With the European Union all set to implement the Directive on falsified medicines from July 2, 2013, the exporters in the country have urged the drugs controller general of India (DCGI) to initiate proactive action to exclude Indian exporters from the purview of this new EU Directive under which the active pharmaceutical ingredients (API) exporters have to submit quality certificates to the European authorities to prove the quality of their products.
As per the new EU Directive No. 2011/62/EU, which is aimed to prevent falsified medicinal products from entering EU from other countries, the APIs meant for medicinal products for human use require written confirmation for each API unit by the enforcement authorities of the exporting countries confirming compliants with GMP standards/rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc. effective from July 2, 2013.
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.
There is apprehension among the industry that this may hamper exports of API products from India to the European countries. So, the industry wanted the DCGI to take a proactive action so that this requirement is waved for those countries having equivalent rules for good manufacturing practices to those in the EU.
The EU Directive is part of the European Union's effort to curb the entry 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, industry experts said.
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.