India’s API exports to Europe reach over 27%: Pharmexcil

Indian pharma exporters secure the highest number – 31% – of manufacturing quality certificates (CEPs) granted by EDQM during January – July 2009

More than 27% of India’s active pharmaceutical ingredient (APIs) or bulk drug exports in the year 2008 were destined to European Union, according to the new data released by Pharmaceuticals Exports Promotion Council of India (Pharmexcil) – the apex body under the Ministry of Commerce governing pharma exports in the country.

Indian pharmaceutical companies that exports to European countries are growing at a compounded annual growth rate (CAGR) of 18.38% for five years.

India received the highest number  or 21.47% of Certificate of suitability of European Pharmacopoeia monographs (CEP) – the quality bench mark for APIs granted by the European Directorate for Quality Medicines and Healthcare (EDQM) — out of 48 countries
globally. India is followed by its closest competitor Italy (11%) and USA (10%).

136 pharmaceutical exporting companies from India have received approval for CEPs from EDQM accounting for more than 200 different molecules.

Indian pharmaceutical exporting companies accounted for 31% of the CEP’s granted during January – July 2009.

In the first seven months of 2009 (Jan-July 2009), India’s share in grant of CEP’s reached 30.5% from that of 11.6% in 2006.

Indian pharma exporters received a total of 539 CEPs during the period January to July for the year 2009.India is followed by Italy which 274 CEPs and USA 254 CEPs.

What is CEP?

CEP stands for Certificate of suitability of European Pharmacopoeia monographs. COS (Certificate of Suitability) means the same, though often used is not the official acronym. The European Directorate for Quality Medicines and Healthcare (EDQM) grants CEPs to manufacturers or suppliers of substances for pharmaceutical use when they have demonstrated compliance with the monographs of the European Pharmacopoeia.
CEPs are equivalent to drug master files (DMFs) granted by US FDA as a quality benchmark for APIs exported to USA.  CEP 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 these monographs.

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.

EDQM issues Chemical CEP for active ingredients including organic or inorganic chemicals obtained by synthesis, extraction or fermentation, herbal drugs/ herbal preparations.

EDQM’s TSE CEP is issued for products with risk of transmitting spongiform encephalopathies e.g.mad cow disease. TSE  CEP which covers products of ruminant origin used in the preparation of active substances, starting materials, intermediates,reagents used in their manufacture: e.g. bovine serum albumin, enzymes, culture media, etc. and also for combination the two.

CEPs, however, doesn’t cover biotech products, finished formulations and human tissues derivatives are beyond the scope of EDQM’s certification procedure.

CEP’s are recognized by about 90 countries globally CEPs are recognised by all signatory states (37 members) of the European Pharmacopoeia Convention and by the European Union.

There are also other countries which have also chosen to recognise CEPs including 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.

Average time taken to obtain a CEP is about 18 months. The target time for initial assessment of a CEP application is 5 months. In most cases, the need for additional data is identified during this initial assessment. In that case, EDQM sends a request for additional information to the applicant,who has to respond within 6 months.

The target time for assessment of the response is 4 months, totalling the target processing time to 15 months.

Currently, the average time to obtain a new CEP for chemical purity is 18 months.