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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 ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare. [2] [3] In 2007, the organization established the Clinical Trials Registry - India, which is India's national registry for clinical trials. [4]
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. [1] Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems. [ 1 ]
Clinical research; Drug trials are conducted. The institute is running a general outpatient department (OPD) on all the days of the week. It has a 50 bedded research hospital for in-patients (IPD) also. This IPD is a reputed center for treatment of psoriasis and patients from all over India get admitted and treated.
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 ...
India is a hub for pharmaceutical and biotechnology industries; world-class scientists, clinical trials and hospitals yet country faces daunting public health challenges like child undernutrition, high rates of neonatal and maternal mortality, growth in noncommunicable diseases, high rates of road traffic accidents and other health related issues.
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
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]