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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 [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
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.
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 ...
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 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 IATA Travel Pass application for smartphone has been developed by the International Air Transport Association (IATA) in early 2021. The mobile app standardizes the health verification process confirming whether passengers have been vaccinated against, or tested negative for, COVID-19 prior to travel. Passengers will use the app to create a ...
Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 – March 2020; Families First Coronavirus Response Act – March 2020; Coronavirus Aid, Relief, and Economic Security Act (CARES Act) – Includes $1200 stimulus checks, March 2020; Paycheck Protection Program and Health Care Enhancement Act – April 2020
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 ...