EU to stop import of herbal products

By May 2003, the European Council was supposed to have reached a consensus on a directive that seeks to regulate the supply of herbal products in the European Union market. Once implemented this -- in tandem with two other regulations -- could rob consumers of the choice of cheap, alternative products and represent a serious setback for preventive healthcare

 
By Vibha Varshney
Published: Thursday 15 May 2003

-- by may 2003, the European Council was supposed to have reached a consensus on a directive that seeks to regulate the supply of herbal products in the European Union (eu) market. Once implemented this -- in tandem with two other regulations -- could rob consumers of the choice of cheap, alternative products and represent a serious setback for preventive healthcare. The move would adversely impact India, too, which exported herbal products worth us $48.57 million to the eu during 2000-2001. "When the restrictions are in place, India might be relegated to the role of an exporter of only raw herbs," fears Balendu Prakash, director, Vaidya Chandra Prakash Research Foundation, Dehradun.

While the eu claims that the directives are being formulated to harmonise rules governing supplements, experts see a protectionist design in the proposed action. In this regard, the Health Sciences Institute, a Baltimore-based organisation promoting herbal products, alleges that a number of eu commissioners have direct links with international pharmaceutical companies which are threatened by herbal products.

Even as there is an air of uncertainty about the May meeting, the directives are slated for finalisation by 2004. They will, however, not be fully operative till 2009.
Controversial clauses The three directives suggested by the European Commission (ec) to control herbal products are the food supplement directive (fsd), the pharmaceutical directive (pd) and the traditional herbal medicinal product directive (thmpd).

fsd : This directive was passed as an eu law on June 10, 2002, but its effect may not be apparent till 2005-2009. At present, it limits ingredients and maximum dosages in food supplements. The rule is likely to omit 285 nutrient sources that are currently used in Europe.

pd : The first reading of this proposed law took place on October 23, 2002. It would cover all dietary supplements not controlled by the fsd . A drug regime would, therefore, apply and this will not be affordable for many non-pharmaceutical manufacturers who make supplements.

thmpd: Its first reading was done on November 21, 2002. It would enable fast-track legislation for eligible herbal products. But the number of products to be included in this category will depend on the pd 's definition of a medicine.

The fallout from the enforcement of these rules would be the imposition of a ban on the entry of natural products as food supplements into the eu market, since they are not listed in the fsd . They would also not be considered a traditional medicine unless already available for at least 10 years in the European market and 15 years in the country of origin. The only alternative left would be to register these products as a drug -- a protracted and expensive process.
India's case India has a rich traditional base in herbal medicine and its exports to the European region have registered a steady rise. For instance, the herbal medicine consignments to Germany have increased by 157 per cent between 1999-2000 and 2000-2001.

With the three directives in place, India would find it difficult to introduce new products in the eu market. As the market in India is unregulated, only a dozen or so products -- whose efficacy and safety can be proved scientifically -- would continue to be exported. "The regulations would be a stumbling block for new preparations," avers Vinayshil Gautam, professor, department of management studies, Indian Institute of Technology, New Delhi. "The move will protect Europe's domestic manufacturers by preventing the entry of Indian and Chinese products," says G G Gangadharan, vice-president, technical, Arya Vaidya Pharmacy (cbe) Limited, Coimbatore.

Damage control
According to experts, there is an urgent need for all the interest groups to join hands. But the department of Indian systems of medicine and homoeopathy (dism&h), under the Union ministry of health and family welfare, is cynical: "These are just businesspersons wanting to make profits," says L Prasad, joint secretary, dism&h.

It is opined that India's herbal products should be aggressively marketed in the eu till such time as the directives are fully operative. This would need regularisation of the sector within the country and a national plan to promote ism. Collaborations between herbal practitioners and allopathic pharmaceutical companies should also be promoted so that production and marketing facilities can be shared. Meanwhile, despite its general indifference, the dism&h has agreed to take a delegation to soft countries such as Hungary and spread awareness about ayurvedic drugs.

Though hundreds of amendments were made in the pd and thmpd during the first readings, no date has been fixed till now for the meeting in which the changes would be discussed. The amendments have to be accepted by the European Council. "This is a critical time for lobbying and pressures have to be maintained," points out Rob Verkerk, executive director, Alliance for Natural Health, Surrey, the uk.

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