STAT+: Pharmalittle: We’re reading about India’s new manufacturing rules, clinical trials in China, and more
India proposed rules requiring regulators to immediately suspend manufacturing licenses for drugs that fail quality standards in government testing
Good morning. Despite overcast skies, our confidence remains strong as we dive into the latest Pharmalot news. Today's focus is on regulatory changes in India and China.
China has tightened its clinical trial rules, limiting the number of investigator-initiated trials. Previously, investigators could begin studies without approval from central regulators, which attracted U.S. drug companies. However, since May, when China introduced stricter regulations, only 164 trials have been approved out of over 1,000 that applied.
Meanwhile, India has proposed new rules to enhance drug manufacturing oversight. If government testing reveals a medicine fails quality standards for impurities, sterility, active ingredient amount, or dissolution, the manufacturer's license would be immediately suspended. The license remains suspended until the company completes a thorough root-cause analysis, implements corrective and preventive actions, and regulators confirm these steps were taken.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
