Pharmalittle: India aims to tighten drug oversight, China investigator trials slow

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will celebrate the notion by brewing still more cups of stimulation. As always, you are invited you to join us. Our choice today is strawberry creme. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The number of investigator-initiated trials, a Chinese regulatory pathway that allowed investigators to start clinical trials without sign-off from central regulators, have slowed considerably, STAT reports. Loosened rules had enabled Chinese companies to test drugs in humans faster and cheaper and prompted U.S. companies to either come to China or push the U.S. Food and Drug Administration to adopt a similar approach. But since May, when the Chinese government issued new restrictions, 164 have been approved under the new regulations and just over 1,000 were submitted for review.

India proposed rules requiring regulators to immediately suspend manufacturing licenses for medicines that fail specified quality standards in government testing, tightening oversight of one of the world’s biggest pharmaceutical industries, Reuters writes. The rules would apply if government testing finds the drug fails quality standards for impurities ‌or sterility, the amount of active ingredient, or dissolution, which assesses how the drug releases that ingredient. The license would remain suspended until the manufacturer conducts an effective root-cause analysis and implements corrective and preventive action, and could be restored only after regulators verify those measures have been implemented.

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