PM Said 2 Lakh PPEs a Day, But Quality Remains a Problem: Docs

PM Said 2 Lakh PPEs a Day, But Quality Remains a Problem: Docs

7 min read
PM Said 2 Lakh PPEs a Day, But Quality Remains a Problem: Docs

Doctors, nurses, technicians and allied workers have long complained about a lack of personal protective equipment or PPEs.

At 8 pm, on Tuesday, 12 March, Prime Minister Modi announced that India was finally manufacturing about 2 lakh PPE kits and 2 lakh N-95 masks, and not relying on any external support.

FIT spoke to manufacturers, healthcare workers and NGOs working on the ground to find out what’s really going on.

More than 2 Lakh PPEs and Masks Per Day Say Manufacturers - But Issues Persist

We reported early last month, during Lockdown 2.0, that PPE deliveries got off to a rocky start.

Sanjiiiv, the Chairman of the Preventive Wear Manufacturers Association of India (PWMAI), told us that the 2 lakh figure is conservative, adding,

He adds that the PM’s statement that India was not manufacturing a single PPE kit in the beginning of the lockdown is false as well. “70 companies were selling medical gowns (which is protective wear, it doesn't always mean coveralls).”

Talking about manufacturing capacity, Paras Anttim Maheshvwari of Paras Trading Corporation, a PPE manufacturer in Kolhapur, says that he can see this number go up to 10 lakh PPEs per day easily.

“Maharashtra’s BMC issued a tender and got 60 manufacturing applicants. I can see the state producing at least 20 to 30,000 kits per day.”

But the numbers alone do not indicate that all is well.

“There is a lack of knowledge of how to safely make, buy or wear these kits. If HCWs are uncomfortable there will be non-compliance. The problem is that the guidelines issued by the MOHFW is not enough and not scientific,” says Sanjiiv.

It is important to note that the NDC - our National Center for Communicable Diseases, or any other body has not issued any guidelines, India just has the MoHFW document for now. An expert committee that explains protection levels and manufacturing requirements is needed.

Abhilash Nair, a project manager and volunteer for where his team authenticates PPE suppliers, said that the volumes were much higher but issues of packaging and standardisation persist.

There was an immediate demand, and many manufacturers rushed in to fill the glut in the market. But not everyone had the right specifications, and a PPE kit needs to be precise and contain all 6 items. “Many manufacturers were mixing and matching items to cut cost,” says Abhilash.

According to the Health Ministry guidelines, PPE kits consist of 6 items:

  • Goggles

  • Face-shield and head cover

  • Mask

  • Gloves

  • Coverall/gowns (with or without aprons)

  • Shoe cover

There needs to be more knowledge on how to authenticate certifications and suppliers, how to gauge demand efficiently and how to wear the kits too.

In the US with systems in place, healthcare workers need to undergo ‘sealability tests’ for N-95 respirators to test their efficiency and fit. “If you have not undergone this, you cannot attend to any patient,” says Sanjeev.

In India, “people do not yet know the difference between an N-95 mask and an N-95 respirator.”

Who Can Manufacture PPEs?

“There are a lot of grey areas in the supply side,” says Sanjiiv. “ NPPA – National Pharmaceutical Price Agency is capping the price of these items saying that from 1 April these are classified as medical devices and they have to right to cap the price.”

He asks,

But till an item is not categorised as a drug, the NPPA cannot come in.

What seems to be the urgent need of the hour is clarity and standardisation.

“The ministry guidelines don't define what has to be the combination of PPEs components. The guidelines say that a full kit is only required for the workers who are conducting aerosol proceedings, which is just 30 per cent. For the other 70, only a face mask is suggested.”

There are different requirements for different healthcare workers in different departments and Sanjiiv adds that he hopes the guidelines suggest a gown or coverall to be worn by all to protect them. There are national guidelines for medical gowns and there will be no shortage. Currently, PWMAI is giving a head-to-toe 98 per cent laminated coverall rather than bulky kits.

By comparison, the US, EU and even China had classified medical garments as medical devices since 1994 - “but India is still thinking about regulating the sector.”

