The Fake Ventilator Scam In Gujarat: No DGCI Licence For 900 Fake Ventilators
Ahmedabad: The fake ventilators that have been installed across government hospitals in Gujarat, do not have the mandatory licence from Drug Controller General of India. Besides, the trial of the equipment was held only on one patient and the ethical committee that is required to monitor it was not formed as per Medical Devices Rules, 2017.
More skeletons are tumbling out of the ‘Gujarat model’ closet in what is turning into an embarrassment festival for Chief Minister Vijay Rupani led Gujarat government which has already been facing flak for its botched handling of Covid-19 and high mortality rate. It now turns out that the performance trial of the equipment was conducted on only one person before 900 fake ventilators were installed at government hospitals across Gujarat.
The makers of these fake ventilators, who gave a demo of the equipment at Ahmedabad Civil Hospital on Monday, admitted these are not ventilators though Gujarat government has been promoting these as ventilators in its press releases. In fact, the medical experts who attended the demonstration said these machines should include humidifier, condenser and a mask as well.
Mirror contributor Vipul Rajput who was present at the demo for the doctors also asked Parakramsinh Jadeja, the CMD of Jyoti CNC, about the performance trials of the ‘ventilator’ but before he could answer, the Dr M M Prabhakar, Officer on Special Duty at Ahmedabad Civil Hospital, snatched the mike from him and digressed.
The fake ventilator scam is now getting murkier. On Monday, Ahmedabad Mirror’s report revealed that the 900 machines fitted at several government hospitals in Gujarat for Covid-19 patients by Gujarat CM’s friend from Rajkot were not exactly ventilators despite the CM calling it so.
If it IS a ventilator, why no protocol followed?
Now, it turns out that Gujarat government which did not bat an eyelid before calling these mechanised ambu bags as ‘ventilators’ did not bother to carry out performance trials of the equipment before installation, violating Medical Devices Rules, 2017.
There was no ethical committee formed as per the rules to carry out performance trial of these machines either, sources told Mirror. What is further shocking is that the trial of the machine was carried out on just ONE patient before installation of 900 machines across government hospitals including 230 at Ahmedabad Civil Hospital.
All medical devices follow a regulatory framework based on drug regulations under Drugs and Cosmetics Act (1940).
But these regulations were clearly flouted and the ‘ventilators’ manufactured by a company run by CM Rupani’s friend were hurriedly installed in hospitals during a global pandemic that was fast claiming lives in Gujarat.
Process for DCGI licence
A top health official from the state government told Mirror, “According to the Act, ventilators fall under C and D category of medical devices for which licence is required from Drug Controller General of India. It therefore falls under the purview of Central government and not the state government.”
He added, “To obtain the licence, the performance trial of the ventilator needs to be conducted for which an ethical committee has to be constituted. The committee comprises director of a medical college/head of a hospital, subject expert, a lawyer, a social worker and expert doctors.” A chief investigator is required to make a presentation in front of the ethical committee specifying the date on which the trial will be held, the number of patients the trial will be conducted on, the medical conditions of the patients and provide letters of consent from the patients.
Rajkot-based private company Jyoti CNC had developed the ventilator ‘Dhaman-1’ in a very short period of just 10 days. The manufacturing cost of ‘Dhaman-1’ is less than Rs 1-lakh per piece. This great achievement would add a new feather to Prime Minister Mr Narendrabhai Modi’s dream campaign of ‘Make in India’
— Gujarat govt press release
No DCGI Licence; Test Only on One Patient
Parakramsinh Jadeja, a friend of Chief Minister Vijay Rupani and CMD of Jyoti CNC whose team developed Dhaman-1 admitted that the machine did not have the DCGI licence and the performance trial was conducted only on one patient. Jadeja said, “We did not take the DCGI licence, but we did test the machine at a lab approved by National Accreditation Board of Laboratories for ISO 86101 and IEC60601.
We are following central guidelines.” Asked if performance trial of the machine was conducted on patients and if yes, on how many, he said, “We carried out performance trial of the machine on one patient in front of the ethical committee at Ahmedabad Civil Hospital.”
However, sources said the committee comprised an anaesthetist and Dr Kamlesh Upadhyay who is a professor of medicine and not a critical care expert. The inefficacy of the machines in the treatment of Covid-19 patients came to light after doctors at Ahmedabad Civil Hospital sought more ventilators from the government inspite of having 230 Dhaman-1 machines.
ON WHAT BASIS IS JAYANTI RAVI PROMOTING THIS?
While Jayanti Ravi, Principal Secretary Health and Family Welfare, was not available for comments on Monday, she had told Mirror on Sunday, “At a time there’s shortage of ventilators world over, including India, Jyoti CNC took initiative and fabricated the devices. With their help, the government received donation of 1,000 ventilators. Their ventilators have been approved by Electronics & Quality Development Centre (EQDC) of the Gujarat government and Civil Hospital doctors following which they were installed. Their technicians trained biomedical engineers about using its various features.
“Accessories like high-flow nasal cannula, a circuit with it, humidifier and flow meter are under process of acquisition to add to the ventilators. It is a matter of pride for Gujarat that the company came up with it. It is in talks with other states and central government for supply of ventilators.”
(Except for the headline, this story has not been edited by CineBuster staff and is published from a syndicated feed.)