In this segment of News Today, the focus is on the deaths of 16 children in Chhindwara who consumed a toxic cough syrup. In an interview, Prashant Reddy, co-author of 'The Truth Pill', states this is the ninth such incident in India since 1972, following similar tragedies in Gambia and Uzbekistan.
00:00Let's now turn to another special guest. I'm joined by Prashant Reddy. He's co-author of the book The Truth Pill that exposed the lid of drug regulation in India.
00:11Appreciate your joining us, Prashant Reddy. When you first heard about these deaths of children who had consumed a particular cough syrup, what was your first reaction?
00:21I mean, I was saddened, but I wasn't surprised because the ninth such incident that we've had since 1972, and this just seems to keep repeating itself.
00:34I mean, the last set of tragedies that we had was in 2022 and 2023, where 70 children died in Gambia, 65 children died in Uzbekistan, another 12 died in Cameroon, all because of cough syrups manufactured from India.
00:51And since then, we've known that there is a problem, because when the government introduced a mandatory testing requirement for exports, 100 companies' samples failed testing.
01:04And that's published in the news. The Economic Times had carried a story on it last year.
01:08So we knew that there was a rampant problem with cough syrups, but we didn't see any systemic steps being taken to protect the domestic market and patients in India.
01:21So specifically, where is the problem? Here you've got a company which is operating virtually out of a tin shed. There's a sense that it's involved in cost-cutting when it comes to drug formulations.
01:36Where is the problem in this entire chain? Is it with the regulator? Is it with the companies? At what stage is the system throwing up, unfortunately, drugs that simply don't meet up to recognize standards?
01:51The issue is definitely systemic, and it spans both the industry and the regulator, because our drug regulatory system was designed in 1940, and we have just built certain layers of additional regulation.
02:07But our system is fundamentally outdated to deal with this kind of regulation, to deal with the growth of the pharmaceutical industry in India.
02:16But a good starting point to understand where the problem is, is to ask the Tamil Nadu drug inspector to show inspection reports of this particular agency, because every facility is supposed to be inspected at least once a year.
02:31Even if that yearly inspection doesn't happen, there should have been an inspection every couple of years.
02:36So we need to find out how was this plant running in such a ramshackle state, if it was being inspected regularly.
02:44But could this be just one consignment of cold fit, or do you believe it's much more than that?
02:55In this case, one consignment, which reached Madhya Pradesh's Chinwara, appears to have been the deadly, toxic cough syrup.
03:03Do you believe it's just a consignment, or it's much wider than that?
03:06This could be today Chinwara, it could be any other part of the country tomorrow.
03:10No, I'm pretty sure it's going to be wider than this, because we've seen previous strategies the way they play out.
03:18Because until the government identifies the supplier of the contaminated ingredient, which in this case is propylene glycol,
03:27the propylene glycol supplied by the chemical trader to this particular company in Tamil Nadu was likely supplied even to other manufacturers.
03:36And if even they fail to do similar testing as the Tamil Nadu manufacturer, chances are this contaminated ingredient has gotten into several more consignments of cough syrups.
03:48Which is why the first response right now should be a public health response, wherein you can wait for prosecutions fixing accountability later.
03:56But the government should focus on tracking down every contaminated consignment of cough syrup, and make sure that they're pulled from the market as quickly as possible,
04:07as well as identify other patients who may have consumed this cough syrup, but where the doctors have not yet detected that it is contaminated.
04:16We know the Chinwada case makes a difference because 12 children together died in a cluster.
04:22But there will be other cases where, you know, one or two children have consumed this cough syrup in different localities,
04:28and the doctors will not even realize that this is a contamination issue over here.
04:33Because it's very, very difficult to diagnose a death because of DEG poisoning, which is what has happened over here.
04:39You know, Mr. Reddy, the Central Drug Standard Control Organization, or CDSCO, I found interestingly in a stunning display of complacency,
04:55initially declared just on Friday that the tests had found no contamination in the syrups that were being linked to the deaths.
05:02Even a Ministry of Health statement that I saw on October 3rd seemed to suggest that various samples collected in coordination with the state authorities contained,
05:15none of the samples contained diethylene glycol.
05:19So, am I to understand that there is something fundamentally wrong with the way in which the body operates,
05:26that there is either lack of transparency or no accountability,
05:30or indeed that there is just weak enforcement?
05:35Well, I mean, yeah, there's definitely been an attempt here to cover up because we now know that as reports are publicly available,
05:42that Tamil Nadu knew on October 2nd that the samples were contaminated.
05:46And on October 3rd, the ministry was putting out these misleading press releases through a news agency.
05:51Now, this is a systemic problem with the industry, with the regulator and the industry.
05:57We saw this happen even in 2022 after the tragedy in Gambia,
06:03where when the World Health Organization first put out an alert,
06:06the then drug controller general put out a very coarsely worded letter accusing the WHO of tarnishing the image of the drug industry.
