Some drugmakers may be feeling a little extra weight this summer vacation season. But it's not the result of poor eating or a break in the exercise routine.
Regulators in the U.S. and India are increasing pharmaceutical company responsibilities by requiring more direct oversight of contractors. In the U.S., the idea is still in the FDA proposal stage: The regulator wants to require manufacturers to conduct on-site audits of contract manufacturer facilities, according to a Wall Street Journal report. The status quo requires only that manufacturers review contractor-provided data about quality controls, manufacturing analyses and product testing.
The FDA's goal is for manufacturers to view contractors as an extension of their own companies. The regulator may even be a considering a two-for-one campaign in which both the drugmaker and the contractor are cited for contractor manufacturing violations.
In India the focus is raw materials, rather than manufacturing services. And the target is China, which supplies most such materials imported by Hindustan. Officials want to stop the influx of cheaper drugs and substandard APIs and other ingredients from the People's Republic.
Indian health department officials will inspect the manufacturing operations of API suppliers to ensure GMP compliance. They will also verify that drugs supplied to India are made at units certified by government agencies.