Dhaman-1 does not require DCGI license as per Medical Device Rules 2017

Jyoti CNC produced ventilators after necessary approval based on IEC 60601 standards under ISO at a time when the entire world is facing shortage of ventilators

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Dhaman-1 does not require DCGI license as per Medical Device Rules 2017

Gujarat has become a model of self-sustenance by the production of Dhaman-1 ventilators. While the entire world is facing a shortage of ventilators, one must appreciate the efforts of Gujarat’s self-sustenance through the production of indigenous ventilators.

  • Jyoti CNC produced ventilators after necessary approval based on IEC 60601 standards under ISO at a time when the entire world is facing shortage of ventilators
  • Rajkot’s Jyoti CNC donated 866 ventilators to serve the COVID-19 patients
  • Ventilators produced by Jyoti CNC have undergone Safety and Performance Test at EQDC which is recognised by the National Accreditation Board for Laboratories, Government of India

There was a sudden increase in the demand of ventilators across the world including Gujarat during the COVID-19 outbreak. Not a single country on the globe was prepared to manage this sudden rise in demand of ventilators amidst the pandemic. In such a scenario, Jyoti CNC of Rajkot, with an aim to aid the government amidst the pandemic, produced ventilators based on the required standards, got them tested and certified and supplied the first batch of 10 ventilators on 18-4-2020. Jyoti CNC has supplied 866 ventilators free of cost to Government of Gujarat at a time when the entire world is facing shortage of ventilators.

Dhaman-1 and other ventilators do not need a license from the DCGI. According to the Drug Controller General of India Dr. V.G Somani, “There is no need for a license from the Central or State government for ventilators as per the regulations of Medical Device Rules-2017.”

The Ministry of Health and Family Welfare has issued a notification GSR 102(E) on 11th February, 2020 with effect from 1st April, 2020. The notification provides a list of 37 medical equipment that require the manufacturers to obtain licenses for their products.Ventilators are not a part of this list of medical equipment. This clearly means that Dhaman-1 does not need any kind of license till date. The notification also states that the producers of medical tools and equipment, other than the 37 medical equipment and devices mentioned in the list, can register themselves within 18 months i.e by 21st October, 2021. In such a scenario, the producers of Dhaman-1 have the freedom to register themselves before 21st October, 2021.

Jyoti CNC has produced ventilators based on IEC 60601 standards under ISO. Dhaman—1 fits the necessary standards given by the High-power Procurement Committee of Government of India. In addition to that, Jyoti CNC is one among the 24 producers for ventilators as approved by this High-power Procurement Committee.

Jyoti CNC, the company producing Dhaman-1 has availed the International Electric Certification and Safety and Performance Test Certificate through EQDC- Electric and Quality Development Centre, a government recognised agency. EQDC is a recognised by the National Accreditation Board for Laboratories, Government of India. The NABL has approved Dhaman-1 based on electrical safety and mechanical safety standards.

Jyoti CNC produced Dhaman-1 based on the required medical standards. At the same time, it is mandatory for the ventilator to be tested on artificial lungs. The company acquired them from Michigan State University- the only producer of artificial lungs in order to conduct the necessary trials. Dhaman-1 showed positive results after undergoing a trial on artificial lungs. Jyoti CNC and EQDC tested the ventilators for 8 hours at their respective centres. Dhaman-1 was successful in the performance tests.

The question is being raised about the performance trial of Dhaman-1. There are no such trials in the first place. Trials are held for medicines, tablets etc. Performance tests are conducted for medical tools and equipment. This makes it clear why Dhaman-1 does not require any clinical trial. The indigenously produced ventilator underwent the performance test and it showed positive results.

Rajkot Jyoti Cnc Made Ventilator Dhaman 1 In Short Period 04

Drugs and Cosmetics Act and Medical Device Rules are not applicable to ventilators. Hence, Dhaman-1 is not bound by its laws. As a result, the rules of Ethical Committee and Medical Device Rules 2017 are not applicable. There is no question of the ventilators being included under Category-C or Category-D.

A live demonstration of the ventilator was held at Civil Hospital, Ahmedabad on 9th April, 2020. The team of medical experts comprising Dr. Shailesh K Shah, Head of Anaesthesia Department from B.J Medical College and Dr. Kamlesh Upadhyay, Head of Medicine Department and the medical superintendent of Civil hospital suggested a few inputs to Jyoti CNC. The company incorporated the necessary changes suggested by the medical team, post which the team of medical experts said, “Dhaman-1 can be used amidst the pandemic”. It was only then that the ventilators were supplied to the hospital for treating the patients.

Rajkot based Jyoti CNC has donated costly ventilators to the state government with a motive to aid the state. It is absolutely amoral to put allegations of corruption during the purchase of ventilators in a situation when the owner of Jyoti CNC Mr.Parakramsinh Jadeja is making an effort to repay his debt to the land of Gujarat by supplying free of cost ventilators. Jyoti CNC decided to produce ventilators at a time when the entire nation is engulfed by the pandemic.

The Government of Puducherry has given an order of 25 ventilators to Jyoti CNC and a private donor has also decided to purchase 25 ventilators to be used to Government of Maharashtra. Even HLL Lifecare Limited- a GOI owned corporation has ordered 5000 ventilators from Jyoti CNC after checking the necessary parameters. The GOI owned corporation has its own parameters of testing and leave no margin for error. The corporation ordered ventilators from Jyoti CNC after taking into consideration its usefulness. This is a proof of the credibility of Dhaman-1.

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Source By : gujaratinformation.net

(This News has not been edited by the Life Care team, it is published directly from the agency feed.)

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