The Pharmaceutical Companies Behind Cough Medicine Deaths In Children | Undercover Asia

Gambia reports deaths of over 68 children with acute renal failure 18 children die in Uzbekistan after taking cold medicine over 200 children have died in Indonesia of acute renal failure medicines they should help us get better not kill us but what if they do between 2022 to 2023 over 300 children die after consuming cough syrup toxic ingredients are found in the medicines it's a poison that is never used in the manufacture of medicines now grieving parents fight for justice and dirty truths spill over in India and Indonesia consideration of Finance is very very important that is the only reason that they go for shortcuts what's behind Asia's tainted medicine scandal foreign foreign Jakarta sodrika's household has fallen silent [Music] a collage of baby pictures hangs on the wall [Music] um foreign [Music] [Music] they sent him to the regional public Hospital the universe foreign [Music] a few days later he is just a year and a half old his kidneys had stopped functioning due to acute renal failure also known as acute kidney injury he's not the only victim [Music] by August 2022 death cases rise parents report similar symptoms in their children as ARCA but doctors cannot explain the cause of this mysterious kidney illness the pediatrician said that they already try many things that supposed to provide a cure for these children but they don't see any good progress so with that they are try to discuss is there any other possibilities such as like any new diseases either from bacteria virus or from fungi the Indonesian Ministry of Health is desperate to find some answers we invite some of the experts especially not only pediatrician but a toxicologist expert epidemiologist we talked about these cases and then again we discuss with who is there any new uh same condition that we are facing currently with other countries [Music] The Who confirms that The Gambia in West Africa had also reported cases of children dying of acute kidney injury soon there are Clues to the mysterious illness it lies in the medicines the children have taken in October 2022 The Who links the deaths of over 68 children in Gambia to deadly toxins in four cough syrups Made in India it puts out a medical product alert for medicines are cuff and cold syrups produced by Maiden Pharmaceuticals Limited in India Cummins all countries detect and remove these products from circulation to prevent further harm to patients the Indonesian government is concerned that these four syrups may be the culprit for the deaths of the children when we check it with the bipom or the FDA they said this uh four or five were not available in Indonesia because they are not registered and not distributed in Indonesia but if these four india-made syrups are not available in Indonesia they cannot be the reason for the deaths the government widens their investigation as an emergency measure they ban the sale of all cough syrups from the market [Music] in India Dr bhavnet bharti is following the story closely the cases have a frightening resemblance to deaths that she had closely witnessed two years earlier when the first time I heard about cough syrups and that linked with the deaths of children in Gambia it was like deja vu in early 2020 half a dozen children from the state of Jammu aborto Hospital in chandigar in North India so these children infants or toddlers coming from a background which was very poor children had caught the usual seasonal cough and cold but these symptoms are followed by vomiting and diarrhea and ultimately kidney injury [Music] this type renal failures seem different from the usual sepsis which would develop as a part of a multi-organ involvement leading on to bacterial sepsis and renal failure so this seemed a little different the hospital sets up a team to probe the illness they begin to suspect some kind of poisoning one of them had died and we had got the biopsy done and the biopsy actually showed it's a toxic nephritis so when the with the possibility of some toxin causing this that's what we were looking for they collect samples of medicines that were last taken by the children as well as soil and water for possible contaminants Dr bhavnet and her team soon find the culprit all the children are believed to have consumed a syrup called cold best PC made by a company called digivision when we found there was one particular batch that was 5201 we found this and we did it with the chromatography so we realized that there was a peak of diethylene glycol this is a shocking discovery diethylene glycol is a powerful industrial solvent industrial solvents are used for the purposes of cleaning degreasing and paint stripping they're found in fuels adhesives cleaning fluids and paints they should never be found in medicines they are toxic that look glycol is nephrotoxic so it affects the kidneys of the children it is more likely to happen in the infancy and the young children since the Toxic effect impacts the kidneys 8 to 24 hours after exposure to lethal doses of the toxin parents and even doctors may not make the link until it is too late often the medication is the last thing to be suspected the causality is very difficult to a certain in our case I think somehow we were able to do that there was another death in one of the old medical colleges and we told them the batch number of 5201 the family produced the same batch number the same drug that's the day we said oh it's the same thing twelve children died in India subsequently that batch is recalled by the drug control authorities Dr bhavnet thinks that was the end of the incident and a one-off tragedy but two years later in December 2022 another Indian company Marion biotech is accused of exporting contaminated cough syrup to the Central Asian country of Uzbekistan over 18 children die after they'd consumed the cough syrup with toxic ingredients another toxic cough syrup tragedy Marion biotech supplied contamination one of the biggest in the world the Indian pharmaceutical industry is worth 