Issues in Verifying Suppliers

Paras tells me another hiccup initially was the need to get quality certified. The government currently has 8 approved laboratories for testing the kits. Most hospitals prefer South India Textiles Research Association (SITRA) certification.

Manufacturers need to provide an affidavit declaring they are legitimate textile manufacturers within their Unique Certification Code (UCC) Certificate. This UCG will then be on all their kits, on each item.

However, Sanjiiv adds that 98 per cent of certifications provided are fake. “CITRA is not a certification body - it is issuing you the prototype of test report sample. Why does a lab need an affidavit from us, are we selling to them? It needs to be done between the buyer and seller. How can the seller give an oath, an affidavit, without having adequate testing facilities that they are complying with the guidelines and can be prosecuted criminally if they are found to be in non-compliance?”

Due diligence and standardisation is what we keep circling back to.

Not everyone needs to supply medical grade equipment. Paras adds that there will be a need for masks for everyone in the coming months - police forces, for labourers, railways, regular people - and these non-expert manufacturers can cater to that demand.

Paras and Abhilash both estimate that there is enough supply to ride out the predicted surge of COVID-19 cases, at least from the manufacturer's side.

But that is just one part of the story. Issues with delivery and demand are another battle.

“We just arranged an order to be delivered to a remote part of Odisha but it took quite long, around 5 days. State governments need to step in to make this easier,” says Abhilash.

“The solution lies in creating a national standard and defining the equipment needed for at least three levels of protection. Then a regulator like CDSO should regulate it,” says Sanjiiv.

Raising Demand a Problem

Across India, healthcare workers have reached out informally or on social media to appeal for help in procuring PPEs. Many instances of those speaking out and getting into trouble have been reported.

“The real situation is hazy, we are not sure if doctors are getting PPE kits too late, or not at all, or not in the right quantities,” says Seema B, director of the NGO Manjhi who is working with Give India to distribute PPE kits to hospitals in Mumbai. “Either way doctors are at risk and so we stepped in.”

A senior doctor at Mumbai’s Bhabha Hospital who spoke to us on the condition of anonymity said that while they had adequate number of PPEs, the quality is not always good and often have even packaging issues. They added that BMC supplied kits were often too short and did not fit properly while others were extremely uncomfortable.

“The BMC says they are giving enough but they do not look into quality assurance,” they add.

In an earlier video, nurses spoke about the discomfort of wearing PPEs.

Different healthcare providers need different kits, and those going to isolation wards or to operation theatres need sterilised kits. “But this comes at an additional cost, so we are making do for now. The BMC also does not supply sterilised kits.”

Manufacturers are often not equipped to provide kits for different uses.

Hospitals get different vendors through their central purchasing partners, through hospital staff reaching out and through donations.

A source in a private hospital in Mumbai said that departments are rationing kits, and often sterilising and re-using their N-95 masks.

But ICU and isolation doctors cannot reuse their masks, and the doctor from Bhabha Hospital says they need 300-400 daily.

“We also will be facing a shortage of oxygen and ventilators,” says the doctor. “We also require body bags, we got 10 from the BMC for two weeks but we need 7-10 daily.” For now, their need has been met through donations although they need ventilator maintenance. “We had 10, but now just 5 are working - this will become an issue.”

Healthcare workers in Maharasthra especially worry about the predicted surge in cases and the looming monsoon seasons. “There are already leakages in some kits, and in the monsoons, this will be more difficult to manage.”

Dr Sangeeta Pikale, a gynaecologist at S L Raheja Fortis Hospital in Mumbai, also warns of additional staff shortages and transport issues as floods often leave the roads ravaged.

But Pikale offers a ray of hope. She tells me that hoarding is a natural human reaction to a shortage and pandemic situation but she sees this reducing. “The fear of the virus in some places is going down, as many people have recovered, some doctors and nurses have bounced back, so the fears are reducing.”

She adds, however, that this current situation is natural as the healthcare sector was not prioritised and going forward needs long-term, sustainable solutions.

(This story was auto-published from a syndicated feed. No part of the story has been edited by The Quint.)

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