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Website. cdsco.gov.in and www.cdscoonline.gov.in. 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.
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. Drugs Controller General of India, comes under the ...
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 CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945.
cdsco.gov.in /opencms /opencms /en /PvPI /. 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] The Central Drugs Standard Control ...
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan ...
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...
a. No person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered. b. Any person who intends to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18 (AA) through the online portal of the Central Government. c.