Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency
bloomberg.com
bloomberg.com
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.
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.
Similarly, when toys from China were found containing lead, there were many stories about the danger this posed, and Im sure Bloomberg was involved in that. The difference is that those factories don’t have a neutral agency inspecting them so you only find problems when they cause an issue and it is widely publicized.
India has nuclear weapons, aircraft carriers and a space programme.
You can have all that and still have 70%+ piss poor population...
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.
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".
Quoting from the article:
"To help Indian factories change their culture in the wake of the Ranbaxy scandal, FDA leadership originally planned to put more inspectors on the ground. This proved harder than expected. Instead, the number of India staff shrank from a high of 12, in 2013. to only four at one point in 2017. Eight FDA employees are stationed at the India outpost now, including two drug inspectors, the agency said."
"The original argument for having foreign offices was that staff would have a chance to learn the customs of the country and build key relationships with government officials to instill best practices, said the FDA’s Woodcock. Inspectors based in-country also don’t need a visa for each round of inspections, while those based in the U.S. do ..."
"The problem is that the FDA can’t find people who want to live in India, Woodcock said. Difficulty hiring forced the agency to close its Mumbai office in 2016."
"Because of those challenges, the agency has largely ditched plans to build up offices in India and China and is instead relying on a U.S.-based cadre of inspectors who fly overseas for a few weeks at a time, she said. This cadre was supposed to number as high as 20 people, but 12 were serving in its ranks as of December."
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.
(Source: I work in a different part of the federal government, but most of these rules are set by State.)
I don't deny that penny-pincher execs are looking for loopholes, but how much of that is triggered from ignorance and not greed?
For many things the only thing that keeps greed and misconduct in check is a robust regulatory regime. They vast majority of people in any society neither has the time not expertise to check products for safety and authenticity.
- https://www.thehindubusinessline.com/companies/ranbaxy-now-f...