Established manufacturers of infection-prevention clothing say that a regulatory mechanism must be in place for purchases by healthcare establishments to check the practice of buying substandard products.What needs to be done?Even in a healthcare setting, everyone is not at equal risk. Dr Relhan points out that the regulations of the importing countries are stringent, and the industry first needs to meet these quality standards. This can lead to a further spread of infections.“The market for personal protective equipment is dominated by a lack of transparency about what is being produced and where, its quality, the amount in stock, and how they are allocated,” said MSF’s Thierry Allafort-Duverger.What about exports?Sections of the local protective gear industry want to tap the export market now that domestic demand has been met, but many insiders strike a cautionary note. “Hence, a standard for safe disposal of bioprotective PPEs is required on an urgent basis,” says PWMAI’s head.Now, there is an oversupply of indigenous PPE kits.
But it is equally important to ensure that Indian doctors, health workers and ordinary citizens are not at risk through use of low-quality protective wear, sanitizers, etc.Atmanirbharta and Make in India must meet the quality challenge at home as well as abroad Workers stitch personal protective equipment (PPE) suits at a private factory. This, they said, posed a serious challenge for the Hockey Tape Manufacturers domestic and export markets.5 billion by 2025. That plan is yet to materialise.There are additional challenges.Another looming challenge is disposal of protective gear. Many are unsold.The Central Drugs Standard Control Organisation has not defined any classification of PPE components intended for medical use, says Dr Sanjeev Relhan, chairman of the Preventive Wear Manufacturers Association of India (PWMAI).India faced an acute crisis in the early weeks of Covid-19 as it was hugely dependent on imports for critical supplies of medical products, including PPEs.Without classification under Medical Device Rules, it is not possible for the industry to understand the applicable regulatory requirements.Amid a global shortage and the world’s strictest lockdown that ground all production to a halt, barring that of essential items, many garment makers, for example, sensed a big opportunity and got into the protective wear space.What about strict quality norms for domestic sales?
No doubt, we can’t afford to risk our reputation in the export market by sending out products which don’t meet international quality norms.The bottomline is that regulation can’t be a cuss word if PPE makers in India wish to nurture a reputation for quality and plug into global supply chains.Worryingly, there is another more serious problem. There may be a ready market for protective wear. India is now the second largest manufacturer of PPEs, after China.Till the time of writing, no export licence has been issued.Last year, the Niti Aayog, the government’s think tank, proposed bringing all medical devices under one regulatory regime in a phased manner and to have a separate Medical Devices Administration with four divisions. The cautionary note struck by the DGFT is welcome.But to get a juicy slice of that, Atmanirbharta and “Make in India” must meet its quality challenge at home as well as abroad.Arguably, low quality in protective wear is not just an Indian problem.
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