The Centre has told the Supreme Court that no governmental aid, assistance or grant was made either for research or development of either Covaxin or Covishield vaccines but some financial assistance was given for conducting clinical trials.
In an affidavit, the Centre said that Covaxin has been developed under public private partnership (PPP) between the Indian Council of Medical Research (ICMR) and Bharat Biotech International Ltd (BBIL). The PPP was executed under a formal MoU between the ICMR and the BBIL which includes a 5 per cent royalty clause for the ICMR on net sales and other clauses like prioritisation of in-country supplies, and the product intellectual property rights are shared.
“ICMR has not provided any funds to BBIL for Covaxin development. However, funds have been spent in various activities undertaken by ICMR-NIV, Pune for Covaxin development. Also, Phase 3 clinical trials of Covaxin have been funded by the ICMR. The trials have been conducted at 22 sites in 25,800 participants,” said the affidavit, which also provided details of activities undertaken by the ICMR-NIV, and that the total estimated expenditure of the ICMR in this was Rs 35 crore.
For Covishield, the Centre said the bridging studies of 1,600 participants in India were supported by the ICMR in partnership with the Serum Institute of India (SII). “No funds were provided to SII. Funds were transferred to 14 clinical trial sites. ICMR also supported laboratory studies on characterisation of immune response related to COVISHIELD at ICMR-National AIDS Research Institute (NARI), Pune,” added the affidavit. The total estimated expenditure of ICMR was Rs 11 crore.
The Centre said the Department of Biotechnology, under the DBT-BIRAC Covid-19 research consortium is supporting the research and development of 11 vaccine candidates by industry and public sector laboratories.
It added that “financial support to Bharat Biotech International Ltd (BBIL) and Serum Institute of India Pvt Ltd (SIIPL), for the production of Covaxin and Covishield, in the form or advance payment (not support or investment) of Rs 1,732.50 crore was released to Serum Institute of India (SII) for 11 crore doses of Covishield vaccine for the months of May, June and July and similarly, an advance payment of Rs 787.50 crore was released to Bharat Biotech India Ltd (BBIL) for 5 crore Covaxin doses for the months of May, June and July.”
The Centre said the current procurement price is based on the price negotiated by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).
“The NEGVAC had interactions with vaccine manufacturers in the initial phases of Covid Vaccination programme to secure adequate vaccine doses. For the initial phases, 6.6 crore doses were secured. Herein, the NEGVAC, after comprehensive deliberation, recommended that vaccines for Covid-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by the United States, the European Medical Agency (EU), the United Kingdom, Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial, in place of conduct of local clinical trial as per the provisions prescribed under the Second Schedule of the New Drugs & Clinical Trials Rules 2019,” added the affidavit.
A bench headed by Justice D.Y. Chandrachud will hearing the Centre’s response in the suo motu case for ensuring distribution of essential supplies and services during the Covid-19 pandemic on May 13.