The World Health Organization is calling from media action to protect children from contaminated medicines after a.
Spate of child deaths linked to cough syrups. Last year, Bloomberg investigative correspondent Zachary Miiter and contributors Swati Gupta and Modu Jeu looked into the tragic deaths of scores of children in Gambia, a small country in western Africa. The children had been given tainted cough syrup imported from a manufacturer in India. India, of course, is known as a
leading exporterer of vaccines and generic drugs. Zach in New York and Swati in New Delhi joined me to share their reporting about a less visible side of the industry of trade in cheaply produced medicines, often sold to some of the world's poorest countries.
At what point did someone switch the raw materials, switch something poisonous for something totally benign.
Nobody is thinking about the ultimate consequence.
I'm West Ksova today on the big take, how poison can get into medicine for kids and why India hasn't done more to stop it. Zach. This story begins at a hospital in Gambia can you tell us what happened.
So, Gambia is a very small country in Africa, and last summer kids started showing up at the hospital they are kind of the biggest, best hospital in the country
with kidney problems. Their kidneys weren't working. This is dozens of kids, and what was confusing to doctors at the hospital was that even when they gave the kids dialysis right away, that should normally mean that they're going to make it, but in this case, like every one of the kids died and usually there were really small kids that were like one to three years.
Old, and what did they find when they were trying to figure out why these kids were done?
So, some of the doctors at the hospital were aware that years earlier in Nigeria there had been a similar outbreak of kids showing up with kidney failure and in that case the cause was traced to basically syrup medication like cough syrup, fever, reducing syrup and stuff that was tainted and so pretty much right away, the doctors had a theory that maybe this was the cause, so they would ask parents when they came into the hospital, what
medicine did you give your kids? Can you show us the bottles, like, they started collecting data on what medicine these kids had been taking, you know, before the onset of these symptoms.
And had all of these kids taken the coughs arup taking the same sort of medicine.
It was a little confusing at the time because if you think about it, people give cough syrup or a set of medicine syrup to their kids kind of all the time without really thinking about it, sometimes without a prescription, and so you might now remember exactly what you gave your kid or when, and so not everybody remembered, and not everyone had the bottle still around, so it was difficult to kind of collect this data and have it be reliable.
You know.
Once they collected these bottles, there was a whole bunch of different brands and stuff, and they had to get them tested, which took time and a lot of waiting around. Meanwhile, while they're waiting, more and more kids are showing up every day. They're in the hospital for a few days, and usually they're dead within three or four days. So eventually they did get test results back, and the results
of those tests were crystal clear. They found that some of the medicine that was circulating in Gambia was contaminated with these toxic substances.
And so they were able to track these different medicines that were causing these children to die to a single source.
So what they found was that there were four different kinds of medication that were circulating in the country that all had the same toxic contamination and they were all made by one company. So it was just one company's medicine that they found was at the root of this problem.
Swadi. They were able to trace this medication and where do they trace it to?
The World Health Organization connected the contaminated cough syrups to a manufacturing a pharmaceutical company in India, which is not located very far from the capital in India, Zach.
How common is it for this sort of investigation happened to trace poison medication like this?
This is the kind of thing the World Health Organization does. If a company or a country finds a product that's no good, oftentimes that'll lead the WHO to call up another country where the product was manufactured and say, hey, we've got a problem here, let's look into it. And nowadays that trail very often leads back to India. Just because India such a major exporter of pharmaceuticals around the world.
And what did the WHO do in this case?
So the WHO helped Gambia like actually arrange the testing and find labs and do the testing of the cough syrups. But then once they knew there was a problem, it was WHO that kind of reached out to India and said, hey, guys, let's look into this. We've got some bad drugs coming
from this manufacturer in India. And at the time they didn't know maybe these drugs have been exported to a bunch of other countries, and so they basically called on the Indian authorities to look into it in their country and kind of get to the bottom of it.
What happened next, What did Indian officials do?
