Context: The Central Drugs Standard Control Organisation(CDSCO), has allowed Bharat Biotech India (BBIL) to conduct human clinical trials for ‘Covaxin’, making it the first indigenously developed Covid-19 vaccine candidate to receive this approval.
About ‘Covaxin’ and progress so far
- It is a vaccine candidate developed by BBIL in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).
- As part of this collaboration, NIV isolated a strain of the virus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May,2019.
- BBIL then used it to work on developing an “inactivated” vaccine–a vaccine that uses a dead virus.
- BBIL’s Covaxin then underwent pre-clinical testing, which is when the vaccine is tested on animals like guinea pigs and mice to see if it is safe, before the firm approached CDSCO for approvals to move on to the next stage of testing human trials.
- BBIL plans to begin its phase I and II trials in July, but is unsure of the overall timeline for testing and approving its vaccine.
Stages in vaccine development
What other Indian companies are working on a Covid-19 vaccine candidate?
- These include Zydus Cadila, Serum Institute of India and, since earlier this month, Panacea Biotec.
Covaxin is still far behind in the global race for a Covid-19 vaccine
- AstraZeneca, whose vaccine candidate “ChAdOx1-S” with the University of Oxford is already at phase III trials, is the frontrunner.
- Serum Institute has an agreement to manufacture this vaccine.
- Moderna, which is also close to beginning phase III trials for its LNP-encapsulated mRNA vaccine candidate with the National Institute of Allergy and Infectious Diseases, is also close behind.
- Apart from Covaxin, at least six other candidates are in Phase I/II trials and another five are in Phase I trials globally.
The Central Drugs Standard Control Organisation(CDSCO)
- CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
- Under the Drugs and Cosmetics Act, 1940, CDSCO is responsible for
- Approval of Drugs,
- Conduct of Clinical Trials,
- Laying down the standards for Drugs,
- Control over the quality of imported drugs in the country and
- Coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.