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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 .
On 1 July 2021, Cadila Healthcare applied to the Drugs Controller General of India (DCGI), seeking approval for Restricted Use in Emergency Situation for the vaccine. [23] On 20 August 2021, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) recommended that the DCGI grant the approval, [ 24 ] which the 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 of drugs and cosmetics sold in the country, approval of new drugs and regulating clinical trials. [3] [4]
In May 2023, it was approved in India to treat acute ischemic stroke. The drug was developed by Pharmazz. [2] Sovateltide stimulates neural progenitor cells in the brain and promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis).
The Central Drugs Standards Control Organisation (CDSCO) in India, on 5 May 2021, granted an Emergency Use Authorization to Roche [23] and Regeneron [43] for use of the casirivimab/imdevimab cocktail in the country.
The subject expert committee of CDSCO has recommended the grant of permission for manufacturing and marketing of Desidustat 25 mg and 50 mg tablets in India, based on some conditions related to package insert, phase 4 protocols, prescription details, and GCP. [3] Clinical trials on desidustat have been done in India and Australia. [4]
Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings.
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.