From oblivion into the spotlight

From oblivion into the spotlight

A segment, almost forgotten and abandoned, has become a savior for the frontline coronavirus warriors

As COVID-19 infections increase, the concern on shortage of personal protective equipment (PPE) for healthcare workers also broadens. PPE, the equipment worn by workers to protect themselves against health and safety risk includes gloves, N95 masks, surgical masks, goggles, face shields, gowns, and aprons. Most of the raw materials and inputs used to produce PPE are outsourced to low-cost suppliers. Production of these items often requires imports of raw materials like cotton fiber, polyester, and polyamide produced by different manufacturers around the world. These are processed by protective clothing manufacturers for sale to end users.

Surge in demand, partly prompted by panic buying, hoarding, and misuse of PPE amid the COVID-19 pandemic, is disrupting supplies. The dramatic rise in demand has resulted in significant price increases and has led to production backlogs of 4–6 months. The most significant challenge is ensuring that critical PPE kits are sourced and allocated to frontline health workers and other responders, those most vulnerable to the spread of coronavirus.

Recently, the World Health Organization estimated that globally 89 million medical masks are required for COVID-19 response each month, along with 76 million examination gloves and 1.6 million medical goggles. WHO itself has so far shipped nearly half a million sets of PPE to 47 countries, but supplies are depleting rapidly. The organisation estimates that a 40 percent increase in production is required.

Indian Market
India is well-armed. There is no shortage of PPE today. The ministry has ordered for the requisite PPE, masks, ventilators, oxygen cylinders, and RT-PCR diagnostic kits. Production has been ramped up where possible, and imports made for other products.

There are only two companies, Venus Safety and Magnum Medicare that manufacture N95 masks in India. They are able to supply 50,000 masks per day at the moment, but are ramping up capacities to make 100,000. The duo has largely been exporting for industrial usage to countries in Europe, the Middle East, and the US for the last 20–25 years. The government has put a ban on their exports. The Defence Research and Development Organisation (DRDO) has also collaborated with local manufacturers to produce about 20,000 N99 masks per day.

Major vendors operating in the Indian PPE market include 3M India, Honeywell, Karam Industries, Mallcom India, and MSA Safety. Other prominent vendors in the market are Armstrong Products Pvt. Ltd., Bata Industrials India, DuPont India, Joseph Leslie and Company LLP, Kimberley-Clark Professional, Lindstrom Services India Pvt. Ltd., Neo Safety Products Pvt. Ltd., Super Safety Services, Sure Safety, Tara Lohia P. Ltd., Udyogi Plastics Pvt. Ltd., and Venus Safety & Health Pvt. Ltd. One of the key trends that is gaining traction in the PPE market in India is the introduction of smart solutions. Manufacturers are introducing smart and technology-oriented PPE and app-based services with sensors, Bluetooth, and wireless technology for workers. This is helping users track workers, send equipment replacement alerts, quick response simulation, monitor the task executed by workers, and provide a timely backup of data.

The ministry of textiles and the ministry of health and family welfare have made proactive efforts to promote manufacturing. Eleven manufacturers have cleared quality test to supply PPE in a time-bound manner. These include Sai Synergy, Gurgaon; Sure Safety, Vadodara; Amaryllis, Bangalore; SCG Enterprises, Ghaziabad; Shree Healthcare, Chennai; Frontiers Protective Wear, West Bengal; Plus Creations Pvt. Limited, Delhi; Shiva Texyarn Ltd., Tirupur; JCT, Phagwara; Venu Healthcare, Ahmedabad; and Hallmark Safety Products, Mumbai. Orders for 2.6 million coveralls have been placed on them. Currently, they are supplying 6000–7000 coveralls per day and this is expected to go up to 15,000 per day. In addition, there are 25 manufacturers, including Shahi Exports, Aditya Birla Fashions, Gokuldas Exports, Kusumgar Corporates, and a few more are expected to be approved.

Nearly 50 percent of the coverall production in the country is from Bengaluru. Other than Bengaluru, they are also being manufactured in Tirupur, Chennai, and Coimbatore in Tamil Nadu, Ahmedabad and Vadodara in Gujarat, Phagwara and Ludhiana in Punjab, Kusumnagar and Bhiwandi in Maharashtra, Dungarpur in Rajasthan, and Kolkata, Delhi, Noida, and Gurugram.

Since body coverall or PPE is a specialized protective suit meant for high level of protection to the health professionals, the health ministry has prescribed stringent technical requirements. As of now, there are four laboratories in the country that have the synthetic blood-penetration resistance test facilities as well as necessary approvals for conducting tests and certification for PPEs. These are South India Textiles Research Association (SITRA), Coimbatore; Defence Research and Development Establishment (DRDE), Gwalior; and two laboratories under Ordnance Factory Board-Heavy Vehicles Factory, Avadi; and Small Arms Factory, Kanpur. For each such test conducted in respect of fabric and the PPE coverall garment, prototype samples are sent by the respective manufacturers, and a Unique Certification Code (UCC-COVID-19) generated.

