First, coronavirus safety gear was held up by government delays. Now, it faces lockdown bottlenecks

At the Patna Medical College and Hospital, students and interns are living in constant fear. Every day, they are called upon to join the hospital’s fight against the coronavirus pandemic – but without any protective gear. They have no masks, gloves, gowns or safety wear to shield them from exposure to the novel coronavirus that has caused the Covid-19 outbreak, even as they are asked to directly attend to patients, they say.

“At a time like this, we are willing to work if needed, but we are not willing to commit suicide,” one final-year student told Scroll.in on the condition of anonymity. “Senior doctors have protective gear, but we are not being given any.”

One reason why India’s health workers are facing such crippling shortages of safety gear is that the Central government released guidelines for the manufacture of Covid-19 safety gear on the same day as it announced a 21-day lockdown.

As a result, workers of the factories that produce the safety gear are struggling to get to work. With transport grinding to a halt, manufacturing firms are also unable to easily send their products for testing and certification at the sole government institute designated for the purpose.

Specifications delayed

In the weeks since the first coronavirus case was confirmed in India on January 31, as reported by Scroll.in previously, manufacturers of personal protection equipment had sent several emails to the health ministry. They asked for clear standards or specifications on the quality, design and testing requirements of safety gear for health workers dealing with Covid-19 patients.

Particularly, firms that make coveralls – also known as hazmat suits – were keen to begin manufacture for the domestic market, since the government had banned the export of coveralls on January 31. (It also banned the export of N-95 masks, surgical masks, shoe covers and gloves, but later revoked the decision. After public criticism mounted, it reintroduced the ban this week.)

Despite the repeated requests by the manufacturers, the health ministry only made the specifications public as late as March 24, when the country already had 536 positive cases. To contain the spread of the virus, that evening, the government announced a complete closure of all mass transport, offices, factories, asking 1.2 billion people to stay at home for three weeks.

This has meant even though the firms now have the specifications to begin production, many of their workers are unable to report to work, severely curtailing their production capacity.

Adding to the complication, many manufacturers say one of the specifications laid down by the government – seam-taping of the coveralls – is difficult to comply with. According to World Health Organisation guidelines, it is not necessary to tape the seams of the coveralls.

With the government insisting on seam-taping as a requirement, and the demand for coveralls soaring across states, several manufacturers told Scroll.in that they have no choice but to supply coveralls without getting the finished garments tested by a government-appointed agency.

This has raised fears that the market could be flooded with untested, substandard safety gear.

Due to delays by the health ministry, India has “missed the boat” on centralised monitoring, said Malini Aisola, the co-convener of the All India Drug Action Network, a non-profit industry watchdog. But she urged states to “set up monitoring systems at the state level, so that they can find out where the need is and how to get the supplies there.”

Lockdown impact

India’s sudden and poorly-planned lockdown has had severe consequences on migrant workers, daily wage workers and several industries supplying essential goods and services. Reports from across the country reveal disturbing police brutality towards people venturing out in public.

Many manufacturers of the safety gear told Scroll.in that the lockdown has made it difficult for their workers to get to the factories.

“Just two days ago, one of my workers got beaten up by the police on his way to the factory, before he could even get a chance to explain where he was going,” said Siddhant Aggarwal, a director of Cartel Healthcare, a manufacturer of medical protective wear in Raipur, Chhattisgarh. Aggarwal’s company has the capacity to manufacture 100 coveralls per day, as long as his employees are able to make it to work amidst the lockdown.

“The workers are now very scared of coming in, even though we are providing transport for them and are trying to motivate them as much as possible,” said Aggarwal.

In Dadra and Nagar Haveli, the head of another manufacturing firm claimed the lockdown forced her to close one of her four factories. “Two other factories will begin production only tomorrow, but our production capacity has reduced because of the lockdown,” said Smita Shah, the managing director of Mediklin.

In Delhi, a manufacturer with the capacity to make 300 coveralls a day claimed that since the lockdown was announced, the police personnel had not allowed many of his factory staff to leave their low-income neighbourhoods.

“I have issued letters to all my workers to clearly describe who they are and what work they do, but the police does not seem to understand,” said Ravi Kumar, the general manager of Dispowear Sterite Company in Delhi. “The lines to get curfew passes are extremely long and could take all day, and I have not received any response to my request for e-passes for my workers.”

A tricky specification

For health workers dealing with highly contagious viruses, personal protective gear must be resistant to tears, abrasions, blood particles and virus penetration, with different specifications for different diseases. According to the World Health Organisation’s latest guidelines, published on February 27, Covid-19 is a different kind of respiratory disease than Ebola, and thus requires different PPEs as well.