Well, that's exactly when the Indian government started pushing back slowly, and then it became more and more aggressive as the WHO refused to kind of back down from the allegations
that they had made. It took two days for the Indian drug authorities to raid the pharmaceutical company in question and confiscate samples that the company had sent to Gambia, and then they took a further three months to test, investigate, and finally announce that there was no discrepancy, found that the samples that they had collected were clean and the pharmaceutical company made them. Pharmaceuticals had done nothing wrong.
Why was there such pushback from government officials.
Well, the Indian government has generally not been open to criticism, and it has become much more difficult to criticize any product that comes out of India or any issues that crop up in India. There is immagerate pushback. It's difficult nowadays to navigate Indian politics and separate the two. In politics is now very tightly intertwined with the image that India wants. You know, in the global economy, India is right now considered as the pharmaceutical capital of the world.
A lot of money comes into India because it provides a lot of generic medication to the rest of the world, and one bad batch of medication can smear the image that India wants of itself in the world.
So zach the who other health officials have procedures in place when they find medication that may have been tainted. But you write that this was an especially big deal because this was a case of exported medicine from another country. Why is that such a significant thing.
This kind of contamination, where cough syrup or other kind of medicinal syrups get contaminated with these toxic chemicals, has happened a bunch of times over the past decades. It seems to crop up like every few years. Basically, it's happened in like Haiti, Panama, Nigi. As I mentioned, in all those previous cases, the drugs weren't imported. They were made in Haiti or Panama, and then they were consumed
there and that's where people died. This was new because it was the first time that contaminated drugs had actually been exported. It wasn't the first time that any drugs that were exported caused problems around the world, but this coft serrup contamination, it was the first time that happened with that. And this is a really important issue because it tends to kill a lot of people when it happens,
and the people tend to be very small. It usually just kills children, and it often kills like dozens of dozens. And it's worth pointing out that the WHO is an arm of the un like they don't have the power to go in to various countries and kind of tell them what to do or do the regulator's job for them, so they can convene, they can call for meetings, they can sort of advise countries and help them with technical expertise and maybe kind of behind the scenes, you know,
nag them to do what they think is right. But at the end of the day, it's up to the national country regulators to actually do the work of regulating. So in this case, you know, the who could call up India and say, please get to the bottom of this, but they couldn't force them to do it. It was really up to India how they would handle this internally and how they would deal with this company.
So why do you talked about how important the pharmaceutical industry is to India, How big an industry is it for India's academy.
It does bring in a lot of money into India. But essentially what India is looking for right now in this current global scenario is soft power. India has steadily been gaining value on the global stage. It is now being consulted in major decisions that are being taken across the world, and the power that India has in providing generic, cheap medication in comparison to what developed country like the USA would provide. It gives India a lot of soft power.
So more than the money, it's about the fact that India is able to provide cheap pharmaceuticals. And we saw that very starkly during COVID nineteen when India started manufacturing the COVID vaccines and was responsible for most of the vaccinations that went out to developing countries across the world. So for India that is immense power. It gives them a lot of leverage with organizations like the WHO or the United Nations.
I might mention one other thing, which is that there's kind of an ugly history when it comes to raising questions about the quality of Indian pharmaceuticals. And we saw this probably most starkly in the early two thousands when Indian drug makers were saying, we want to make cheap, affordable age drugs the first time ever. We're going to
send them to Africa and save millions of lives. We're going to make AIDS drugs for a dollar a day when they were costing something like eight thousand dollars a year at the time, and Western drug companies weren't having it. They were saying, you know, they wanted to protect their patents among other things. They said, well, if you buy them from India, what's the guarantee they're going to be any good. Maybe they're going to be of low quality.
And so I think from that point on, the Indian pharmaceutical community is sort of primed to expect that when they hear concerns about quality, especially coming from foreign critics, they're going to suspect that maybe that's really just big pharma trying to protect its turf, trying to protect its patents against cheaper Indian products that are just as good.
