On April 21, a small consignment of coronavirus-protection coveralls travelled from Mumbai to the Institute of Nuclear Medicine and Allied Sciences in Delhi. The institute is part of the Defence Research and Development Organisation, India’s premier military research agency.
The coveralls are a critical component of the personal protective equipment that shield doctors, nurses and other health workers from the novel coronavirus, which has infected over 46,000 Indians and killed over 2,200 so far.
These coveralls cannot be supplied to government hospitals unless they are tested for quality and given certifications of approval by one of eight government-appointed laboratories. The Institute of Nuclear Medicine and Allied Sciences, INMAS, is one of them.
The company that sent the coveralls from Mumbai was Reubens Hospitech, a medium-sized firm located in the Dadar area.
The day it sent the samples, INMAS issued a notice that said it could take up to five weeks to provide manufacturers with the test results of their samples because of the large number of samples that had been submitted.
For Reuben Hospitech, this came as a blow: it could mean waiting up till May 26 to know if its samples have passed the quality test. “Without the test results and the certification code they provide, we cannot bid for any tenders for supplying coveralls to public hospitals,” said Joshua Reuben, the chief executive officer of Reubens Hospitech, which manufactures both PPE and ventilators.
Inconsistent timelines
Delays in testing and certification are slowing down production, say manufacturers, at a time when healthcare workers across India continue to face shortages of protective equipment.
Worse, manufacturers allege there is inconsistency in testing timelines.
While Reuben Hospitech is still waiting in line for INMAS to test its samples sent on April 21, manufacturers point out the laboratory has already tested and approved several samples that were submitted on a later date.
Scroll.in examined 71 certificates of approval available on the DRDO website up till May 8. All testing laboratories are required to inform manufacturers whether their sample has passed or failed the test. Only samples that pass the test are given a certification code, with the report uploaded on the agency’s website.
Of the 71 certificates on the DRDO website, 31 certificates were for samples submitted after April 21 – the day when INMAS announced it could take upto five weeks to test samples.
Sixteen of these 31 samples had been tested on the same day as their submission and six samples had received certificates within two days of testing. The time taken to test the samples ranged from one day to 11 days. The time taken to generate the certificate after the test was also uneven, varying from two days to 14 days. At least nine samples were submitted as recently as May 3 and May 4, but had already received certificates by May 8.
“I know of at least six manufacturers who submitted samples between April 16 and 21 and are still waiting for their test to be done, so how come those who came after them already get their certificates?” said a manufacturer from Delhi, who did not wish to be identified. “Are they adopting a pick and choose policy?”
Dr Narendra Arya, the director of DRDO’s Directorate of Public Interface, said INMAS was overwhelmed. “We are receiving about 60-74 samples everyday, and have a backlog of about 800 samples,” he said. Until recently, the lab had only one machine for testing. With each test taking upto two and a half hours, the lab has been able to do just 12 to 14 tests a day, despite working 24 hours a day, he said. “Now capacity has been augmented and the situation will improve,” he added.
But what explained the variation in the time taken to certify samples of different firms? Arya said the variation was because INMAS has prioritised samples submitted through HLL Lifecare Limited, a public sector company that the Union health ministry has appointed for procuring and supplying PPE to all central government hospitals.
“Same day tests were done for HLL authorised samples on top priority,” Arya said. Other samples tested on priority, he said, were ones sent in from “research and joint development” – PPE made by the DRDO in collaboration with other companies – and from “import consignments of government”.
Scroll.in asked Arya to specify which certificates pertained to samples tested on priority. He declined further comment and said “all the information is uploaded on the DRDO website”.
Of the 31 certificates issued since April 21, only three explicitly state they had been submitted through HLL. All three were samples imported from China. Two companies that had received the certificates said they were neither supplying to HLL, nor collaborating with the DRDO, and their consignments had not been imported.
Batch testing
To protect health workers from exposure to the virus, coveralls must be made of viral-barrier fabric. The government has mandated that a few samples of stitched coveralls are tested from every batch of fabric purchased. This means every manufacturing company has to repeatedly send samples for testing – a one-time test is not enough.
