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PWMAI urges CDSCO to bring PPE kits under licensing framework to improve quality

Laxmi Yadav, Mumbai
Monday, May 11, 2020, 08:00 Hrs  [IST]

The Preventive Wear Manufacturers' Association of India (PWMAI), representing personal protective equipment (PPE) coverall/kit, masks, gowns and surgical drape manufacturers, has urged the Drugs Controller General of India (DCGI) to bring PPE kits manufacturing under licensing framework with immediate effect to ensure its quality.

It is learnt that there are lakhs of substandard PPE kits available in the market. Taking advantage of lack of law regulating PPE kit manufacturing, anyone from toy manufacturer to garment maker is making PPE kits. The substandard PPE kits have put healthcare professionals at an increased risk of contracting COVID-19.

Medical Devices (Amendment) Rules 2020 came into force on April 1, 2020. As per the Rules, all medical devices sold in the country are treated as drugs under the Drugs and Cosmetics Act with effect from April 1. The Rules have made it compulsory for PPE kit manufacturer to get licence after 18 months. Currently, the absence of law is taking its toll on the production of quality PPE kits in the country, said Dr Sanjiv Relhan, chairman, PWMAI.

Instead of specifying national standards for PPE kits manufacturing, the Union ministry of health and family welfare has come up with two guidelines describing technical specifications for PPE kit manufacturing based on World Health Organization’s guidelines.

The health ministry’s guidelines are merely buyer specifications, technical specifications such as breathability is missing in the guidelines. So far, the procurer for central government, HLL Lifecare, institutes such as AIIMS, and different state governments all have different specifications for procurement, he said.

Dr Relhan further stated that Unique Certification Code (UCC) which needs to be applied to PPE garments and fabric passing the laboratory tests to ensure quality of PPE kits has led to rise in substandard PPEs flooding the market.

As per the Union textile ministry’s norms, manufacturers of PPE are required to mark their products with a unique code and tamper-proof stickers. The UCC now forms the basis for placement of orders by HLL Lifecare for PPE coveralls.

The UCC is applied to PPE garments and fabric which pass the laboratory tests laid down by the South India Textile Research Association (SITRA) and Defence Research & Development Establishment (DRDE). The Code records the type of garment, its test procedure, date of test. The certification will be valid for a certain time period and both SITRA and DRDE will preserve the sample sent by the producer. In the case of coveralls, the manufacturer is required to print in indelible ink or in a tamper-proof sticker details such as name of producer, code, test standard, batch number, order details.

Most of the manufacturers who availed UCC after their PPE samples got tested at testing facilities are engaged in malpractices. They have sold the Code to other PPE manufacturers who lacked it. The buyers of the Code put it on non-conforming and non-scientific PPE kits and supply them in the market thus playing with lives of people. 80 per cent of PPE makers are doing this, he said.

A coverall manufactured by approved manufacturers costs Rs. 450 and HLL’s buying price from approved manufacturers stands at Rs. 635 per piece. Most of the substandard manufacturers are selling entire PPE kits comprising coverall, goggle, gloves, mask, shoe cover etc at Rs. 400, he lamented.

Dr Relhan said textile ministry’s recent order stating that government-approved laboratories will accept the PPE samples only on submission of a notarized affidavit from the manufacturer, taking responsibility of quality, agreeing to face penal action, in case the products fail to meet minimum technical guideline, has further delayed the production of PPE kits as existing testing labs have a huge backlog of samples to be tested. This will further lead to substandard PPE kits flooding the market.

The genuine manufacturers are facing challenges due to the recent order. How a manufacture can give an affidavit stating that every product of his facility will have no quality issue in absence of adequate infrastructure including testing machines, he asked.


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Anil kumar sethi May 14, 2021 11:35 PM
Licence for PPE manufacturing
i wnat licence
Karthik Jun 2, 2020 10:27 AM
Hi We are trying to manufacture PPE Kit so we need to know which kind of licence or certificate we need so let us know.
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