Maharashtra was witnessing an alarming surge in Covid-19 cases and deaths when 150 ventilators arrived at the Government Medical College and Hospital in Aurangabad in the third week of April. The Union health ministry had sent them.
The hospital further distributed the machines to other district and private hospitals in the Marathwada region. But within days, many of the hospitals sent them back. The ventilators were simply unusable, doctors complained.
According to a report prepared by a team of eight doctors from these hospitals who specialise in critical care treatment and who operated these machines, patients “started complaining about breathlessness and associated symptoms within hours of the ventilators having been switched on”.
A team of engineers from Jyoti CNC, the company that had made them, serviced some of the devices on May 14. But according to a Bombay High Court order dated May 28, citing the doctors’ report, “they worked well overnight” but “next day by afternoon patients complained about poor oxygen and showed signs of restlessness”.
As of date, all 117 ventilators which were unboxed from the batch of 150 lie unused. The authorities at Aurangabad’s Government Medical College and Hospital told the Bombay High Court that they saw no point in unboxing the rest of the 33 ventilators given their experience with the rest.
“It is too risky to use them,” said Dr Shivaji Balabhau, dean of the Sukreswami Ramanand Teerth Rural Medical College in Beed district, which received 25 ventilators from Aurangabad. “There is a real chance of the patient dying because the FiO2 drops to as low as 20% when you want it to be 100%.” FiO2 or Fraction of Inspired Oxygen is the percentage of oxygen in the air that is being mechanically pumped into the patient’s lung using the ventilator.
Last year in the months of March and April, the Centre had placed orders worth around Rs 2,350 crores for over 60,000 ventilators, according to information furnished by the government in court affidavits and as part of various Right to Information requests. Of these, 50,000 ventilators costing Rs 2,000 crores were funded via the PM-Cares corpus.
According to the Central government, “ventilators allocated to states and Union Territories under PM Cares and the health ministry have more than tripled availability of the critical care machines in public hospitals”.
But many states do not share the same jubilation. Availability does not guarantee usability, they say. Apart from Maharashtra, at least four other states – Rajasthan, Punjab, Jharkhand and Chhattisgarh – have publicly expressed their disappointment with the devices.
The Centre, however, has doggedly defended these ventilators time and again, asserting the problem lay not in the devices, but in their handling by the states.
Union health minister Harsh Vardhan even suggested the criticism of the ventilators was driven by vested political interests, given that most complaints came from states run by the Opposition.
As the criticism grew louder, Prime Minister Narendra Modi on May 15 ordered for an audit of the ventilators. But his statement also called for health workers to be provided “refresher training for properly operating ventilators…if necessary”, reiterating the Centre’s original stance on the matter.
So what really is the matter with the ventilators that India spent Rs 2,250 crores on? Are the machines faulty as several states have alleged, or is this a case of inept handling and politically-motivated attacks as the Centre has claimed?
Scroll.in spoke to a range of doctors, government officials and ventilator manufacturers. Here is what we found:
Firstly, disappointment with the ventilators is not restricted to Opposition-run states. It is just that states governed by the Bharatiya Janata Party did not go public with the grievances of their doctors.
Doctors in three BJP-ruled states, Uttar Pradesh, Gujarat, and Goa, told Scroll.in that some of the ventilators supplied to their hospitals did not serve any purpose at all.
Secondly, the performance of the ventilators varied greatly from one manufacturer to another, said doctors who have handled them. The models of two private companies were particularly prone to snags.
One is AgVa, headquartered in Noida. Red flags about AgVa’s model were raised last year itself. The other is Jyoti CNC, a Rajkot-based firm that, until 2019, counted among its major shareholders a businessman who had controversially gifted an expensive suit to Prime Minister Narendra Modi monogrammed with his name.
Neither of the two companies had any prior experience making critical care ventilators.
Thirdly, of the seven companies that supplied ventilators to the Central government, the company which had the most experience – it had been making ventilators for two decades – got among the least orders.
Oddly, none of the ventilators it supplied to the government were sent to states, suggesting that the Centre kept them for its own hospitals.
