Wednesday, August 4, 2021

Government takes crucial steps to ramp up the vaccine supply in India from International and Domestic sources

The Government of India is making constant efforts to ramp up the supply of Covid-19 vaccines in the country. These efforts come in the form of measures that intend to increase the stock of vaccines from both – international sourcing and domestic manufacturing.

Recently, The Drugs Controller General of India (DCGI) waivered some specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies such as the World Health Organisation.

The move is likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement.

In a letter, DCGI Chief VG Somani said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.

In the same letter, the DGCI Chief also issued a notice over Guidance for approval of COVID19 vaccines in India for restricted use in an emergency situation, which are already approved for restricted use by these international regulatory bodies.

DGCI Chief added that the requirement for conduction of post-approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be excused – for vaccines that are widely in circulation from the standpoint that millions have already been vaccinated with the said vaccines.

The waiver also applied to vaccine whose batch/lot has been certified and released by the National Control Laboratory of the Country of Origin.

This further stands as testimony to the commitment & relentless efforts by the Government to fight against COVID, minding the due certification and safety application of foreign vaccines.

Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission

Last year, the Government announced the third stimulus package of Rs. 900 Crore for the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission.

This grant was provided to the Department of Biotechnology (DBT) for the Research & Development of Indian COVID-19 vaccines.

On 3rd June 2021, the Ministry of Health finalised arrangements with Hyderabad based vaccine manufacturer Biological-E to reserve 30 crores of COVID-19 vaccine doses.

These vaccine doses will be manufactured and stockpiled by M/s Biological-E from August-December 2021. And for this purpose, the Ministry of Health will be making an advance payment of Rs. 1500 crore to M/s Biological-E.

The COVID-19 vaccine of Biological-E is currently undergoing Phase-3 clinical trial after showing promising results in Phase 1 and 2 clinical trials.

Moreover, the vaccine being developed by Biological-E is an RBD protein sub-unit vaccine that is likely to be available in the next few months.

National Expert Group on Vaccine Administration for COVID-19 carried out thorough scrutiny of Biological-E’s proposal before it was dually examined and recommended for approval.

The arrangement between M/s Biological-E and the Government of India is part of a wider plan that intends to support indigenous vaccine manufacturers financially and encourage them for further Research & Development.

The Mission COVID Suraksha for COVID-19 Vaccine Development in the country is the government’s crucial step towards providing safe, efficacious, affordable and accessible COVID-19 Vaccine to all citizens of India.

The Mission is supporting the development of 5 to 6 COVID-19 vaccine candidates wherein some of these are now closer to licensure and introduction in public health systems.

The Mission has accelerated COVID-19 Vaccine development efforts and fostered a robust end-to-end vaccine development ecosystem in the country.
This, in turn, will be available for other ongoing and future research and developmental activities for various other vaccines.

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