Copy of letter from Rajiv Nath, coordinator, Association of Indian medical device industry

NEW DELHI:At a time when government has enforced a 21-day lockdown to contain Coronavirus spread, a controversy has erupted after some makers of personal protective equipment (PPE) are asking the government to change certain guidelines for manufacturing including allowing them to “self-attest” their products instead of getting them tested at a lab, claiming that precious time could be saved in the race to protect healthcare workers fighting Covid-19 Union textile minister Smriti Irani , however, told TOI that no norms would be dilluted as utmost precaution needs to be taken while following WHO guidelines . The letter to the government from two health-sector manufacturing associations — Preventive Wear Manufacturers’ Association of India and Association of Indian Medical Device Industry (AIMED) — has demanded that the requirement for mandatory testing of protective gear at the South Indian Textile Research Association (SITRA) laboratory in Coimbatore, Tamil Nadu, be lifted to avoid delays.The associations have suggested that raw materials recommended by SITRA can be used and body coveralls be self-attested. At present, samples have to be sent to the lab for testing and certification.A joint secretary-rank official added that 11 manufacturers had already undergone necessary tests to conform to technical standards and there was no reason exceptions should be made.TOI had earlier reported that 11 firms, including denim maker Arvind Mills , has been roped in to produce protective gear.""We cannot bypass the established test standards This is a ministry norm. The fabric used is a special non woven polypropylene made only by specific manufacturers. We must not take any risks at this stage," Gautam Nair, executive committee member, apparel export promotion council told TOI.The associations have also demanded removal of HLL — a government of India undertaking — as the sole supplier of PPE kits; roping in garment exporters and fabricators workforce to augment production under supervision of 20 listed manufacturers. They have also sought removal of the requirement of tape on seams of the body suit. The tape prevents entry of fluids or droplets.Irani however told TOI,"Internationally-mandated specifications cannot be diluted as it may risk the lives of medical and healthcare professionals. I am grateful that earlier 11 manufacturers and now three more(14 now) have stepped up to a challenge in less than a month to manufacture PPE, kits indigenously, after meeting all medico-technical standards and passing all mandatory tests."A senior textile official said, “Testing only takes two to three days and we can’t go against the norms. It’s a difficult time and the manufacturers should support us to ensure fast supply.”