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EU/India joint inspections

This article was originally published in The Gold Sheet

Executive Summary

There may soon be joint inspections of drug manufacturing sites conducted by EU and Indian inspectors under the framework of the European Pharmacopoeia procedure of certification under the terms of a recent agreement. Signatories included the European Directorate for the Quality of Medicines and Healthcare (EDQM), the Ministry of Health of India, and the Indian Pharmacopoeia Committee (IPC). Under the terms of the agreement, drugs manufactured and approved for sale in either market may be subject to expedited approval. Officials announced that the other potential areas of collaboration include the development of harmonized chemical and herbals monographs, common training activities in the pharmacopoeial field, scientific cooperation by inviting pharmaceutical scientists to the EDQM, and observer status for the European Pharmacopoeia to the Indian Pharmacopoeia Commission. EDQM Director Susanne Keitel and EDQM official Dr. Claude Coune of EDQM met with Dr. Anbumani Ramadoss, India's Minister of Health and Family Welfare, Dr. Surinder Singh, drugs controller general of India and Dr. G.N. Singh, the incoming scientific director of the Indian Pharmacopoeia (IPC) in New Delhi and IPC's headquarters in Ghaziabad, India to finalize the agreement



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