India has so far failed to get any assurance from the European Union to reconsider the ban on herbal medicines, even though the issue has been raised with the EU several times.
The ban came into effect on May 1, 2011, following a new EU regulatory procedure 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 the medicine through traditional use for at least 30 years, of which 15 years should be within the EU.
The directive, which came into force in 2004, granted a seven-year transitional period to all unlicensed herbal medicine manufacturers to comply with the requirements. The period ended on April 30, 2011. Now, all unlicensed herbal products, marketed in the EU, have to be either registered as traditional herbal medicinal products or get marketing authorisation as regular medicinal products, or carry on as dietary supplements. Products sold as dietary supplements make no medicinal claims and are marketed under a restrictive environment.
With a large number of Indian companies failing to fulfil the requirements, the door to the European market has been shut for them, 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, Department of Ayurveda, Siddha, Unani and Homeopathy, told reporters here.
Upset with the development, the AYUSH doctors and companies say the move would deprive millions of the benefits of Ayurvedic drugs. In 2008, India exported $53.1 million worth of herbal ingredients to the European Union.
The Department of AYUSH has also set up a working group to monitor the international media's coverage of India's traditional system of medicines. It gives immediate response to any negative or incorrect information, followed by a detailed report to the media house concerned.