06:15They also sent my co-author and me a legal notice calling us anti-national because we gave an interview to India today, coincidentally,
06:23on certain issues pertaining to that tragedy.
06:26So, the reflex reaction of the bureaucracy generally in these tragedies is to try and cover up and protect itself from further scrutiny.
06:36And this is reflective of the larger political economy of the pharma industry, you know,
06:42wherein for about the last 30, 40 years, the political signal sent to the regulator is,
06:48please ensure that the pharma industry grows.
06:51The focus has not been on quality control.
06:54And trying to, you know, trying to take apart that kind of mindset in the government is very, very difficult.
07:01The first attempt is to always protect the industry.
07:04You know, linked to that, I am again stunned.
07:11In 2023, the Lok Sabha passed the Jan Vishwas 2023 bill,
07:17which effectively diluted the provisions that would ensure strong criminal action
07:23against pharmaceutical bodies and hold them accountable for substandard medicines.
07:28Instead, what I see is that it has decriminalized provisions and actually said that you will
07:35only have to go through a monetary file, a fine of rupees 1 lakh.
07:40So, it seems as if the pharmaceutical industry has got now huge leeway.
07:47These are profit-making companies, many of them very large.
07:50And therefore, at the cost of the patient,
07:54it's the pharma companies who in some way have become non-accountable.
07:57Would I be right in saying that?
08:00Yes, Mr. Dathai, you're absolutely right.
08:02In fact, the government introduced this Jan Vishwas bill just two months after the tragedy in Gambia.
08:09That is around the last week of December 2022 is when they had introduced this bill.
08:15And despite my co-author and me trying to, you know, point out,
08:19at least we wrote in newspapers pointing out that this is an, you know,
08:22absolutely insane way to go about regulating the pharmaceutical industry,
08:26that you can't decriminalize one set of offenses, they went ahead and did it.
08:31And the Ministry of Health, in fact, they tried again to obfuscate the issue.
08:37There was, you know, spreading press releases and WhatsApp groups for journalists trying to discredit us.
08:43But it went through.
08:44Now, to be clear, this kind of case of, you know, adulterated cough syrups is still a criminal offense under the law.
08:52They can't get away with this particular case.
08:54But there are several other instances where, for example, a drug may not have enough active ingredient
08:59or may fail a sterility test, which can also kill, by the way.
09:03In Karnataka, we lost five young mothers in November last year because of sterility issues.
09:09Those kind of offenses have been decriminalized.
09:12The first offense has been decriminalized in the sense that if you get caught the first time,
09:16you can pay a fine of 20,000 rupees and get away with it.
09:19It's not even a lakh, by the way.
09:20It's just 20,000 rupees.
09:21So, in a way, of course, we don't want to generalize and say all pharmaceutical companies do it.
09:31But as we are seeing, there are smaller ones who are clearly cutting corners
09:35and their drugs are proliferating in many ways across markets.
09:39In conclusion, therefore, if there was one thing that you would recommend today
09:44to ensure that tragedies like this, which were presumably avoidable, do not recur,
09:48I go back to even the JJ tragedy that took place all those years ago in Mumbai,
09:54where, again, several people died for consuming the same drug
09:57for which young children have died today in Madhya Pradesh.
10:00That was in Mumbai.
10:02I ask you, what is that one thing you would like to see changed?
10:07The one thing I would like to see change is more transference.
10:10For example, if a manufacturing facility is inspected by a drug inspector,
10:16the inspection report should be publicly available.
10:18Other countries do it.
10:19There's no reason we can't.
10:20You can redact it to protect commercial information,
10:23but the rest of the report should be publicly available.
10:26Similarly, testing reports, right?
10:28The government does a lot of random sampling and testing of drugs
10:31from the market and its labs.
10:34Those test reports need to be publicly available in a public database,
10:37which is accessible and which people can search.
10:41Because even when, for example, big hospitals,
10:43big government departments are procuring drugs,
10:47they have absolutely no way to verify the antecedents of a company
10:52from which they are purchasing drugs.
10:55And the information is available.
10:57It is just locked up in government files and government computers.
11:00They don't make the information publicly available.
11:03What's the point of spending all this money on drug inspectors,
11:07doing these tests and inspections,
11:08that they're not sharing the information with the public?
11:15Well, those are very...
11:17I hope those words are being listened to
11:20by someone within our governmental system.
11:23You need to deep bureaucratize it,
11:25make it more transparent,
11:26and ensure stricter enforcement, surely, in the future.
11:31I appreciate your joining us here,
11:34Mr. Reddy, here on the news today.
11:36Thank you very much.
11:37Thank you for having me.
11:42And all I can assure our viewers is
11:44these are the stories that we will put right on top.
11:47This country needs better drug regulation.
11:5116 innocent children died
11:53because they consumed a toxic and poisonous cough syrup.
11:58Simply unacceptable.
12:00And because it happened in Chindwara,
12:02maybe it hasn't evoked the kind of public outrage
12:05it would have had this happen in any of our metro cities.
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