Lastly, while many doctors say the ventilators are malfunctioning, some concede a shortage of trained personnel to operate them is part of the problem.
Flawed procurement
The current crisis is rooted in decisions taken by the Central government last year.
It placed orders with companies that had no prior experience in making ventilators. Only two of the seven companies – Skanray, whom government-run Bharat Electronics Limited collaborated with, and Allied Medical Limited – had any substantial track record of manufacturing critical care ventilators.
That the Centre set no bar in terms of experience is understandable given the emergency situation and the limited indigenous manufacturing capacity, but the procurement process lacked transparency, say the executives of companies that participated in it. For example, Allied Medical Limited, despite having the most experience, was awarded one of the smallest volume: just 350 units. In contrast, AgVa and Jyoti CNC, with negligible experience, got orders of 10,000 and 5,000 units respectively.
When the government was placing orders, companies were told they would have to deliver the equipment by June 30, 2020. “So we gave a realistic quantity and delivered in the time frame,” said Allied’s managing director Aditya Kohli. “We are the only company which actually did that.” Some companies completed deliveries they were supposed to do by June 30 only this year, he said.
Details provided by the government as part of Right to Information requests show that two companies that got orders, AMTZ and Jyoti CNC, had not delivered even a single unit till September.
“I understand that in March 2020, the government panicked since there were no supplies from anywhere in the world,” said Kohli. “But once the June deadline [for delivery] had expired, they should have distributed whatever quantities they had been looking at among companies which had performed.”
Kohli claimed there had not been any complaints with his company’s ventilators. “After that we supplied 2,000 ventilators in the first wave and another 2,000 in the second, mostly to private hospitals.”
The price of the ventilators bought by the Centre ranged from Rs 15.34 lakh to Rs 1.66 lakh.
In a letter sent to the states on May 9, the Union health ministry listed out the names and contact details of the manufacturers whose ventilators had been supplied to the states. The names of the companies making higher-end models were missing, suggesting expensive ventilators had been allocated to hospitals run directly by the Centre, while cheaper ones were sent to states.
The health ministry did not respond to questions seeking details of the allocations.
AgVa: ‘Less a ventilator, more a respirator’
The Centre placed orders for the AgVa devices on March 27 last year, its first ventilator purchases since the breakout of the Covid-19 pandemic. The orders were placed even before an empowered committee was constituted to “ensure availability of essential medical equipment”.
The order was worth Rs 166.38 crore for 10,000 ventilators. That amounts to Rs 1.66 lakh per unit – a rather paltry sum for a ventilator. A high-end ventilator usually costs upwards of Rs 12 lakh.
Some say the cost effectiveness has come at the expense of quality. “Although it has been called a ventilator, it is more of a respirator since it can’t be used on a critical patient with high oxygen requirement,” said Dr Dileep Kumar S R, general manager, Kerala Medical Services Corporation.
Kerala has received a total of 480 ventilators from the Centre – 320 made by the government-run Bharat Electronics Limited and the rest by AgVa. “In the AgVa ventilators, everything from software and hardware is defective,” said Dileep Kumar. “If you asked me to rate it on 10, I would give it 1-2.”
To be sure, grievances against AgVa’s ventilators transcend political and state boundaries.
GMERS Medical College and Hospital in Gandhinagar, Gujarat, was provided with ventilators of two makes – BEL and AgVa. While the former worked fine, the AgVa ventilators were susceptible to snags. “Whenever we would use it on a patient, it would not deliver the required amount of oxygen,” said Dr Bharti Rajani, associate professor of anaesthesiology at the hospital. “Patients would also complain that they are not getting enough oxygen.” Complaints led to AgVa upgrading the software in the machines, but they still could not be used on critical patents, said Rajani.
In Goa, Dr Deepa Corriea, medical superintendent at the Margao district hospital, had a similar experience to share. The hospital, too, received BEL and AgVa ventilators. While the BEL ventilators were working fine – the only problem faced by the hospital was that it had to separately buy flowmeters and circuits for them – the AgVa ventilators were “problematic” and “not very user friendly”, said Corriea.