42 billion US Dollars and it is attracting a lot of undue attention as a manufacturer I was scared how will it impact us how will it impact our customers how will our customers react to that that was definitely my first reaction India exports to 200 countries 40 of over-the-counter and prescription generics sold in the U.S and 25 of those in the UK come from India it's a major supplier to Africa Latin America and Asia globally it is the third largest supplier of generic drugs by volume India is considered the pharmacy of the world so there's really a lot at stake here now this lucrative industry is in the firing line at the end of 2022 and early 2023 300 children across the world have died they had consumed cough syrups made either in India or Indonesia in November the licenses of two indonesia-based manufacturers are revoked for making toxic medicines that may have killed the children in Indonesia over 200 children succumbed to acute kidney injury foreign a few neighborhoods away resty safetri is battling an equally emotional period is [Music] [Music] in May 2022 he too was Ill with fever and given the Fateful paracetamol syrup in the government Hospital the contaminated cough syrup did not kill Evan but punishes him and his family with a terrible fate um foreign [Music] [Music] sunny Leone foreign [Music] contains the same chemicals discovered by doctors in India industrial chemicals diethylene glycol and ethylene glycol are anti-freeze agents used widely as lubricant car brake fluid and in plastic production only the tiniest trace of these are permitted in medicine any more would make the medicine poisonous children under the age of five are the most vulnerable what happens in infants and young children they will not complain they may be just crying episodes they will have fever they have cough they're not going to complain about abdominal pain headache what's worse most often the children are accidentally poisoned by their own unsuspecting parents parents are sometimes very concerned about young children and would like to give repeated medications to ensure that the cough is resolved as early as possible they're likely to give a higher dose or a repeated dose and in case it is contaminated it's likely to give a more chances of renal failure like all medicines cough syrups have an active pharmaceutical ingredient the substance that actually treats a specific condition and excipients which are inactive substances that give color form and taste to the medicine cough syrups use glycerol or propylene glycol as a base to thicken and sweeten the medicine they are harmless industrial solvents like dipholene glycol are not it is more sweet than the usual glycerol which is used for making these syrups so this was more palatable diphylene glycol has a diabolic past in 1937 it killed over a hundred people in the United States when it was used in liquid antibiotic a third of them were children since then cases have been found in Bangladesh China India Nigeria and Panama in most cases the toxin was found in pediatric cough syrups in India in the eye of the storm are the two manufacturing companies Maiden Pharmaceuticals which supplied the medicines to Gambia and Marion biotech which exported to Uzbekistan as the controversy rages Maiden Pharmaceuticals puts out a public statement in its defense but the incident brings into Focus the mammoth problem of poor quality medicines across the world The Who reckons that 10.5 percent of medicines worldwide may be falsified or substandard falsified medicine is essentially a fake one that perverts to be something that it is not a substandard medicine on the other hand may be actually manufactured by a licensed pharmaceutical company but may not meet the standards that are required for it to be effective poor quality medicine has given rise to antimicrobial resistance and drug-resistant infections by prolonging illnesses and their treatment this is a global problem and the reason for that is quite simple because the supply chain of pharmaceuticals is a global one you may have active ingredients coming in from from one country you it may be formulated in another country and then import it into your own country for distribution and consumption so as a regulator it's a tremendous challenge to make sure that the supply chain is secured and that you are protecting the health and safety of the patients who are consuming those drugs in your country India has 3 000 companies with over 10 000 factories some of the biggest names in the pharmaceutical world are based there along with smaller companies implementing stringent regulations is a challenge in any country but India's complex drug control system makes it more complicated in India we have two different lists the government of India has a central list which the government of India has complete control over and there is a concurrent list where States and centers share responsibility among both in the federal structure of the Union the center approves new medicines clinical trials and sets standards for drugs the 28 States and eight union territories issue licenses and monitor the manufacture sale and distribution of drugs in their territory they have their own rules and regulations Dinesh thakur is the co-author of the truth pill an investigative book on drug regulation laws in India in October 2022 when the who put out a product alert against the toxic cough syrups Thacker began researching deeper for information on Maiden Pharmaceuticals what we were able to find out was this company had a history of manufacturing bad quality medicine even in India even before you know the incident in The Gambia had happened and that's what we made public it is also among nearly 40 Indian pharmaceutical companies blacklisted by Vietnam for exporting substandard products now the question is how is it a company that has a track record of making bad quality medicine blacklisted by states in India how is it possible for them to be able to continue to make and ship medicine the answer is very simple there is no Consolidated database