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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 DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pre-licensing and post-licensing inspections, post-market surveillance, and drug recalls (where necessary). Manufacturers who deal with the authority required to name an Authorized Indian ...
Schedule X is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules introduced in 1945. These are drugs which cannot be purchased over the counter without a valid prescription of a Registered Medical Practitioner (RMP). Also, the retailer has to preserve the prescription for a period of two years. [1]
Schedule J: Contains a list of various diseases and medical conditions that cannot be treated under any drug currently in market. No drug may legally claim to treat these diseases. [3] Schedule X: Schedule X lists addictive drugs (e.g. narcotics, psychotropics [6]) having medicinal uses that must be kept under lock and key. All the regulations ...
The initial list includes common prescriptions such as penicillin, metformin, lithium and albuterol asthma inhalers, as well as drugs for high cholesterol, high blood pressure and other chronic ...
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 ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [48] The trials are conducted at AIIMS Delhi and Patna. [49] As many as 54 children had registered at the AIIMS Patna. [50] In total 525 participants are enrolled in the study as per clinical trial data. [51]