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Companies conducting clinical trials in India often do so through a contract research organization. [39] Since the 2000s there has been recognition that India is an attractive place to grow an industry of drug research. [39] A 2008 report described the entry of multinational companies into India for clinical trials research as a frenzy. [40]
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
In November 2020, a U.S. National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with COVID-19 formally concluded that the drug provided no clinical benefit for COVID-19 treatment and recommended against its use. [56] [57] [1]
The CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...
A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants. [4] The phase II concluded in April 2021. [12] [13] [14] In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy ...
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [48] The trials are conducted at AIIMS Delhi and Patna. [49] As many as 54 children had registered at the AIIMS Patna. [50] In total 525 participants are enrolled in the study as per clinical trial data. [51]
The COVID-19 Clinical Research Coalition has goals to 1) facilitate rapid reviews of clinical trial proposals by ethics committees and national regulatory agencies, 2) fast-track approvals for the candidate therapeutic compounds, 3) ensure standardised and rapid analysis of emerging efficacy and safety data, and 4) facilitate sharing of ...
Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research. [5] As a result of the ruling in 2014 India published new requirements for clinical trials. [6] The Supreme Court reprimanded an organization for not compensating victims who were injured. [7]