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 stated it allowed manufacturing and stockpiling of COVID-19 vaccine underneath scientific trial for advertising and marketing authorization on the market or distribution.
“Because of this rule, it grew to become attainable for us to manufacture and stockpile the COVID-19 vaccine throughout scientific trial and we may make the vaccine accessible in such a brief span of time interval to shield 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 Singh as having communicated in the letter to the minister.
Singh additionally sought permission to use the remaining portions of batches of Covid and non-Covid vaccines for industrial functions which have been used in scientific 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 used in scientific 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,” 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 said that on the instructions of the prime minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory techniques in India was fashioned underneath 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 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’,” Singh talked about in the letter.