As of May 1st, 2011, the European Union has categorically banned sale of any form of unlicenced traditional drugs in the EU market including Traditional Chinese Medicines (TCM). The Indian Ayurvedic Drugs export figures which standsÂ Rs 50 crore to Western Europe seems to have ceased to exist with this swift stroke of the EU scalpel, but the repercussions of this directive , we feel, will have far-reaching consequences.
According to the Traditional Herbal Medicine Product Directive, a drug which needs to be marketed, in EU has to meet three criteria. To get the licence to market in EU, firstly, the drug should be manufactured in an EU-good-manufacturing-compliant facility. Secondly, the drug has been in use for at least 30 years, of which, at least 15 years have to be in an EU country. Also, clinical evidence to prove the safety and efficacy of our products has to be furnished.
A BBC news module on the directive.
Read a related article in the Economic Times here