European Union (EU) has finally conceded to give the Indian companies a fair chance to represent their case at all the official meetings relating to the on going matter on traditional medicines under the Traditional Herbal Medicinal Products Directive (THMPD) that took effect from May 1 this year.
It is understood that the EU which relented to the repeated demands of the Indian industry is seriously considering to grant India with the observer status under which Indian representatives will be given the chance to be privy to the proceedings of all the meetings only if the Department of Ayush. takes the required steps. The decision to grant the long pending demand for 'observer status' comes as a huge relief to the EU based export dependent Ayurveda, Siddha, Unani & Homoeopathy (ASU&H) industry which has been going through a very rough phase since the implementation of the Directive.
As an observer, India would be allowed to be part of the meetings and deliberations that will take place to discuss the future course of this issue, a privilege which is at present enjoyed by China alone. Having observer status will grant India the privilege to allow one government representative and one representative from the industry to be present at all the EU meeting relating to the controversial EU directive.
The EU's Traditional Herbal Medical Products Directive which was passed in 2004 states that every herbal medicines that is sold over the counter will need to have either a Traditional Herbal Registration or a marketing authorisation.
According to Shashank Sandu, treasurer, ADMA, “The implementation of THMPD has severely affected the market dynamics of the export of ASU drugs which now had come down to almost nil. But what is more alarming is the developing trend of the Indian manufacturers exporting traditional medicines as either food supplements or nutraceutical products which is jeopardising the existence of the traditional medicines completely. The government have been supportive of our cause and we hope that they will take the necessary steps at the earliest to address this burning issue.”
Sources inform that since the herbal medicines pose no significant risk to the public under previous and present legislation, when policed properly, it is unreasonable to completely ban the products just because they are not registered. Sandu stressed that THMPD is just a ploy to circumvent and stall the exports to the EU creating non tariff trade barrier for the non EU based traditional drug exporters.
Industry demanded the government to utilise this opportunity to set the wheels running to raise this issue and defend Indian exporters position at the EU by seeking observer status as soon as possible to prove that the Indian ASU drugs are efficacious and safe for use.