A wave of innovation swept through India as the Coronavirus disease-19 (COVID-19) pandemic unfolded in the country. Ventilators took center stage and the wheels of medical device manufacturing started churning. Academic institutions, automobile manufacturers, Government PSUs and even engineering graduates started dreaming about ventilators. The domestic manufacturers were happy to help and others were trying to fix their logistical hurdles to be able to service the growing demand in India? It seemed like India was set for the ventilator shortage challenge and become the largest ventilator producer in the world in no time.
What started as an epidemic from China in Dec 2019, spread across the globe quickly to become a pandemic by March, 2020. A new coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was wreaking havoc in the European countries; England, Spain and Italy were devastated. This new virus was causing a flu-like disease which was much more deadly, Covid-19 had arrived. Because of its highly contagion nature and death toll, governments across the world had to take drastic measures to avoid it. India went into total lockdown on March 24, 2020. Taking cue from Italy and England India ramped up its healthcare infrastructure. Covid isolation wards were earmarked at both government and private hospitals and Covid quarantine centres were set up on war footing. However, when the cases started to explode, the lack of co-ordination among government departments, healthcare providers and policy makers; shortage of medical equipment; unavailability of hospital beds and rising death toll overshadowed our gains.
Ascendancy: Why ventilator took centre stage during Covid-19
As clinicians around the world learned more about Covid-19 it was clear that patients with severe disease needed breathing support. “In severe cases of COVID-19, patients may contract pneumonia,” says Dr K K Aggarwal, Former President, Indian Medical Association. “The resulting fluid build-up in the lungs reduces the ability to take in oxygen and expel carbon dioxide,” he explains. Ventilators helps the patients breathe or in some cases breaths for the patient. A mechanical ventilator is a machine that works as an external lung, when patients are not able to breathe properly on their own. “The mechanical ventilator is used when oxygen levels are low or patients have severe shortness of breath from an infection such as pneumonia,” explains Dr Aggarwal. In March, 2020 industry body AiMed (Association of Indian Medical Device Industry) said that India will face shortage of ventilators by mid-May. AiMed said that the country might need anywhere between 110000 – 220000 ventilators by May 15 in the worst-case scenario and there were only 57000 ventilators available in India at that time. “There is a pressing need for ventilators in India and a huge disparity in their availability in various states. For instance, Mumbai alone has 800-1000 ventilators, while states such as Tamil Nadu and Madhya Pradesh have 1500 and 1800 respectively. The city of Bengaluru, has approximately 400 ventilators, whereas Kerala has 5000,” said Rajiv Nath, Forum Coordinator, AiMeD. Sensing an opportunity in the demand and supply gap in India’s healthcare space, many veterans from other industries took to collaboration and manufacturing medical devices. Large companies like Maruti, Mahindra & Mahindra, Kalyaani Group, Tata Motors, Hyundai etc., joined hands with domestic manufacturers to rapidly scale up production of ventilators. This brought ventilators to the limelight. Now, people even in remote villages started to innovate on breathing devices. Ventilator became a part of the national vocabulary and everyone had an opinion on what ventilator should be and how it should be used. Between March and April, many deals were signed to scale up production capacity of ventilator manufacturers. Mysuru based, Skanray Technology created a consortium with BEL, BHEL and Mahindra & Mahindra to ramp up production from standard 2000 pcs per month to currently 5000 pcs per month and 30,000 pcs per month by May. Similarly, AgVa has tied up with Maruti to scale up production from 400 pcs per month to 4000 pcs per month in April to 10,000 pcs per month by May.Large companies like Maruti, Mahindra & Mahindra, Kalyaani Group, Tata Motors, Hyundai etc., joined hands with domestic manufacturers to rapidly scale up production of ventilators.
At the same time, the PM CARES Fund Trust said that it would allocate two thousand crore rupees to equip government run COVID hospitals in all States and Union Territories with 50 thousand ‘Made-in-India’ ventilators.While the domestic manufacturers were busy ramping up production, traditional ventilator manufacturers around the world were also looking to enhance their production. Large medical device manufacturers like Hamilton Medical, Dräger, Mindray, Medtronic, Löwenstein, Vyaire Medical, Philips, GE Heathcare, and Fisher & Paykel Healthcare, among others were constantly trying to break the supplychain and logistic barriers. In fact, Medtronic made the full design specifications, produce manuals and design documents for its portable ventilator hardware public so that engineers around the world could benefit from it.
