You are right, it is an incredibly fascinating story.
From beer to insulin to generic statins.
Those that fear yet another sector of America to be outsourced are not leaders. Ms. Shaw appears as a real leader. We possibly could use more of her type in the USA. But her hands may not be so clean.
In any case hers is an exceptional story.
If Americans want to compete with Ms. Shaw's legacy, they need to:
1. Cure Diabetes (yes it is possible).
2. Find a substantially superior molecule to generic lovastatin (already done).
3. Find a superior relief medicine for RA.
It is tempting to add to that list that regulatory barriers should be lowered for USA drug researchers, but that is inadvisable as there are plenty of recent cases where FDA approval led to putting products on the market that kill people.
This leads to another risk factor for Ms. Shaw's legacy. As the population in India becomes more aware of product liability and legally enabled to make claims over such, companies such as Biocon are at risk of being destroyed by class actions over new drug molecules that have poisonous or disabling side effects. The consequence will be higher development costs in India.
For years global pharma has used third world populations to 'test' new drugs. Notice the article mentions Ms. Shaw as having started a drug research services company. It's a good bet she supplied diabetic persons to be enrolled in a drug or biologic trial for a large pharmaceutical company. Possibly then she used the knowledge she gained to start production of an insulin product within her company Biocon.
Pharmaceutical trials in third world countries are very inexpensive because of the lack of regulation. But we must keep in mind that the test of any new medicine or alteration of an old medicine can have the effect of a poison. Although there may be beneficial consequences to the targeted disease, there can also be fatal side effects.
So the last competitive goal for Americans is:
4. Know the human body so well that a new medicine's effects are highly predictable and the risk is acceptable.
This last goal means Americans are safer, and yes they are.
Good points, all! I for one am a sucker for admiring an entreprenuer no matter where he or she may be from. And when the obstacles are significant, it makes the story even more compelling. An entreprenuerial soul speaks to human freedom and the desire for personal liberty, and that intrigues me wherever and whenever it occurs. V's wife.