RT-PCR testing kits are being procured from Seegene and SD Biosensor in South Korea, Altona Diagnostic, Germany; Life Technologies, USA; and Shanghai Forum, China. SD Biosensor has supplied kits to India earlier too. These include VTM, RNA extraction kits, and RT-PCR kits. All real-time RT-PCR kits are approved by USFDA and European CE. In addition, real-time RT-PCR kits have also been validated by ICMR-NIV, Pune.

The Department of Health Research (DHR) has assessed the requirement of manual RT-PCR kits as 35 lakhs, for which probe, primer, and master mix – reagents needed to conduct successful RT-PCR tests – have been ordered. Apart from the order of 6.3 million test kits sourced from overseas, material for about 1.64 million tests has been received. A further order of 200,000 kits was placed with domestic manufacturers as well, which is still awaited to be delivered. Further, the DHR has ordered 200,000 Roche’s COBAS test kits, of which 60,000 kits have been received. These are high-speed testing kits.

Rising to the occasion
Imaginarium, Mumbai, a large rapid prototyping and advanced manufacturing center, has announced its plan to commence the production of 3D-printed face shields and other PPEs in its existing facility. The manufacturer has come up with a unique concept to protect the entire face of an individual by creating a 3D-printed face shield that provides complete coverage of the face, ears, and neck. With an ergonomic, lightweight design, it is a product designed for comfortable usage during long working hours. The 3D-printed face shield is the first in a line-up of products shortlisted by our team for designing and manufacturing during this time. The vendor has also been working on the development of safety goggles, aerosol intubation boxes, ventilator components, and other critical supplies that can be distributed to every part of the country immediately. These products are tested and approved by doctors.

Karam, a PPE manufacturing company, has started manufacturing medical face shields to offer protection to healthcare workers treating COVID-19 patients. The company has been manufacturing 10,000 face shields on a daily basis, and is looking at ramping up its production. This is the company’s second initiative to provide support to healthcare workers. Earlier this month, they had partnered with the government to manufacture protective goggles for doctors and the police workforce across the country, and have manufactured around 450,000 goggles that have been distributed across the stakeholders.

IIT Kanpur students and faculty members came up with the idea of manufacturing a PPE kit at the cost of only Rs 100, which is 20 times cheaper than a standard PPE kit. Referred as PIPES (polyethylene-based improvised protective equipment under scarcity), they used polyethylene instead of non-woven polypropylene, and during the different stages of designing, were constantly taking feedback from the local doctors about the design. These PPE kits are not tested by the government as the standards set by the government are for doctors working in the ICU, whereas these are for sanitary workers, policemen, and grocery vendors. Currently, they have one manufacturer in Kanpur and are aiming to increase the manufacturing in other cities as well, and hence have released their design as open-source so that anyone can use it to manufacture the kits, without paying royalty.

The Indian Railways has set itself a target of manufacturing 1000 PPE coveralls in its 17 workshops every day. It has received a nod from the DRDO. The PPE overall will offer much-needed protection to railway doctors and paramedics working at their hospitals. They are also considering to supply 50 percent of the garments to other medical professionals in the country.

Vedanta Limited has enabled mass production of PPEs in Gurugram. The company has imported 23 PPE machines recently in collaboration with the ministry of textiles, and teamed up with authorized apparel manufacturers to roll out over 5000 PPEs per day. The company has also provided more than 350,000 masks through its business units to the local communities. and has handed over another 200,000 N95 masks to the Ministry of Health. Vedanta has spent Rs 150 crore on its COVID-19 initiatives till now.

Mukesh Ambani-led Reliance Industries and the Red Cross have together donated 60,000 PPE kits to the Ministry of Health and Family Welfare. Another 300,000 PPE coveralls are expected to arrive soon. TikTok has also donated 70,000 PPEs. The company had earlier donated 140,000 kits. Vivo India has donated 15,000 PPE suits and 50,000 liters of sanitizer to the central government.

Sources for PPE kits are being identified by the ministry of external affairs overseas. A Singapore-based online platform has been identified, which can supply 10 lakh PPE kits, and an order has been placed on them. Another supplier based in Korea, who has tie ups with production companies in Vietnam and Turkey, has been identified with daily production capacity of over 100,000 PPE kits. Orders are being placed on this company for supplying 2 million PPE kits.

In a country of the size of India, there had to be issues
Counterfeiters set up shop overnight to cater to these requirements. It manifested itself not only as a threat to legitimate brand owners, who are likely to suffer a loss in revenue and reputation, but also as a major risk to the health and safety of the public at large. An investigation conducted by India Today TV revealed that sweatshops-cum-PPE factories were churning out make-shift medical equipment, using blazer covers and carry bags.

As regards online channels, counterfeit face masks made in China were available for sale on online platforms in India and other South-East Asian countries. They have been recently removed after it was revealed that the masks were falsely bearing the registered trademark VALPRO, along with an approval number assigned to 3M.

There was an upsurge in the import of counterfeit PPEs, in particular from China, a majority of which failed the quality and safety test and had to be dumped. In response, the Chinese government has introduced stricter norms for manufacture of PPEs, and the Indian customs officials in India are on high alert.

An allegation was made at the All India Institute of Medical Sciences (AIIMS) that Rs 50 lakh received from Bharat Dynamics through CSR, and earmarked for procurement of PPE, had been diverted to the PM CARES Fund. Doctors affiliated with the Resident Doctors Association maintain that the AIIMS administration is functioning in an opaque manner.

Complaints were also received from some medical staffers about the lack of quality standards for their protection gear, which they find difficult to wear for long hours. Doctors said it is difficult to breathe in the coveralls.

Global Scenario
Against a global industry average growth of 3–5 percent per annum, the COVID-19 pandemic has caught the world by surprise, and the PPE segment is experiencing an estimated 80–100 percent increase in demand.

Market size. The global PPE market is valued at USD 52.7 billion in 2019, expected to reach USD 92.5 billion by 2025, growing at a CAGR of 8.7 percent during 2020–2025, according to Globe Newswire. This estimate includes its application in oil and gas, construction, chemicals, transportation, manufacturing, pharmaceuticals, food, and mining verticals. Among all, pharmaceuticals segment is expected to contribute the largest revenue by 2025 as people all over the world are rapidly demanding PPE to protect themselves from COVID-19 pandemic.

Geographically, Europe was the largest PPE market. This is owing to the increase in the COVID-19 patients in the region. The demand for PPE has been exceeded by European Union in order to fight coronavirus. The demand for PPEs from this region is 10 times more as compared to what is available in stock.

The government authorities globally have allotted funds toward COVID-19 in the following manner: Germany is expected to incur USD 808 billion, France USD 50 billion, Spain USD 223 billion, and the UK USD 14.8 billion. Furthermore, Brazil is anticipated to spend USD 144 billion, Switzerland USD 42.6 billion, Austria USD 42 billion, and Canada USD 82 billion toward recovering from COVID-19 situation. Huge initiatives undertaken by the government authorities across the globe to fight COVID-19 are significantly attributing toward the growth of the global PPE market.

Production. China is the largest producer of PPE finished products, as well as of many of the raw materials needed to manufacture these products. The mainland produces an estimated 50 percent of surgical masks globally (estimated to be 20 million masks a day, pre-pandemic) and has reportedly increased the production of masks more than five-fold, providing a daily production capacity of 110 million units. Taiwan alone makes up 20 percent of the global supply of face masks. Other countries with PPE production capacity include India, Japan, Korea, Malaysia, Mexico, Thailand, US, and several European countries.

On the other hand, Europe has its own regional capacity with sources of PPEs somewhat diversified among suppliers. This may help the region withstand the supply shock originating from Asia to an extent. However, production capacity in Europe is unlikely to meet the demand surge associated with the rapid spread of COVID-19. The US also depends heavily on overseas production and is expected to face a critical shortage of PPEs.

Competitive insight. Some of the key players operating in the global PPE market are the 3M Company, Ansell Limited, Honeywell International Inc., Sioen Industries NV, Kimberly-Clark Corporation, E I DuPont de Nemours and Co., MSA Safety Inc., Lakeland Industries, Alpha Pro Tech, Ltd., Radians Inc., Delta Plus Group, Uvex Safety, Avon Rubber, and Metric AG.

The manufacturers are working to provide an uninterrupted supply of PPEs during this crisis. This is opening doors for new entrants, alliances, and partnership opportunities. For instance, Cummins has partnered with 3M to manufacture high-efficiency particulate filters for use in 3M’s powered air-purifying respirators for healthcare workers. Cummins will use its workforce and existing equipment at its Neillsville, Wisconsin, facility to pleat the media, assemble it into cartridge housings, and do final testing before shipping the filter to Valley, Nebraska, where 3M’s PAPRs are manufactured.

Across countries, large mask distributors have been nabbed taking advantage of this heightened demand and charging higher prices than normal for the equipment, the shortage of masks forcing hospitals, nursing homes and first responders to ration masks and other protective gear as they treat infected and high-risk patients, creating a secondary health crisis among first line providers, and ban in some countries to export PPE equipment were expected.’

