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

World’s largest vaccine producer by quantity, Serum Institute of India (SII) has written to Union Health Minister Mansukh Mandaviya suggesting reforms within the present drug regulatory system, together with permitting manufacturing and stockpiling of non-Covid vaccines whereas present process medical 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 mentioned it allowed manufacturing and stockpiling of COVID-19 vaccine beneath medical trial for advertising and marketing authorization on the market or distribution.

“Because of this rule, it turned attainable for us to fabricate and stockpile the COVID-19 vaccine throughout medical trial and we might make the vaccine out there in such a brief span of time interval to guard thousands and thousands of lives.

“It will be a big help for the vaccine industry if this rule is implemented for non-COVID-19 vaccines also,” a supply quoted Mr. Singh as having communicated within the letter to the Minister.

Mr. Singh additionally sought permission to make use of the remaining portions of batches of Covid and non-Covid vaccines for industrial functions which have been utilized in medical trial.

In this context, he mentioned the Health Ministry had issued draft guidelines dated April 12, 2018, to permit remaining portions of batches of vaccines which have been utilized in medical trial for industrial use after granting of permission in kind 46 (now it’s kind 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,” Mr. Singh mentioned. He additionally sought the implementation of suggestions of a high-powered inter-ministerial committee for reforming the drug regulatory methods in india.

The letter said that on the instructions of the prime minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory methods in India was fashioned beneath the chairmanship of then OSD, Rajesh Bhushan who’s 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 different factors additionally associated to regulatory reforms and said, “If few rules/regulatory provisions are amended, it will be a great help and encouragement for the vaccine industry to grow faster. We are putting forward the following points w.r.t. Reforms in the drug regulatory system for your kind consideration which will take the Vaccine Industry of our country to further new heights.”

“In view of the genuine difficulties being faced by the vaccine industry, I sincerely request for your kind intervention for the regulatory reforms. This will also be in line with our prime minister’s vision of ease of doing business in India and will further encourage his dream project ‘Making in India for the World’,” Mr. Singh talked about within the letter.


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