Indian exports of bulk drugs to European Union (EU) is growing at a higher pace, as the country has bagged the highest number of Certificate of suitability of European Pharmacopoeia monographs (CEPs), of late, according to a study released by the Pharmaceuticals Exports Promotion Council of India (Pharmexcil).

According to the study, out of 48 countries globally pursuing the EU market, India received 21.47 per cent of CEP approvals from The European Directorate for Quality Medicines and Healthcare (EDQM), followed by its closest competitor Italy (11 per cent) and USA (10 per cent). Almost 136 companies have received approval for CEPs from EDQM accounting for more than 200 different molecules.

Apparently, the bulk drug exports to European Union reached to more than 27 per cent of India's total bulk drug exports in the year 2008 and is growing at a compound annual growth rate of 18.38 per cent for five years, reveals the study.

India's share in grant of CEP's reached 30.5 per cent in July 2009, from 11.6 per cent reported in 2006, demonstrating the country's strengths and aggressiveness in adhering to global quality standards. Out of the 2003 CEPs issued by EDQM for the top ten countries consisting of India, Italy, USA, Germany, China, France, Spain, Switzerland, Japan and Israel from 2006 to July 2009, India owns 539 certificates even as Italy has 274 CEPs, USA 254 CEPs, Germany 228 CEPs and China 194 CEPs.

The EDQM grants CEPs to manufacturers or suppliers for substances for pharmaceutical use when they have demonstrated compliance with the monographs of the European Pharmacopoeia. The certificate guarantees that all the impurities and potential contaminations related to the manufacturing process (including the manufacturing site and raw materials) are satisfactorily controlled using the requirements of the monographs.

The certificate will open a vast market of almost 90 countries to the manufacturer including the 37 member states of the European Pharmacopoeia Convention and the EU. Other countries which have also chosen to recognise CEP granted by EDQM includes Algeria, Argentina, Armenia, Aruba, Australia, Bahrain, Belarus, Bolivia, Botswana, Brazil, Bulgaria, Chile, Columbia, Dutch Antilles, Ecuador, Georgia, Ghana, Hong Kong, Indonesia, Israel, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Malawi, Malaysia, Mexico, Moldova, Morocco, New Zealand, Nigeria, Oman, Palestine, Paraguay, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Taiwan, Tanzania, Tunisia, Ukraine, United Arab Emirate, Venezuela, Yemen, Zambia and Zimbabwe.

Moreover, CEP certification procedure is aimed at facilitating and simplifying exchanges between the partners during the product registration to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia.