Indian health workers are putting their lives at risk to fight the coronavirus disease. But opaque government decision-making is delaying the supply of crucial equipment needed to shield them from infection, prompting manufacturer' associations to allege that "malintentions" have undermined the procurement process, an investigation by Scroll.in has revealed.

Gloves, masks, eye protection, hazmat coverall suits — called personal protection equipment or PPE — are a mandatory requirement for all health workers testing or treating Covid-19 patients, as per the World Health Organisation’s latest guidelines. But India could take weeks, if not months, to make them, even as experts ask the country to prepare for "a tsunami of coronavirus cases".

India detected its first case of the coronavirus disease on January 31. The very next day, the government moved to ban the export of personal protection equipment.

But a month and a half later, the heads of two associations of PPE manufacturers told Scroll.in that the government had not placed any substantial orders with their members. In addition, it had not publicly issued any clear standards or specifications for the design, quality and testing of Covid-19 safety gear, without which the manufacturers said they cannot begin production.

These associations are the prominent industry voice, representing nearly 150 Indian medical PPE makers, public health activists who act as watchdogs of the sector confirmed.

Last week, as coronavirus-infected cases rose sharply across India, the Ministry of Textiles called the associations for a meeting on March 18 with representatives of the health ministry. The textile ministry had been assigned the task of ensuring the availability of safety gear in India by the cabinet secretary on March 8.

In the March 18 meeting, it was decided that HLL Lifecare Limited, a public sector company under the health ministry, would be the sole PPE procurement agency for Central and state government hospitals, minutes accessed by Scroll.in show. HLL is supposed to procure various PPE components from manufacturers, assemble them into complete kits and supply the kits to public hospitals across the country.

The health ministry said in the meeting that it required 7.25 lakh body coveralls, 60 lakh N-95 masks and one crore three-ply masks. It added that HLL had already placed orders for 10.5 lakh N-95 masks and 10 lakh three-ply masks, meeting a small part of the requirement. However, for the most expensive item on the list — the body coverall — the full requirement had already been ordered.

This came as a surprise for the two PPE manufacturers associations. "Except for a few companies, none of our member companies have received any orders from HLL for protective equipment," Dr Sanjeev Relhan, the chairman of the Preventive Wear Manufacturer Association of India, one of the two associations, told Scroll.in on March 20. He was present at the March 18 meeting.

A mystery tender

On the morning of March 21, a report appeared in the Times of India flagging the concerns of the associations.

Shortly after, on the afternoon of March 21, 14 companies from the Preventive Wear Manufacturer Association of India received emails from HLL asking them to manufacture coveralls for an "urgent requirement" of 80,000 pieces "at the earliest". The emails, which Scroll.in has seen, listed detailed design and quality specifications for the products.

In the evening, manufacturers also spotted three tender documents on the HLL website soliciting bids for the supply of a range of PPEs including coveralls, goggles, N-95 masks with nitrate valves, three-ply surgical masks, nitrile gloves and face shields. The first document carried March 5 as the date of issue and listed March 16 as the last date for submitting bids. The second was an amendment dated March 16, which extended the deadline to March 20. The third, also an amendment dated March 20, further extended the deadline to March 25. Scroll.in could not ascertain when these tenders had been uploaded to the website.

But the manufacturers allege that these documents were not available on the website earlier. They say they did not know about the tender at all. They blame HLL and the government for concealing an important document in the middle of a nationwide health crisis.

"I had not heard of this tender before today," said Smita Shah, managing director of PPE manufacturing company Mediklin, speaking to Scroll.in late on Saturday night. Shah said her company has the capacity to make up to 10,000 coveralls a day, but had not received any orders from HLL so far. "It is clear now what their malintentions were — they only wanted the tender to be circulated among a few manufacturers," she alleged.

Rajiv Nath, the founder and coordinator of the Association of Indian Medical Device Industry, the second association of PPE makers, echoed this allegation. "The government has not been transparent with us at all, even though we have been writing to them and talking to them for weeks," he said.

Questions emailed to the textile ministry and the health ministry went unanswered.

