The Hindu Business Line : EU headache brews for traditional drug makers

FOR once may be the formidable Chinese traditional medicine sector ought to join hands with its Indian counterpart to ward off "perceived entry barriers" into the European Union. Come 2005 and traditional herbal medicinal products would be put through a stringent framework of regulations, including having to register themselves as medicines, in order to enter Europe as a single market.

A host of home-grown companies in the traditional medicine segment, such as Dabur, Himalaya, Baidyanath, Zandu and Maharishi, hitherto enjoying an unhindered access to the European market, stand to be affected by the European Council's directive. Rules to the directive are in the process of being framed and domestic companies are out on a limb trying to tone down the directive's fine print. And even the Chinese, despite a better detailing system, stand to face the ramifications of this directive, the popularity of their medicines notwithstanding.

The crux of the directive is that it seeks to establish a harmonised legislative framework for traditional herbal medicinal products. And in the absence of sufficient scientific published literature for several herbal medicinal products, the ostensible reason for the directive is to ensure the safety of its consumers. However, the traditional medicine industry points out that this could be worked around to become an "unreasonable trade barrier" for a burgeoning segment.

The Dabur Research Foundation Director, Dr D.B. Anantha Narayana, points out that while it is laudable to protect public health from fly-by-night operators in the traditional medicine segment, genuine players are also likely to get hit by the directive that lays priority on publishing data. "Consider Chywanaprash, which comprises 42 herbs. With 10-odd companies producing the product in India, will all of them have to compile data on all 42 herbs, besides a consolidated profile on the final formulation or product? Treating traditional medicine like an allopathic drug is not comparable; besides it would require huge investments by individual companies."

Rueing the absence of an Asian platform to address the issue, he points out that in Europe, for instance, there is the European Co-operative for Herbal Medicines.

Meanwhile, the Indian industry has had meetings with the Department of Indian Systems of Medicine and Homoeopathy and urged the officials to actively pursue the issue with the European Union. An important parameter that the industry wants changed is the safety record provision - every product needs to have a proven safety over a 30-year period anywhere in the world and 15 years in the EU.

A `healing' visit

TO drive home their point, the Department of Indian Systems of Medicine and Homoeopathy (DISM&H) and the domestic industry are preparing to take a delegation to the European Union member countries next month. The delegation is likely to visit Brussels, Holland, Italy, France and the UK, DISM&H sources said.

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