India – India’s CDSCO Publishes List of Drugs Covered by Bioequivalence Study Rules

India’s Central Drugs Standard Control Organization (CDSCO) has published a list of drugs covered by its rules on molecules in category II and IV of the Biopharmaceutics Classification System (BCS). The list is intended to help developers of generic medicines.

In 2017, CDSCO issued a notice calling for developers of BSC II and IV medicines to submit the results of bioequivalence studies alongside their applications for oral drug licenses. The requirement set the drug regulator up to see data on the bioequivalence of low-solubility generic drugs to their reference products at the time it reviewed filings for licensing…