India Issues New GMP-Inspection Rules

Aug 14, 2014

India’s Central Drugs Standard Control Organization (CDSCO) has issued new guidelines for state inspectors on how to prepare for and conduct GMP inspections of drug manufacturing facilities.

According to RAPS, the steps outlined in the Aug. 6 letter call for inspectors to focus on the GMP requirements for establishing shelf life, validation studies, and ensuring recalls of non-compliant products. Additionally, immediate regulatory action should be taken following an inspection that reveals conditions that could compromise drug quiality, safety and efficacy.

The letter comes amid an ongoing U.S. FDA crackdown on quality-control violations by numerous Indian drug makers. The Indian regulator hopes its effort will not only upgrade India's drug supply quality but also rebuild confidence in India’s contribution to the global pharmaceutical supply chain.

In July, India press reported that the Indian government may also offer a financing scheme to its domestic pharmaceutical industry to upgrade manufacturing facilities and meet stringent standards of the world's leading export markets.