Centre rushes to prepare for ventilator shortage, repeats mistake of protective-gear crisis

The end of March witnessed a flurry of activity to deal with COVID-19 crisis, indicating that the government is finally waking up from its slumber on the rapidly progressing pandemic. With severe shortages in medical equipment already, India’s doctors will face the prospect of having to ration goods and services, especially with one lifesaving medical equipment that has become more valuable than gold dust: mechanical ventilators. In the last week, the centre issued notifications to ban its export, formed a national-level committee for its procurement and held a meeting with the civil-aviation department to prepare itself for an inevitable ventilator shortage. Yet, the centre appears not to have learnt any lessons from its failure to stockpile personal protective equipment and its raw material, because it took till 24 March to prohibit the export of all respiratory apparatuses and breathing devices.

A ventilator helps patients who cannot properly breathe on their own by pumping air into their lungs through a tube inserted into their windpipes. The COVID-19 virus affects the respiratory system, which has led to a sharp spike in the number of hospitalised patients in need of breathing assistance. Both Italy and China, which faced the worst of the pandemic, have already had to deal with this, and it is likely that India will struggle with it as well. “The decisions are coming a few weeks too late, and I hope the delay does not cost us a lot,” Malini Aisola, the co-convenor of a non-profit industry watchdog called the All India Drug Action Network, told me. “There seems to be a multi-pronged concerted effort in place now, and it gives hope that it will ensure we get ventilators in time for when cases start surging.”

Despite the international patterns of exponential rise in cases and the shortage of essential medical equipment witnessed by multiple countries, the Indian government has repeatedly failed to heed the warnings and act ahead of the spread. It took the centre till 19 March to issue its first notification during the public-health crisis to prohibit the export of ventilators. The same notification also prohibited the export of raw materials for coveralls and masks, three weeks after the World Health Organisation had issued guidelines informing countries to expect a disruption in the supply of protective equipment for medical staff. Yet, it took the government five more days before it issued an order prohibiting the export of the component parts of ventilators. On 24 March, the directorate general of foreign trade prohibited the export of “all ventilators, including any artificial respiratory apparatus or oxygen therapy apparatus or any other breathing appliance/device.”

During a press briefing on 22 March, Lav Agrawal, a joint secretary in the union health ministry, said that the centre had placed an order to procure 1,200 new ventilators, but that may still leave doctors well short of the required amount. This is particularly true for Maharashtra, where the state government has specified that ventilators made in India should be certified by the United States’ Food and Drug Administration or the European Union’s CE—a certification mark indicating that a product meets the health standards in practice within the European Economic Area. The steep standards are impossible to follow, given the dire need, shortage of time and the global lockdown of flights. The decision also suggests an inexplicable lack of urgency, considering that Maharashtra has been the worst affected so far among Indian states, recording over a hundred cases.

A ventilator manufacturer, who spoke to me on the condition of anonymity, said that he had approached the state government, urging it to rethink the impractical standards. He wrote to the government, “In these times of crisis, it is appalling that CE approval and US FDA is made mandatory.” He requested the state to devise specifications that are “practical, achievable, and possible for Indian manufacturers to meet,” adding that “only the minimum modes or specifications should be asked.”

Meanwhile, the lockdown has affected the manufacture of ventilators across the country. In an interview to the Economic Times, Diwakar Vaish, a co-founder of AgVa Healthcare, which makes ventilators at one-fifth the cost of imported ones, said the flight ban had hit supply of sensors, chips and micro controllers from China, critical to building ventilators in large numbers. To meet the growing demand, the company is looking to scale up production to 20,000 units, which is presently made difficult by the lack of access to the necessary resources. “The electronic components are ready at Shenzhen,” Vaish said. “They are unable to ship it to us because of the flight ban.”

In late March, the central government, with direct involvement of the Prime Minister’s Office, formed a National Committee for Facilitation of Ventilator Procurement. Nine Indian ventilator manufacturers told the committee that the ban on the entry of commercial airlines in India would lead to a paucity of components required to assemble ventilators. According to Rajiv Nath, the founder of the Association of Indian Medical Device Industry, the PMO, at the request of manufacturers, is exploring the possibility of sending cargo flights to China to bring back sensors, chips and controllers required to assemble the ventilator. (China has lifted the ban on exports as it is recovering from the first wave of COVID-19.)

The exact number of ventilators in India’s healthcare system has not been made public by the government, but given the nature of the pandemic, the growing demand for ventilators will soon outstrip the limited supply in the country. According to an estimate by the Brookings Institution, a non-profit public-policy organisation, five­–ten percent of India’s patients will require critical care in form of ventilator support. Another estimate, published by the COV-IND-19 Study Group—an interdisciplinary group of scholars and data scientists—stated that by 15 May, India would see 2.2 million cases in India by May 15 without any intervention. Referring to the COV-IND-19 Study Group’s estimate, Brookings reported that India would need 110,000 to 220,000 ventilators. The Brookings report continued:

We have no official figures on the number of ventilators available in the public sector, however, we arrive at an estimated figure using the number of hospital beds available — 7,13,986 total government beds, out of which 5-8% are ICU beds (35,699 to 57,119 ICU beds). Assuming that 50% of these ICU beds have ventilators, we arrive at an estimate of 17,850 to 25,556 ventilators in the country. Even in the best-case scenario where all ICU beds are equipped with ventilators, we have a maximum of ~57k ventilators to cater to a growing number of COVID-19 patients.

Clearly, the situation is dire. “We are working closely with the government to see how quickly raw materials and components the industry needs from abroad can be procured,” Nath told me. He said that PD Vaghela, the secretary of the department of pharmaceuticals, had called a meeting of four national carriers along with the civil-aviation department on 24 March, to “discuss the arrangements to air freight raw material and components by cargo planes from China and USA and Japan et cetera.” Nath added, “We are thankful for the measures being taken and next challenge to restart is domestic couriers and local tempo/ trucking.”

As of the afternoon of 26 March, the health ministry reported a total of 593 active COVID-19 cases, 42 cured and discharged cases and 13 deaths. Given the shortage of medical equipment and the rising number of cases, the rationing of safety gear, beds, and doctors is not unprecedented. Of all the medical care that will have to be rationed in the coming months, the most problematic will be the rationing of mechanical ventilation. In Italy, the European epicentre of the coronavirus outbreak, doctors were forced to make heart-wrenching decisions about who receives ventilators and who does not, as hospitals overflowed with COVID-19 patients.

In the United States, automakers including Ford, General Electric and Tesla are lending a hand to produce ventilators to make up the shortfall. In the United Kingdom, the British government is pushing for large manufacturers to switch from making cars and airplane engines to ventilator equipment. In India, Mahindra Group has stated that it will make ventilators. “We need to create scores of temporary hospitals and we have a scarcity of ventilators. To help in the response of this unprecedented threat, we at the Mahindra Group will immediately begin work on how our manufacturing facilities can make ventilators,” Anand Mahindra said in a series of tweets.

However, states governments such as Maharashtra have created an unnecessary bottleneck by mandating specifications that require international certification, further hindering the supply of an already precious resource. The manufacturer who requested anonymity noted this specifically in his message to the government. “There are many groups from IIT and allied universities who are designing ventilators which can be mass produced. In this situation, they can’t be expected to be CE or US FDA approved.”

Email queries sent to Vaghela and to Shubhra Singh, the chairperson of the National Pharmaceutical Pricing Authority, both of whom are working closely with the PMO on the ventilator shortage, were not answered.