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To boost the ‘Make in India’ initiative, the Indian Council of Medical Research (ICMR) had handed over the SARS-CoV-2 strain to Hyderabad’s Bharat Biotech International Ltd for developing an indigenous vaccine.
Bharati Pravin Pawar, Minister of State for Health and Family Welfare, said this in a written reply to the Rajya Sabha, responding to queries on the alliance between the ICMR and Bharat Biotech, the funds extended to support its R&D effort, and the royalty payment.
The company had agreed to provide the home-grown vaccine at a reasonable and negotiated price and had a BSL-3 (biosafety level 3) facility, the Minister said, outlining reasons for handing over the vaccine manufacturing to Bharat Biotech.
Other companies like Serum Institute of India were not interested in developing indigenous vaccines, she added.
The deal also involved the licencee paying a seed money of ₹5 lakh for transfer of the inactivated virus strain, the Minister said.
“ICMR-NIV, Pune, had isolated live SARS-CoV-2 virus in March 2020, which paved the way for the development of an indigenous vaccine.
“The ICMR was approached by Bharat Biotech with a request to hand over the live SARS-CoV-2 virus isolated at ICMR-NIV, Pune, in April 2020. Bharat Biotech wanted to develop an inactivated vaccine for SARS-CoV-2 using the well-characterised virus strain available at ICMR-NIV, Pune,” she said.
Other companies such as Cadila and Biological E did not have a validated BSL-3 facility. Besides, the ICMR team had inspected and approved Bharat Biotech’s BSL-3 facility in October 2019, as it had then proposed to use the facility for the development of the inactivated polio vaccine. “The facility has now been re-purposed for Covid 19 vaccine development,” she added.
Royalty payments
The Minister said royalty obligations of Bharat Biotech were 5 per cent of net sales, to be paid on a half-yearly basis.
This was decided based on the “benchmarking royalty percentages in the licensing of vaccine technologies followed by other government departments/institutes” and international organisations such as World Health Organisation and United Nations Development Programme.
Pawar also revealed that the ICMR had not provided funds to Bharat Biotech for Covaxin development, but money was spent on the activities undertaken by ICMR-National Institute of Virology, Pune, for developing the vaccine.
“Also, Phase 3 clinical trials of Covaxin were funded by the ICMR.
The trials were conducted at 25 sites on 25,800 participants. The total estimated expenditure of the ICMR is ₹35 crore,” she said, responding to the question on the cost incurred by the exchequer on research and development of Covaxin.
A non-exclusive license was given with a clear mandate to commercialise the vaccine within two years, starting April 2020, Pawar added.
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