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Tuesday, September 21, 2021

No breathability norms in place, ‘sweat chamber’ PPE kits pile up

Healthcare experts at the forefront of the race to contain the Covid outbreak continue to complain that these kits are “suffocating” and “unwearable”.

Written by Jay Mazoomdaar | New Delhi |
Updated: July 21, 2020 7:49:05 am
On the flip side, production capacity has far outpaced domestic demand, with the price slumping from up to Rs 1,500 to under Rs 300 per kit. Doctors wearing PPE kit at LNJP Hospital in New Delhi.

FROM FACING an acute shortage due to the “disrupted global supply chain” in March to certifying over 600 domestic makers by May, India emerged as the world’s second largest manufacturer of PPE kits, after China, in just 60 days. But in the rush to boost production, quality norms were left behind, with these kits being dubbed as “sweat chambers” by medical professionals and “unfit” for domestic use or export by several stakeholders.

So much so, that an estimated overall stock of more than 20 lakh kits remained unsold in the first week of July amid a stall in production. And although PPE was shifted from “prohibited” to the “restricted” export category with a limit of 5 million kits on June 29, sources say no licence has been issued so far.

On the flip side, production capacity has far outpaced domestic demand, with the price slumping from up to Rs 1,500 to under Rs 300 per kit. But healthcare experts at the forefront of the race to contain the Covid outbreak continue to complain that these kits are “suffocating” and “unwearable”.

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Professor Dr Arvind Baronia, head of critical care, Sanjay Gandhi Post-Graduate Institute of Medical Sciences, Lucknow, said the facility “returned 60-70% of the PPEs supplied”. “It is difficult to spend even a few minutes in those made from cheap non-woven fabric with polyethylene lamination,” he said.

On April 14, the Bureau of Indian Standards (BIS) sought testing of PPEs under ISO 11092 (sweating guarded-hotplate test) because “materials without the ability to allow moisture transmission are generally uncomfortable” and “doctors/healthcare personnel are subjected to heat stress” while using them for “prolonged duration”.

But these norms were withdrawn in three days, with sources saying that it was aimed at “encouraging mass production”. On April 17, the BIS tweeted: “As of now standards specified by the Ministry of Health and Family Welfare are applicable”. The Ministry’s standards required PPEs only to be “impermeable to blood and body fluids.” And experts say several manufacturers achieved this with lamination that allowed no breathing at all.

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Two months later, on June 16, the BIS issued norms “as interim arrangements” based on the Health Ministry’s guidelines on PPEs. There was no mention of “moisture transmission” tests or “breathability”.

“Requirements in standards are prescribed after extensive deliberations and consultations with all stakeholders taking into consideration a number of factors, e.g. manufacturing capabilities in the country, availability of suitable raw materials, availability of test methods and test facilities, manufacturing capacity versus demand, cost factor, etc. and after evolving consensus,” said a BIS spokesperson.

“A panel consisting of stakeholders and experts has already been constituted and based on the recommendations of the panel, further action shall be taken in due course of time to revise the standard comprehensively,” the spokesperson said.

Read | Govt urges states to add labs to ramp up testing, get more kits

The BIS did not comment on why the standards issued on April 14 were withdrawn. The Health Ministry did not respond to emails, phone calls, and messages seeking comment.

Stakeholders say, most new entrants in PPE manufacturing, including some textile majors, followed “inadequate standards”.

Kulin Lalbhai, Executive Director of Arvind Limited, said: “Arvind used breathable fabrics from the onset and proactively did moisture/vapour transmission tests on its kits, which were suitable for higher tier or type of medical PPEs. Arvind is exploring export opportunities. Certification from Europe and US agencies will be critical for exports, and most manufacturers will need to acquire those in the months to come.”

Nishith Dand, managing director, Sure Safety, a Vadodara firm that has developed reusable PPE kits, said: “A few companies may still find some takers in Africa or in our neighbourhood but no developed country will touch these ‘sweat chambers’ passed as PPEs. This situation is completely unwarranted since using breathable fabrics increases the cost by only 10-15 percent.”

Meanwhile, production has been stalled, including in Tamil Nadu’s textile hub Tiruppur. “Over 100 units in our garment cluster used to make PPE kits. Then we received a lot of complaints and realised that breathable fabric was a basic requirement. We have found the right material and will start production soon,” said Periasamy Subramaniam, CEO of Tamil Nadu’s Tiruppur Incubation Centre for Textiles & Apparels, which is supported by NITI Aayog.

In May, a report by Invest India, the national investment promotion and facilitation agency, stated that the Tiruppur Exporters Association (TEA) estimated “an INR 10,000-15,000 crore revenue opportunity, this year alone” through the export of PPEs.

The outlook has changed dramatically. “The fabric we used for PPEs was not on par with the international requirement. It was also difficult to sterilise our garment units as thoroughly as required. We will have to resolve these issues. Now only a few units are making PPEs against some domestic orders,” said R Senthil Kumar, joint secretary, TEA.

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To make matters worse, global demand has slumped from the peak it hit in April-May. “Most manufacturers are sitting on at least one week’s product plus raw stock. The government should have allowed export earlier to release some stocks,” said a manufacturer based in Raipur.

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