It's difficult to assess the situation without having the WHO report or an inspection.
The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace.
There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so.
If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors).
The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.
The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace. There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so. If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors). The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.