In Lala Lajpat Rai Memorial Medical College in Meerut, Uttar Pradesh, senior anaesthesiologist Dr Vipin Dhama also shared a dim view of the AgVa devices. “They cannot go for long-term production,” he said, indicating that they were not fit to be considered for use after the pandemic was over. “They can’t be used in good medical colleges.”
Those closely following the story of the government’s ventilator purchases would perhaps not be surprised at the substandard performance of the AgVA devices. In June 2020, a government panel had warned that the AgVa devices “should not be considered as a replacement for high-end ventilators in tertiary care ICUs”, HuffPost India had reported.
AgVa did not respond to Scroll.in’s email queries seeking response.
Jyoti CNC: ‘Not fit for use’
Similarly, doctors also have few good things to say about Jyoti CNC’s ventilators. The Maharashtra doctors’ panel in its report on the company’s ventilators provided to Aurangabad Medical College and Hospital said the devices “developed errors from day one”.
“They are not fit for use,” said Dr Shivaji Balabhau of Beed’s Sukreswami Ramanand Teerth Rural Medical College. “The point of ventilators is to deliver oxygen to the patients, which these devices don’t do properly.”
Complaints about the ventilators produced by JyotiCNC had been first sounded in Gujarat last year.
In May 2020, doctors in Ahmedabad’s civil hospital said the company’s ventilators were not yielding “desired results”. However, those had been sourced by the state government and were a different model, going by their names. It is not clear what the differences in terms of features are in the model the Centre procured.
The company did not respond to queries seeking details.
Information furnished by the Union health ministry as part of Right to Information requests shows that the Centre placed orders amounting to Rs 120.96 crores with JyotiCNC for 5,000 ventilators. That adds up to Rs 2.41 lakh per ventilator – again considerably less than what quality ventilators usually cost.
Both Jyoti CNC and AgVa, the government has said, made their products under the Prime Minister’s flagship Make in India scheme that incentivises local manufacturers. Another company that bagged a substantial number of orders was the state-run Andhra Pradesh Medtech Zone Limited, which reportedly passed them to a Chennai-based private firm. None of the state officials and doctors Scroll.in spoke to claimed to have used ventilators supplied by AMTZ.
BEL: ‘Not foolproof but manageable’
The Centre placed the largest tranche of orders for ventilators – 30,000 of them at Rs 5.05 lakh apiece – with Bharat Electronics Limited, a public sector company under the defence ministry.
The company essentially used its manufacturing line, with the support of the Defence Research and Development Organisation, to scale up the production of ventilators designed by Skanray Technologies, a private company based in Mysuru. It did so on very short notice, and according to most accounts, quite effectively.
Unlike the devices produced by AgVa and Jyoti CNC, most doctors Scroll.in interviewed for this story shared a largely favourable opinion of the BEL ventilators – they were not the best, the doctors said, but they got the job done.
“You can’t obviously compare it to an international product,” said a doctor in a government hospital in Uttar Pradesh. “Let me put it this way – a Mercedes and a Maruti are both cars, but there is always going to be a difference. But when there is a crisis you take what you get. ”
Kerala’s Kerala Medical Services Corporation had a similar view. The ventilators were, he said, “not entirely foolproof” but definitely “manageable”.
However, some health officials and doctors Scroll.in spoke to said the BEL devices also broke down too frequently for comfort. To add to that, the company’s service was not up to mark, they said.
In Uttar Pradesh, Dr Anil Nigam, chief medical superintendent at Ursula Horsman Memorial Hospital in Kanpur Nagar, said the hospital’s experience with them had not been too smooth. “The PM Cares ventilators run for some time and then stop,” he said.
Dr Raj Bahadur Punjab, professional adviser to Punjab’s Covid-19 response and procurement committee, said the state’s experience with the BEL ventilators revealed three problems. “Compressors tend to break down, the sensors are not working at times, tidal volume is not as promised,” he said. Tidal volume is the volume of air delivered to the lungs with each breath by the ventilator.
