COVID-19: Questions raised over quality of indigenous ventilator Dhaman-1

In the wake of coronavirus pandemic, a Rajkot-based company Jyoti CNC had developed an indigenous ventilator named Dhaman-1. However, questions were raised over the quality and efficacy of the Dhaman-1 ventilator after over 300 coronavirus patients died in the Civil Hospital.

Ahmedabad:In the wake of shortage of hospital facilities, drugs and ventilators to cope with the spread of COVID-19 pandemic, a Rajkot-based company Jyoti CNC developed an indigenous ventilator naming it as Dhaman-1, which was launched by Gujarat Chief Minister Vijay Rupani.

The Jyoti CNC company gave 1,000 units of Dhaman ventilator to Ahmedabad Civil Hospital and had assured to supply more ventilators if required.

However, questions were raised over the quality and efficacy of the Dhaman-1 ventilator after over 300 coronavirus patients died in the Civil Hospital.

Have these indigenous ventilators failed? Were they used before testing? A controversy has erupted over Dhaman-1 with the state government and the opposition Congress indulging in a slanging match with allegations and counter-allegations.

ETV Bharat has examined the truth behind the Dhaman-1 ventilators.

A 2,000-bed new hospital for COVID-19 patients has been set in Ahmedabad’s Civil Hospital, which is the biggest hospital in the country. The name of the Ahmedabad Civil Hospital is known throughout the country as one of the best public hospitals.

Read:Ahmedabad hospital reports highest COVID-19 deaths in Gujarat

The same hospital has now become controversial with the death of as many as over 300 coronavirus patients admitted there. This has raised questions about the quality of the Dhaman-1 ventilators. Why did over 300 patients die despite having put on Dhaman-1 ventilators? Does it not show that Dhaman-1 ventilators were flawed?

The question about the efficiency of Dhaman-1 has been raised on the 56th day of the lockdown implemented to check the spread of coronavirus pandemic.

Talking to ETV Bharat, Gujarat Congress president Amit Chavda alleged that the BJP government was playing with the life of people by using the Dhaman-1 ventilator after it had failed on the front of the fight against the coronavirus pandemic.

The Gujarat Chief Minister had put the lives of the people at stake to market the ventilator made by his friend’s company and to earn cheap publicity for himself.

During these 56 days of lockdown, the chief minister had come out of his residence on April 5 only once to launch Dhaman-1 ventilator.

Today, people of Gujarat are a worried lot, hundreds have died and the chief minister claimed on April 5 that the state would supply low-priced indigenous ventilator not only for the state but for the need of the whole country.

The manufacturers of Dhaman-1 had clarified on the very first day about the limitations and drawback of the ventilator and explained this to the state government.

The government knew very well that they cannot solely depend on Dhaman-1 for the treatment of coronavirus patients.

Read:Amidst rising cases, Gujarat fighting a tough battle against COVID-19

Despite knowing that it would not be possible to save the lives of coronavirus patients with the help of the indigenous ventilator, people were kept in the dark.

This raises the question on the state government as to why it trumpeted about the indigenous ventilator. Why were the lives of people of Gujarat put at risk only to market the ventilator manufactured by the company owned by the chief minister’s friend? People are asking this question today.

Amit Chavda asked whether the government had obtained the opinion of experts before installing Dhaman-1? How many of the 300 patients who died in Ahmedabad Civil Hospital were put on Dhaman-1 ventilator? Was the approval of DGCI taken before installing the ventilator?

It is mandatory to obtain the approval of DGCI before using any medical instrument, especially ventilator.

After making the ventilator, on how many people and how much time the manufacturer had carried out its trial test? It is only after conducting a trial test under well-defined conditions that the ventilator can be put to use in the hospital.

Without carrying out such scrutiny, the state government used the ventilator directly on the patients. The government must come out with a satisfactory clarification on all this.

After the opposition from the Congress, state government’s health secretary Jayanti Ravi promptly convened a press conference.

Read:Guidelines for containment and non-containment zones to be issued in Gujarat: CM

She said that by manufacturing Dhaman-1 ventilator Gujarat has set an unparalleled example of self-reliance before the country. One must praise and encourage this initiative of self-reliance when there is an acute shortage of ventilator in the country.

Health secretary clarified that the Jyoti CNC Pvt Ltd of Rajkot had supplied the first batch of ten ventilators on April 18 to the state government after carrying out necessary tests and obtaining certificates to lend its support in the fight against the pandemic.

At a time when the whole world including India is facing an acute shortage of ventilators, Jyoti CNC Pvt Ltd has so far supplied 866 Dhaman-1 and that too free of cost.

She said that there is no need to obtain the approval of Drug Controller General of India (DGCI) for the manufacture of use of the ventilator. The drug controller general Dr VG Somani said that under the medical device rules – 2017 there is no need for obtaining licence either from the state or central government for the ventilator.

The Ministry of Health and Family Welfare has issued a notification on February 11, 2020 – GSR 102 (E). Effective April 1, 2020, there are 37 items notified which require a licence.

The ventilator is not in this list. Hence, there is no need for Dhaman-1 to obtain a licence.

The notification allows manufacturers to voluntarily register their products which are not in the list of 37 items for 18 months, that is till October 21, 2021.

Accordingly, the manufacturer of Dhaman-1 has time until October 2021 to get its product registered and licenced.

Before making Dhaman-1, Jyoti CNC had followed all the necessary precautions. For the test of Dhaman-1 on artificial lungs, the company procured artificial lungs from the Michigan State University which is the only producer of artificial lungs in the world and conducted the performance test.

Its performance was found to be up to the mark. The EQDC had tested Dhaman-1 in the laboratory for eight hours and after that, another performance test was conducted for eight hours and in all the tests the ventilator had come out with flying colours.

The ventilator does not come under the purview of the present drugs and cosmetics act and medical device rules.

Therefore, it also does not come under the domain of ethical committee and the medical rules, 2017 does not apply to it. Therefore, the category -C or category D does not apply to it.

Rajkot’s Jyoti CNC has given the expensive ventilators at no cost as a donation.

Read:Non-BJP ruled states also ordered Dhaman-1 ventilators, claims Gujarat Dy CM

When the owner of Jyoti CNC Parakramsinh Jadeja has acted purely to serve his motherland, to make an allegation of corruption in the purchase of the ventilators is not only inhuman but mean.

Jyoti CNC had undertaken the difficult task of manufacturing the ventilator when the country is passing through a very critical period under lockdown.

The Pondicherry government has placed an order to Jyoti CNC for 25 units of the ventilator while a private donor had placed an order for 25 ventilators for the use of the Maharashtra government.

The central government’s HLL Lifecare Ltd too has placed an order for the purchase of 5,000 ventilators from Jyoti CNC after testing its quality.

State BJP president Jitubhai Vaghani and party spokesman Bharat Pandya too have reacted sharply to the allegations made by the Congress party while the Congress spokesman Manish Doshi has demanded action against the people responsible for using the ventilator.

Thus politics has become heated over Dhaman-1 but that does not give an excuse to the state government for not holding an inquiry into the death of over 300 coronavirus patients in the Civil Hospital.

The controversy over Dhaman-1 has not yet died down. The owner of Jyoti CNC Parakramsinh has gone to Delhi for the testing of Dhaman-3. Parakramsinh told ETV Bharat that after the testing he plans to launch Dhaman-3.