India and China may together move the World Trade Organisation (WTO) against the European Union (EU) regulation on bulk drugs which may affect the current exports of Active Pharmaceutical Ingredients (APIs) from both the countries to Europe.
EU has changed the rules for importing active substances into EU for medicinal products for human use and the amended regulation would come into effect fully by July 2013. It would make mandatory the current good manufacturing practices (cGMP) certificate from the local authority for all bulk drugs exports.
Sources said the Commerce Ministry had already taken up the matter with the EU authorities as the directive is expected to pose serious challenge to the API exports and is meant to secure the EU pharma supply chain.
Under the technical barrier to trade (TBT) provisions, India can raise the issue at the WTO forum and it is learnt that India would all possibly make a joint statement with China at the next meeting of the WTO. China Chamber of Commerce had already written to Pharmaceutical Export Promotion Council of India (Pharmexcil) on the possibility of making joint representation, it is learnt.
China’s share in EU’s API imports is 12 per cent while India commands only two percent share in the API imports into the EU. Hence, China is going to be affected more than India.
The Commerce Ministry has also sought the opinion of the Bulk Drug Manufacturers Association over the issue.
Meanwhile, the industry representatives are also trying to take up the issue with Drugs Controller General of India (DCGI). Industry had pointed out that the DCGI was not authorized or conversant enough with EU GMP standards to issue certification. The companies will have to produce such certificates even after their manufacturing facilities and products (meant for exports) get all regulatory clearances directly from the EU drug regulatory authorities in that case.