November 28, 2022

SII appeals to PMO with proposed reforms for the drug regulatory system

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Pune-based Serum Institute of India has a written a letter to the Prime Minister’s Office (PMO) with proposed reforms which can be implemented in the drug regulatory system, which comprises of giving permit for manufacturing and stockpiling of non-Covid vaccines while subjected to clinical trials.

Prakash Kumar Singh, Director of Government and Regulatory Affairs, Serum Institute of India in the letter addressed to the May 18, 2020 gazette notification by the Health Ministry iterating about the permit given for manufacturing and stockpiling of Covid-19 vaccine which is ongoing clinical trials for marketing authorization towards sale or distribution.

In the letter dated March 2, he wrote, “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.”

SII had already manufactured 50 million dosages of Covishield prior to the approval from Drugs Controller General of India (DCGI) for emergency use of the vaccine by 2020 end.

The approval for emergency use authorization was passed in early January.

Singh stated, “In view of the successful result of this provision for Covid-19 vaccine, this provision should also be implemented for non-Covid-19 vaccines.”

In the letter Singh asked for the permit to use the remnant quantities of Covid and non-Covid batches for commercial purposes post the permission grant in Form 46 and manufacturing license in Form 28D.

Singh added, “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 further asked for implementing the suggestions of a high-powered inter ministerial committee to introduce some reforms in the Drug Regulatory Systems in India. He said, “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.”

In the letter written by Singh, several other points were highlighted adhering to the regulatory reforms saying, “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.”

Singh further appreciated the vision of Narendra Modi saying, “It is a matter of great pride for all of us that because of our Hon’ble Prime Minister’s vision about the regulatory reforms, the vaccine industry of our country is growing very fast and under his global leadership, our country has proved that we are the world leader in vaccine sector.”

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