This report shocked me, I didn’t expect quality control of generics to be that bad. Some choice quotes:
ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation.
The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show.
For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered
ProPublica’s analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas’ clonazepam, a sedative and epilepsy drug, reported getting “brain zaps” and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban.
There’s much, much more. The issue seems to be that to avoid shortages, FDA is at the mercy of these generics manufacturers. The root cause seems to be some kind of market failure, since FDA apparently can’t actually punish manufacturers:
[…] a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can’t force companies concerned about slim profit margins to produce generic drugs.
Those of us that buy directly from India better do more due diligence about where our products are coming from.