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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]
In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants in the 12–99 age group. [15] [16] Of this, about 1,000 individuals were in the 12–18 age group. [17] [18] Interim results from the phase III trials were made available in July 2021. [19]
Enrolling people with COVID-19 infection is simplified by gathering informed consent, and capturing data on an online clinical trial platform (Castor EDC). [ 6 ] [ 2 ] After the trial staff determine the drugs available at the hospital, the platform randomizes the hospitalized subject to one of the trial drugs or to the hospital standard of ...
India tested its COVID-19 vaccine delivery system with a nationwide trial on Saturday, as it prepares to roll out an inoculation program to stem the coronavirus pandemic. The trial included data ...
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 ...
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.
On 2 June 2021, the DCGI removed the requirement that India-specific clinical trials (bridging trials) be held for vaccine candidates developed outside of India, provided that they are already approved by a recognised international public health agency such as the World Health Organization (WHO), European Medicines Agency (EMA), US Food and ...
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]