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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.
The government earlier on 14 August 2019 appointed Dr. VG Somani as Drug Controller General of India (DCGI). 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 ...
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Pharmacovigilance ( PV, or PhV ), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1] : 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to ...
The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. [1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. [2] The related Drugs and Cosmetics Rules ...
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.
On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission, which was granted the next day. Covaxin was to be used in a "clinical trial mode" i.e. the public vaccination drive was to be an open-label, single-arm clinical trial in itself.
Desidustat. Desidustat ( INN, also known as ZYAN1) is a drug for the treatment of anemia of chronic kidney disease. This drug with the brand name Oxemia is discovered and developed by Zydus Life Sciences. [1] Desidustat reduces the requirement of recombinant erythropoietin requirement in anemia, and decreases EPO-resistance, by reducing IL-6 ...