The Modi government delayed framing proper guidelines and standards for the manufacture of Personal Protective Equipment (PPE) — meant for health workers and first responders treating coronavirus patients — in India.

The delay is one of the reasons that health workers in India are now facing a severe shortage in high quality protective suits, the convenor of the Preventive Wear Manufacturers’ Association of India Sanjeev Ralhan told #KhabarLive in an interview.

In this interview, Ralhan, who has been manufacturing surgical gowns and drapes since 2002, explains that his association sought the government’s directions and guidelines on the manufacture of PPE meant for health workers treating coronavirus patients as early as the first week of February — only to be met with silence.

Since then the shortage of PPE has become an achilles heel in India’s response to the COVID-19 pandemic. A flurry of videos on social media have shown doctors and nurses struggling to perform their duties either without the necessary protection, or wearing substandard suits. News reports in and on NDTV have highlighted shortcomings in the tendering and procurement process.

Ralhan says the problems go even deeper — the Modi government’s early inaction has cost vendors precious weeks in which they could have sourced raw materials and machinery. When the guidelines finally came in, the country had already been put under a lockdown making manufacture and transport a logistical nightmare.

That apart, Ralhan said that the kind of suits the government wants them to manufacture are “practically impossible for us to produce under these circumstances”. Meanwhile, the desperation of health workers have led to the manufacture of sub-standard suits, which the former are being forced to use in the absence of proper gear.

Excerpts from the interview:

We are witnessing an explosion of complaints about low quality PPE…

One of the reasons is for the longest time, there were no quality guidelines or standards set by the government in India for the manufacture of PPEs. It only began in 2018.

As people who have been working in this industry, it’s also our duty to see what we can do as businessmen when something like a pandemic or epidemic happens — both for business purpose and for preparedness. We can understand what is going to happen. What are the loopholes in our systems and who will steal or won’t deliver and all that.

So I believe, as soon as 3 February, we started working on this. We started approaching the government. Our only plea that time was, the government and our association together will come up with a set of guidelines, so that pan-India we have at least one benchmark for quality of PPE.

When you say ‘started working on it’, what do you mean? What did you do?

At the beginning of February, we noticed that the price of masks has shot up to Rs 16-20 a piece from the manufacturers end, that’s way more than the usual price. We also found that every face mask that was being sold in the market was not up to standard. Now we have an Indian standard for face masks in place for one-and-half years. So we issued two advisories:

One was for users, saying, ‘Whatever you buy, these are the standards for PPE, these are the standards for face masks, please ask your seller to provide you products in compliance with these standards.’

We also asked manufacturers, ‘Please make sure that whatever you are selling is complying with these standards.’

The other advisory was about prices, only meant for manufacturers and traders. We said that we understand there is a surge in prices of raw materials so you have to increase prices, but hike prices in a way it is proportional to the raw materials. It should not be irrational.

And what communication did you send to the government?

The first mail we sent to the government was on 7 February. That time people were only talking about the outbreak in China. Although we could not foresee that this will be in this magnitude, but yes, from the information being put out by the WHO which we have to read regularly for work, we understood this will be a big issue. We thought, even if this doesn’t come to India, as an Indian industry, this could be an opportunity for us to expand. We could create some quality products and sell them. We could try to be producers.

We work with our umbrella body AIMED (Association of Indian Medical Device Industry). So whatever information we gathered from our industry — data and concerns — we sent to AIMED, who compiled them and sent them to the government.

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Which government agencies were these mails sent to?

We requested them to issue advisories similar to the ones we had issued. Advisories on anti-profiteering and maintaining quality standards. A word from the ministry of health would have definitely helped on this. Because if we as an association receive something from the government, we can also pressurise our members to follow them. We do not otherwise have the legal authority to pressurise them and make them adhere to standards.

At that time our primary focus was face masks.

We did not have the full picture about the virus back then as well. We thought that if this is a SARS virus, we would need a fabric to make PPE, which is a viral barrier. And we don’t manufacture viral barrier fabric in India. We also don’t have the testing facilities to test viral penetration PPE. Of the five processes needed to ensure a fabric acts like a viral barrier, we have facilities for only three. Even if we come up with a fabric like that, we cannot test it here. So we asked about that.

We sent another mail on 13 February, asking the government for a copy of the standards to make a viral barrier PPE to us, so that we can work with manufacturers and laboratories to come up with test methods and also see if we can manufacture a viral barrier fabric. At this time, we were working around the idea that this is a SARS virus which will need a viral barrier fabric and all the information we were gathering ourselves.

