The Indian Council of Medical Research (ICMR) on Wednesday called for experienced pharmaceutical companies and research organisations to “collaborate on royalty basis” for developing monkeypox vaccine and diagnostic kits. This comes on a day when its Pune-based National Institute of Virology (NIV) announced that it has successfully isolated the virus from the patient’s sample, meaning the researchers can grow it [virus] further in the laboratory.
The ‘expression of interest’ issued by ICMR states that NIV has achieved “bulk propagation of the virus stock”. The document states that ICMR will reserve the intellectual property rights and commercialisation rights for monkeypox virus isolates, and the protocols for purification, propagation, and characterisation.
The expression of interest document states that ICMR’s agreement with companies will be non-exclusive (meaning, the research institute will be free to share the technology with more than one company) with the condition of royalty of not less than 5% on the net sales of the end product. It also states that the research body will not only help in developing diagnostic kits but also validate them.
“In the event of default in payment of royalty as above, interest @12% per annum on the royalty due shall be charged for the first six months. If default persists for more than six months, interest at similar rate will be charged on the accrued interest also from the due dates of payments till realisation/recovery of such amounts by the ICMR,” the document states.
This is a similar contract that the research institute entered with for sharing the isolates of SARS-CoV-2 virus with Bharat Biotech for developing Covaxin, 33.9 crore doses of which have been administered as part of country’s Covid-19 vaccination drive.
Isolating the virus is the first step towards developing drug, diagnostics, and vaccines for any new infection. “The monkeypox virus is isolated from the clinical specimen of a patient by the ICMR – National Institute of Virology Pune @ICMRDELHI,” the institute said in a tweet. The lab was also the first in the country to isolate the SARS-CoV-2 virus in March 2020 soon after Covid-19 cases started increasing in the country.
Unlike Covid-19, however, monkeypox is not a completely unknown infection in humans. In fact, the first human case of the viral infection was reported in 1970 in Congo. “The thing is that we already know almost everything about monkeypox. We know which cell lines have to be used to grow the virus. We already have drugs and vaccines – which were developed for smallpox – that can be used for monkeypox as well,” said a senior virologist, on condition of anonymity.
However, India did not have any viral isolate for monkeypox. “Without a viral culture, we cannot develop a vaccine, molecular testing kits, or immunological testing assays. And we cannot validate them. We should be self-sufficient if needed,” said Dr Pragya Yadav, senior scientist from the NIV.
So far, India has reported four cases of monkeypox – three from Kerala with history of international travel and one from Delhi without any such travel history. Nearly 16,000 cases of the infection have been reported from 75 countries this year.
The infection was usually reported from West and Central African countries, with the first outbreak outside continent seen in 2003 in the United States when 70 cases were reported. This resulted in the World Health Organisation declaring it a public health emergency of international concern.