of information within India where a buyer can go in and look at it and say how good is this company has it been cited for making bad quality medicines in the past we just don't have a Consolidated database of that despite past allegations Maiden Pharmaceuticals continues its medicine production until the cough syrup incident when operations temporary halt the company denies any wrongdoing and the tests at the government laboratory find no toxins in the control samples that the authorities have collected from them this result contradicted who findings undercover Asia reaches out to the who for a clarification [Music] every batch of medicine marketed the manufacturer is required to retain a certain number of control samples from the same batch for future investigation it represents the exact ingredients which have gone into the final product in that batch but there is a fundamental risk it relies on the Integrity of the Pharma company control samples basically they are the property of the manufacturer these samples are not sealed by the drug Authority these samples are not in such a condition that nobody can temper it nobody can open these are as good as the finished goods manufacturer has all the Liberty to open the sample portion change the sample portion to alter the sample portion whatever you want he can do 100 percent Faith or our report on control sample is not okay over the past few decades India has become a formidable Giant in medicine making but in 2022 deaths linked to contaminated cough syrups threatened to Mar the reputation of its 42 billion US dollar Pharma industry under Global scrutiny after the cough syrup's controversies Indian regulatory authorities conduct a massive Crackdown on 76 firms all around India in March 2023 18 companies lose their licenses it exposes the weaknesses in the system the state drug control departments are on the front lines of quality control and the drug inspectors are the foot soldiers of regulations so much depends on them but according to former State drug controller of haryana Dr GL single there aren't enough boots on the ground the center law says that every unit may be sale or manufacturing has to be inspected at least once in a year but practically it is not happening so in haryana we have around 25 000 climate shop only 10 inspectors not even one in each district we have about 500 manufacturing units in the state of Arena again 10 inspectors and Kevin show up you can go and inspect within three four or six hours but manufacturing inspection is not so easy and so short sometime it's safe two videos also the infrequent checking of manufacturing units in some states means that for most part companies have to self-regulate the quality of their medicines once you enter into Pharma it should be ingrained in your own self why I have to maintain the quality because it is for human consumption for export the guidelines are clearly marked out whatever is the expiry of that particular product to that extent you have to retain the control sample as well as the raw material and excipient issue records then batch manufacturing records then test records all those things you have to retain to ensure the safety of medicines all companies across the world are mandated to adhere to stringent guidelines known as good manufacturing practice or GMP [Music] is a part of quality assurance it ensures that you human into the product when they say each unit each capsule or each tablet or each ampule will perform its function and either cure or reduce the infection that the person has if you look at scheduling or if you look at usfda guidelines the semantics may be different but ultimate objective is is the product safe to the customer let there be no doubt that the Indian regulations are anyway inferior to any other regulation of the world no it is not so contaminants like daphalene glycol and ethylene glycol can enter the process of pharmaceutical manufacturing as raw materials which is why GMP mandates rigorous testing of raw materials [Music] you're obligated to test all the raw materials which we use in our formulations even if they are tested by the manufacture we still have to test it ourselves and certify that it is fit enough to be used in our formulations and with the tests are critical like protein glucose there are typically two kinds of propylene glycol available industrial grade used in engine coolants liquid cleaners latex paints and pharmaceutical grade used as a solvent to make medicines the technical grade of propylene glycol has a much higher content of ethylene glycol and Dyson compared to the pharmaceutical grade of propylene glycos people who use their Industries are not really aware of implication of dicyclin glycol and ethylene glycolin human body and many manufacturers might use industrial gate because it literally comes cheaper [Music] industrial-grade propylene glycol is half the cost of pharmaceutical grade propylene glycol as is the cost of diethylene glycol toxins can get into raw materials by accident mislabeling or human error but they can also get in by Design unscrupulous chemical suppliers could deliberately Substitute part or entire barrels of pharmaceutical grade with cheaper solvents it is crucial to test the raw materials as they are received as experience begin to get mixed into the formulations the impurities become more difficult to detect later in the manufacturing process [Music] this is a product it's a liquid product which contains active ingredient and several recipients let's say maybe something like 14 to 15 recipients are likely to be present what important the active pharmaceutical ingredient which is going to act on the human body there are several other recipients they will have impurities on their own those impurities have to be tested and the raw material screening itself but testing is costly and some smaller manufacturers flout regulations to cut costs the testing of propylene glycol for the presence of impurity diethylene glycol requires a very very sophisticated instrument GLC that is around 20-25 lakh cost