The central government may not exercise the provisions under the Patents Act to issue compulsory licenses to generic pharmaceutical companies for manufacturing of low cost versions of COVID-19 medicines like Remdesivir and Tocilizumab .
In an affidavit submitted before the Supreme Court in response to SC's observations that the central government can consider using its powers under Sections 92, 100 or 102 of the Patents Act to increase production of essential drugs to ensure that it is commensurate to the demand, the government said the move may be counterproductive at the moment.
The availability of certain inputs to manufacture Remdesivir is becoming a major constraint in further upscaling production, rather than addition of the manufacturing capacity, the government stated. However, the government said that it can consider applications for a compulsory license under Section 92, if any manufacturer applies for it as such permissions will build capacities to effectively handle any future crises.
The affidavit said the health ministry has worked out an estimated requirement of 1 crore vials of Remdesivir per month in case the situation of new active cases continues at the present 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 seven licensed manufacturers, 35 additional manufacturing sites for Remdesivir have been approved by Drug Controller General of India, taking the total number of sites to 57, and monthly manufacturing capacity to 1 crore vials," the government informed the apex court.
It also said that all efforts to address the supplies of essential inputs, raw materials such as APIs etc. to ensure that the installed capacities are fully utilised are on. "Department of Pharmaceuticals and Ministry of External Affairs are closely supporting sourcing of raw materials to ensure optimum production levels of Remdesivir in the country. In fact, availability of certain inputs is becoming a major constraint in further upscaling the production, rather than addition of the manufacturing capacity," the government said.
The affidavit also pointed out that the shortage of COVID-19 medicines is not India specific problem but a global problem. "When there is a surge in cases and in demand of patented medicines/drugs/vaccines from all over the world the solution needs to be found out essentially at an executive level engaging at diplomatic levels. Any exercise of statutory powers either under the patents act 1970 read with Trips agreement and Doha declaration or in any other way can only prove to be counter-productive at this stage," the government said.
Stating that the central government is very actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India, the affidavit argued that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform using all its resources, good-will and good-offices though diplomatic and other channels.
On Tocilizumab, the government said the applications for new drug permission for those who are applying for manufacturing permission, are being processed by the drug regulator expeditiously.