (2005) "Ethical issues in HIV/AIDS research" (2005) "Capacity Building for ClinicalTrialsinIndia" (2006, with Falguni...
(DMSO) in an application known as reversible inhibition of sperm under guidance (RISUG). The process is under phase III clinicaltrialsinIndia and is...
It conducts clinicaltrials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization...
service (SaaS) for clinicaltrials. These include protocol development, clinical site collaboration and management; randomization and trial supply management;...
Zydus Cadila Desidustat Gets USFDA Nod To Initiate ClinicalTrials On Cancer Patients The Times Of India 23 July 2020 "Cadila Healthcare changes name to...
considered guilty. These trials relied on the belief that some underlying spirit would distinguish between innocence and guilt. Trials by ordeal using cerberin...
Global Information