With the number of Covid-19 cases going up steadily across the country, the demand for ventilators is set to see a similar rise. Many Indian innovators are taking the challenge head on, as these life-saving machines are not readily available on order in the international market. But the key challenge before indigenous manufacturers is quality.

As the number of cases is hovering around 1.15 lakh, facilities treating Covid-19 patients in the country still have a sufficient inventory of ventilators. However, the situation can change fast if the numbers continue to shoot up. According to one calculation, India may require 1.5 lakh ventilators if the pandemic does not blow over quickly.

The Drugs Controller General of India (DCGI) on March 23 gave out an open call to any firm willing to come forward and manufacture ventilators — this included existing ventilator makers as well as new groups.

Around the last week of March, state-owned HLL Lifecare Ltd (formerly Hindustan Latex Ltd), which acts as procurement agency for ventilators and other Covid-related medical supplies, came out with the first tender for made-in-India ventilators. Two firms bagged the contract — Mysuru-based Skanray Technologies, for 30,000 units, and Noida-based start-up AgVa Healthcare, for 10,000 units.

Change in requirements

However, a series of amendments made by HLL to its original tender documents over the next 18 days raised eyebrows, with some in the medical devices space alleging that the changes were made to favour a particular bidder. Among the major modifications was a lowering of specifications on some key parameters such as flow rate and tidal volume.

Making amendments to tender documents per se is not a crime, particularly when the situation is an unusual one, like the current crisis, pointed out industry experts. The company would probably have copied the specifications from some well known model and subsequently realised that some of them are not actually needed, they said.

“What is, however, important is to ensure they do not compromise the safety of patients. I am sure HLL would have taken care of that,” an expert said. HLL did not respond to phone calls and messages despite several attempts.

Limited choice

“It is possible that they might have favoured some company. But they did not have any choice at that point in time. In April first week, there were only two technologies available in India — one by SkanRay and the other from AgVa. You either meet your requirement with them or do not have anything at all,” said another industry veteran with two decades of experience in dealing in ventilators.

Both the firms, being small, had to get into short-term partnerships with others to ensure the timely delivery of ventilators. While SkanRay tied up with Bharat Electronics and Mahindra, AgVa is working with Maruti Suzuki.

Diwakar Vaish, the roboticist who co-founded AgVa along with a doctor at AIIMS, New Delhi, vehemently denied that his firm was unduly favoured. “Our ventilator meets each of the 50 parameters listed by HLL. In fact, the frequent changes brought in requirements subsequently affected us, too, and upset our delivery schedule, apart from adding to the cost,” he said.

“AgVa may have fallen short of some specifications initially. So, some alterations were made in some parameters. We all know that the first set of ventilators produced by AgVa were non-ICU ventilators. But it’s possible that they may have come up with new designs that meet the requirements of an ICU ventilator,” said the industry veteran quoted earlier.

Vaish said the ventilators that AgVa is making are suitable for ICU operations. He said his firm, together with Maruti, is in a position to make 500 ventilators a day. And they currently have orders for 15,000 ventilators, including some from various State governments. AgVa has taken a banquet hall in Noida on hire to expedite ventilator production. Each of its units costs around ₹1.48 lakh while imported ones are priced at least five times more.

Global certification

On the issue of Indian makers often claiming that they have been certified by European (CE) and USFDA standards bodies, veterans said, before Covid-19, India had been importing 85-90 per cent of the ventilators used in the country. Since there was hardly any indigenous technology available for the device, all government procurement agencies used to insist on CE and USFDA certification/compliance, till a few years ago.

“Even though the Central government subsequently clarified that there is no need for FDA and CE standards as long as ventilators met Indian standards, the State governments continued to insist on them. As a result, most Indian ventilator makers, who used to fall short on this condition, used to ‘fake’ these certifications, even though it wasn’t right,” said the industry veteran.

As these firms never exported their ventilators to European and US markets, the claims were never contested. While some said even AgVa used to claim the same for its ventilators till very recently, Vaish denied it and insisted that they never made any such claim.