comment: >
  
  How do you propose this occurs in a gmp warehouse? Added bonus, explain how in process, finished product, and stability testing miss this.  Assume assay and impurity testing by HPLC using current USP monographs.  Or EP, or BP depending on the label.
context: The countries this happened in are Gambia, Indonesia and Uzbekistan. There are four additional countries where this cough syrup might have been sold: Cambodia, the Philippines, East Timor and Senegal. This has been going on since JULY 2022. >
  
  My personal philosophy is to not base my decisions of couple of incidents that blew up in the media, especially when the country is as large as India and China.  
  People gotta realize, this is a company, it doesn't reflect all Indian products ffs. The company should be sued the fuck out and has to provide relief to all the families, but calling it a nation-wide problem is factually incorrect. >
  
  Medication is not just any peoduct to take quality risks. That’s why most countries have great oversight of its production. This only reflects on the poor job of the government pr India doing that. It’not the only case, another Indian company has been asked to stop production of eye drops related to vision loss issues in the US this month. In 2013 US fined Indian company $500 million for several reasons. Since then , since 2007 they have sampled thousands of drugs made in India and more tahn 7,000 of them were declared “low quality. Ao you see, it’s not a problem of this one company. >
  
  The comment I replied to said anything you eat, not medicine.   
  And even in Medicine, The product should hold more value than the company. Where it is from doesn't matter. Does the medicine do what it's supposed to? What are the side-effects? What is the cost? The nationality of the company producing shouldn't matter at all. If company A has some foreign substances consciously added in it that has severe side effects, then Company A should be punished. Not the whole fucking country. >
  
  Crucial part:
  
  According to the WHO, the cough syrups contained "unacceptable" amounts of diethylene glycol and /or ethylene glycol as contaminants. "Levels varied for specific details of laboratory tests," it added.
  
  Ethylene Glycol.
  Diethylene Glycol.
  Anti-Freeze. They made kids drink anti-freeze. >
  
  I don't get it, if you're making shitty medicine why not just put extra water in it instead of poison. >
  
  Glycerol is a common ingredient in cough syrups because it's syrupy, it's mildly sweet-tasting, lots of things dissolve easily in it, and it will prevent sugar from crystallizing.  Food grade glycerol is pure and safe to consume (it's probably in something you've eaten or put on your skin today), but sometimes glycerol intended for use as an industrial solvent or soap/shampoo additive is contaminated with ethylene glycol, which has similar properties (but is toxic).
  It's likely that somebody at some point in the supply chain thought they could save some money by substituting in a cheaper source of glycerol, or maybe they mixed up the two similar-looking chemicals. >
  
  I guarantee you this person was warned it was highly toxic and did not give a shit, multiple people likely noticed who all decided 'Not my kid who is gonna die, Not my problem'.
  The fact India government is decided there is 'no evidence' tells me everything I need to know about what kind of culture they have. >
  
  I am pretty sure that the manufacturer didn't know. A lot of times (in India) what happens is that someone(can be plural) along the supply chain adulterates some material, which can even be from a trusted brand.
  So you could buy the best material, but it can be adulterated by middlemen and you would not know better.
  Is the manufacturer not at fault then? Nope they are still at fault and should be prosecuted, as it was their job to ensure that the raw materials they used weren't adulterated. Ensuring the quality of raw materials is the bare minimum they should be doing. >
  
  
  I am pretty sure that the manufacturer didn't know. A lot of times (in India) what happens is that someone(can be plural) along the supply chain adulterates some material, which can even be from a trusted brand.
  So you could buy the best material, but it can be adulterated by middlemen and you would not know better.
  
  Bullshit.  Current good manufacturing practices require an ID on all incoming raw materials (Even vendors qualified for reduced testing would still have every lot received subject to at least description and ID tests).  The easiest and most common way to do an ID would be by FTIR spectrum.  Would take all of 10 minutes, and would indicate something wasn't right, which would have led to full testing, where the lot would have obviously failed assay and impurities.
  Or at least this would have happened in a company with a functioning quality unit with a robust culture of quality.  But a huge number of Indian companies don't give a shit about anything but profit.  And it doesn't matter if they are large or small, it's the same story.
  Source: career in pharma.  I've seen it, lived it, and am living it every day at work. >
  
  Suppose you have 100 vats of medical grade glycerol. Somewhere between delivery and actual use it would not be difficult to swap 10 vats and swap the labels.  The problem happens after delivery, so even if your incoming quality team did an FTIR scan, you can't catch it. 
  When someone swaps only 10% of the vats, and your outgoing quality team practices skip lot sampling, it would be statistically probable to miss it.