We knew that the government of India in the past purchased some of these PPE sets from two renowned American companies.

So what happened after that?

There was no reply, no response. Not even an acknowledgement of those emails.

So we stopped working on this. Because we assumed that was the fabric we need and without government support we cannot manufacture the textile.

Then on 20th of February, WHO came up with a document named ‘rational use of PPE during COVID 19’ where they specified that this virus is not 100% airborne, hence we do not need an Ebola PPE. They then downgraded it to a normal surgical gown made from flu resistant fabric. And if we can’t find flu resistant fabric, the gown should be made with normal material and should be worn with a plastic apron over it. There was no response from our government still.

There was no reply, no response. Not even an acknowledgement of those emails.

We looked at the guidelines issued by America’s Center for Disease Control (CDC) which said that these PPEs could be made from normal cloth, as long as it is laundered after every wash.

Then you know how things are in India and we realised if we do not set any standards, people will make just anything and sell it to people. So we wrote up an advisory to our manufacturers saying the fabric in India has to be flu resistant in the least.

Then all of a sudden, we started getting tenders from government, states, army, railways. This was the first week of March.

Considering the government had still not responded to your emails about creating a standard for PPE, what were these orders demanding?

Again, that was a problem. Every tender had a specific set of demands. Somebody was asking for a PPE kit, somebody was asking for a coverall, somebody was asking for a level 4 gown. Now the fear was, because there were so many variants being demanded by so many agencies, manufacturers will not be able to create a stockpile for themselves that can be supplied during emergencies.

Apart from not knowing what to make, they will be afraid to make a lot of any of those orders because these will not sell throughout the year. And they are not even sure what is exactly needed at this point and will sell, so they don’t know which variant of order they should make in more numbers.

When did the government finally act and issue guidelines?

Then on 16th of March we finally met the representatives of the union ministry of health and family welfare and requested them to come up with a set of guidelines in collaboration with us and the textile ministry.

So they now want these PPEs to be made of flu resistant material and the seams of the garments to be taped. Now for that taping, we need a special machine. Flu resistant material is available in India, unlike the viral resistant material I mentioned earlier.

India doesn’t manufacture these taping machines, importing such machines has become a problem.
These government guidelines finally came into existence on 21 March and 24 March (when India had nearly 600 detected cases), almost at the time of the lockdown. India doesn’t manufacture these taping machines, importing such machines has become a problem.

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Even with the machines, the problem is, if a small factory can make 1000 coveralls per day, with tape, they can manufacture only 200 a day.

Can you explain what a tape is?

So there is a tape, which is applied to the seams of garments using heat and other technology which seals the garment, makes it leak proof.

So 90% of Indian manufacturers don’t have these machines. And the remaining 10% could only buy after these specifications came from the government. Some of the manufacturers sourced it from the people who make truck tarpaulins, then use this to make the seams waterproof. Some sellers could find a few machines on Indiamart etc and bought them. Two, three or five maybe.

So with this escalating demands for PPEs, how will you match supply?

So basically now, you are asking for something that is practically impossible to us to produce under these circumstances.

We suggested that maybe then we should restrict these higher guidelines for a few specific procedures, and for the rest provide PPEs in accordance with the WHO or CDC guidelines. At least, they will have some level of protection that way.

So in the absence of new guidelines on what to do if taped coveralls are not available, people are selling anything and everything because there is such a high demand and health workers too are not understanding what to buy, what will protect them.

You can see on social media that people are complaining about sub-standard and poor quality PPEs, this is the reason.

So manufacturers are making whatever they want to, to meet demands?

When you don’t have regulations, this happens. When we talk about an industry which is purely unorganised sector and is MSME, it is the government’s duty to handhold them and train them. If we look at China, the government supported their ideas and even funded their ideas.

Have you been able to come up with any solutions?

I am trying to explain to manufacturers how to come up with solutions. If they 10,000 gowns which cannot have taping, I am asking them to make 10,000 plastic aprons and put it in the kit. If you have to sell them, at least the health-worker has a proper layer of protection.

What about the glasses which are also an important part of the PPE?

I believe there are one or two manufacturers. Same for the face shields, they were always imported from China. Now I am seeing videos that people are making face shields without any standard specification and possibly non-scientifically designed.

So what happens now with this demand? How many legit PPEs can India manufacture now? Has the lockdown affected your work?

We cannot say anything now and it is difficult to come up with any numbers. Suddenly the lockdown was announced.

