The government, under the directions of Prime Minister Narendra Modi, has adopted a four-pronged strategy on a state-private sector partnership model for speeding up vaccine development and production, government sources told ET.
The four pillars of this strategy are: ensuring financial support to vaccine makers; providing institutional help 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 production.
Government sources said in May 2020, Modi had told senior government officials not to differentiate between public and private sector and treat vaccine making companies as partners. The dispensation was to act as investor, incubator, evaluator and buyer of the vaccines as it went through the stages. The aim was to remove all obstacles and make vaccines available to all Indians in the shortest time.
Based on this, the Indian Council of Medical Research provided Rs 10 crore assistance to Serum Institute of India for trials of Covishield, and another Rs 10 crore for Covavax (Novavax) vaccine trials. ICMR also gave Rs 30 crore to Bharat Biotech India Limited for Covaxin trials. Zydus Cadilla was also extended financial assistance for its vaccine.
The Biotechnology Industry Research Assistance Council (BIRAC), a Department of Biotechnology PSU, is supporting nearly 15 vaccine candidates at a cost of Rs 100 cr, disclosed government sources.
“Mission Covid Suraksha”, which was announced as part of Atmanirbhar Bharat 3.0 package, has allocated Rs 900 crore for one year. Five vaccine candidates in advanced clinical development stage are being supported under this mission. Further, officials said, 19 clinical trial sites across the country, three immunogenicity assay labs and three animal challenge facilities are being supported by the government.
Besides this, official sources said, the government has provided institutional support to strengthen end-to-end vaccine development ecosystem. Eleven GCLP-compliant clinical trial sites have been established for quick trials. Each site has access to a cohort of about 50,000 to 1 Lakh volunteers. 34 hospital sites are also facilitating vaccine trials. Four autonomous institutes of DBT are involved in generating animal models for SARS-CoV-2.
As a result, government officials said, India has vaccinated more people daily than most other countries in the world. Though there are reports of shortage of vaccines in some states, they added that the Centre is taking steps to get foreign vaccines approved by other countries and helping the Indian companies ramp up production.
Approval of new vaccines was also expedited by steps like enabling stockpiling of vaccines while it’s under clinical trial, adaptive clinical trial design, emergency use approval, faster review and approval process, rolling review data, frequent expert committee meetings as well as collaboration with international regulators.
As for ‘out-of-the-box solutions’ to ramp up vaccine production, officials said a system of providing advance payment against supplies was approved as an incentive to augment production capacity. For this purpose, an inter-ministerial group was created to oversee and facilitate increase in capacity of domestic vaccine manufacturing. This group has been instrumental in upscaling domestic manufacturing capacities by optimal utilization of existing capacities, by tying up with other private and public sector entities.
This how Indian Immunologicals, Hyderabad; Haffekine Biopharmaceuticals, Mumbai; and Bharat Immunologicals and Biologicals, Bulandshahr were roped in, added officials. With funds of nearly Rs 200 crore, government plans to ramp up manufacture of Covaxin 10 times more from 10 million doses per month in the coming months.
To fast track the entry of foreign made Covid19 vaccines into India, government recently cleared a special regulatory dispensation to provide EUA to Covid19 vaccines approved for emergency use by credible foreign regulators.