instrument only and majority of the haryana manufacturer do not have this instrument even if they are Manufacturing and using problem glycol and the test from the market is very costly if you go to a genuine testing laboratory otherwise there are number of laboratory which give a certificate that we have tested is okay and our inspectors goes there this is report is there okay there is also no requirement for manufacturers to test finished medicines for the presence of toxic chemicals as regulatory bodies assume that the raw materials have been cleared flaws in the testing process are a global problem it is not required to be tested by any Revolution across the world foreign the Indonesian Food and Drug authorities Too Faced the daunting task of explaining the presence of these toxins to the parents who have lost their children they put out a press statement Indonesian police investigation found in January 2023 the Food and Drug monitoring agency bpom tracks the trail of the poison medicines the Indonesian police find the culprit for the toxic cough syrups in 2021 post-pandemic disruptions caused the price of propylene glycol to spike and there's a worldwide shortage of the solvent a local Trader CV samudera forges the labels of industrial propylene glycol marking them as pharmaceutical grade solvent manufactured by Dow chemicals Thailand it then distributes a solvent to manufacturing firms dubious raw materials lack of tests companies forging labels the supply chain for medicines is complex to rely only on a mere guarantee certificate from the chemical supplier is dangerous the negligence by the manufacturers and the government for preventing the leak of the toxins into medicines enrages parents they file a lawsuit against the government is no but the lawsuit seeks compensation of 195 000 US dollars for every child killed and about a hundred and thirty thousand US dollars for every child injured um [Music] foreign the case continues and the families hope for justice close on the tail of the tainted cough syrups a brand of eye drops exported from India is held responsible for a superbug outbreak in the United States Indian Pharma company recalls eye drops controversial eye drops that were the reason according to the United States for one death and 55 infections [Music] um foreign twenty two and 2023 tainted medicines leave a trail of fatalities across the world claiming lives and causing permanent damage to the lives of young children the deaths of more than 300 children began in The Gambia followed by cases in Indonesia and Uzbekistan all linked to syrups Made in India and Indonesia puts a spotlight on the weaknesses in the global supply chain [Applause] forces that governs that particular you know trade between two countries is what's called a certificate of pharmaceutical product this is a global framework set up by the World Health Organization it's a it's a voluntary disclosure frame bracket there is no teeth behind it it basically says to the country that is selling has to voluntarily disclose certain information to the country that is mine and the country that is buying has to do some due diligence before you buy medicines in the country that is selling so the certification is for the manufacturing facility it's not for the medicine there is nobody looking at individual batch of medicine to say whether the batch of medicine is actually of good quality or not in February 2023 a few months after the scandal of the poisonous cough syrups the American Federal drugs agency the FDA announces the recall of a brand of eye drops the eye drops Were Made in India this threatens to open another chapter of Tainted medicines Dr Guillermo amezcua a cornea specialist is used to treating a plethora of eye infections especially in summer South Florida here in Miami we're in a tropical subtropical area and you know access to pools the ocean so we tend to see many patients with fungal infections of the cornea in May 2022 he notices that the antibiotics he was prescribing weren't working it was last summer when we started seeing patients that were coming with very difficult to treat a corneal infections specifically with an organism called pseudomonas what we were noticing is that these patients were coming with very severe infections we were giving the standard of care that we normally give and uh the patients were not getting better one of our patients that came with a history of using the contaminated artificial tears we we had to take them to surgery and do an emerging corneal transplant so that was an early warning sign over the next few months cases show up across the United States a deadly superbug outbreak is detected contaminated eye drops have been linked to four deaths in the United States 14 people have gone blind and four have had to have eyeball surgery an outbreak caused by eye drops has infected 81 people in 19 States investigators trace it to eye drops used by the patients one stands out is recare artificial tears Made in India by global Pharma and distributed Nationwide over the internet some of those patients had to get emerging corneal transplants some of them had to get emergency retina surgery because the infection got inside the eye there are two ways that eye drops can get contaminated one the manufacturing process itself if the drops have no preservatives or the bacteria is resistant to the preservatives bacteria could grow two if the user accidentally touches the dropper cap or tip to the eye it may get infected with the bacteria that live around the eye that bacteria May grow in the eye drop eye drops are over-the-counter drugs and not as strictly monitored as prescription drugs the challenges with over-the-counter medications are very similar to prescription medications they're often made in the same facilities they have the same issues with a lack of independent testing David light a biotech entrepreneur is the founder of an online pharmacy and independent laboratory called Valley Shore in the United States it has discovered several regulatory mishaps so there's many points in