Bharat Biotech had agreed to offer vaccine at reasonable rates to Govt: MoH

ICMR has spent Rs 35 cr on Covaxin clinical trials

Covaxin maker Bharat Biotech India (BBIL) had agreed to provide the vaccine at a ‘reasonable and negotiated’ price to the Indian Council of Medical Research (ICMR) as well as all Central and state government bodies, minister of state for health revealed in the Parliament.

Responding to a query in the Rajya Sabha, Bharti Pravin Pawar, minister of state, Health and Family Welfare, said: “BBIL had agreed to provide vaccine at a reasonable and negotiated price to ICMR as well as all Central and State Government bodies or affiliates etc as and when the vaccine is available for use.”

BBIL had said in June that the Centre’s procurement price of Rs 150 per dose was not sustainable in the long run. Recently, the Centre has revised the procurement price to Rs 225 (including taxes) per dose for Covaxin.

“If we keep supplying at Rs 150 per dose then we will no longer be a ‘healthy’ organisation,” a senior Bharat Biotech official had told Business Standard earlier. The company said it has invested Rs 500 crore from internal accruals for Covaxin — development and setting up manufacturing facilities.The company pays royalties based on product sales to ICMR for its support — like providing the Sars-CoV-2 strain, help with animal studies, and partial funding of clinical trial sites.

In her reply, the minister also divulged that the ICMR has not provided any funds to BBIL for Covaxin development. “However, funds have been spent in various activities undertaken by ICMR-National Institute of Virology (NIV), Pune for Covaxin development. Also, phase-3 clinical trials of Covaxin have been funded by ICMR. The trials have been conducted at 25 sites in 25,800 participants. Total estimated expenditure of ICMR: Rs 35 crore,” she added.

BBIL will pay royalty at the rate of 5 percent of net sales (to be remitted on half yearly basis) to ICMR, the minister informed. ICMR’s logo will feature on the vaccine.

Elaborating on how the percentage of royalty was determined, she said that benchmarking royalty percentages in the licensing of vaccine technologies followed by other government departments or institutions was considered. For example, the brucella vaccine technology developed by Indian Council of Agriculture Research (ICAR) was transferred by Biotechnology Industry Research Assistance Council (BIRAC), a Department of Biotechnology company to Gujarat’s Hester Biosciences at 5 percent Royalty on Net Sales, payable for 10 years in the year 2019.

ICMR-NIV, Pune had isolated live SARS-CoV-2 virus in March 2020.

BBIL approached ICMR with a request to hand over the live strain of the virus in April. “BBIL had a validated BSL-3 facility ready for use. This is essential, as during the preclinical studies, it is essential to challenge the small animals with SARS-CoV-2 virus. Other companies with interest in SARS-CoV-2 vaccine development like Serum Institute of India were not interested in developing indigenous vaccine. Other companies like Cadila, Biological E did not have a validated BSL-3 facility available,” she said.

Besides, ICMR team had inspected and approved the BBIL BSL-3 facility in October 2019 as at that time BBIL proposed to use the BSL-3 for development of inactivated Polio Vaccine. “The facility has now been re-purposed for Covid-19 vaccine development,” she added.