Back in India, innovative ventilators prototypes were making news every day. According to news reports, a first-year student of Industrial Design Centre at IIT Bombay developed Ruhdaar a low-cost ventilator using locally available materials. Then, Sree Chitra Tirunal Institute for Medical Sciences and Technology, jointly build a prototype of an emergency ventilator system based on artificial manual breathing unit with Wipro 3D. A group from IIT Roorkee collaborated with AIIMS, Rishikesh to create the low-cost, portable Prana-Vayu ventilator. Even the Indian start-ups jumped into the ventilator innovation bandwagon. A few 3D printing start-ups like Supercraft3D and Ethereal Machines came up with ventilator splitters to help administer breathing to two patients simultaneously. A start-up from Startup Incubation and Innovation Centre, IIT Kanpur, Nocca Robotics, designed and developed a fully functional invasive ventilator, the NOCCA V310 ICU ventilator. The Biodesign Innovation Labs, built an emergency and transport ventilator called RespirAID. In fact, government agencies were also not left behind in the race to develop a path-breaking low-cost product. Indian Railways, announced the development of a low-cost ventilator at its Kapurthala Rail Coach Factory, called Jeevan. Interestingly, Council of Scientific and Industrial Research (CSIR) and National Aerospace Laboratories came up with a non-invasive Bilevel Positive Airway Pressure (BiPAP) ventilator called SwasthVayu.
This overwhelming response to Covid-19 and ventilator requirement meant that India’s entrepreneurial zeal would soon turn it into a global exporter of ventilators. However, the ground reality painted a different picture.
Accessibility: Ventilator Shortage, Overuse and Spare Capacity
In the beginning of June 2020, the health ministry reported 336 deaths in one day with the total death toll climbing to 12,573. The total number of Covid-19 positive patients in India was rising to breach five lakh mark. The lockdown had been eased and patients were returning to hospitals for other pressing medical conditions. Consequently, ventilators became somewhat prized. So much so that people started to buy mechanical ventilators for personal use.
Sadly, reports of patients dying due to unavailability of healthcare interventions started making headlines. The Indian Express reported the death of a 68-year-old man who needed ventilation, but was not able to avail one. Similar reports emerged from Gujrat, Telangana and even Karnataka. Many patient groups and politicians started to raise the issue of shortage of ventilators in India.
“For a hundred bed hospital about 5-10 percent beds are demarcated for ICU and half of these beds have ventilators,” explains Ayanabh DebGupta, Co-founder & Group President, Medica Hospitals. At large teaching hospitals this could go up to 15 percent of total bed strength, he adds. The number of ICU beds at government tertiary care centers and medical colleges like AIIMS could go up to 20 percent of the available bed strength. According to a paper published by the Center For Disease Dynamics, Economics & Policy, India currently has 19 lakh hospital beds out of which 95 thousand beds are ICU beds and 48 thousand beds have ventilators. However, it was not clear if all available ventilators were in use or whether all ventilators were in working condition. “Ventilator shortage has not occurred in Delhi,” says Dr Kapil Kochhar, Additional Director, Department of Bariatric, Minimal Access & General Surgery, Fortis Hospital, Noida. “For some time in June when cases were increasing exponentially there could have been a shortage, but by mid-July things were under control. Today, most mechanical ventilators are easily available in India,” he adds. Dr Binila Chacko, Professor and intensivist, CMC Vellore says that even in developed countries, when there was a surge of cases, there was demand-supply mismatch in terms of ICU beds and ventilators. “It is likely that India is also facing similar challenges, especially in pockets where a large number of cases have been reported,” she says. Even as clinicians were worrying about ventilator shortage, a few critical care specialists flagged the overuse of ventilators. They argued that most of the patients could be treated with less invasive and simple respiratory support even though their oxygen levels were low. “About five percent of patients with COVID-19 infection develop severe lung injury that requires ventilatory support,” explains Dr Chacko. Though, some clinicians were baffled by the findings that Covid-19 patients with very low oxygen concentrations were still not exhibiting any signs of organ damage or brain inactivity. On the contrary, they were quite active. In a letter published in the American Journal of Respiratory and Critical Care Medicine, researchers from Germany and Italy wrote that their Covid-19 patients were unlike any others with acute respiratory distress. They said that these patients’ lungs were relatively compliant, a sign of healthy lung in sharp contrast to expectations for severe ARDS, even when they had low blood oxygen.For long, oxygen saturation rate below 93 per cent (normal range 95-100 per cent) is accepted as a sign of potential hypoxia and impending organ damage. Dr Kochhar says, “When the oxygen saturation in a patient goes below 95% and there are other clinical symptoms along with it then we start off with all the measures to improve oxygen saturation.”