Serum Institute Of India Writes To Prime Minister's Office, Proposes Reforms In Drug Regulatory System
The world's largest vaccine manufacturer by volume, Serum Institute of India, has written to the Prime Minister's Office proposing reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-COVID vaccines while undergoing clinical trial.
In the letter, Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based Serum Institute of India (SII) referred to the Health Ministry's May 18, 2020, gazette notification, saying it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution.
"Because of this rule, it became possible for us to manufacture and stockpile the COVID-19 vaccine during the clinical trial and we could make the vaccine available in such a short span of time to protect millions of lives," he said in the letter dated March 2.
By the end of 2020, SII has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine "Covishield", even while it awaited the Drugs Controller General of India''s (DCGI) nod for emergency use of its vaccine in the country.