India’s CDSCO wants tighter rules for clinical trial imports

PharmaTimes reports that India’s Central Drugs Standard Control Organisation (CDSCO) wants to tighten up conditions for the import of larger quantities of drugs for use in clinical trials.

Write Peter Mansell reports that, the CDSCO has issued a proposed guideline that calls for additional documentation and evidence when contract research organisations (CROs) or other companies/institutions apply to import “appreciably large” volumes of drugs.

The regulations do not specify what “small quantities” are, and recently there have been a number of cases of manufacturers, CROs and other importers “submitting applications for the import of reasonably large quantities of active pharmaceutical ingredients and/or drug formulations which do not comply with the provisions of Rule 33”, , the CDSCO notes.

According to the CDSCO, the rationale behind the guideline is to facilitate drug R&D/contract research and to “boost the scientific and technological activities in this knowledge-based industry”.

India’s CDSCO wants tighter rules for clinical trial imports