Reuben Hospitech has machine capacity to produce 1,000 coveralls per day. It can make 3,000 coveralls from every ton of fabric purchased as raw material. It buys a batch of two or three tons of fabric at a time – enough for 6,000 or 9,000 coveralls.
“But now we have reduced our production to just 350 coveralls a day, because we are still waiting for the test results for our last batch,” said Joshua Reuben.
Since the lockdown began on March 24, Reubens Hospitech has supplied more than 2,000 PPE coveralls, made from tested and approved fabric, to public hospitals in several districts across Maharashtra. But for now, it can only supply coveralls to private hospitals, since they do not ask for the certification code, said Joshua Reuben.
A long wait
The INMAS notice of a five-week waiting period for testing is a fallout of the central government’s mismanagement of PPE supply right from the time India reported its first case of Covid-19 in January, say health activists.
Instead of preparing stockpiles of all protective medical gear in anticipation of the pandemic, the Centre allowed the export of surgical masks through most of February and half of March. While coverall manufacturers had been asking the government to issue specifications for the design, quality and testing of PPE since February, the Centre waited till March 24 to publicly release the specifications, which had been quietly issued on March 2.
By this time, the nationwide lockdown had come into effect. Even though PPE are an essential commodity, factory workers found it difficult to get to work, raw materials took longer to reach factories and manufacturers struggled to send their PPE samples for testing to laboratories.
At the start of the lockdown, the Centre had authorised just one laboratory – the South India Textile Research Association in Coimbatore – to test and approve PPE coveralls. Despite rising demand for more testing facilities from manufacturers, the government took five weeks to gradually equip more laboratories with the ability to conduct synthetic blood penetration tests on coveralls.
It was April 30 by the time eight laboratories had been appointed for testing, including INMAS in Delhi, three centres in Uttar Pradesh, one more in Tamil Nadu and one each in West Bengal and Maharashtra. When Reuben Hospitech sent coverall samples to Delhi on April 21, for instance, there was no laboratory in Maharashtra.
During the five weeks the government took to increase the number of testing centres, India’s Covid-19 cases had increased from 536 to 34,863. Health workers dealing with these surging cases need to change their PPE several times a day, which means Indian hospitals need lakhs of PPE on a daily basis.
‘What will I do with the stock?’
Several coverall manufacturers told Scroll.in they are keen to ramp up production to meet health workers’ needs, but the long waiting periods at major testing laboratories like INMAS was slowing them down.
“My company has stopped production of coveralls for the past 12 days, because I cannot keep piling up inventory while the laboratory takes so much time to do the test,” said one manufacturer in Delhi who did not wish to be named. The manufacturer has the capacity to make more than 1,000 coveralls a day. “If my samples do not get approved, what will I do with all the stock?”
In Chhattisgarh, Cartel Healthcare, which can make up to 400 coveralls per day, has also stopped production for the past week. In mid-April, the company had sent samples to Delhi for testing by speed post, which took more than a week to deliver the samples to INMAS.
On April 22, the day when the samples were delivered, the Ministry of Textiles directed all PPE testing laboratories to accept samples only when manufacturers submit a notarised affidavit listing the details of the company and of the fabric or garment to be tested. This proved costly for Siddhant Aggarwal, the director of Cartel Healthcare.
“Because my samples had reached them without an affidavit, INMAS did not accept them,” said Aggarwal, who then got an affidavit made. “But they refused to accept a scanned version of the affidavit sent on email or Whatsapp – they wanted a hard copy.”
After several failed attempts to get INMAS to accept his samples for testing, Aggarwal has now arranged for private vehicles and transport permissions to send a fresh set of samples to two different laboratories – one in Coimbatore and one in Kanpur. Both sets of samples were dispatched on May 5, and Aggarwal is unsure of how long the laboratories will take to test and approve them. “Once we get the approvals, we will start production again,” he said.
In Mumbai, Joshua Reuben was keen to send fresh coverall samples to the Ordnance Factory in Ambarnath, which was added to the list of authorised testing facilities on April 30 and is just two hours away from the city. “But so far we have not been able to reach a single official at the Ambarnath laboratory for help,” said Reuben in an interview last week. “One of my staff members has gone to the Ordnance Factory there but no one agreed to speak to him.”