The shortfall in medical oxygen supply to hospitals treating Covid-19 patients and to individuals given medical care at home led to a number of casualties during the April-May period, grabbing headlines in national and international media. According to a study conducted by a professional group, around 524 deaths were reported in India either due to lack of oxygen, shortage, or denial till May 16, during the peak of the second wave of Covid-19. The highest number of oxygen-related deaths took place in Goa, followed by Karnataka, Maharashtra, Delhi, Andhra Pradesh, and Tamil Nadu, most of which are known for relatively better health infrastructure.
The actual situation regarding oxygen supply was more dreadful than reported in the media. There was chaos across India, to say the least. In Delhi, the situation during the third and fourth weeks of April was aptly described as frightening, as many private hospitals asked patients’ relatives to arrange oxygen cylinders. One can imagine the situation in hospitals located in remote places as they don’t have storage tanks and relies on cylinders transported on a regular basis.
The horrid images of corpses floating in rivers and buried in sand on river banks give enough hint of what patients in those areas had to go through. Social media platforms have been filled with posts by desperate families looking for cylinders and refilling facilities. Despite pathetic conditions prevailing, there was no stopping unscrupulous traders engaging in the black marketing of cylinders and concentrators that were sold far above their usual retail prices.
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Even before the pandemic, pneumonia or bronchiolitis, diseases treated with oxygen, were a leading cause of mortality, causing at least 2.5 million deaths worldwide. So, oxygen is a lifesaving need in healthcare. The demand for medical oxygen before the Covid-19 outbreak last year in India was about 700 MT/day which went up to 5500 MT/day during the second wave of the pandemic.
During the first wave of Covid-19 in 2020, the daily demand for oxygen shot up to 2800 MT/ day. This should have alerted healthcare experts and planners ahead of the second wave. Unfortunately, those engaged in healthcare infrastructure upgradation failed to see the demand-supply gap as well as the gaps in logistics for the movement of medical oxygen. The result was the countless stories of tragedy across India.
Making available oxygen in the required quantity and quality to hypoxemia patients requires a holistic system of facilities, equipment, consumables for oxygen generation, transportation, and technologies for flow regulation as per the medical condition of patients. A reliable and quality power supply, devices for monitoring oxygen concentration, and spare parts for equipment maintenance, are other essential components of an effective oxygen system.
No less important is proper training to the user. Even if oxygen is available with a reliable supply position, but the equipment is not properly maintained, and technicians/ healthcare staff do not have adequate training to use the equipment, the repercussions could be serious. This was evident in the ongoing surge of covid cases when the staff in ICU of large hospitals in Delhi were found unaware of the operating procedure of the oxygen concentrators.
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Industrial oxygen vs medical oxygen
As far as oxygen availability is concerned, it has been often reported that India is producing enough oxygen, over 7,000 tonne a day, mostly for industrial use that can be diverted for medical purposes. Steel producing companies with captive plants to produce oxygen used in steel production, both in the public and private sectors, rose to the occasion and produced close to 4000 MT per day of liquid oxygen in the first week of May to meet the medical requirement of oxygen, compared with 1500-1700 tonnes /day dispatched in mid-April.
Oxygen used in industries for combustion, oxidation, cutting, and chemical reactions may not be appropriate for human use because of impurities or contaminants creeping into it during the process of generation, transportation and storage. Although medical oxygen is considered fit for use with 96-98% purity against 99.67 % purity of industrial use oxygen, the other contents are equally vital for human health.
As per standards published by the Indian Pharmacopoeia Commission, medical oxygen is considered safe for human use if it contains not less than 99.0% V/V of oxygen, not more than 5 ppm of carbon monoxide, not more than 300 ppm of carbon dioxide, free from any kind of halogen and polymers, free from all forms of oxidizing substances, and free from moisture.
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In 2017, the World Health Organization (WHO) included oxygen on the WHO list of essential medicines (EML) beyond use during anaesthesia, due to its proven lifesaving properties, safety, and cost-effectiveness. To ensure contamination-free oxygen production for medical use, it requires to be generated by medical air compressors and not an incorrect compressor in use for other grades of oxygen. Medical compressors generally are oil-free to avoid contamination.
In the US, medical oxygen is strictly regulated by the Food and Drug Administration (FDA) to ensure patient safety. All medical gases intended for human drug use that are not certified or do not otherwise have an approved marketing application will be considered unapproved new drugs and could be subject to enforcement action in terms of the Food and Drug Administration Safety and Innovation Act (FDASIA).
Since the FDA classifies medical-grade oxygen as a drug, one must have a prescription to purchase it and other oxygen-related medical devices, such as oxygen concentrators. Even cylinders that had been previously used for storing and transportation of oxygen for industrial purposes should not be used for medical purposes unless the cylinders were evacuated, thoroughly cleaned, and labelled accordingly. This is more important as oxygen in cylinders is used by smaller hospitals that have limited trained staff.
Last year, following the Covid-19 crisis, the Petroleum and Explosives Safety Organisation (PESO) came up with standard operating procedures (SOPs) for conversion of industrial oxygen cylinders and non-toxic non-inflammable gas cylinders to allow industrial gas filling units to convert their industrial and inert gas cylinders to medical oxygen. It would be interesting to do a fact-check randomly on the compliance level of the SOP by small and medium units filling oxygen in cylinders for hospitals and home care as it might present shocking statistics.