And yet Zach, in this case, they did trace this poison back to a single company in India. Can you tell us about that company? So, Maiden Pharmaceuticals is a family owned company. It's based in the Delhi area. And this isn't one of these like giant, publicly traded Indian pharmaceutical companies that export a lot of drugs into highly regulated markets like the US or the European Union. This is more like a company that specializes in sending drugs
to kind of the least regulated pharma countries. So you know, Maiden sends a lot of drugs to Afghanistan, Venezuela, Iraq, places where there's not necessarily really high quality drug regulations. If you're a small country like Gambia, you might not have the resources to send somebody to India to check out the factory. You might basically just have to go by whatever paperwork the pharmaceutical company gives you saying these drugs are okay after the break, What was the poison
found in these medicines? What did the regulators do when they went to this company.
Well, there's a difference in what they are supposed to do and what actually happened, and a lot of it is very mulky because new authorities are not releasing a lot of information on their investigation. So they are supposed to go in and seize all the samples for the batches that the WHO has flagged as contaminated, and then those samples have to be sent to a government regulated lab to be tested and to be seen whether they
are contaminated as well. The authorities in India did not release this information till a few months later, where they just gave a clean chit to the company. They refused to have any kind of conversation about exactly how many samples that they had taken, or how they were processed, what exactly was found in those samples. They did not release any of that information publicly, Zach.
The Indian government's claims that Maiden did not have anything to do with this contaminated coughs era was not found to be persuasive by other people who looked into it.
Is that right, Yeah, The main point that the Indian government kind of rested its case on was that the drugs that they tested didn't have any contamination in them. But the drugs they tested were not the same as the drugs tested in Gambia. They weren't taken from a medicine cabinet of a sick kid in Gambia. They were taken from the Maiden Pharmaceuticals factory. And drug makers are supposed to set aside samples of each batch they make in case there's a problem later they need to test it.
And so those are the samples that the Indian regulators seized and tested and said we're fine. So obviously you've got to assume that those samples actually really did correspond to the drugs that were sent overseas. The other thing is that Maiden Pharmaceuticals, the manufact xture, was notified by WHO on September twenty ninth that their drugs had failed this test in Gambia and they were full of poison.
But it wasn't until two days later, October first, that the Indian regulators actually showed up at their factory and seized these samples. So if the Indian regulators wanted to be absolutely sure that these samples were really the same ones that had been sent to Gambia, they could have gone to the factory right away and gotten them. Instead, they left a two day window when who knows, somebody
could have moved things around. We don't know that that happened, but the fact that there was this two day delay means that the regulators created a window of opportunity there.
So how do they think this happened? How did this poison get into this cough syrup and then get from there all the way to Gambia.
So the official position of the Indian government is that these drugs weren't contaminated, but you know, the international consensus everybody else's looked at this says they were so to your question in how could they have gotten contaminated? If you look at similar cases that have happened in the past, it's basically always the same. Cause you've got a drug that's like a syrup, a liquid formulation, and the active
ingredient is like a powder. It's like a little bit of a set of metaphin which people outside the US called paracetamol, or it might be a cough suppressant of some kind. And so I for you to just put it in some water, the stuff would just settle out, it wouldn't mix properly with the liquid, and so you need another chemical that's going to dissolve the active ingredient
in the liquid. And so what drug companies tend to use is this substance called propylene glycol, which is like totally harmless, clear, tastes a little sweet, It's pretty easy to get your hands on. There's a lot of it in the world, and you just put some of that in there and everything works right. So the problem is that propylene glycol. There are some other chemicals that look and act just like it. They're called diethylene glycol and ethylene glycol. They dissolve the act of ingredients in the
same way. The only difference really is that they're cheaper and that they're deadly poison And so if you look at all these kind of historical cases where this kind of poisoning has happened, it's because somewhere along the way in the supply chain, propylene glycol gets switched out with one of these kind of cheaper toxic substitutes.
Swaty, is this something that can just happen accidentally, where you just mistakenly use one for the other.
