Serum Institute writes to PMO seeking reforms in drug regulations on non-COVID vaccines

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 18 May 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 2 March.

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. It got the nod in early January this year.

"In view of the successful result of this provision for COVID-19 vaccine, this provision should also be implemented for non-COVID-19 vaccines," Singh said.

In the letter to the PMO, he also sought permission to use the remaining quantities of batches of COVID and non-COVID vaccines for commercial purpose which have been used in a clinical trial. In this context, he said the Health Ministry had issued draft rules dated 12 April 2018, to allow the remaining quantities of batches of vaccines which have been used in a clinical trial for commercial use after the grant of permission in Form 46 (now it is Form CT-23) and manufacturing licence in Form 28D.

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