Rise in the number of cases of Mucormycosis, a fungal infection triggered by COVID-19 or black fungus causing the death of patients ICUs needs to be medically probed to ascertain doubts raised by many senior medical professionals suggesting contaminants in industrial oxygen as one of the probable reasons behind the fungal infection. With the spike in demand for oxygen, cylinders used for industrial applications have been routinely used for a medical purpose without properly following processes as it needs both time and money.
Augmenting capacity for medical oxygen generation
As regards the oxygen generating plants, there are mainly three types of oxygen production units at present operating in India. These are the air separation units (ASU) that are used for commercial purposes, pressure swing adsorption (PSAs) for producing on a medium scale, an oxygen concentrator, which is used to manufacture oxygen at homes and small rooms.
ASUs are used to produce oxygen in large quantities by manufacturers such as Inox Air Products, India’s largest manufacturer. An ASU plant of around 200 MT per day of oxygen will cost around Rs 250 crore. In comparison, Pressure Swing Adsorption (PSA) medical oxygen generation plants are small, suitable to produce oxygen for requirements in small hospitals, say with 100 beds, if there is no large oxygen plant near the hospital. It is common knowledge that many hospitals at the district level do not have adequate basic infrastructure, not to mention an on-site oxygen plant.
Amid the first wave in 2020, the health ministry issued tenders for on-site oxygen plants for such hospitals. Tenders for procurement of 162 PSA plants were floated on 21 October by Central Medical Services Society with identified consignee hospitals in different states and documents from the bidders were to be submitted by 10.11.2020.
The procurement and installation of plants showed a lack of urgency, and only around 33 such plants were commissioned till March this year. This was not enough to meet the demand for a life-saving input during the unprecedented surge of Covid-19 pandemic this year. Experts say that it takes hardly a week for installing a Pressure Swing Absorption (PSA) oxygen plant and the recent installations of such plants in Delhi hospitals confirm the same.
Steps for streamlining procurement, supply
Another important step taken by the government in the wake of oxygen shortage was the formation of the empowered group 2 (EG2) under DPIIT. It was assigned the responsibility of procuring liquid oxygen for medical use from suppliers, private manufacturers, government units, and distribution to various state governments, central government hospitals, and private hospitals. EG2 also assigns the procured oxygen based on each state’s need keeping in view the prevailing situation.
The empowered group 2 is reported to have started an exercise for mapping the sources of medical oxygen in the country and their production capacity. This is considered the right step, but should have been initiated earlier. The mapping exercise and subsequent planning and coordination for supply to states are time taking processes. It would be useful once completed, but not a solution for the current crisis.
The need for mapping exercise also reflects poorly on the quality of industrial production data compiled by the CSO which was out of sync with the actual status of industries in different sectors. The production data suffers from the non-reporting by manufacturing units across industries. A properly managed industrial database would have been handy in managing procurement and supply of medical oxygen to hospitals treating covid patients.
The administrative ministries of different industrial sectors need to impress upon the manufacturing units the importance and necessity of reporting their production in time to the authorities. Perhaps, realizing the time-consuming nature of steps initiated for streamlining oxygen supply and the gap in demand and supply, EG2 has decided to float a tender to import 50,000 tonne medical oxygen.
Future-proofing medical oxygen supply
The current situation in India has exposed the imbalance between demand and availability of hospital beds, ICU beds, ventilators, PPE, and trained medical personnel in the country. The shortage of oxygen, a life-saving input, has highlighted the need for a holistic approach in developing health infrastructure. The last budget, the first after covid-19, saw only a marginal increase in expenditure on health infrastructure upgradation.
Some specific suggestions for ramping up oxygen generation and transportation for medical purpose and to avoid preventable casualty due to oxygen deficiency both in quantity and quality:
- It should be mandatory for big (to be categorized on the number of beds) hospitals whether government or private to establish a captive PSA plant for medical oxygen within their premises.
- The current proposal for setting up 162 PSA plants and another 551 plants to be established under PM CARES Fund should be distributed across the country so that no hospital offering treatment to critical patients is located beyond a distance of 100 km by road.
- Conversion of plants for industrial oxygen generation to medical oxygen production should be permitted under intimation to the administrative authority.
- The standard operating procedure (SOP) for the conversion of industrial oxygen cylinders and non-toxic non-inflammable gas cylinders into medical oxygen cylinders for healthcare purpose has to be strictly complied with and the workers in the gas filling units should be trained to avoid contamination in medical oxygen.
- For the patients undergoing homecare, delivery of oxygen cylinders at their doorsteps would greatly relieve their relatives and friends of the hassle of finding gas filling units and carrying heavy cylinders for re-filling. A government portal for booking oxygen cylinders as proposed by the Delhi government should be put in place at the earliest. It would also help stop black-marketing of gas cylinders as witnessed in Delhi recently.
- Oxygen concentrators should be immediately included in the list of medical products under the PLI scheme to promote local manufacturing.
(Krishna Kumar Sinha is an industrial policy and FDI expert based in New Delhi. His last assignment was as an industrial adviser in the department of industrial policy and promotion, DIPP, currently known as DPIIT, under the ministry of commerce and industry of the government of India.)
Krishna Kumar Sinha is an industrial policy and FDI expert based in New Delhi. His last assignment was as an industrial adviser in the department of industrial policy and promotion, DIPP, currently known as DPIIT, under the ministry of commerce and industry of the government of India.