Across countries, large mask distributors have been nabbed taking advantage of this heightened demand and charging higher prices than normal for the equipment, the shortage of masks forcing hospitals, nursing homes and first responders to ration masks and other protective gear as they treat infected and high-risk patients, creating a secondary health crisis among first-line providers, and ban in some countries to export PPE was expected.

USA, a case study
American manufacturers say it will be months before they meet demand for high-quality masks, part of a broader breakdown in the effort to supply enough protective gear and lifesaving equipment to fight the coronavirus pandemic.

3M Company and a half dozen smaller competitors are making 50 million N95 masks each month. That is far short of the 300 million N95 masks the US Department of Health and Human Services (HHS) estimated, in March 2020, required. US hospitals that previously purchased masks from abroad have turned to overburdened domestic suppliers after many countries blocked exports to fight the virus within their own borders.

Companies are racing to add machines and hire staff to make tens of millions more masks each month. The domestic production boom is a reversal after three decades that manufacturers spent moving production of masks and other medical gear to China and elsewhere, amid the broader shift of industrial capacity to lower-cost countries. Hospital buyers supported a strategy that kept down costs for critical equipment.

3M’s N95 masks are considered the gold standard by medical workers and public-health officials. The company began ramping up mask production after the World Health Organization on January 11 reported the first deaths from COVID-19, the disease caused by the coronavirus. By mid-March, 3M had doubled its output to nearly 100 million masks a month globally, and 35 million a month in the US, at plants in South Dakota and Nebraska. It plans 50 million masks a month in the US by June. The company will import 10 million masks this month from its factory in China, which earlier this year was restricted from sending goods abroad.

Honeywell, which primarily made masks outside the US before the pandemic, plans to hire 1000 workers to make 20 million N95 masks a month by May at its plants in Rhode Island and Phoenix.

Smaller manufacturers, Moldex-Metric and Prestige Ameritech, are making two million and eight million N95 masks a month, respectively. Dozens of other smaller manufacturers are also buying equipment to start making masks. But many of their new machines will not be installed for months.

Some mask components, including filtering material polypropylene, are also in tight supply. Total Petrochemicals USA, a division of France’s Total SA, a major supplier of polypropylene to manufacturers including 3M, has boosted global production of polypropylene to meet the rising demand.

Strong Manufacturers, a medical-equipment distributor, recently installed three mask-making machines at a factory in North Carolina, but cannot find enough raw materials to use them. The machines need a hard-to-find shape of elastic band.

Medicom Group, a Montreal-based mask maker is opening a factory in Canada after signing a supply agreement with the Canadian government. The company wants a similar commitment from officials in the US to buy its masks even after the pandemic ends.

Other verticals not impacted
The shortage of PPE in the healthcare segment has not impacted the chemical industry, for instance. Some chemical manufacturers, such as DuPont de Nemours, Eastman Chemical, and Huntsman Corporation have switched their production lines to make chemical materials used in the production of PPEs, yet it is not having a knock-on effect on the ability of companies to retain sufficient equipment for protecting their workers from chemical exposure.

Outlook
COVID-19 has brought many learnings. The unexpected is the new normal in many aspects of life. PPE, a neglected segment, where USA, and India for that matter, along with many others had relegated manufacturing to other countries, is back with a bang. The powers that be in each country have put their heads together, banned exports, allocated resources, appealed to large successful companies to pitch in and divert their respective production lines and ramp up production in their own countries. Reducing foreign dependency overnight has become a priority!

Harsh Vardhan
Union Health Minister

“As on date, more than 1 lakh PPE kits and N95 masks are being manufactured every day in the country. There are at present 104 domestic manufacturer of PPE kits while three manufacturers are making N95 masks. In addition, production of ventilators has also started and orders have been placed for more than 59,000 units through nine manufacturers.”

PD Vaghela
Secretary, Department of Pharmaceuticals and Chairman,
Empowered Group-3

“Earlier, there was no domestic manufacturing of PPE in the country, and almost all of them were imported. Now, we have 111 indigenous manufacturers, with a Rs 7000-crore PPE industry in India, the biggest after China.”

Mike Roman
Chief Executive,
3M

“The demand we have exceeds our production capacity. The first step was ramping up our idle capacity. The second step is expanding it.”

John Waldron
President and CEO,
Honeywell Safety and Productivity Solutions

“Responding to COVID-19 is an all-hands-on-deck effort, and Honeywell is proud of its role in providing essential equipment to the first responders and medical professionals we are relying on during this crisis. We are working hard to ensure governments, states, and cities are able to get the supplies and resources they need.”

Dr Tedros Adhanom Ghebreyesus
Director-General,
World Health Organisation

“The current global stockpile of PPE is insufficient, particularly for medical masks and respirators; the supply of gowns and goggles is soon expected to be insufficient also. The capacity to expand PPE production is limited, and the current demand for respirators and masks cannot be met, especially if widespread inappropriate use of PPE continues”

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