I have an Invention ... Now What? / Re: How to make patent reform to lower the prices of patent drugs in India?« on: Yesterday at 10:02 pm »
To be sure, a lot of "drugs" do get impoted from India, both APIs compounded here and finished dosage forms, by companies that have a US sub, and there is a DMF on file and all facilities are subject to inspection. One unnamed India dug company (nearly or in fact) had their FDA approval revoked for blatant GMP violations (crap in the API, crap in tablets, FDA's lax enforcement, heck it's India, put melamine in water and call it milk - oops that was China, big difference?), suspended some importation, and consented to remedial action and stricter FDA inspections (if they ever do it) as a condition for continuing business i US. But all this is different from what I percieve as op's point(?), set up an import-export company and buy tablets properly made under license (or "parallel patent") in India for the India market for prevailing price in India of $1 per tablet, and sell in US, where prevailing price for domestic production is $8 per tablet, for 5$ per tablet. First, the API may be protected by a US patent. A "parallel patent" is irrelevant. That's India's business. And if there is no DMF for that facility that maufactures for the India market, the tablets are misbranded. Could even be seized at portof entry.