Several of India's API manufacturing units are keen to go in for compliance as per European Union GMP. They are increasingly seeking Certificate of Suitability or the Certificate of European Pharmacopoeia (CEP) from European Directorate of Quality of Medicines (EDQM).

The EDQM is prepared to give an 'observer status' to India. In this regard it is now only awaiting for a formal application from India. The 'Observer Status' will allow India to become one of the participants in the activities of European Pharmacopoeia.

Early this year, EDQM represented by Dr Susanne Keitel, director EDQM and Dr Claude Coune, head, Publications & Multimedia, EDQM met up with Dr Surinder Singh, DCGI and Dr GN Singh, secretary and scientific director, IPC to discuss the potential areas of partnership. These included elaboration of chemical and herbal monographs, development of joint inspections of production plants under the framework of European Pharmacopoeia procedure of certification.

Further, alliances have been sought for the promotion of common training activities in the pharmacopoeia field and scientific cooperation by inviting pharma scientists to the EDQM to facilitate information exchange.

The European market is throwing open several opportunities for Indian pharma companies in the API space. CEP filing is a preferred route of filing for APIs which are there in the European Pharmacopoeia, said Vijay U Kshirsagar, executive vice president, Corporate Quality Assurance & Regulatory Affairs, Unichem Laboratories, Mumbai which has a EDQM inspected and approved API manufacturing unit at Roha in Maharashtra.

The new guidelines on Process Validation by US FDA are going to be official soon. There will be a paradigm shift in the manner in which process validation is currently addressed and Indian companies should be prepared for it, Kshirsagar told Pharmabiz.
EDQM has already inspected 157 sites in more than 22 countries including India, China, Mexico and Canada. Out of the 110 inspections, deficiencies were found in 19 inspections, which led to the suspension of CEP.

EDQM approval is not an enormously expensive affair but subsequent cost of variation is quite high in Europe. The inspection team from EDQM will constitute representatives from any of the European countries and therefore Indian API units will need to be well prepared in all aspects of the compliance. The EU regulator inspects the plant based on ICH Q7, which is a harmonized tripartite guideline on GMP for API.

Going by India's capability in contract manufacture, pharma plants here are preferred not only for economies of scale but for their huge scientific brainpower and quality driven manufacturing plants approved by several international regulatory agencies including EDQM. India is also known to have an aggressive domestic API market, with relative low cost of manufacture and innovation.

"Since we are armed with such strengths, we need to maintain the customer expectation with simultaneous compliance with EU and US FDA certification and an all time readiness for audits. There is also a need for continual improvement in regulatory compliance that will give us an edge in the global arena, said Kshirsagar.

Some of the EDQM approved facilities in India are Unichem Labs in Maharashtra, Shilpa Medicare and Global Calcium in Karnataka, Suven, Alembic, Aurobindo, Shasun Chemicals and Divi Labs in other states.