The Himalaya Drug Company is working closely with the Department of Ayush to arrive at a solution that will allow Indian herbal drug manufactures market their products in the European Union after the Traditional Herbal Medicinal Products Directive (THMPD) has imposed a ban from April 2011.
The company has a presence in several EU countries like Poland, Austria and Romania. The company has products that have been in use traditionally in EU for many years and hence may comply with the EU directive. Moreover, it also has an EU-GMP compliant manufacturing plant, which is another mandatory requirement under the directive.
A number of Himalaya’s leading therapeutic brands were launched decades ago and continue to be widely prescribed globally. These brands are already present in several EU countries and the Mutually Recognized EU nations like Switzerland, which may qualify them as Traditional Herbal Medicinal Product (THMP) under the new directive. “While we agree that the quality of herbal medicines must be established, we believe that the criteria must not be that of traditional use but rather scientific studies and empirical evidence that proves safety and efficacy of the product,” Raghuvir Singh Rathore, head, International Regulatory Affairs, the Himalaya Drug Company told Pharmabiz.
A stringent national regulatory framework for herbal medicines, with comprehensive guidelines complimenting Traditional Herbal Medicinal Products Directive (THMPD), will help companies comply with international quality norms, he added.
THMPD was established to provide a regulatory approval process for herbal medicines in the EU. Since 30 October 2005, herbal medicines in the EU / UK are now controlled under the EU regulation, 2004/24/EC. Under this regulation, a company needs to demonstrate the safety and efficacy of the herbal medicine through traditional use. It demands that for a product to apply for traditional use registration, it should provide sufficient data to prove that it has been in use for a minimum period of 30 years of which 15 years should be within the EU.
According to the directive, a transition period of seven years was given to companies in order to take necessary proactive corrective measures to comply with the requirements as many of their products may not pass the new registration procedure. These products may lack evidence of safe use at least for 15 years in the EU, but may have a long history of use outside Europe, said Rathore.
Presently, in the EU, most herbal products fall under the food supplement/nutraceuticals category. The global demand for nutraceutical ingredients is set to grow by 5.8 per cent annually in 2010. There is huge potential for probiotics, soy additives, lycopene, lutein, sterol-based additives, green tea, glucosamine and chondroitin, and coenzyme Q10. In this segment, China and India will be the fastest growing markets, while the US will remain the largest.
Ayurveda is gaining attention within the global community. Its holistic approach, natural and mostly safe methods have the potential of addressing several unmet health needs. Mainly, the Europeans and Americans have emerged as strong supporters of this age-old Indian wisdom, said Rathore.
India is an important market in the EU herbal drug space. UK is aggressively promoting Indian and Chinese medicine. There is a growing demand for complementary and alternative medicines and Ayurveda is gaining popularity here. However, the demand is essentially for herbal products which are validated by modern scientific research, he said.
As far as market size of herbal medicines is concerned, Germany, France, Italy and UK have a sizeable share of 38, 21, 8 and 5 per cent respectively.