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Don’t buy just any mask or PPE kit, no one knows if they’ve passed quality checks

As the number of PPE kit manufacturers grows, industry players say it’s time to introduce strict checks and audits on the quality of the kits being sent to the market.

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New Delhi: When India was thrown into the Covid-19 crisis last year, it didn’t have enough capacity to produce personal protective equipment (PPE). Several players then jumped into the manufacturing of these kits.

PPE includes goggles, face shields, masks, gloves, gowns, head cover and shoe covers.

The government’s condition for the approval of such kits was simple — blood shouldn’t penetrate the PPE. The rule to establish a quality testing laboratory on the manufacturing unit’s premises was also waived for a certain period.

From being completely import dependent, India started producing nearly 4.5 lakh PPE kits daily. The Union Ministry of Textiles announced that India became the world’s second largest PPE kits manufacturer within just 60 days.

Now, amid an abundance of manufacturers, industry players say it’s time to introduce strict checks and audits on the quality of the kits doled out in the market.

According to the Safe Appliances Manufacturers Association (SAMA), a lobby of 250 PPE makers, there are over 1,000 such manufacturers in India, of which only 330 are certified by the Bureau of Indian Standards (BIS), the national standards body.

Out of these 330, only two manufacturers have the certification to produce N95 masks in India.

ThePrint reached BIS for a comment via email on 27 June, but there was no response until the publishing of this report.

Speaking to ThePrint on condition of anonymity, an official from the Ministry of Textiles said, “Rules have been put in place according to the need of the hour. India was completely dependent on imports but now it is one of the largest manufacturers of PPE kits.”

He added, “The ministry is working on several set of standards. It keeps taking inspiration from global standards and rules. While majority of rules are at par with the global standards, the given relaxations will soon go away once the demand supply gap stabilises.”

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‘Bogus’ players flooding market

Over half a dozen PPE makers told ThePrint that a number of “bogus” manufacturers have entered the market, and started producing PPE as a “side-business”.

“They jump into mask making as their side-business when Covid cases go up. They don’t intend to follow rules, establish quality testing labs in their premises or acquire certification. This is leading to a flood of sub-standards masks in India,” said Hemant Sapra, president of SAMA and founder of Karam Safety, a Noida-based manufacturer.

A BIS-certified company, Karam Safety has manufactured over 1 crore disposable masks, 30 lakh chemical splash goggles and large amounts of face shields and coveralls since the Covid outbreak in the country.

“Bogus suppliers are flooding the markets with low-quality PPE at lower prices. These substandard-quality PPE kits do not comply with the regulatory safety norms. The government must conduct awareness programmes to train hospital staff in identifying the gaps between original and counterfeit PPE,” he said.

“The sub-quality PPE kit makers started manufacturing plastic laminated products, which pass the test of not allowing blood penetration, but will drench doctors in sweat because they won’t allow air to pass in as well,” said Karan Bose, managing director of Hula Global, which produces around 1.5 lakh kits a month.

Pravesh Chopra, founder of Pantley Fashion, a textile maker that jumped into the manufacturing of high-quality masks and PPE kits last year, pointed out that the government had announced that it is mandatory for every manufacturer to print their name on the products, but the rule is being openly flouted now.

“The companies which are not allowed to sell products directly to the public, they don’t print their names on the products and sell them in the market. No one can trace them,” he said.

How the kits are being made to skirt around rules

Currently, the only test performed in India to certify PPE kits is of blood penetration, according to the industry.

“They only check if the blood passes through the pores of PPE kit contents or not. The solution is clear, laminate the entire PPE kit, blood will not pass,” Bose said. “While the cost of breathable PPE kits will be around Rs 350 to Rs 450, the price of laminated PPE kits would be around Rs 150.”

While the textiles ministry is in charge of maintaining the supply of PPE kits, the government-run Hindustan Latex Limited is the centralised agency for medical procurement of these products for hospital staffers.

The agencies involved for testing these products are the South India Textile Research Association (SITRA) and the Defence Research and Development Organisation.

To maintain quality of high standards, rules mandate a Unique Certification Code (UCC) for each tested sample, prior to supply, and embossing the details of UCC, name of manufacturer, date of manufacturing/batch number etc. on each PPE.

However, SAMA said only a “handful” of players have UCC details right now.

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Testing conditions leeway being misused

According to a BIS notification issued in February 2020, prior to the nationwide lockdown, the licences to PPE makers “were to be granted on the condition that the manufacturers will establish the required in-house testing facilities within 4 months of being granted a licence”.

The players were allowed to sell products for government procurement but not directly to the public.

On 15 May, the agency revised the rules, saying given the “high costs of setting up in-house testing facilities, it would be difficult for manufacturers, especially MSME units to set up test facilities in-house even after these 4 months, especially in the dire economic environment prevailing due to the COVID-19 pandemic”.

“Accordingly, it has now been decided that even after a lapse of 4 months, BIS shall not insist that the units establish in-house testing facilities,” the standards testing body said.

Moreover, the agency also withdrew the condition that after the grant of licence, the licensees were required to get samples tested weekly for all standard requirements in a BIS-licensee lab or third-party labs, till the time in-house test facilities have been established.

“Instead, the licensee shall be required to comply with the requirements of the modified Scheme of Inspection and Testing, circulated separately, in which the frequency of the daily tests has been relaxed to weekly and subcontracting of all tests has been permitted,” it said.

Not establishing labs

SAMA president Hemant Sapra said, “Even today more than 90 per cent of these players have not yet established the lab.”

The conditional licences clearly mentioned that unless manufacturers meet the criteria, they are not allowed to sell products directly to the public.

The players were given deadlines to establish labs by May 2020. However, citing the huge investment costs, the industry managed to get an extension in the deadline until 31 December 2020, and then until 10 May.

The manufacturers have again been given an extension to establish labs for PPE kits testing until 30 December.

Moreover, “ISI (the BIS mark) and the government have been trusting manufacturers that they are not selling their products in the local market”, Sapra added.

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