Dr. Reddy’s Laboratories Ltd. announced that it has received permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act. In September 2020, Dr. Reddy’s […]
Tag: DCGI
Cipla Limited announced that it has been granted regulatory approval by the Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza. The accelerated approval for manufacturing and marketing of the drug is aimed at meeting the urgent and unmet medical need for COVID-19 treatment options […]
Zydus, an innovation-driven global pharmaceutical company, announced that it’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II […]
Sun Pharmaceutical Industries Ltd, a Mumbai-headquartered pharmaceutical company, announced that it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in Covid-19 patients. The company said that Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation […]
Glenmark Pharmaceuticals, a research-led integrated global pharmaceutical company, announced that it has initiated Phase 3 clinical trials in India on Antiviral tablet Favipiravir, for which it received approval from India’s drug regulator DCGI in late April. Glenmark claims to be the first company in India to initiate Phase 3 clinical trials on Favipiravir for COVID-19 […]