Prakash Kumar Singh, director of government and regulatory affairs at the Pune-based SII, in a letter referred to a notification in the Union Health Ministry gazette on May 18, 2020

The world’s largest vaccine manufacturer by volume, the Serum Institute of India (SII) wrote to Union Health Minister Mansukh Mandaviya, suggesting reforms to the existing drug regulatory system, including allowing the manufacture and storage of non-Covid vaccines during clinical trials.

According to official sources, Prakash Kumar Singh, director of government and regulatory affairs at the Pune-based SII, in a letter referred to a notification in the Union Ministry of Health gazette on May 18, 2020.

He said this allowed the manufacture and storage of the COVID-19 vaccine under clinical trial for market authorization for sale or distribution.

“Because of this rule, it became possible for us to manufacture and store the COVID-19 vaccine during clinical trials and we were able to make the vaccine available in such a short period of time to protect millions of lives.

“It will be of great help to the vaccine industry if this rule is implemented for non-COVID-19 vaccines as well,” a source quoted Mr. Singh in the letter to the minister.

Mr Singh also requested permission to use the remaining quantities of Covid and non-Covid vaccine lots for commercial purposes that were used in clinical trials.

In this context, he said that the Ministry of Health had published a draft rule, dated April 12, 2018, to allow the remaining quantities of batches of vaccines that were used in clinical trials for commercial purposes after the granting of authorization under form 46 (now form CT -23) and manufacturing license in form 28D.

“However, the gazette’s notification in this regard has not yet been issued for the implementation of the same,” Singh said. He also called for the implementation of the recommendations of a high-level inter-ministerial committee for the reform of drug regulatory systems in India.

The letter said that on the instructions of the Prime Minister, a high-level inter-ministerial committee for the reform of drug regulatory systems in India had been formed under the chairmanship of the then OSD, Rajesh Bhushan, who is currently the Secretary of Health. “The recommendations of this inter-ministerial committee should be implemented immediately in accordance with the ‘ease of doing business.’

The letter highlighted a few other points also related to regulatory reforms and said: “If few rules / regulations are changed, it will be a great help and encouragement for the vaccine industry to grow faster. We submit for your kind consideration the following points regarding reforms of the drug regulatory system, which will propel the vaccine industry in our country to new heights. ”

“In view of the real difficulties encountered by the vaccine industry, I sincerely ask for your kind intervention on regulatory reforms. It will also be in line with our Prime Minister’s vision on making it easy to do business in India and further encourage his dream project “Doing in India for the World”, ”Singh said in the letter.

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