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SII writes letter to PMO recommending reforms in drug regulatory system

The letter requests that the provision for manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorisation for sale or distribution should be implemented for non-COVID-19 vaccines as well

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Serum Institute of India (SII) 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 Serum Institute of India 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 authorisation 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.

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 April 12, 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.

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

Singh also sought 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 Prime Minister Narendra Modi, a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India was constituted on May 11 last year under the chairmanship of then officer on special duty Rajesh Bhushan, who is presently the union health secretary.

“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,” he said.

Singh’s letter highlighted a few other points also related to regulatory reforms and said, “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.”

(Edits by EP News Bureau)

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