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Quick pill: On amendments to drug rules
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The Hindu - Home
The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism.
Once a ‘notice of intent’ is acknowledged online, a company is free to go ahead with drug synthesis, strictly for research.
Specific low-risk bioavailability and bioequivalence studies can also commence after an online intimation on the portal.
The paperless, prior intimation mechanism will no doubt reduce the time spent twiddling thumbs, waiting for a physical copy of the licence.
No drug, however speedily produced, is worth the blister it is packaged in if it comes with quality lapses.