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Centre rules out issuing compulsory licensing under Patents Act to increase production of Covid drugs

Laxmi Yadav, Mumbai
Tuesday, May 11, 2021, 08:00 Hrs  [IST]

The Central government has ruled out issuing compulsory licensing and government authorization using powers under Sections 92 and 100 of the Patents Act to shore up availability of Covid drugs and vaccines in the country, saying that the availability of raw materials and essential inputs is main constraint in the current scenario and therefore any additional licenses may not result in increased production.

In an affidavit filed before the Supreme Court, the government stated that it is engaging in diplomatic level talks with other countries for procurement of vaccines and medicines, and any discussion on exercise of statutory powers under Patents Act read with TRIPS agreement and Doha declaration or in any other way can only prove to be counter-productive at this stage.

The government’s submission came in response to the queries made by the apex court with regard to the use of powers under Patents Act over Covid drugs.

A bench comprising Justices DY Chandrachud, L Nageswara Rao and S Ravindra Bhat had asked the Central government why it was not considering options like compulsory licensing and government authorization using powers under Sections 92 and 100 of the Patents Act to facilitate manufacturing generic version of Covid drugs-- remdesivir, tolicizumab etc.

Section 92 of the Patents Act is a special provision empowering the government to issue compulsory licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the Patents Act empowers the government to use patented inventions for government purposes.

The bench, while considering the suo-moto case in re distribution of essential supplies and services during pandemic, stated that since Covid-19 was a public health emergency, the situation was apt for invoking such emergency powers to increase the affordability and accessibility of the medicines and vaccines.

The Central government’s affidavit in response stated that "...in view of the current constraints on availability of raw materials and other essential inputs, mere addition of more production capacity may not lead to the desired outcomes of enhanced supplies.”

However, the government clarified that if any manufacturer applies for a compulsory license under Section 92 of the Patents Act, the same might be suitably considered by the Controller of Patents.

The Central government told the court that it has projected the need of remdesivir vials to be 1 crore per month if the active Covid-19 cases continue at the current level.

"While the production levels prior to the recent surge in Covid cases was only around 60,000 per day, with the efforts of the government, have increased to almost three and a half times in a span of three weeks to around 2 lakh per day. To enhance the production capacities of the 7 licensed manufacturers, 35 additional manufacturing sites for remdesivir have been approved by the Drugs Controller General of India (DCGI), taking the total number of sites to 57, and monthly manufacturing capacity to 1 crore vials," the affidavit says.

It is also stated that the government is taking steps to import remdesivir from foreign countries. The Ministry of External Affairs is placing orders procuring 3 lakh doses of remdesivir with a company called Eva Pharma in Egypt for supplies during May and first week of June, 2021.

In addition, Union health ministry has secured donations of remdesivir from other countries: 1.25 lakh vials through US AID, 4.50 lakh vials from Gilead Sciences and small quantities from other countries as well. Around 2.8 lakh doses have arrived and have been distributed across the country.

Besides this, the DCGI will continue to expeditiously process any applications for new drug permissions for remdesivir, added the government.

The apex court has fixed May 13, 2021 as next date of hearing.


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