Conference 'understanding Regulatory Perspectives Of Excipients' Hosted By Ipec

Experts, manufacturers and consumers attending the conference discussed the ever-evolving regulatory framework that guides the Indian excipients industry how active communication between the suppliers and users can decrease instances of quality negligence

THE INTERNATIONAL

Pharmaceutical Excipients Council (IPEC) recently organised a conference to boost communication and understanding between manufacturers and consumers involved in the supply chain for the excipients segment. Held in Mumbai, the theme of the one-day conference was 'Understanding Regulatory Perspectives of Excipients'. Speakers and experts attending the conference also discussed the ever-evolving regulatory framework that guides the Indian excipients industry and the need for Indian manufacturers to diligently adopt global GMP standards in times when they are facing stiff competition from China, USA and Europe.

Commenting on this the issue, Subodh Priolkar, Vice Chairman, IPEC India and CEO, Wincoat Colours and Coatings, spoke during his welcome address, “The Chinese Pharmacopoeia has included functional related characteristics (FRC) in a monograph which will create imbalance under the current regulatory regime. But this would definitely help excipients to perform critical functional attributes for drug safety. These are particle size, mean particle size, bulk density, viscosity, etc besides assay and chemical test. The challenge that lies in this context is that regulated markets cannot modify GMP Requirements for Certificates of Analysis (CoA) and according to Chinese regulations basis if there is a special material manufactured in China as per the local regulations. Just as if any regulated market comes out with a regulation on elemental impurities to comply with, it would be really difficult to comply when we are talking about global regulatory harmonisation.”