There are a lot of checks and measures that are built to make sure that this doesn't happen. The companies that are making the propelling glacol have to sell it in sealed drums, and there is documentation that has to be attached with it every step of the way, and the pharmaceutical company that is buying this propelling glacol has to test it. But somewhere along the way from the manufacturers of the chemical and by the time it reaches a manufacturer of the medicines, there is a little bit
of switch. Barrels are changed or mislabeled, and people are trying to make a profit on the side.
And Zach, you're writ in the story that in fact, there's a whole trade in these barrels that can make it look like one chemical is the other.
Yeah, So Swadi and I met with this chemical trader in Delhi who told us that mislabeling is so common in the chemical industry that if you're selling like some like old used barrels, you can actually get more money for them if you leave the labels on, you can get a premium. And the reason that they're more valuable with the labels on is because somebody might want to put something else in there and keep the original labels in other words, that they might try to counterfeit, and
so to make everything kind of more complicated. Propylene glackol has all these other uses that don't involve humans consuming them. You can use it to make paint, you use it to you know, cigar humidors. So as a trader, you might think, well, if this is just going in a paint, what is anyone going to care? If I switch these chemicals,
it won't harm anyone. The other thing is that if you're mostly a trader who deals in industrial chemicals, you might not even be aware that this stuff is actually poisonous because it just would never enter into your mind that someone would would ever consume it.
To just add to what Zach said, to check some balances that are placed. They have to fail at multiple levels for this to happen. The regulators have to drop the ball somewhere in the surprise checks that they do at the factories, or the company has to not test the samples that they are buying off these chemical producers, and these guys also have to be unaware of what
purpose they are selling the chemical for. You have the big cheese, and then you have a long list of middlemen who are in the supply chain, and then you have the ultimate consumer. So why the chemical is moving across the list of middlemen. The switch can happen at any point. The main manufacturer will not sell to a very small farmer company. They sell in bigger quantities. So a smaller distributor buys maybe fifty barrels, and then he sells about twenty of those to another distributor, and so
on it goes. So we spoke to one of the middlemen. His name is Punkach Mehra. He has a tiny office in the basement, and throughout our conversation he was picking up his phone every ten to fifteen minutes and selling barrels of chemicals over the phone, negotiating rates. It's a very tiny picture into this very chaotic manner in which chemicals are sold, where one trader is sitting in a tiny office somewhere in Deli and he's selling chemicals in a state which is five hundred miles away.
And Zach, what did he say about how the industry works.
He said, adulteration is a temptation. I mean, he kind of ran the numbers in his head. I was like, oh, yeah, diethylene glac all is about half the price of propylene glycol right now, So if you were to put a propylene glycol label on a barrel of diatheling glycol, you could double your money. Maybe you don't know it's going into a product that someone is going to consume. It just might not cross your mind that this is a problem. So this guy, punkash Mehra, he didn't have anything to
do with any of these poisoning cases. He says he only does business with very legitimate suppliers. He's just he understands the business because he's been in it since nineteen fifty one, so he knows enough about the business to explain kind of what the temptations.
Are and what does Maiden say about these allegations that their coughs are contain this poisonous chemical.
Midim Pharmaceuticals has largely been silent on this, and they've been just waiting on the regulators to allow them to reopen their factories. We understood that they have applied for authorization to reopen, but the last time I went to the factory, they had taken down the signboard and the premises were under construction, So we don't know what they're planning to do now.
And I should add they have made some public comments since this happened, and they said they followed all the rules, they did nothing wrong, and they've kind of floated these alternative theories of what might have killed the kids in Gambia, like maybe there's a bacterial infection. Nobody else really takes those theories seriously.
When we come back, tainted medicine found in another country raises new questions, Twady. Despite this happening, there was still another poisoning that happened after it. Can you tell us what happened then?
Sometimes December last year was bakised On also announced that it had also traced contaminated cofser up to a pharmaceutical company in India. In that case, the authorities moved very swiftly and they immediately raided the place. They canceled the license of the film.