For testing and treating Ebola, the WHO recommends the highest level of protective wear to ensure that the air-borne virus does not have even the smallest opening to invade the health worker’s body. This means that hazmat suits or coveralls for Ebola have to be taped and sealed at the seams in a way that closes all the tiny holes formed in the fabric while sewing the garment together.

For Covid-19, the WHO guidelines are far more lax, recommending gowns (long garments without covers for the feet, neck or head) rather than coveralls. “Coveralls [sometimes called Ebola PPE] are not required when managing Covid-19 patients,” the guidelines say.

The WHO’s main requirement for gowns is that they should be fluid-resistant, specifically in situations where aerosol particles are generated, such as tracheal intubation, bronchoscopy or ventilation of patients. For such procedures, the guidelines state that healthcare workers should use “respirators, eye-protection, gloves and gowns; aprons should also be used if gowns are not fluid resistant”. Aprons are typically made of plastic.

Despite this, the Indian specifications require full body coveralls for health workers managing Covid-19 patients, and expect the coveralls to be taped at the seams.

Manufacturers claim that seam-taping is a specialised procedure that is not possible for every coverall maker to do. “Seam-taping can be done only on special viral-barrier fabric that is not manufactured in India,” said Dr Sanjeev Rehlan, chairman of the Preventive Wear Manufacturer Association of India, one of the two main associations in the industry. Relhan claims his association’s appeals to the government to drop the seam-taping specification has not succeeded so far.

“The government has made it clear that it is not backing down from the requirement of seam-taping,” said Malini Aisola, the co-convener of the All India Drug Action Network, a non-profit industry watchdog. “This means the central government will be able to procure coveralls only from a limited set of manufacturers who are able to do seam-taping, instead of using the full industry capacity.”

Scroll.in emailed questions to the health ministry asking why it considered seam-taping necessary. The email went unanswered.

Side-stepping testing

The government’s insistence on seam-taping coveralls could have different kinds of implications for central, state, and private hospitals and laboratories.

On March 22, an investigative report in Scroll.in flagged another reason for mounting delays in the supply of safety gear in India: the health ministry had appointed HLL Lifecare, a public sector company, as the sole procurement agency for government hospitals. Scroll.in accessed minutes of a meeting held on March 18 in which manufacturers were told that HLL Lifecare had already placed orders for 7.5 lakh coveralls. However, neither of the two main industry associations knew about this. After their grievances became public, HLL Lifecare placed orders with 14 firms and asked other firms that were willing to supply PPE to contact it.

A textile ministry notification has identified a group of nodal officers whose job is to ensure that the PPE supplies to central government hospitals are duly tested for resistance to fluid, blood and aerosol penetration at the South India Textile Research Association or SITRA in Coimbatore.

State governments and private hospitals, meanwhile, are procuring PPEs independently from individual manufacturers without any monitoring from the Centre. Since they are not insisting on seam-taping coveralls or getting PPEs tested at SITRA, several manufacturers who cannot comply with the Centre’s seam-taping specification are now taking up large orders from them.

In Raipur, for instance, Siddhant Aggarwal from Cartel Healthcare claims he is manufacturing 100 coveralls and around 1.25 lakh masks per day to cater to orders from across state-run and private hospitals in Chhattisgarh. “We are following all the government specifications except seam-taping,” said Aggarwal. “We send batches of fabric to SITRA for testing and approval, rather than sending the stitched garments for testing.”

Direct supply

Aggarwal is among the handful of manufacturers that HLL had approached last week with an order of 80,000 coveralls. He declined the order, and is now among a group of 20 coverall makers from the two main manufacturers’ associations – Preventive Wear Manufacturer Association of India and the Association of Indian Medical Device Industry – who plan to supply directly to state and private hospitals without seam-taping and without getting their stitched garments tested at SITRA. Together, these 20 companies can manufacture up to 17,000 coveralls a day, according to data provided by AIMED.

“We are asking our fabric supplier to directly send fabric samples to SITRA for testing for fluid resistance, and we make coveralls out of the approved fabric,” said Ravi Kumar from Delhi’s Dispowear Sterite Company.

But this is adding to delays, say manufacturers, since transporting samples to SITRA is not easy in the current lockdown. It can take upto 15 days to get the clearances, they said.

Some companies are choosing to bypass the testing entirely.

“I have orders from some private and state hospitals who know the quality of my PPEs through past experience, so I am not getting them tested,” said Smita Shah of Mediklin, which is manufacturing masks, coveralls and shoe-covers for Covid-19 health workers. “I know I cannot comply with the seam-taping requirement, so why waste time when there is an urgent demand?”