EU ban on herbal medicines

India has, so far, failed to get any assurance from the European Union to reconsider its ban on Indian herbal medicines even though the issue was raised at the EU through the official channel several times.The ban has come into effect from May 1, 2011, following a new EU regulatory procedure that was approved seven years back.

According to the EU Traditional Herbal Medicinal Products Directive, a herbal medicine company needs to demonstrate the safety and efficacy of herbal medicine through traditional use for at least 30 years, out of which 15 years should be within the EU.

The directive came into force in 2004 granting seven year transitional period to all unlicensed herbal medicines to comply with the directive's requirements. The seven year period ended on April 30, 2011. Consequently all unlicensed herbal products which were marketed in the EU now have to be either registered as traditional herbal medicinal products or get marketing authorisation as regular medicinal product, or carry on as dietary supplements. Products sold as dietary supplements had never made any health of medicinal claims in any way but were always marketed under a very restrictive environment.

With a large number of Indian companies failing to fulfil the requirement, the doors to the European market is shut for Indian herbal medicine, at least for the time being. However, there is no restriction on Ayurvedic supplements.

“The Union Commerce Ministry and the Department of AYUSH have requested the EU to reduce the trial period. The EU said it would look at the issue. But no assurance has come,” Anil Kumar, Secretary in the department of Ayurveda, Siddha, Unani and Homeopathy told reporters here.

Upset over the developments, the Indian AYUSH doctors and companies say the move would deprive millions, from the benefits of ayurvedic drugs. In 2008, India exported Dollars US 53.1 million worth of herbal ingredients to European Union.

Meanwhile, the Department of AYUSH has also set up a working group that monitors the international media on India’s traditional system of medicines. There is an immediate response to any negative or incorrect information which is followed by a detailed report to the media house concerned.

Courtesy : The Hindu