A new directive on falsified medicines, which is under the consideration of the European Union (EU) authorities, may hamper exports of active pharmaceutical ingredients (API) from India to the European countries, it is learnt.

The EU directive on falsified medicines seeks the exporters of APIs to get a clearance certificate for each of its consignments from the domestic drug regulators ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU.

The European Commission had, almost six months back, put forward a proposal to have a written declaration by the exporting country attesting the ‘equivalence of standards’ to those of the EU. The drug regulator in the exporting country should also conduct regular inspection in the relevant exporters' site to ensure compliance with the GMP standards, informed Government of India officials.

If the new directive is implemented, the API exports to at least the 37 member states of EU will have to wait for a long time to get each consignments approved by the drug regulator. Keeping constant alert on the drug regulatory and policy developments in European Union (EU) following the seizure of Indian pharmaceutical consignments in its provinces, the Government of India has now acted in advance to express its concerns over the proposed regulation, according to sources from the Ministry of Commerce and Industry. The ministry has sought expert opinion from the Pharmaceuticals Export Promotion Council (Pharmexcil) on the issue.

“We have informed the ministry that the proposed directive is equivalent to a trade barrier for Indian companies, as the Indian drug regulator has to verify and certify each and every consignments meant for EU countries. Further, it is not clear how the drug regulator in India can inspect the manufacturing premises to ensure European GMP standards,” said Dr P V Appaji, executive director, Pharmexcil.

The Council has also suggested that the EU can follow the norms similar to what it has approved for the imports of generic formulations from other countries, that is to rely on third party auditors for inspecting the manufacturing premises and issuing certificates, in lieu to the new directive pertaining to the API imports. The Council's suggestion has been sent to the ministry and the Government of India would forward it to the EU through its Embassy in Brussels.

The EU directive is part of the EC's effort to curb the entrance of counterfeit medicines into the supply chain maintained in its province. At present, the Indian exporters of APIs are following the standards set by the European Directorate for the Quality of Medicines (EDQM) ensured through Certificate of suitability of European Pharmacopoeia monographs (CEPs). For exports to countries not coming under the authority of EDQM, the companies have to comply with the standards set by the individual countries, according to industry experts.

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 contamination related to the manufacturing process (including the manufacturing site and raw materials) are satisfactorily controlled using the requirements of the monographs.

According to a study released by Pharmexcil in October, 2009, India holds the highest number of CEPs at the time. 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.

Out of 48 countries globally pursuing the EU market, India received 21.47 per cent of CEP approvals from the 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. Out of the 2003 CEPs issued by EDQM for the top 10 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.