the supply chain that these kinds of contamination issues and real safety concerns can happen Valsartan or the Angiotensin receptor blocker drugs like Valsartan losartan herb sartin were some of the first drugs in 2018 to be identified with what are called nitrosamine carcinogens that is a probable human carcinogen that is extremely potent causes is actually used to induce cancer in rats in clinical trials that's really the primary use of ndma while researching they find carcinogens in several medicines we found ndma in Zantac and all generic forms of Ranitidine which is an antacid medication we found it in a significant percentage of Metformin drug products so metformin is the number one diabetes medication in the United States many of these findings have caused recalls not just in the United States but all over the world India has the maximum number of U.S FDA approved manufacturing units outside the U.S but regulating Industries outside the country isn't easy the FDA does many challenges in overseeing the quality of the manufacturing of medicines which is global there's obviously language barriers they have to get interpreters they have to even staff employees overseas which they've had a lot of difficulty doing over the years a 2019 Bloomberg article mentioned at the FDA is able to check only one percent of drugs for impurities before they're imported issue however is that it's being treated as a commodity product just like oil and even oil is actually tested independently at ports when it comes into the United States however this is not being done with medicines the only consistent testing of products is being done at the manufacturer largely in India and China and then self-reported to Regulatory Agencies May 2023 the US FDA inspection at the global Pharma manufacturing unit in Chennai finds several concerns including missing safeguards and procedures but the state authorities in India finds no issues with the control samples collected from the manufacturing unit the problem in the United States is that for the last 10 years the human's government and the U.S FDA had walked a very fine line between penalizing Indian manufacturers who Supply a large amount of medicines curatively meaning that that you know holding them accountable from Lee because they're afraid of the fact that there could be drug shortages in this country the global circulation of poor quality drugs is made worse with the easy availability of medicines on the internet there is one of the major Threat all around the world that is the self-medication in all over the globe there is a very common problem also that is known as the cyberchondria what people they generally do because when they are feeling unwell they start searching on the search engine then what problem they are facing what is the best treatment of that problem and then again they start finding those products which are used for the treatment on online pharmacies if e-pharmacies they are delivering you the product without prescription that means there is a much more risk with the health of the person while it takes lab tests to determine whether or not a drug is substandard consumers need to watch out for some telltale signs right just like in this case it is cracking on the tablets so that there is a cracking on the tablet means there is some binder is missing so such kind of product if there is a cracking it indicate that it will definitely influence or impact the dissolution profile of the tablet the second is if there is a capsule for example this is a capsule it's a soft gelatin capsules sometimes it happens then due to some circumstances there is a leakage in the blistering over here right so such kind of product should not be take another is that before you are buying the product you have to check the expiry date because that is very very important because when product is expired that means the product get 10 percent degraded it is known as the shelf life as the world wakes up to the devastation that adulterated medicines have wreaked humans have begun to make regulatory changes including India there is a regulation that is coming up and that is going to be implemented effective August 1st of this year requiring QR codes on the top 300 brands in India that can be scanned by any consumer to get information about the validity the genuineness of the product as well as certain other attributes about the product and as a consumer you must pull out your mobile phone check it scan the code it is the easiest thing and you'll get information yourself which will Empower you and give you that assurance that what you're taking is safe but with a lack of a solid Global regulatory framework the international supply chain remains vulnerable to poor quality drugs it's really industry that needs to lead with pushing for independent testing being part of purchasing decisions and contracts to more proactively evaluate something other than just price most of the conversation today is around access and affordability quality is never actually on top of anybody's list in March 2023 Marion biotech the Indian company which supplied the cough syrups to Uzbekistan is found to have violated the compliance rules three members of the company are arrested and its license canceled three months later in June there are reports that Marion biotech had used industrial grade propylene glycol in their cough syrups [Music] in June there are allegations that the state drug controller of haryana was bribed 600 000 US dollars to switch control samples in The Gambia cough syrup case the families of the children who died in The Gambia file a lawsuit against Maiden Pharmaceuticals in Indonesia drug regulator officials are summoned for potential criminal wrongdoing Indonesia's police are saying accountability from the Food and Drug agency people but grieving parents still hope for justice thank you [Music] and those who have survived are a living testimony to the tainted medicine Scandal that should never have happened in the first place please [Music] [Music] [Music] foreign [Music] [Music]

