European and Indian Pharmacopoeias Coordinate on Quality Standards

May 17, 2018

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

The European Directorate for the Quality of Medicines and Healthcare (EDQM), the European Pharmacopoeia Commission (Ph. Eur.), and the Indian Pharmacopoeia Commission (IPC) held a symposium on April 26 in Mumbai to discuss how the two pharmacopeias could work together to pool resources to improve quality standards for medicines and to harmonize activities.

The IPC has had Observer status since 2016 and has participated in Ph. Eur. Commission working groups. The symposium was attended by authorities and manufacturers of APIs.

An overview of reference standards policies and processes was presented as well as advice on how to interpret European Pharmacopoeia general chapters and monographs. To address the complex nature of global API sourcing, EDQM’s Procedure for Certification of Suitability (CEP), which offers industry and regulators a centralized procedure for accessing highly regulated markets, was discussed.

“The collaboration between the two Pharmacopoeias shows the commitment on both sides in making the best scientific resources available for the protection of health in India, in Europe and the rest of the world,” stated Susanne Keitel, PhD, director of EDQM, in a press release. “In today’s globalised pharmaceutical industry with complex supply chains, new risks and challenges, the cooperation and interaction with its Observers is crucial for the Ph. Eur. With the Indian pharmaceutical industry leading in the provision of high quality generics to the world, IPC is one of our most prominent partners,” Keitel said.

Source: