The inventor of a device to neutralise the novel coronavirus has said the equipment does not require approval from Indian regulators since it is non-medical.
Dr Rajah Vijay Kumar, the inventor of Shycocan, shot to fame in March when he claimed that the device could kill the S protein of coronavirus, the anchor the virus uses to latch on to the healthy cells. Now, 1,600 units of the device have already been manufactured.
Shycocan received the United States Food and Drug Administration’s emergency use authorisation and a European CE mark last month, which clears it to be sold in the US and the European Union.
Five companies — Mysore Science and Technology Services, Psychocare Health, Medwin Healthcare, Godrej and Eureka Forbes — have manufacturing licences for the production of Shycocan, Dr Kumar said. “The understanding is that since it has approvals of foreign regulatory bodies, it does not require Indian regulatory approvals,” he told DH.
Despite Shycocan not qualifying as a medical device, Kumar has submitted papers for review to the Central Drugs Standard Control Organisation (CDSCO), he said.
Physicists Ajay Kumar Sood and Arindam Ghosh, both professors at IISc, have been following the announcements made with regard to Shycocan. A glaring question that both raise is the absence of safety and efficacy studies of Shycocan in public domain, and why the device was not tested in an Indian Biosafety Level (BSL)-3 lab.
Sood told DH: “There are many BSL-3 labs in the country. Why test in Mexico? Also, there is no scientific evidence available in the public domain on the parameters in which the studies were conducted, the viral load that the device was exposed to, and the duration for which it was exposed.”
Ghosh reviewed the seven-page technical write-up shared by the company on Shycocan and told DH: “The basic mechanism is unclear. It is not known whether creating a large number of electrons around the S protein of coronavirus would mitigate or deactivate it. It could be an empirical observation, but I do not know of any biological or another scientific basis behind it.”
There is no clear peer-reviewed publication regarding this, Ghosh said. “There has to be data. There has to, at least, be a scientific paper. It may not be a medical device, but are there any health hazards of having a charged atmosphere?
We have a BSL-3 lab at IISc itself, a lab next door in the same city,” he said.
A nod from the Central Drugs Standard Control Organisation (CDSCO) is not something that the companies are waiting for to mass-produce Shycocan.
Debashis Bose, CEO, Medwin Healthcare, said the company had already made 1,600 Shycocan machines and have a target to make 30,000 machines for the first year.
Though the 1,600 machines are currently being tested by the company for safety, “500 of these have already been distributed, including to the Ramakrishna Mission Hospital”, Bose said.