The Union Government is expecting “a likely solution” to issues regarding EU (European Union) licensing norms — impacting Indian exports of traditional ayurvedic and other herbal medicines — during the bi-lateral discussions scheduled on May 17 and 18.
Over 8,000 small and medium units across the country have been affected with the EU imposing stricter licensing norms for such medicines from May 1, this year.
According to the Ayurvedic Drug Manufacturer's Association (ADMA), the new norms — requiring herbal medicines sold over-the-counter to have either a Traditional Herbal Registration or a marketing authorisation — have reportedly stopped Indian exports to Europe.
“The matter is expected to come up in the India-EU bi-lateral trade discussions scheduled later this month. We are hoping to strike a likely solution to the issue,” a Union Government official told
Stop in sale
According to Mr Chandrakant Bhanushali, Honorary General Secretary of ADMA, “Sale of traditional ayurvedic and herbal medicines in EU has come to a halt since May 1. We have heard that the Centre has taken up the issue with the EU.”
While, ADMA puts the expected size of the business with EU to Rs 50 crore, industry sources put the size to be around Rs 500 crore.
In 2004, the EU had come out with a Traditional Herbal Medicinal Products Directive (THMPD) to regulate the traditional medicinal products and other Indian systems of medicines in member countries.
The Department of AYUSH, under the Union Ministry of Health, has since then been negotiating with EU to relax the various norms.
According to Mr Bhanushali, AYUSH products exported from India are mainly sold as dietary supplements and not medicines. Compliance with EU directives will result in high cost occurrence for Indian companies on account of higher registration charges.
Need for recognition
ADMA has also pointed out to the need for recognition of Indian monographs, since only seven medicinal plants have registered monographs under the THMPD. The plants so registered are common ones and have limited usage in AYUSH medicines.
The Department of Ayush, meanwhile, in a meeting with the European Commission (EC) has pointed out the need for a separate legislature along with the recognition of Indian monograph as an authentic source of information. A request to reduce the cost of registration of products under THMPD has also been made.