Brussels? bid to create a ?trade barrier? to Indian exports of herbal medicines to the 27-country European Union has prompted policymakers here to move the World Trade Organisation for mediation. The EU?s recent traditional herbal medicine product directive (THMPD) would practically make it impossible for most ayurvedic drugs here to be marketed in EU member countries after March 2011.
Companies like Himalaya Drug Company, Shree Baidyanath Ayurved Bhawan Ltd and Zandu Pharmaceutical Works Ltd market ayurvedic products in European countries.
The EU move has damaging economic implications for India as the country with 15,000 plant species is aggressively trying to expand its share in the $75-billion global market for herbal medicines, which is now dominated by China. India?s total exports of herbal medicines and medicinal plants come close to $1 billion.
The ministries of health and family welfare and commerce are acting in unison to legally challenge the EU directive. It may, however, take a few months to complete the documentation, a senior government official told FE. The commerce ministry has hired a legal agency and is preparing to prove that the directive is an ?unnecessary? trade barrier.
The THMPD, known as a ?draconian directive? in the Indian ayurveda circuit, mandates the manufacturer or the marketing agency to produce data related to the drug?s quality and prove that the drug has been in use for at least 30 years, of which at least evidence of 15 years in an EU country should be there, if it is to be marketed as a non-prescription product.
This will virtually bar the entry of new ayurvedic drugs from India to the EU market, as the industry here barely keeps documented history of such usage. Drugs failing to produce such data would have to undergo the full procedure that an allopathic drug has to follow by furnishing proof of efficacy, quality and safety?a process that could be too expensive for most Indian units to follow.
Further, even if one manages to furnish data of continuous use, the estimated fee for registration of one product with four ingredients could cost ?75,000 to 100,000 ($115,663 to $154,205), estimates Praful Patel of International Ayurveda Foundation. According to the UK regulator, Medicines and Healthcare Products Regulatory Agency?s own estimate, the average cost of preparing a single registration application for a simple, single-herb product could be close to ?40,000 ($61,542) before factoring in expenses needed to be incurred on good manufacturing practices upgradation. Globally, the herbal products market? which includes medicines–is valued at around $200 billion, almost 45% of it in Europe alone. Of this, the herbal medicines market is estimated at $75 billion, again Europe accounting for half of it. However, ayurveda constitutes a small part of the total herbal market, even though it is growing at an annual rate of 10-15% and is expected to maintain that growth rate for the next ten years.
