COVID DRUG GOT EMERGENCY APPROVAL
The Central Drugs Standards Control Organisation gave emergency use approval to the antibody combination of Casirivimab and Imdevimab, prepared by Roche India.
It has partnered with Cipla to market and distribute the same.
The approval was based on the data provided by the EUA in the United States of America and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
This can be administered for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older, weighing at least 40 kg) who have been confirmed with SARS-CoV2 infection and are at high risk of developing severe COVID-19 disease.
The Combination Drug of Casirivimab and Imdevimab is approved at a dose of 1,200 mg (600 mg of each drug).
It can be administered through intravenous infusion or subcutaneous route.
It needs a storage temperature ranging from 2 °C to 8 °C.
CENTRAL DRUGS STANDARDS CONTROL ORGANISATION:
It is the National regulatory authority of India.
It comes under the Directorate General of HealthServices, ministry of Helath and Family welfare.
Its headquarters are located in New Delhi.
Central and state regulators derive its power and its responsibilities from Drugs & Cosmetics Act,1940 and rules 1945.
CDSCO aims to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.