India – Indian Pharmacopoeia joins global discussion group pilot

The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the European Union, Japan and the US.

Almost one year ago, PDG revealed it was preparing a pilot to integrate additional world pharmacopeias. PDG is currently made up of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, with the World Health Organization acting as an observer. Together, the groups have harmonized and maintained 29 general chapters, plus 46 excipient monographs, since PDG began operations in 1989. The expansion pilot is intended to drive global pharmacopoeial convergence.

PDG reviewed applications to join the pilot expansion against criteria that required pharmacopeias to have approaches and policies equivalent to the existing members, apply selected International Council for Harmonisation quality guidelines such as Q2, Q3C and Q3D as principles for standard development and implement all harmonized general chapters and monographs…