Inventor of device to neutralise coronavirus says device is not medical

The inventor of a coronavirus neutralising device, Dr Rajah Vijay Kumar, shot to fame earlier this year in March when he claimed his device Shycocan could kill the S protein of the coronavirus, the anchor that the virus uses to latch on to healthy cells. Now with 1,600 units of his device already manufactured, he says since the device is not medical, it does not require the nod of the Indian regulators.

Shycocan received the United States Food and Drug Administration (US FDA)'s emergency use authorisation, and a European CE mark last month that clears it to be sold in the US and the European Union.

Dr Kumar told DH, "Five companies: Mysore Science and Technology Services, Psychocare Health, Medwin Healthcare, Godrej and Eureka Forbes, now have manufacturing licences for production of Shycocan. The understanding is that since it has approvals of foreign regulatory bodies, it does not require Indian regulatory approvals."

Despite not qualifying as a medical device, he has submitted papers for review to the Central Drugs Standard Control Organisation, he said. However, a nod from the CDSCO is not something that the companies are waiting for to mass produce Shycocan. Medwin Healthcare CEO Debashis Bose in a press conference on August 25 said that the company had already made 1,600 Shycocan machines and have a target to make 1,30,000 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 Ramakrishna Mission Hospital,' Bose 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 the 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 if you create a large number of electrons around the S protein of the coronavirus, it will get mitigated or deactivated. It could be an empirical observation but I do not know of any biological or other 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 heath hazards of having a charged atmosphere? We have a BSL-3 lab at IISc itself, a lab next door in the same city."

Dr Kumar responded in the August 25 saying, "We could not get the device tested in any Indian BSL-3 lab or above as the labs were busy in doing Covid-19 tests and doing research in Covid-19 treatment. The US FDA approval came on June 26 while the European CE aaproval came on July 20. We will soon be publishing our findings in a leading international peer-reviewed journal."