The Indian Council of Medical Research (ICMR) called on experienced pharmaceutical companies and research organisations to “collaborate on a royalty basis” in developing monkeypox vaccine and diagnostic kits on Wednesday. This comes on the same day that the National Institute of Virology (NIV) in Pune announced that it had successfully isolated the virus from the patient’s sample, allowing researchers to grow it [virus] further in the lab.
According to the ICMR’s ‘expression of interest,’ NIV has achieved “mass propagation of the virus stock.” According to the document, the ICMR will retain intellectual property and commercialization rights for monkeypox virus isolates as well as the protocols for purification, propagation, and characterisation.
According to the expression of interest document, ICMR’s agreement with companies will be non-exclusive (meaning that the research institute will be free to share the technology with more than one company) with a royalty of not less than 5% on net sales of the end product. It also states that the research organisation will not only assist in the development of diagnostic kits, but will also validate them.
In the event of a royalty payment default as described above, interest at 12% per annum on the royalty due will be charged for the first six months. If the default continues for more than six months, interest at a similar rate will be charged on the accrued interest from the due dates of payments until the ICMR realizes/recovers such amounts,” the document states.
This is a contract similar to the one entered into by the research institute for sharing SARS-CoV-2 virus isolates with Bharat Biotech for the development of Covaxin, 33.9 crore doses of which have been administered as part of the country’s Covid-19 vaccination drive.
The first step in developing drugs, diagnostics, and vaccines for any new infection is to isolate the virus. “The ICMR – National Institute of Virology Pune @ICMRDELHI isolated the monkeypox virus from a clinical specimen of a patient,” the institute tweeted. In March 2020, the lab was also the first in the country to isolate the SARS-CoV-2 virus, shortly after Covid-19 cases began to rise in the country.
Monkeypox, unlike Covid-19, is not a completely unknown infection in humans. The first human case of the viral infection was reported in Congo in 1970. “The thing is, we already know almost everything there is to know about monkeypox.” We know which cell lines must be used to propagate the virus. We already have drugs and vaccines developed for smallpox that can be used for monkeypox,” a senior virologist said on the condition of anonymity.
However, India lacked a viral isolate for monkeypox. “We cannot develop a vaccine, molecular testing kits, or immunological testing assays without a viral culture.” And we are unable to validate them. “If necessary, we should be self-sufficient,” said Dr Pragya Yadav, senior scientist at the NIV.
So far, four cases of monkeypox have been reported in India, three from Kerala with a history of international travel and one from Delhi with no such history. This year, nearly 16,000 cases of the infection have been reported from 75 countries.
The infection was typically reported from West and Central African countries, with the first outbreak outside the continent occurring in the United States in 2003, when 70 cases were reported. The World Health Organization declared it a public health emergency of international concern as a result.