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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 established the CTRI on 20 July 2007. [1] By the end of 2007 the registry indexed 31 trials. [citation needed] In February 2008 various editors of medical journals in India pledged to avoid publishing articles about any clinical trial in India which was not registered. [4]
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.
Indian pharmaceutical company Strides Pharma Science Ltd <SRID.NS> on Thursday received regulatory approval to start clinical trials of antiviral drug favipiravir, which has been touted as a ...
The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research. [5] Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India. [6]
The Clinical Establishments (Registration and Regulation) Act, 2010 is an Act of the Parliament of India.It seeks to regulate all clinical establishments in India. On April 15, 2010, the Clinical Establishments (Registration and Regulation) Bill, 2010 was introduced in the Lok Sabha for the first time.
Dr. VG Somani succeeded S Eswara Reddy, the interim DCGI who was appointed in February 2018. DCGI heads the Indian drug regulatory body the Central Drugs Standard Control Organisation (CDSCO), whose functions include ensuring the quality of drugs and cosmetics sold in the country, approval of new drugs and regulating clinical trials. [3] [4]
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]