It's worth parting out here. You know about twenty kids died in the Uzbekistan case, and that manufacturer is also based in the Delhi area. So that raised the question of like, could the chemicals have had a common source. And it turns out that's actually a possibility because the chemical dealer that provided some of the raw materials for the Uzbekistan drugs was also doing business with the supplier that supplied some of the chemicals for the drugs that
went to the Gambia. And so this one chemical dealer seemed to be a key player in the supply chain. And Swadi went to that warehouse and.
I found that the entire warehouse had been borne down. Nobody knows what the cause of the fire was. The drums, chemicals, everything had melted away, I.
Should say here. The company the authority shut down told Bloomberg in January that it complied with drug making rules and was cooperating with authorities. It did not respond to subsequent requests for comment, and the company whose warehouse burned down it did not reply to Bloomberg's request for comment.
So, in a situation like this, where the raw materials are in question, what the authorities should be doing is getting to the bottom of it, tracing the actual origin, where was it, At what point did someone switch the raw materials, switch something poisonous for something totally benign, and then identify where all of this tainted material came from. But they only traced it so far and then they
kind of stopped. And what we heard from the authorities we talked to on an anonymous basis was that there is no way we could and get into that, Like the chemical industry in India is just impossible to regulate, and so they just kind of let the trail go cold.
Swadi, What is the solution here? How can this problem start to be fixed?
Well, the Indian government is not acknowledging that there is a widespread problem here. One of the steps that they took was to actually mandate that every batch of cough syrup that is going out of India needs to be tested. Besides that the government has not made any move to regulate this market that just rampantly is distributing chemicals Zach.
In the story, you write that advocates for drug safety are skeptical that this is a real solution.
That's right. There's a bunch of questions about this. It's unclear what syrup would actually fall under the new rule, because the most poisonous syrup sent to Gambia wasn't actually a cough syrup, it was an anti nausea syrup. So would that need to be tested under this new rule. Nobody seems to know. And you know, the law only applies to exports. So one of the recent cases of coughs are poisoning happened in India in two thousand, killed
about a dozen kits. That medicine would not have had to be tested under this new law because it only applies to exports. So, just on a broader level, if you talk to public health advocates who pay attention to drug regulation India, they say there needs to be a much more comprehensive fix. Whole drug regulatory system needs to
move from promoting the industry to policing it. There need to be more staff and resources for drug inspectors, and there needs to be better coordination between the National Drug Regulator and the more than thirty local drug regulators in the States and territories.
So have these widely publicized cases hurt business. Are other countries now hesitant to import drugs from India?
Well, Gambia is Gambia just recently passed a rule requiring testing of all imports from India. But keep in mind, Gambia is a very small country. It's not going to make much of a dent in like a fifty billion dollar Indian pharmaceutical industry. And beyond that, there's not a lot of evidence that this has really impacted enthusiasm for
Indian medications. On the other hand, there's been kind of a drumbeat of bad news this year about Indian drugs, not just the cough syrup ex sports, but other kinds of medication that have caused problems around the world. And so you can imagine if that were to continue, that could be a real threat to the Indian pharmaceutical industry and its ability to keep growing.
SWATI, As you continue to cover this story, what are you watching for? Where do you think things go from here?
I'm hoping that somewhere the who is able to convince the Indian government of how the pharmaceutical industries are connected to the contamination, and at least there is some very concrete trap percussions for the companies involved. Once you have that, then other companies will be more mindful. I spoke to Mehra again a couple of days ago, and he did mention that the distributors that he's talking to are talking
about very very customers. They are trying really hard to make sure that the properly inclacole, that the buie is legit sweatie.
Zach, thanks so much for speaking with me, Thanks us, Thanks for listening to us here at The Big Take. It's a daily podcast from Bloomberg and iHeartRadio. For more shows from iHeartRadio, visit the iHeartRadio app, Apple Podcasts, or wherever you listen, and we'd love to hear from you. Email us questions or comments at Big Take at Bloomberg dot net. The supervising producer of The Big Take is Vicky Ergolino. Our senior producer is Catherine Fink. Our producers
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