India News

Serum Institute writes to Union Health Minister proposing reforms in drug regulatory system

 New Delhi, July 21

The world’s largest vaccine manufacturer by volume, Serum Institute of India (SII) has written to Union Health Minister Mansukh Mandaviya suggesting reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-Covid vaccines while undergoing clinical trial.

According to official sources, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Pune-based SII, in a letter, referred to a gazette notification by the Union Health Ministry on May 18, 2020.

He said 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 clinical trial and we could make the vaccine available in such a short span of time period to protect millions of lives.

“It will be a big help for the vaccine industry if this rule is implemented for non-Covid-19 vaccines also,” a source quoted Singh as having communicated in the letter to the minister.


Singh also sought permission to use the remaining quantities of batches of Covid and non-Covid vaccines for commercial purposes which have been used in clinical trial.

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