India steps up control of imports

The U.S. Senate has singled out India--along with China--in its attempts to crack down on sub-par drugs and drug components from foreign sources. However, India itself is fighting to stay out of pharma-supply reputation basement and is banning the import of raw materials from 10 Chinese suppliers. And to further enhance its reputation, the nation is planning overseas inspections of manufacturing sites.

"[I]t's high time India too started the practice of inspecting manufacturing sites to bring more transparency into the drug approval system," a Pharmabiz article quotes a drug official saying. To further this effort, Indian officials plan to hire drug inspectors to visit the foreign manufacturing facilities of companies that supply the nation's drugmakers. Officials are identifying a pool of 64 inspectors and will eventually whittle that number to about 20, according to an article in Pharmabiz.

Another change being considered is confiscating and destroying unlicensed and sub-par drug and raw material imports and thus replacing the current practice of re-exportation.

- here's the article

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.