Question:On June 29, 2020, Central Drug Standard Control Organisation has granted approval to conduct human clinical trials for Corona Vaccine called ‘Covaxin’. By whom it has been developed?
(a) Glenmark
(b) Cipla
(c) Lupin
(d) NIV, Pune & Bharat Biotech
Answer: (d)
Related facts:
- The Central Drug Standard Control Organisation, the National regulatory body for Indian Pharmaceuticals and medical devices, has granted approval to Bharat Biotech India to conduct human clinical trials for Corona Vaccine called ‘Covaxin’.
- It is the first indigenous COVID-19 vaccine to receive the approval.
- The Covaxin has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune.
- The Drug Controller General of India approved Bharat Biotech’s application to conduct phase I and II clinical trials for Covaxin. · The permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response.
- The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
- The indigenous, inactivated vaccine developed and manufactured at the Bio-safety level 3 lab of the Bharat Biotech located in Genome Valley in Hyderabad.
By-Amar Mani Upadhyay