Government hospitals in Gujarat have fake ventilators installed that do not have the mandatory licence from Drug Controller General of India. Also, the trial of the equipment was held only on one patient and the ethical committee to monitor the trial was not formed as per Medical Devices Rules, 2017.

Chief Minister Vijay Rupani led Gujarat government has already been facing criticism for its poor handling of COVID-19 crisis and high mortality rate. And now, the performance trial of the equipment was performed only on one person before 900 fake ventilators were installed at government hospitals throughout Gujarat.

On Monday, the manufacturers of these fake ventilators, who had given a demo of this equipment at Ahmedabad Civil Hospital, admitted that these are not ventilators; however Gujarat government is seen promoting these as ventilators in its press releases. The medical experts who attended the demonstration trial said that these machines should also include humidifier, condenser and a mask too.

Mirror contributor Vipul Rajput was present at the demo for the doctors asked Parakramsinh Jadeja, the CMD of Jyoti CNC, regarding the performance trials of the ‘ventilator’ but even before he could answer, the Dr M M Prabhakar, Officer on Special Duty at Ahmedabad Civil Hospital, suddenly snatched the mike from him and deviated the topic.

The fake ventilator scam is now getting messier. It turns out that Gujarat government did not bother to perform the trials of the equipment before installation, violating Medical Devices Rules, 2017 and kept calling these mechanised ambu bags as ‘ventilators’. The regulations were clearly violated and the ‘ventilators’ manufactured by a company run by CM Rupani’s friend were installed in hospitals in a hurry as the global pandemic was claiming lives rapidly in Gujarat.

A top health official from the state government said that according to the Act, ventilators come under C and D category of medical devices and a licence is required from Drug Controller General of India. It falls under the range of Central government and not the state government.

Parakramsinh Jadeja, who is a friend of Chief Minister Vijay Rupani and CMD of Jyoti CNC and his team developed Dhaman-1 and admitted that the machine does not have the DCGI licence and the performance trial was done only on one patient. Jadeja said that they did not take the DCGI licence, but tested the machine at a laboratory approved by National Accreditation Board of Laboratories for ISO 86101 and IEC60601. They are following central guidelines. He further said that they have carried out performance trial of the machine on one patient in front of the ethical committee at Ahmedabad Civil Hospital.

Sources have confirmed that the committee comprised of an anaesthetist and Dr Kamlesh Upadhyay, a professor of medicine and not a critical care expert. The ineffectiveness of the machines in the treatment of coronavirus patients came out after doctors at Ahmedabad Civil Hospital wanted more ventilators from the government in spite of having 230 Dhaman-1 machines.

Jayanti Ravi, Principal Secretary Health and Family Welfare, had told Mirror on Sunday that there is shortage of ventilators around the world, including India. Jyoti CNC had taken the initiative and fabricated these devices and with their help, the government has received donation of 1,000 ventilators. These ventilators are approved by Electronics & Quality Development Centre (EQDC) of the Gujarat government and Civil Hospital doctors and then they were installed. Their technicians have trained biomedical engineers about various features and usage. It is a matter of pride for Gujarat that the company came to their rescue. They are in talks with other states and central government for supply of ventilators.

Source: ET Healthworld