Using all options: On Covaxin licensing

Enabling other manufacturers to produce Covaxin is a necessary step

As the second COVID-19 wave continues to ravage the country, it is now clear that universal and swift vaccination is the only way out to mitigate the effects of the pandemic. But with only 3% and 10.4% of the total population estimated to have taken the second and a single dose, respectively, the goal of vaccinating a substantial number of people to achieve immunity against SARS-CoV-2 and its variants, remains a tall order for India. Supply constraints in delivering the only two vaccines available to Indians so far — Covishield and Covaxin — (the Russian-developed Sputnik V vaccine has just been deployed) are one of the reasons why the pace of vaccination has fallen. Karnataka and Maharashtra have halted vaccination for the 18-44 age group to address this as well. While the manufacturers, Serum Institute of India and Bharat Biotech, have promised an augmentation in production capacity, the dependence on them till other vaccines, including those from abroad, are made available over the long term, will remain a constraint in the pace of vaccination and expose much of the population to the possibility of infection. India has rightly sought (along with South Africa) a temporary waiver of provisions in the TRIPS Agreement to facilitate universal access to COVID-19 vaccines. But the Centre has done nothing to bring vaccines and medicines under a statutory regime in India to allow for wider availability and a diversity of options.

In fact, the Centre’s submission to the Supreme Court that the “exercise of statutory powers... under the Patents Act, 1970... can only prove to be counter-productive at this stage”, is clearly contradictory to its international position for a temporary waiver in the TRIPS Agreement. The Agreement allows exceptions to the rights of patent owners by grant of compulsory licences. Section 100 of the Patents Act, 1970, allows the Centre to license specific companies to manufacture the vaccines, while Section 92 of the Act allows the Centre to issue a compulsory licence in circumstances of a national or an extreme emergency. Considering the impact of the second wave, the daily toll and the high case load, the Centre should revisit its rigid and contradictory stance on the issue of compulsory licensing that would allow the manufacture of vaccines and important drugs without the consent of the patent holder. In the case of Bharat Biotech’s Covaxin, which was developed in collaboration with the publicly funded ICMR and the NIV, even this route is redundant. The ICMR can license other public sector vaccine manufacturers to help augment its supply over the medium term. As of now, two central PSUs, Indian Immunologicals Ltd and BIBCOL, have already entered into a technology transfer agreement with Bharat Biotech, besides the Haffkine Bio-pharmaceutical Corporation based in Mumbai. Other manufacturers can also re-purpose their plants to produce the vaccine.



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