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Deadly Incompetence in India

Here, then, is the bottom of the drug-manufacturing barrel: the recent case in India where women at a sterilization clinic were poisoned by defective ciprofloxacin tablets. They were supposed to be getting 500mg of the antibiotic, but after several deaths, analysis has shown there there was perhaps 300mg of the actual drug present, and some zinc phosphide rat poison as well.
This is horrifying and inexplicable. Zinc phosphide is a smelly grey-to-black powder, and ciprofloxacin is white and odorless. It goes without saying that no facility processing antibiotic tablets should be preparing rodenticide as well, and there is no way that the two could be mixed short of absolutely criminal incompetence. The companies involved are two Indian generic manufacturers, Mahawar Pharmaceutical and Kavita Pharma. There are reports in the Indian press that when authorities raided the companies for samples of the drugs that a significant amount of drug material appeared to have been recently burnt.
India has major problems with corruption in its state-run health care, and there are suspicions in this case as well. (The press is also reporting that at least one of the companies has been fined for substandard or fake drugs in the recent past, which brings up the question of why the government was dealing with them now). And overall, the top end of Indian technology and medicine is something that the country can be proud of – but the bottom is a disgrace, as Indian citizens themselves are well aware.

14 comments on “Deadly Incompetence in India”

  1. Inslicoconsulting says:

    DL,
    Your last sentence is very welcome, particularly from an Indian who has had a lotta trouble making exactly the same point in the midst of the chindia campaigns, here and elsewhere.
    We are seeing more accountability and will get there.

  2. skatesailor says:

    Derek:
    This claim, that “…a significant amount of material appeared to have been recently burnt” would benefit from amplification.

  3. Derek Lowe says:

    #2 – I’ve added a bit more detail – thanks!

  4. David Stone says:

    A couple of the local generic pharmaceutical companies here have also been in trouble recently with materials and products produced at their Indian facilities or partners. Both the FDA and, more recently, Health Canada, have found problems supply-side.
    See
    http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/api-ipa-eng.php

  5. Hap says:

    This seems less like incompetence and more like reckless indifference – the level of incompetence is so high that either they were stupid beyond accounting, conscienceless enough not to care about what they made and sold or the people to whom they sold it, or murderers.
    I wish there were not people looking to see if they could go lower than Ranbaxy.

  6. Miramon says:

    It seems like deliberate homicide to me.
    It’s one thing to pack capsules with starch or chalk to stretch out your drugs: that’s criminal and evil in itself, but at least for the average patient it won’t be deadly (though no doubt it could lead to death).
    But it’s just inconceivable that poison could be used instead. And as noted, there’s no way to mistake the poison used for either the drug or for a neutral filler.

  7. dave w says:

    I agree with #6 – if someone were just trying to stretch the supply by padding out pills with less than the advertised unit dosage, it seems implausible that they would go out of their way to pick an unusually toxic substance as the diluent… are we supposed to believe that, in their eagerness to cut corners, the manufacturers just happened to grab a supply of rat-poison, which happened th be handy nearby, with which to dilute the batch? This sounds more like someone trying to poison folks – but why?

  8. gippgig says:

    Plausible scenario: They had zinc phosphide around because they had a rat problem in the factory. Someone picked up a sealed (therefore odorless) bag of zinc phosphide that was sitting next to the bags of ciprofloxacin and threw it into the hopper without paying attention. Sound unlikely? The same sort of thing happened in the U.S. – a bag of Firemaster got in the bags of Feedmaster and a worker didn’t notice, threw it in the mixer, and contaminated a sizable fraction of U.S. cattle with polybrominated biphenyls.

  9. Nile says:

    You might want to think of this as an ‘Ethics Deficit’ – a gap between the moral standards we should have, and the things that we actually do.
    It’s small in some organisations, large in others.
    The gap has been noticeable in some pharma companies in the US, too.
    The question is whether there is a culture that weeds out ‘rogue’ individuals who cut corners and commit unethical acts; or whether they are rewarded for profitable-but-questionable behaviour for too long, and become senior managers.
    …And whether that can happen for long enough, for enough people, that unethical people progress and succeed acress the board because of their flaws, not despite them, and this becomes the dominant culture.
    As with companies, so with an entire industry: competitive and profitable companies succeed and grow, and if success comes through gaining a competitive edge by actions damaging to the host society, who can stop it? What’s to ‘weed out’ the bad actors before they dominate the industry?
    What if the Indian pharmaceutical industry has become their ‘Wall Street’, owning its regulators in a country with weak government and unenforced laws, and no effective consumer power?

  10. I am also from india, i am regularly follwing news update on these, actually it was more of careless action from pharma companies, how will a patient will ever come to know weather a drug is poisoned unless they are informed off. more over these happened in a small village were many people not educated and they cant even identify weather a medicine is expired or not
    Its a mistake of both Pharma company and pharmaceutical store which sold them

  11. Anonymous says:

    Typo alert! Missing a space between your number and units in the second sentence.

  12. Chris says:

    There are scarier sides to the story than the alleged drug poisoning. Consider a gynecologist’s POV:
    http://drjengunter.wordpress.com/2014/11/12/sterilization-camp-in-india-kills-11-women-a-government-funded-slaughterhouse/

  13. Anonymous says:

    @10: “Its a mistake of both Pharma company and pharmaceutical store which sold them…”
    I am not sure if I would call this just a mistake. People seem to be pretty forgiving, which is sad, given the scandals from so many generic companies in India such as Rambaxy.
    We are taking about people’s lives here. I don’t know what is going on there, but one thing I know for sure is to stay away from those generic drugs that are manufactured there.

  14. li zhi says:

    Very late to comment. Why would anyone intentionally wish to harm women who are engaging in reproductive “choice”? Seriously? Wow. You must be living a very sheltered life. Other than husbands, boyfriends, family, and religious believers I can’t think of anyone with a motive.

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