For coverall you need fabric. Say, the fabric person has supplied you two lots and now his polymer is finished, so he has to get it from the polymer guy. Then you need zippers. You need machine needles, labels ― the total supply chain has been disrupted. It is impossible to convince the police wala that the needle is a part of PPE, he won’t understand.

Then they are beaten by police, so it is very difficult to do this now ― every unit which manufactures PPEs has now only 30-40% attendance.
The Central government has been pretty active on this and whatever complaint we did, next morning we had a notification. But it is the local governance system and the police who are not sensitised yet. If I am travelling and the police stops me, I usually say, I am going to work to make PPEs. But the police man doesn’t understand that. Toh usko bolta padta hai, ’bhai woh jo doctor kapde pehente hai, woh banate hai, thoda urgent hai yaar. Kaun apne life ko khatre main dal ke nahin toh lock down main ghumne nikelega? (So we have to tell them, those clothes that doctors wear, we make those clothes. It is very urgent. Why else will we risk our lives and roam around now?)

Then they let us go.

But it is not the same for the labour which works in these factories. It is very difficult for them. Their families are already reluctant in sending them to work, they are afraid. Then they are beaten by police, so it is very difficult to do this now ― every unit which manufactures PPEs has now only 30-40% attendance.

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How will this work out in the long term then?

So the health minister and the minister of textiles said they have enough PPEs and they have ordered enough. So they have enough. So I guess, people like me can rest now. The government will take care.

But the problem is, saying this is easy. It’s been 19 years and those healthcare workers are like family to us. So when they call us desperately, from hospitals, asking for 5-10 PPEs, saying they will pay from their own pockets when the hospitals and government should be paying, how can we say no?

What is your plan to work through the lockdown?

The department of pharmaceuticals have set up a helpline. So I am gathering information — say someone can’t travel, someone is not getting cartons. Then I am telling this to the helpline. Then they are mailing the local authorities, asking them to help. We have created a form for doctors and hospitals for demands. So once we get a demand, we are forwarding it to manufacturers closest to them so that we save time on logistics.

What is India’s background of manufacturing the coverall, do we have enough manufacturers for this?

Coverall has always been a part of medical equipment, but it is only preferred during an outbreak. Like the last time it was used in big quantities was when we had the bird flu and swine flu and it is used sporadically when these cases recur in India. People had to go to fields to cull chicken, then it was used. But there were always problems in this sector.

This sector was never regulated. There was nobody to see what we are doing. There were no standards. So we were fighting for it to be regulated but almost 15 years. Because these medical garments have been considered a part of medical equipment in the US and UK since 1994. Because it is the first point of infection, like bedsheets.

However, the Medical Device Rules of 2017 were finally implemented in 2018 and then it was announced that drapes and gowns will be a part of medical devices.

So you are saying there was no law governing the manufacture and sale of these medical garments prior to that?

Yes, none. There was no standard to cite. There was no guideline on what to sell. And anybody could come up with machines, start manufacturing and start selling. Anybody was doing anything.

Quality was never a parameter.
I am not looking out for just my business. I knew there were manufacturers who have devoted 15-20 years to manufacturing these garments. Because there were no rules as such for so long, out of those manufacturers 60-70% won’t understand what standards are. All are MSMEs no doubt, and all of a sudden when regulations come we cannot just chuck them out because they don’t understand English or because they have a language barrier. So we came up with our association, to create awareness among the manufacturers first that now this sector is going to be regulated. So let’s learn collectively. And if we start following standards and protocols, we can go global also. It is an opportunity.

So focus was to train them. And if still people won’t follow standards, we will haul them up. This organisation, then, was formed in 2019.

So before these regulations, when you were to manufacture coveralls or any PPE, what standards were you following?

A few of us who had access to information, we were following standards set by other countries. For example, USA has AAMI (The Association for the Advancement of Medical Instrumentation) levels, we were following those documents.

So when hospitals — both government and private — were purchasing these medical garments from Indian makers, how were they doing quality checks, based on which standards?

That was a huge problem. There was no scientific way to do it. And because it was counted as a medical linen issue, the users (doctors, hospital staff who wear them) were not interested and even if they were interested, they were never given a chance to have a say. It was always the duty of the purchase department of these establishments to procure supplies. And these interactions were mostly based on money, not quality. “Uss aadmi ne toh gown 50 ka diya hai, aap 45 main de do (he is giving it to us for 50, you give for 45). It was an L-one game completely, whether it was government or private. In our parlance, ‘L one’ means ‘lowest one’, whoever gives the lowest price gets the order. Quality was never a parameter. #KhabarLive