SII proposes reformatory measures related to the existing drug regulatory system

Serum Institute of India (SII) has put forward a proposal to the Prime Minister’s Office regarding the reforms in the existing drug regulatory system, which includes allowing manufacturing and stockpiling of non-Covid vaccines during the clinical trials.

The Director of Government and Regulatory Affairs at Serum Institute of India, Prakash Kumar Singh, has in a letter referred to the Health Ministry’s May 18, 2020, gazette notification, pointing out that it gave permission for manufacturing and stockpiling of Covid-19 vaccine under clinical trial for the sake of marketing authorization for sale or distribution.

In a letter written on March 2, he stated, “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”.

Even while waiting for approval from the Drugs Controller General of India (DCGI) for its emergency usage in the country, SII has already manufactured nearly 50 million doses of the Oxford-AstraZeneca Covid-19 vaccine, termed as “Covishield”, by the end of the previous year.

Finally, it has received approval at the beginning of this year.

Singh further added, “In view of the successful result of this provision for Covid-19 vaccine, this provision should also be implemented for non-Covid-19 vaccines”.

While writing to the PMO, he also asked permission to use the leftover quantities of Covid and non-Covid vaccines for commercial purposes in clinical trials.

In this respect, he reported that the Health Ministry had issued draft rules dated April 12, 2018, to give permission to the remaining quantities of the vaccines that have been commercially used in clinical trials after the grant permission in Form 46 (now Form CT-23) and manufacturing license in Form 28D.

Singh reported, “However, this draft rule has not been implemented till now. This draft rule should be implemented shortly to avoid wastage of life-saving vaccines”.

In a motif to reform the Drug Regulatory Systems in India, he also sought implementation of recommendations of a high-powered inter-ministerial committee.

According to the letter, upon the direction of Prime Minister Narendra Modi, a high-powered inter-ministerial committee for the reformation of the Drug Regulatory Systems in India was formed on May 1 the previous year under the leadership of Rajesh Bhushan, the then officer on special duty and who is now the union health secretary.

He further exclaimed, “A series of meetings of this committee was held starting May 2020. Recommendations of this inter-ministerial committee should be implemented immediately in line with the ease of doing business”.

In his letter, few other points related to regulatory reforms were highlighted. He concluded by saying, “We are putting forward the following points with relation to necessary regulatory reforms in the existing Drug Regulatory system for your kind reference and intervention, which will take the vaccine industry of our country to new heights in the world”.