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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.
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 ...
ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.
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]
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 ...
The MDRF is recognized by the Tamil Nadu Dr. MGR Medical University and the University of Madras for conducting courses leading to the award of PhD degree. [10] [11] The organization has also been offering a 'Postgraduate Course in Diabetology' in association with American Diabetes Association (ADA) to train medical professionals in diabetes care and management.