On Saturday morning, the director of HLL, T Rajasekar, asked Scroll.in to approach the health ministry with all questions about PPEs, adding that the ministry is in "total control of the situation, not to worry".

Late on Saturday night, in response to follow up questions about the tenders, Rajasekar said, "Please understand it’s an emergency and it’s unprecedented; we are working 24x7 even now our team is in the warehouse at this hour trying to receive and dispatch emergency relief materials to various institutions across the country. It’s very easy to find fault with the system but very difficult to deliver in the prevailing situation. Just wait for some more time things will change in the next seven days. Please be assured there’s nothing wrong in any of the system, allow us to focus on the supplies."

This article will be updated if there is a response from the ministries.

Meanwhile, manufacturers who received emails from HLL on Saturday afternoon are now unsure of whether to respond to the mails and begin manufacturing coveralls, or submit bids for the tender.

"If HLL has already placed orders, then why is there a tender? And if there has been a tender all this while, why have orders been placed?" said Dr Sanjeev Relhan, chairman of the Preventive Wear Manufacturer Association of India, which represents 120 PPE makers. "Why was the tender not mentioned in the meeting on March 18 when they talked about orders being placed? This indicates that they have not been transparent."

Beyond the lack of transparency, say manufacturers and public health activists, are concerns over mounting delays in health workers around the country getting the protection they needed to save lives — of others and their own.

Relhan estimates it would take at least a month to make, test and send 80,000 coveralls to HLL, at the rate of 20,000 coveralls a week. Nath estimates some manufacturers could take even longer.

Until March 22 morning, 315 people had tested positive for the coronavirus disease in India. Many experts fear the numbers could rise dramatically over the next few days, and with it, the number of PPEs that health workers would need.

For instance, Malini Aisola, the co-convener of a non-profit industry watchdog called All India Drug Action Network, estimates that health workers across India could need upwards of five lakh body coveralls a day. This figure that is completely at odds with the health ministry’s projection, during the March 18 meeting, that it would need 7.25 lakh coveralls up to May.

"There was never any attempt to forecast the need for PPE kits and components on the basis of rational quantification, as recommended by WHO, to protect healthcare workers in coming days," said Aisola. "As a result, quantities being ordered are wholly inadequate and do not tap into the manufacturing capacity of the local industry."

Concerns over centralisation

Even before they came to know about the HLL tenders on Saturday, manufacturers had raised questions over the centralisation of procurement through the public sector company. They said it would cause unnecessary delays in the delivery of protective gear.

HLL, which comes under the Ministry of Health and Family Welfare, is headquartered in Thiruvananthapuram. It has a handful of centres in other parts of the country, largely in South India.

"If I am manufacturing in western India, and I have to send all my material to the south to be assembled into kits before it is sent to different hospitals in the country, it is going to take up so many days," said Shah in an interview on March 20.

The emails that 14 manufacturers received from HLL on March 21 mention Delhi as the centre where all the goods had to be sent from across the country. This still raises questions about centralisation.

"Does HLL have the capacity and the facilities to assemble and sterilise lakhs of PPEs that will be needed every day?" Shah asked. "The system has to be decentralised."

With the government ordering all public and private hospitals to prepare isolation wards and PPE stocks, many private hospitals that normally do not usually keep stocks of protective gear meant for infectious diseases will also need them.

Public health experts believe the orders placed by HLL will not be adequate.

"A health worker handling Covid-19 would need to change protective gear for every patient," said T Sundararaman, the former executive director of the National Health Systems Resource Centre, an advisory body to the health ministry. This means India is likely to see a huge surge in the demand for PPEs, given the rate at which the virus is now spreading.

"If the disease spreads to rural areas, all ASHAs will need masks and sanitisers," he said, referring to women enrolled in the government’s Accredited Social Health Activist programme. "We will need a strong supply chain of PPEs to not only increase production but also to distribute it everywhere."

