Skippy, I give you points for persistence, but this seems like kind of a dumb point to be pushing - even for you.
Yes, this stuff doesn't cost a lot to manufacture. So what? Is it USP grade? Was it made in a certified and FDA or EU-approved GMP facility?
And when it passes those hurdles, how do you get it to patients? Do you really think IPF patients will be buying this stuff on the black market? It may benefit patients in countries where no patents apply, but that isn't going help many patients in the EU or US unless they want to live abroad.
If Skippy-the-entrepeneur smuggles 100 kg of Indian-made pirfenidone into the EU, what then? Standing outside pulmonary clinics in a trench coat whispering "hey, monsieur...".
Why can't the patient buy a drug from India for a fraction of a cost? It's not standing on the street corner or anything. Even flying to India to get a drug seems cheaper then paying $45K a year. You have to differentiate simple compounds vs proteins or more complex structures. There are drugs that generic versions of could be materially different due to the reverse engineering of the product. But on the level of this drug, there really is no difference between a generic version and the brand name except for the availability in EU pharmacies. But with internet and globalization, a lot of old concepts and businesses went into oblivion. Music business is one example. Americans as a rule don't go to other countries to get medical help. Europeans do that more freely. If you go to India (but you probably don't have to as you can do it through the internet) and pay next to nothing for the drug, then some people will do that. SOme will buy brand name no matter what. Some will not be able to afford the brand name and will be forced to find ways around it anyway.
Complicated protein based or drugs with tricky know how production are somewhat protected against what is actually a piracy. This thing is existing compound that will be used for this particular disease, so in China and India and Russia they can manufacture generic version and sell it on the internet (which is what they will try to do anyway). Have you seen the performance of traditional pharmas with the advent of generic drugs and globalization? Its terrible. The drug needs to be complex, branded well and difficult to reverse engineer to be valuable source of sales.