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Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
The National Institute of Virology in Pune, India is an Indian virology research institute and part of the Indian Council of Medical Research (ICMR). [2] It was previously known as 'Virus Research Centre' and was founded in collaboration with the Rockefeller Foundation. It has been designated as a WHO H5 reference laboratory for SE Asia region. [3]
Some further PV regulatory examples from the pharmerging nations are as follows. In India, the PV regulatory authority is the Indian Pharmacopoeia Commission, with a National Coordination Centre under the Pharmacovigilance Program of India, in the Ministry of Health and Family Welfare.
The National Institute of Translational Virology and AIDS Research (formerly National AIDS Research Institute NARI) is a research institute, [1] [2] run by Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research. [3]
The Society of Pharmacovigilance, India (SoPI), is an Indian national non-profit scientific organisation, which aims at organizing training programmes and providing expertise in pharmacovigilance and enhance all aspects of the safe and proper use of medicines [1]
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices.It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
Centre for Excellence in Basic Sciences (Civil Service) Mumbai: College of Defence Management (Defence Service) Secunderabad: Deccan College Post-Graduate and Research Institute (Social Science) Pune: ESIC Medical College and PGIMSR, Gulbarga : Kalaburagi: Film and Television Institute of India (Entertainment) Pune
This is the list of manufacturing facilities based in India: [18] Solid Dosage facility at Hinjawadi - In 2006, Emcure received US FDA approval for its solid dosages facility at Hinjawadi, Pune. The plant manufactures solid oral formulations for the international regulated markets, but currently under FDA warning letter [19]