
Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency - pseudolus
https://www.bloomberg.com/news/features/2019-01-31/culture-of-bending-rules-in-india-challenges-u-s-drug-agency
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wtmt
Talking about India for a moment, if you ask any Indian living in India (or a
recent emigrant) about "bending rules", it's certain that they will say it
happens all the time, everywhere, in every industry, in every government
department/ministry, and that that's how things are and have been. It's an
accepted sense of resignation in the mindset of people. This also triggers a
mindset to "just get things done at any cost", as the article describes
(usually this kind of corruption starts at the top levels of a company).

If you get goods made in China, I doubt if you can be sure of the quality
unless you go there, stay there, live there, and work there to make sure that
those companies understand what you need and are doing the right things in the
right way and not cutting corners.

IMO, all this is the price you pay for getting "cheap stuff" from a remote
place with a different culture and history. I'm not implying that everything
(or even the majority of things) made in the U.S. automatically comes at a
better level of quality — there is no denying that fraud and "bending rules"
are universal. What matters is how much can be controlled and what compromises
one is willing to make. It just so happens that large markets with higher
costs that need cheaper stuff on one hand, and countries that want higher
exports and have weaker systems (policies, laws, law enforcement) on the other
hand make this issue much larger and difficult to deal with. I personally
don't think there are any easy or quick solutions here that can retain the
costs at current levels while achieving everything else. Something must give.

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rossdavidh
1) having audited lower-income countries' factories, for a tiny bit years ago,
convinced me that this is true of just about any country at a lower level of
economic development. Rigorous regulatory enforcement is expensive, and poor
countries are poor.

2) it is not just a problem with generic drugs in India, it is a problem with
anything that is painted (lead?), anything with plastics in it, etc. etc.

3) it is interesting that the one case where Bloomberg seems to be saying
"this outsourcing our manufacturing to the Third World is a problem", is the
case where the industry in question has a profit-related reason to want it to
stop. In most industries, the U.S. companies want to manufacture there, so
that is "free trade", and I think Bloomberg would be in favor and unlikely to
run a story like this.

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gaius
_poor countries are poor_

India has nuclear weapons, aircraft carriers and a space programme.

~~~
rossdavidh
Sorry if that sounded like I was saying "primitive". I was not meaning to. The
relevant fact is that it takes a lot of money, proportional to the size of the
country, to have good environmental, health, and safety regulations, and
enforce them. A very large country such as India, which does have many
technologically savvy people, can have nuclear weapons, aircraft carriers, and
a space program for far less money than it takes to make all your
manufacturing not cut corners in E,H,&S regulations.

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webmobdev
I don't think think this has to do with "culture of bending rules".

This just seems an excuse to me of what is evident every where in the world -
greedy corporates will always test the boundaries of the law to the maximum,
to maximise their profits, testing the limits of the government to see what
they can get away with.

As the article itself highlights, once the FDA started being more strict
complaints from India decreased and compliance increased. (And India was more
responsive than China.)

In fact, if the article is right, there seems to be an opportunity here for
outsourcing FDA's inspection to a third party, as FDA seems to be finding it
difficult to get its staff to stay in India (and possibly other asian
countries) for inspection.

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renholder
>...as FDA seems to be finding it difficult to get its staff to stay in India
(and possibly other asian countries) for inspection.

The staff works for the FDA, which is a part of the government, yeah? In other
words, it's not a for-profit business that can register itself it in India
and, thereby, sponsor visas to live in India. I imagine that this is the
principal reason _why_ they can't "get its staff to stay in India".

~~~
lotsofpulp
I doubt it, especially with the weight a US government agency would have in
getting visas.

On the other hand, professionals who have options, such as those working for
the FDA, would probably need a sizeable premium to give up the comforts of
living in a nicer place and instead have to live in a poorer, more crowded,
dirtier, foreign country with increased risks.

~~~
MrMorden
A US government employee stationed in a foreign country receives allowances
that pay for the full cost of housing and utilities. In Mumbai, the housing
allowance is relatively small as such things go ($1500ish/mo depending on
grade level and family size), but there's also a 25% hardship allowance and an
education allowance sufficient to send your K-12 children to an eye-
wateringly-expensive private school. Other benefits include four to six weeks
a year of vacation, three weeks a year of home leave, most likely both US and
Indian holidays, and they probably have authority to throw in a 25% relocation
incentive on top of that. FDA is also allowed to pay in excess of the usual
federal pay cap for some positions. If they really can't find people willing
to take that deal, they've got some major organizational issues that need to
be addressed.

(Source: I work in a different part of the federal government, but most of
these rules are set by State.)

~~~
lotsofpulp
Organizational issues could also be a part, but there exists some number that
would attract people. Personally, I wouldn’t give up my lifestyle in the US
for a few hundred thousand a year, but make it $500k+ for 4 day workweeks and
I might think about. There might be people qualified for the position that
will do it for less, but the employer just needs to keep raising the number
until people bite.

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signal11
For context, the Ranbaxy scandal the article refers to is covered very well by
Fortune’s remarkable story “Dirty Medicine”[1]. The people behind Ranbaxy have
since sold their stake to a Japanese firm and are now running a chain of
hospitals in India.

[1] [http://fortune.com/2013/05/15/dirty-
medicine/](http://fortune.com/2013/05/15/dirty-medicine/)

~~~
webmobdev
Those chain of hospitals too are now in the news and being investigated by the
government ( [https://timesofindia.indiatimes.com/india/fir-registered-
aga...](https://timesofindia.indiatimes.com/india/fir-registered-against-
fortis-hospital-in-dengue-death-controversy/articleshow/62005768.cms) ).

\- [https://www.thehindubusinessline.com/companies/ranbaxy-
now-f...](https://www.thehindubusinessline.com/companies/ranbaxy-now-fortis-
hospitals-its-curtains-in-healthcare-for-the-singh-
brothers/article23372302.ece)

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abhinai
Lower drug prices and higher availability of generics is a good thing that
helps millions of people. Now let's talk about how we can ensure drug labs, no
matter where they are in the world, produce high quality drugs.

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scarejunba
Is there a news believability index somewhere. I’m getting a bit leery of
Bloomberg “exposés” after it turned out the Supermicro story was bullshit.

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known
I'm not surprised since
[http://business.rediff.com/report/2009/sep/24/indians-
among-...](http://business.rediff.com/report/2009/sep/24/indians-among-most-
corrupt-while-doing-business-abroad.htm)

