The Indian Pharmacopoeia Commission (IPC) says it wants to follow standards set by the Pharmacopoeial Discussion Group (PDG). In a meeting last week, the IPC indicated it want to come into alignment with the USP, European and Japanese Pharmacopoeia standards.
IPC plans to collaborate with USP, who will in turn provide IPC with USP reference standards. IPC also plans to pick up USP convention nomenclature in labelling. The IPC also invited the USP to the 13th annual Indain Drug Manufacturing Association - Pharmaceutical Analysts Convention in Mumbai next month. See in-Pharma Technologist.com.
Harmonization is increasingly important to a global pharmaceutical industry. Suppliers of raw materials operate globally but are often forced to adapt locally to test methods and SOPs. Pharmaceutical manufacturers similarly have to adapt test methods and licensing files to local requirements. These steps add a lot of costs that don't add a lot of value and are effectively passed to the patients and healthcare system. Harmonization not only clarifies the rules for all players, but decreases costs and increases efficiencies.
If interested in this topic, you may also wish to refer to this talk by Dr. R. Ramakrishna, Dy.Drugs Controller India, entitlted "Advances in Indian Medicines Regulation with Special Focus on Pharmacopoeial Standards"
Posted by Bruce Lehr September 7th 2010.