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Invoke emergency licence rules to rapidly ramp up COVID-19 vaccine production

Time to press for Sections 92, 100 and 102 of the Indian Patents Act. Vaccines are the only forceful arsenal to win this war. These need to be produced in hundreds of millions in rapid time 

May 03, 2021 / 05:28 PM IST
Image credit: Suneesh K

Image credit: Suneesh K

In less than a month India has earned the dubious distinction of reporting the largest number of daily COVID-19 cases among all countries in the world. The scale of the second wave, which is nothing short of a continuous series of massive explosions across many cities and towns, has left both scientists, medical practitioners and bio-statisticians under-prepared.

Almost every family has a haunting tale of sudden death or crisis to narrate about the wave that continues to exact a heavy human toll.

No one is sure when the ‘peaking’ will happen. Infections continue to rise despite weeks of lockdown in many high caseload cities and states. The goal of any lockdown in such a situation is to contain the spread by lowering human contact as people stay put at homes.

The jury is still out about the effectiveness of social distancing through administratively-imposed lockdowns in dealing with COVID-19. What, however, has a greater degree of certainty is the efficacy of the vaccines as a tool to counter the virus.

There is no gainsaying that mass immunisation remains India’s most potent weapon to blunt the virus.


The ability to carry out the world’s largest mass vaccination exercise in record time, will depend on keeping vaccine supplies of hundreds of millions of doses flowing uninterruptedly for months.

India’s first goal should be to vaccinate about 700 million people, which would include all above 18 years. The task, for vaccine producers and the government, is to secure continuous supplies of 1.4 billion doses over a 12-month period. Given this titanic necessity, the current COVID-19 vaccine supply capacities fall significantly short.

Currently, two vaccine producers — the Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech — are producing 64 million doses a month in India. The SII is manufacturing 60 million doses of Covishield, while Bharat Biotech is producing 4 million doses of Covaxin a month.

This, effectively, translates into just above two million jabs a day. The current rate of more than four million daily shots is primarily driven by existing supplies that have been stockpiled since January.

If India has to vaccinate hundreds of millions of people quickly, why aren’t companies other than Bharat Biotech being given out contracts to manufacture the indigenously-developed Covaxin in bulk? Such a move will allow ramping up of vaccine production by several millions.

Covaxin is an indigenous vaccine candidate. Importantly, it is also a government-backed shot, developed by Bharat Biotech with institutional and research support from the Indian Council of Medical Research (Delhi) and the National Institute of Virology (Pune).

It is also little baffling on why the government isn’t considering to invoke Section 100 of the Indian Patents Act. This section empowers the central government to use or authorise companies to use patents or a pending patent application for the ‘purposes of government’.

This could well allow the government to transfer the technical knowhow or the patent of Covaxin to local drug companies to manufacture the vaccine that the country so desperately needs to win this war against the highly-infectious and deadly virus.

The Indian Patents Act also allows the Centre to acquire inventions patents for a ‘public purpose’. This provision, detailed in Section 102 of the Indian Patents Act empowers the central government to acquire a patent or an invention on an agreed price for a public purpose by publishing a notification in the official gazette. After completing the acquisition, the government can allow local companies to produce generic versions of the drug.

In the current context, there cannot be a greater public purpose other than to quickly vaccinate hundreds of millions to combat COVID-19 that has already killed hundreds of thousands.

This public health emergency may also support the invoking of Section 92 of the Indian Patents Act . This may allow a clutch of India local drug companies to make the University of Oxford-AstraZeneca’s patented Covishield through compulsory licensing.

Currently, the SII is producing Covishield through a voluntary licencing pact with the University of Oxford-AstraZeneca, giving SII the right to manufacture, import and distribute a pharmaceutical product and much more.

Section 92 of the Indian Patents Act, however, is compatible with the World Trade Organisation’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS), empowers the Controller of Patents to grant licenses to third parties in cases of ‘national emergency’.

There is no standard definition of a ‘national emergency’ either in TRIPS or in the Indian Patents Act. The law, however, allows for the use of compulsory licensing in instances of “public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics”.

Can there be a greater case of a national health emergency than the COVID-19 pandemic? Certainly not. Vaccines are the only forceful arsenal to win this war. These need to be produced in hundreds of millions in rapid time.

India can ill-afford to waste crucial time and lose so many lives when the domestic laws are armed with appropriate provisions to deal with such a situation. It is time to press the emergency buttons on vaccine production.
Gaurav Choudhury is consulting editor, Network18.
first published: May 3, 2021 05:17 pm

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