Central Drugs Standard Control Organisation
Indian Apex Drug Regulatory Body
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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 European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the State Administration for Market Regulation of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
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Astra Zeneca gets nod for anticoagulant drugAstraZeneca Pharma India announced that it has received approval from the Central Drugs Standard Control Organisation for the import and marketing of Andexanet Alfa. The therapy addresses..IndiaTimes - Published | |
AstraZeneca gets CDSCO nod for drug to treat biliary tract cancerIndiaTimes - Published | |
World's first intranasal Covid vaccine from Bharat Biotech gets CDSCO approvaliNCOVACC: Bharat Biotech said that launch dates, pricing and availability will be announced in due course of time.DNA - Published | |
Bharat Biotech's intranasal Covid-19 vaccine iNCOVACC gets CDSCO nod for heterologous booster dosesIndiaTimes - Published | |
Deaths in Gambia due to India-made cough syrups: Centre takes steps to curb damage, Haryana firm remains non-operationalCentral Drugs Standard Control Organisation (CDSCO) launched an inquiry and alerted Haryana last week after learning about the Gambia tragedy.DNA - Published | |
Firm behind Gambia child deaths a repeat offender in IndiaThe Central Drug Standard Control Organisation (CDSCO) has been quick to assure people that the cough syrup which killed 66 children in Gambia was not being sold locally in India, but the same company,..IndiaTimes - Published | |
Drug regulator launches probe on WHO alert over deaths in Gambia linked to India-made cough syrups: ReportThe CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation.DNA - Published | |
CDSCO grants EUA to Bharat Bio's intranasal Covid-19 vaccineThe Central Drugs Standard Control Organisation (CDSCO) has granted approval to BBV154 for restricted use in emergency situation, Union health minister Dr Mansukh Mandaviya announced via a tweet on..IndiaTimes - Published | |
Zenara Pharma gets CDSCO nod to manufacture Covid drugIndiaTimes - Published | |
Hyd-based Zenara Pharma gets CDSCO nod to make generic version of Pfizer's Covid-19 pillIndiaTimes - Published | |
Biocon executive among 5 held in 'bribery' caseThe CBI on Tuesday arrested three persons including L Praveen Kumar, associate vice president and head-national regulatory affairs of Bengaluru-based Biocon Biologics Limited, a company founded by..IndiaTimes - Published | |
Expert panel recommends Corbevax Covid jab for 5-12 years age groupBiological E’s Covid-19 vaccine, Corbevax, is likely to get an emergency-use authorisation (EUA) for use in children in the 5-12 years age bracket following recommendations from the subject expert..IndiaTimes - Published | |
Serum Institute has applied for full market authorisation of Covishield: CEO Adar PoonawalaSerum Institute has applied to the Indian health ministry and Central Drugs Standard Control Organisation (CDSCO) for full market authorisation for its Covishield vaccine, company's CEO Adar Poonawalla..IndiaTimes - Published | Bio E's Corbevax, SII's Covovax & antiviral drug Molnupiravir get EUA nodIn a significant boost for India’s fight against Covid-19, the Central Drugs Standard Control Organisation (CDSCO) has granted emergency use authorisation for two more Covid-19 vaccines – Corbevax..IndiaTimes - Published |
CDSCO panel recommends emergency use authorisation for SII's Covid vaccine CovovaxIndiaTimes - Published | CDSCO panel seeks local clinical trial data from SII for approval of Covishield as booster doseIndiaTimes - Published |
Covaxin gets shelf life extension up to 12 monthsVaccine maker Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of Covid-19 vaccine Covaxin up to 12 months from the date..IndiaTimes - Published | Bharat Biotech submits clinical trial data of Covaxin in children to CDSCOIndiaTimes - Published |
Covid-19: Johnson & Johnson seeks approval to conduct vaccine trials for 12-17 age groupJohnson & Johnson has submitted an application to the central drugs standard control organisation (CDSCO) to conduct a study of its Covid-19 vaccine in India in adolescents aged 12-17 years.IndiaTimes - Published | CDSCO expert panel recommends nod to study on mixing doses of Covaxin, CovishieldAn expert panel of India's central drug authority on Thursday recommended granting permission to the Christian Medical College (CMC) in Vellore for conducting a clinical trial of mixing of two Covid-19..IndiaTimes - Published |