Due to the urgency of the situation, the All India Drug Action Network has now demanded that HLL be immediately removed as the nodal agency for centralised procurement of PPEs. "Healthcare institutions should be permitted to procure PPEs independently," said Aisola. To enable this, she said that the health ministry should publish PPE specifications in the public domain and centrally monitor the procurements.

Opaque decisions

In order to properly shield medical workers from infectious viruses, protective gear must be made from materials of a specified quality, with specified designs. The materials and designs must both be tested at certified laboratories with specific testing tools.

The World Health Organisation recommends following standards laid down by the International Organisation for Standardisation to ensure that PPEs have the required resistance to tears, abrasions, blood particles and virus penetration, among other things, depending on the nature of the infectious disease.

In India, the Bureau of Indian Standards has not issued specific standards for PPEs for medical workers dealing with infectious diseases.

But in the March 18 meeting, as the minutes seen by Scroll.in show, the textile ministry claimed that the health ministry "has already set the technical and test requirement for body coveralls" and that "all government procurements should be synchronised with the technical standards prescribed by Ministry of Health and Family Welfare".

Scroll.in also accessed a letter that the health ministry sent on March 6 to the directors of various AIIMS hospitals in India, in which the ministry mentions that it has provided specifications for PPE kit products to HLL.

But when Scroll.in spoke to PPE manufacturers before March 21, they claimed that they were completely unaware of what these specifications and standards are. "The specifications mentioned by the ministry are not in the public domain, even though we have been writing to the government and asking for them for a long time," Dr Sanjeev Relhan of the Preventive Wear Manufacturer Association of India had said.

The Association of Indian Manufacturers of Medical Devices claimed it had sent a set of PPE specifications for approval to the central government a year ago, but has still not received a response.

"Manufacturers are frustrated because exports have been banned, but we are not being told exactly what to manufacture for the local market now," Rajiv Nath, of AIMED claimed last week. "There is no point in manufacturing something that will not be as per required specifications."

Relhan also pointed out last week that one of the many things left unspecified is the design of the coveralls in the PPE kit. "If health workers are dealing with infectious viruses like Covid-19, the coveralls should ideally be designed in a way that lets the wearer put it on and remove it without touching the outer surface at all," he said. "Right now, many of the gowns and coveralls in the market are of simpler designs and lower quality, which can be risky for health workers."

Scroll.in emailed the ministry of health to ask about the nature of the specifications and standards for PPEs in the context of Covid-19, but did not receive any response.

In the email send to 14 manufacturers on Saturday afternoon, HLL mentions some specifications for the types of coveralls to be made: medium and large sizes, with shoe covers, single use, impermeable to blood and body fluids and lighter colours, among others.

Avoidable delays

Design and quality specifications for protective gear also include a specification of the lab tests they must go through for approval. In India, the Centre of Excellence for Medical Textiles at the South India Textile Research Association in Coimbatore is responsible for testing PPEs for the medical sector.

However, SITRA does not seem to have the tools needed to conduct all the tests required by WHO for protective wear, particularly coveralls. UB Das, the chief medical officer of the health ministry’s Emergency Medical Response division, has told The Times of India that the baseline specifications for testing PPEs are the same as that for Ebola, "but we do not have all the tests that need to be done for Ebola level equipment in India".

While Das claimed that the textile ministry was to hold a meeting to modify the specifications to suit tests that can be done in India, Relhan claimed last week that the government is still expecting SITRA to test coveralls for "seam-taping", a process through which garment seams are sealed to prevent the entry of any virus-laden aerosol particles.

"Seam-taping was required for PPEs at the time of the Ebola virus, but for coronavirus, WHO does not require it," Relhan had said. "From what I know, SITRA has also written to the government to say that seam-taping is not currently required, so insisting on it will waste a lot of manufacturing time which we don’t have right now."

Scroll.in has emailed officials at SITRA as well as the health and textile ministries to seek confirmation and clarification about this, but has not received any responses so far.

In the email sent to 14 manufacturers of Saturday afternoon, HLL says the coveralls produced must be tested for "synthetic blood penetration resistance test" conducted at SITRA.

This piece originally appeared on Scroll.in and has been reproduced with permission.