India ramps up PPE production, but quality remains a challenge
The government also used the learning to work with 39 domestic manufacturers to scale up the production of PPE kits to 50,000 a day. But the capacity needs to be doubled to meet India’s daily requirement for PPEs.Updated: Apr 16, 2020, 18:45 IST
Thousands of personal protective equipment (PPE) kits among the 1.7 lakh donated for coronavirus disease (Covid-19) protection by the world’s main supplier China, failed the safety tests at the government-approved laboratories. These included coveralls, headgear, foot cover, mask, goggles or face shields, and gloves for healthcare and lab workers who are higher risk of infection from closely handling sick people and infected samples.
“Yes, some of the samples of PPE kits from the imported lot did fail the safety tests,” said an official from the Defence Research and Development Establishment in Gwalior, where the kits had been sent for testing after arriving in India on April 5.
Since then, the Bureau of Indian Standards has set stringent standards for PPE, which were issued on April 14.
The government also used the learning to work with 39 domestic manufacturers to scale up the production of PPE kits to 50,000 a day. But the capacity needs to be doubled to meet India’s daily requirement for PPEs.
“We were initially about to start our production with fluid-resistant materials, but we stopped even before we began because there were talks of viral-barrier suits. Now the challenge is availability of the raw material and the taping machines. These are dampners when it comes to scaling up production in the country. We have now managed to source material for viral-barrier suits and have started manufacturing, but our product is yet to be certified. The Chennai Lab is not yet ready to test the products. Our PPE kits should reach the market next week,” said Dr GSK Velu, chairman and managing director, Trivitron Group.
“The government should enforce the uniform standards for all kits, including the imported kits. Right now, several manufacturers are selling products that do not comply with any of the specifications,” he said.
Some suggest purchasing the critical missing materials, rather than entire PPE kits.
“What is the guarantee that the manufacturers who claim CE and US FDA approval are okay. We have seen Chinese manufacturers exporting poor quality kits to India and other countries where the regulations are not as stringent. It is better to import critical missing raw material fabric for PPE that’s breathable and yet is fluid and viral resistant, rather than importing plane loads of PPE Kits,” said Rajiv Nath, founder and forum coordinator of the Association of Indian Medical Device Industry (AiMeD).
The new specifications released by the Bureau of Indian Standards on the bio-protective coveralls has manufacturers in a tizzy. The problem? The requirement that the suits be impermeable to viruses.
“These guidelines are impractical. India does not have materials to make viral barrier suits. Instead, most companies are now laminating the coverall material and looking at sealing the seams to make the suits fluid and viral resistant. However, this is like wearing a raincoat in a non-AC ward, you can imagine the discomfort,” said Dr Ghanshyam Das Agarwal, chief managing director, G Surgiwear one of the manufacturers of PPE kits.
“Breathability should be a bigger concern. Government should instead allow suits made of GSM 50 non-woven material, which will not pass the current test but is breathable and can provide 95 to 98% protection,” he said.
Even for the makeshift suits, there are very few sealing machines in India. “The government is currently accepting the suits made in India, which might not be viral-resistant. However, to improve quality the government is developing newer materials and is also looking at importing these machines as well,” according to an industry expert, who knows about the matter.
The earlier ministry of health specifications released on March 24 just required the suits to be fluid-resistant.
“The higher standard specifications have been released by the BIS, but this is in a developing stage. Our feedback has already been sent through the official channels, so I cannot comment. But, it is likely that the specifications will be changed,” said Vijaya Shankara from Shree Hari Healthcare, one of the 39 manufacturers approved by the government.
The newly released guidelines for bio-protective coveralls were removed from the BIS website on Thursday.
The implementation of quality control, when it comes to the PPE kits, is patchy across the country owing to the extreme shortage.
“However, the implementation is patchy. The manufacturers are required to get certified from these agencies to sell their product to HLL, which is the agency procuring for the central government. However, different state government follow different specifications and they do not necessarily ask for the certification,” said Malini Aisola, Co-convenor of All India Drug Action Network (AIDAN).
This is the case in Delhi, which had floated a tender for 1.2 lakh PPE kits through the Central Procurement Agency in March.
“This tender is being given to us as aa piece-meal of about three to four thousand kits a day. When we had floated the tender there were very few manufacturers who had come forward, and many did not necessarily have the certification. Even the ones with good products were not able to reach the only certification agency then – SITRA – in Tamil Nadu because of the lockdown. So, we started procuring the products after checking them for fluid-resistance ourselves,” said a senior Delhi government official.
To test, water was poured into the bodysuit to check for leaks.