Breathing a new life: India should try benchmarking domestic ventilators to European or American standards

According to their risk level, the classification of medical devices under Medical Device Rules 2017 and 2020 entails a four-category division.

By Ashok Patel

Quality of care is directly proportional to the quality of devices used for dispensing care in tandem with skill sets and expertise of the caregiver, training and the experience of the attendants. This is particularly relevant for a device such as a mechanical ventilator. The role of ventilators has been amplified several-fold during the ongoing Covid-19 pandemic. Low-scale small-sized ventilator manufacturers, PSUs, automobile companies, research organisations, start-ups and the government all ‘stood up’ to meet the impending challenge.

Incidentally, the phenomenal increase in quantity has also been backed with specified standards to ensure quality. However, this is not enough. If India truly wishes to become a world-class manufacturer, the specifications must be upgraded further to those mandated for the American and European ventilator manufacturers. Unless the Indian technical specifications and standards are rigorously calibrated to align with Western countries’ specifications, the Indian domestic manufacturing companies will remain in a cocoon competing only against one another.

According to their risk level, the classification of medical devices under Medical Device Rules 2017 and 2020 entails a four-category division. Ventilators fall under Class C that covers moderate-to high-risk devices (bone fixation plates are also under the same class), one grade lower than the high-risk devices such as heart valves and implantable pacemakers.

Earlier, the bulk of ventilators used in the country were imported. Government purchases always used to insist upon only FDA or CE-certified ventilators. In fact, until the implementation of Medical Device Rules 2017 and 2020, ventilators were not classified as regulated medical devices under BIS nor under CDSCO. During the beginning of the pandemic, on March 30, 2020, MoHFW, under the guidance of an empowered committee, formed and released guidelines and minimum specifications for ventilators to be used for the treatment of Covid-19. These were basic level specifications enabling bulk manufacturing of ventilators in a short time. Since these specifications were fundamental and inadequate, BIS later released standard number ISO13485 to regulate/control spurious products entering the market during scarcity.

What we need is to manufacture world-class medical devices as per international standards and nothing below that level.

One good step taken by GoI is the implementation of MDR 2020, which will bring all medical device manufacturers, importers, and distributors follow the requirements of ISO 13485. The mandatory implementation is to be observed within 18 months from April 2020.

Similarly, medical devices being manufactured by various manufacturers shall comply with applicable BIS/ISO product standards within the specified duration of 24-42 months. For ventilators, this period is 42 months, effective April 2020. This step will upgrade and regulate the quality of domestic ventilators .

The author is founder & CEO, Max Ventilator. Views are personal

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