The letter highlighted factors associated to regulatory reforms (File)
New Delhi:
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.
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, official sources instructed information company Press Trust Of India.
He stated it allowed manufacturing and stockpiling of COVID-19 vaccine below medical trial for advertising and marketing authorization on the market 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 supply quoted Mr Singh as having communicated within the letter to the minister, reported information company Press Trust Of India.
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 stated 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 type 46 (now it’s type 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 stated. He additionally sought the implementation of suggestions of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.
The letter acknowledged that on the instructions of the prime minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory methods in India was fashioned below the chairmanship of then OSD, Rajesh Bhushan who’s presently the well being 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 acknowledged, “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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