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

Singh 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.

Published: 21st July 2021 05:00 PM  |   Last Updated: 21st July 2021 05:00 PM   |  A+A-

In this file photo, employees pack boxes containing vials of Covishield, a version of the AstraZeneca vaccine, at the Serum Institute of India in Pune | AP


NEW DELHI: 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.

"However, the gazette notification in this regard has not been issued so far for the implementation of the same," Singh said.

He also sought the implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

The letter stated that on the directions of the prime minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory systems in India was formed under the chairmanship of then OSD, Rajesh Bhushan who is presently the health secretary.

"Recommendations of this inter-ministerial committee should be implemented immediately in line with 'ease of doing business".

The letter highlighted few other points also related to regulatory reforms and stated, "If few rules/regulatory provisions are amended, it will be a great help and encouragement for the vaccine industry to grow faster.

Follow The New Indian Express channel on WhatsApp


Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on are those of the comment writers alone. They do not represent the views or opinions of or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp