17 February 2011
By Kounteya Sinha
New Delhi, India
Wants Europe To Defer Ban On Over–Counter Med Sales From May 1
According to the EU’s Traditional Herbal Medicinal Products Directive (THMPD), companies making herbal products will have to provide clinical data to demonstrate its safety through the use of those products for a minimum of 30 or 15 years within the EU, and 30 years outside it.
A senior Ayush official said: "We’ve asked the EU to change the clause into 30 years of use anywhere in the world or country of origin. In this way, we can show how ayurveda and herbal products have been used in India for hundreds of years, and are both safe and efficacious."
India has also urged the EU to accept ayurveda, siddha, unani and homeopathy pharmacopoeia’s specifications and quality parameters. An official said, "Pharmacopoeias are official government publications. It is a comprehensive database on Indian plants in use for their health benefits, which is endorsed by the Union government.
It should be recognized by the EU." India has also asked the EU to extend the scope of THMPD to include non–herbal ingredients. "In ayurveda, we are also using nonherbal components like honey and ghee. We have asked the EU to incorporate non–herbal materials as they are safe," the official said.
He added, "We have told the EU that Indian monographs should be reviewed as an authentic source of information for evidence when assessing applications. Good Manufacturing Practice certificates issued by India should be recognised by the EU. We’ve also asked for a separate legislative framework for Ayush medicines. The EU should put in place a simplified application dossier for registration of traditional Ayurveda products."
According to EU norms, companies making herbal products will have to prove their safety through records of use for a minimum of 30 or 15 years within the EU and 30 years outside it. Indiaa has urged EU to change the clause into 30 years of use anywhere in the world or the country of origin. In this way, they can show how ayurvedic products have been used in India for hundreds of years