Channel: CNA Insider

Views: 233,354

Keywords:

Id: AyCcZQ68mjI

Length: 46min 47sec (2807 seconds)

Published: Sat Jul 29 2023

Reddit Comments

[u/Meemeemiaw23]

Spoiler Alert:

Ada rekanan yg bergerak di industri ini. Ini kasus bener2 fatal banget, trus ketika hal ini dibicarakan dlm sebuah pertemuan.

"It's collateral damage. The number is still small compared to our customers. Less than 1%. It can happen to anybody."

Rekanan gw abis denger itu, 3 bulan kmudian langsung resign dan sampe sekarang ga mau kasih anak-anaknya obat sirup sm sekali.

[u/KnowledgeMission7894]

Makes you wonder, if dodgy procurement is happening for child medication it sure as shit is happening for all types of drugs.

[u/motoxim]

Ini salah satu berita yang harunya lebih ke blow up tapi tau tau redup gak pernah diberitain lagi. Apa ada permainan biar diredam gitu beritanya? Atau saya yang emang kudet ketinggalan berita? Gimana jadi akhirnya, obatnya ditarik? Ini awalnya karena ada pencemaran pas ngolah obatnya gitu kan di India?

[u/Less_Ice7747]

Kasus ini proses hukumnya bagaimana ya? ada yang bertanggung-jawab? apakah ada kompensasi kepada keluarga korban dan apakah produsen mendapatkan sanksi denda atau yang lain?

[u/Shougee369]

Memang seharusnya gak boleh ada toxic component di obat2an, tapi kita gak bisa anggap kejadian kayak gini gak bakal terjadi lagi. dari video udah liat sistem surveillance kesehatan udah bagus bisa notice ada something dari beberapa kasus yang sama, cuma kenapa buat cari causenya masih agak terhambat dan ngandelin WHO? gimana kalau kasus2nya cuma terjadi lokal di Indonesia? Apakah di Indonesia gak dilakukan biopsy post-mortem?

[u/dratst]

and what's being done afterwards?

nothing

[u/Apprehensive_Main850]

Siti Tarmidzi ngemeng we alrdy did our best blabla and then another scene the lawyer highlighted it takes Indon 10 month to figure out is a fkin gold.