New Delhi: The direction of India’s vaccination strategy was set in the Prime Minister’s initial meeting on the subject in May 2020. The PM told top government officials to look at private companies making vaccines as partners. He urged them to remove the distinction between the public sector and the private sector and work together with a common goal of making available vaccines to all Indians in the fastest possible time.
India’s ‘Entrepreneurial State’ has worked in a never-before-seen manner to ensure no obstacles to quick vaccine delivery. This has happened due to PM Modi’s focus on making the government work as an incubator for vaccine development while removing red-tapism of all kinds. The results are visible today when India is able to vaccinate more people daily than any other country in the world.
PM also asked the national expert group on vaccines and officers to continue the approach India used to ramp up testing facilities and PPE manufacturing despite having negligible capacity at the start of the pandemic. He stressed that government will have to play the role of an investor, an incubator, an evaluator as well as a buyer. Hence it becomes very important for all arms of the Government to come together and work with a common goal.
He advised officers to not stop at their work allocation but go beyond the line of duty to help scientists and manufacturers working on vaccines.
It is with this mindset that the PM visited three vaccine manufacturers and held a VC with another three of them in November 2020. He stressed to the scientists and entrepreneurs working on vaccines that his Government will support them in any possible manner to ensure that Indians get vaccines at the earliest.
As a result of the PM’s approach, the government worked in partnership with the private sector. This partnership between the Indian state and the private sector extends across multiple levels:
-Providing financial support to vaccine makers
-Providing institutional to vaccine makers for virus isolation, testing, pre-clinical and clinical trials
-Accelerating the pathway to vaccine approval
-Providing out-of-the-box solutions to ramp up vaccine production.
Department of Health Research and Indian Council of Medical Research actively assisted all domestic vaccine manufacturers to accelerate their R&D. ICMR provided Rs 10 crore assistance to SII for conducting the trial of Covishield vaccine. In addition, ICMR has also extended Rs 10 crore assistance to SII for Covavax (Novavax) vaccine trials. ICMR has extended Rs 30 crore assistance to BBIL for Covaxin vaccine trials. ICMR has also extended financial assistance to Zydus Cadilla for conducting pre-clinical animal trials for their Covid vaccine.
Similarly, DBT is supporting vaccine manufacturers for the development of covid vaccine candidates. DBT and its Public Sector Undertaking Biotechnology Industry Research Assistance Council (BIRAC), are supporting nearly 15, vaccine candidates, at a cost of about Rs 100 crore.
To further reinforce and accelerate the COVID-19 vaccine development efforts, ‘Mission COVID Suraksha’ was announced by the Government as part of the Atmanirbhar Bharat 3.0 package, at a total cost of Rs 900 crore for 12 months. Five vaccine candidates in advanced clinical development stage are being supported under this Mission. Additionally, 19 clinical trial sites across the nation, 03 immunogenicity assay laboratories and 03 animal challenge facilities are also being supported under the Mission.
In addition to direct financial support, the Government has played a very important facilitatory role for vaccine development and manufacturing. Considering that vaccine development is a complex multistage process the government has also provided support for strengthening the end to end vaccine development ecosystem for accelerated development.
11 GCLP Compliant clinical trial sites have been established for facilitating quick clinical trials. Each site has access to a cohort of about 50,000 – 1,00,000 healthy volunteers, who can be tracked for prolonged periods of time. 34 hospital sites are also facilitating the vaccine trials.
4 Autonomous Institutes of DBT are involved in generating animal models for SARS-CoV-2. The Immunoassay labs are serving as National Service facilities for supporting vaccine development. This is a critical requirement for vaccine development and immunogenicity studies. These facilities and laboratories have partnered with all the vaccine manufacturers during the testing and development stage.
Accelerated Pathway to approvals
CDSCO has taken the following measures to expedite approvals of new vaccines:
-Issued notification enabling Stockpiling of Covid-19 vaccine while it is under the clinical trial
-Adaptive clinical trial design such as Phase I/II, II/III etc
-Emergency use approval
-Accelerated review process
-Accelerated approval process
-Rolling review of data
-Frequent Subject Expert Committee meetings
-Collaboration with International regulators
-Release of batches by the CDL, Kasuali based on a review of batch manufacturing records in certain cases.
-Providing out of the box solutions to ramp up vaccine production
To augment the production capacity of domestic vaccine manufacturers Government is providing them advance payment against supplies as an incentive.
The government of India constituted an Inter-ministerial Group to facilitate the capacity augmentation of domestic vaccines manufactured in the country for COVID-19. This group engaged in regular dialogue with indigenous manufacturers to facilitate rapid upscaling of domestic manufacturing capacities by optimal utilization of existing capacities, by tying up with other private sectors/public sector entities.
The group proactively visited the two vaccine manufacturers (SII & BB) weeks back, to explore ways to help augment production.
Support at multiple levels, including paying advance money, helping secure funding, etc are being explored. Support is also being planned for private and public sector manufacturing facilities to make them ready for enhanced capacities to support augmented vaccine production- including facilities of Bharat Biotech as well as Indian Immunologicals in Hyderabad, Haffekine Biopharmaceuticals in Mumbai and Bharat Immunologicals and Biologicals in Bulandshar. With the support of approximately Rs 200 crore it is proposed that the current manufacturing of COVAXIN of 10 million doses/ month will be enhanced by 10 times in the coming months.
To fast track the entry of foreign-made Covid vaccines into India the Central Government has provided special regulatory dispensation to provide EUA to Covid vaccines approved for emergency use by credible foreign regulators.
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