European & Indian Pharmacopoeias set to maximise competencies of each other for high quality medicines
The European
Pharmacopoeia (EDQM) and the Indian Pharmacopoeia Commission (IPC) are working
to cooperate on quality control of medicines. Going by the importance of harmonization
to maximize the competence in every country’s drug manufacture capability, the
European Pharmacopoeia recognized Indian pharma's indispensability to the
global market.
The objective of the collaboration by the main pharmacopoeias of the world was to combine resources needed to make the best use of competences. It was here that the Indian pharma expertise was recognized as the key for international cooperation.
At a recently held symposium on the quality control of medicines in the context of the pharmaceutical legislation and regulatory requirements that exist in Europe and India, the discussions on the EDQM’s Procedure for Certification of Suitability or CEP to source APIs which is a strategic challenge for pharmaceutical companies was brought to the fore.
The CEP offers industry and regulatory authorities a centralized procedure that supports manufacturers in accessing highly regulated markets, like the European Union. There are currently over 4,200 valid certificates granted to manufacturers from around 50 countries covering more than 1,000 substances. Of these, 40% or 1,673 are granted to Indian pharma which is the highest globally for CEPs.
According to Dr. G. N. Singh, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, the European Pharmacopoeia represents an important step to supporting in further improving its capacity of protecting global health adhering to high quality standards. “Our collaboration with the European Pharmacopoeia shows the commitment of both organizations in making the best scientific resources available for the protection of health in India, in Europe and globally.”
European Pharmacopoeia Commission comprehended the contribution of India’s pharma manufacturing expertise in the production of generics and vaccines.
Currently, the European Pharmacopoeia includes over 2800 quality standards. The pharma industry with complex supply chains, new risks and challenges, is crucial for the Pharmacopoeia. With the Indian pharmaceutical industry leading in the provision of high-quality generics to the world, IPC is one of our most prominent partners, said Dr. Susanne Keitel, Director, EDQM, Council.
Practical advice was also given on using and interpreting the European Pharmacopoeia General Chapters and Monographs, together with an overview of the policies and processes used to establish Pharmaceutical Reference Standards.
There are thirty-nine members of the European
Pharmacopoeia Commission: Austria, Belgium, Bosnia and Herzegovina, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Republic of Moldova, Montenegro, Netherlands, Norway, Poland, Portugal,
Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, “the
former Yugoslav Republic of Macedonia”, Turkey, Ukraine, United Kingdom and the
European Union.
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