REVIEW ON INDIAN REGULATORY REQUIREMENTS OF CLINICAL TRIALS ON COVID VACCINES

• Published in: Journal of advanced scientific research 2023-08, Vol.14 (6), p.19-29
• Main Authors: Geetha, Karra, Sri, D. Kavya, Pooja, L., Rahmathullah, Md, Rao, T. Rama
• Format: Article
• Language: English
• ISSN: 0976-9595; 0976-9595
• DOI: 10.55218/JASR.202314603

COVID-19 is an infectious disease caused by a coronavirus strain that was discovered in December 2019 in Wuhan city,China. Corona viruses are a type of virus that causes common colds, MERS (Middle East Respiratory Syndrome), SARS(Severe Acute Respiratory Syndrome) and other illnesses. After the United States and Brazil, India has risen to third placein the world in terms of the number of COVID-19 cases. To protect humans from the disease, a race among vaccinedevelopers around the world has begun, with hundreds of COVID-19 vaccine candidates in various stages of clinicaltrials. On January 16, 2021, India's government began offering free COVID-19 vaccinations, and as part of what isanticipated to be the world's largest immunization campaign, it is asking all of its residents to get vaccinated. FourCOVID-19 vaccines, out of the eight being tested in various phases of clinical trials in India, were created. The Indianmedicines regulator has given its approval. Covishield, the Oxford-AstraZeneca vaccine, and Covaxin, a locally producedvaccine made by Bharat Biotech, are only to be used in cases of extreme urgency. The capability of Indian producers tosupply the nation's anticipated future demand for COVID-19 vaccines has been confirmed. The initial immunisation of30 million healthcare workers can be completed with the help of the staff and cold-chain infrastructure in place prior tothe pandemic. The Indian government has acted quickly to increase the nation's capacity for vaccine production and hasalso created an effective digital system to handle and monitor all facets of vaccine administration.