Bahadur alleged the company’s engineers tended to undermine these problems. “Their engineers are reluctant to write what they see,” he said. “I don’t know why they do that.”
Rajasthan’s medical education secretary Vaibhav Galriya said the western state’s experience with BEL’s service had been unsavoury. The state has received a mix of BEL and AgVa ventilators. “Given that the BEL ventilators have better specifications, the hospitals and doctors are more inclined to use them,” said Galriya. But the devices were susceptible to snags and the company’s service was not up to mark, he said. “They have deployed a team [of engineers], but we have not been satisfied both in terms of number of personnel as well as quality of personnel.”
BEL did not respond to queries seeking a response to these allegations.
However, Vishwaprasad Alva, managing director of Skanray, the company that has designed the BEL devices, refuted the allegations about the machines malfunctioning. “I don’t know about other makes, but whatever BEL is supplying is being used all over the world,” he said.
Alva also strongly contested claims that BEL’s post-installation service was underwhelming. “These ventilators are high-end equipment which require highly-specialised intensivists, not just normal anaesthesiologists,” he said. “India simply doesn’t have so many of them.”
Lack of intensivists
Intensivists are doctors who super-specialise in critical care. They are usually drawn from the departments of medicine, pulmonology and anaesthesia. As Alva pointed out, there are not too many of them in India – barely 4,500, most of whom are limited to the metros. A Scroll.in investigation had revealed that in Bihar, a shortage of trained personnel had resulted in most ventilators in the state lying unused.
But not everyone agrees that entirely explains the debacle with the new lot of made-in-India ventilators. Dr Muralidhar Joshi, president of the Indian Society of Anaesthesiologists, said even well-trained anaesthesiologists with years of experience were complaining about the new ventilators.
“One hospital will complain if it’s a problem with anaesthesiologists but all over the country everyone is [complaining],” he said, adding that he didn’t believe specialised intensivists were required to run ventilators. “Doctors won’t sit it in front of a ventilator, nurses will.”
Others, however, said this may be overly simplistic. “Anaesthesiologists can operate basic modes on a ventilator, ventilating someone with ARDS (acute respiratory disease syndrome) as in Covid, needs special training,” said Dr Gunjan Chanchalani, a Mumbai-based consultant physician and intensivist.
Dr Deepak Govil, president of the Indian Society of Critical Care Medicine, tended to agree. “If a specialist is not available in the system, the ventilators will not be utilised maximally,” said Govil, who is the director of the critical care unit at Gurugram’s Medanta hospital.
Govil, however, added that there was undoubtedly a problem with some of the new Made-in-India ventilators. “The ventilators that have been supplied, a few of them are good, others are not,” he said. “From what I gather from talking to doctors, both the things are existing – in some centres, ventilators are not up to the mark, and in some centres, there are no trained personnel.”
‘Holding the brief for the manufacturer’
Apart from the lack of trained specialists, the Central government has also claimed that many hospitals did not have the physical infrastructure required for the optimal functioning of ventilators. For instance, the health ministry on May 13 in a statement said the “non availability of required pressure in the central oxygen gas pipelines” was resulting in glitches.
However, hospital authorities across the country that Scroll.in spoke to – including in states run by the BJP – rejected the government’s contention, saying that other ventilators worked just fine on the same oxygen connection.
In its May 28 order, the Bombay High Court snubbed the Union health ministry for “holding the brief for the manufacturer” and suggesting that “the ventilators are in working condition and the deficiencies are with the hospitals and the doctors/paramedics/technicians”. The ministry, it said, should “refrain from questioning… medical experts”.
But given the Centre’s reluctance to accept any faults with the machines, states and hospital authorities seem to be looking for other options on their own. “We have ordered 20 new ventilators from abroad, which have given us no problems in the past,” said Dr Shivaji Balabhau of Beed’s Sukreswami Ramanand Teerth Rural Medical College. “Our district collector and guardian minister are giving us funds for that.”
Corrections: The Centre placed ventilator orders with seven companies, not six, as an earlier version of this story had stated.