India's ayurvedic and herbal exports to Europe are going to get seriously affected with the enforcement of the Traditional Herbal Medicinal Products Directive (THMPD) by the European Union from May 1. It was known to everyone in the industry since last year that the directive was to take effect from this year and some had already initiated steps to tackle the new scenario. The directive does not seem to be entirely a non tariff barrier as there has been certain serious quality issues relating to Indian herbal exports in the past. THMPD is stated to have framed to provide a regulatory approval process for herbal medicines entering the EU countries. Since October 2005, herbal medicines in most EU countries are being controlled under the EU regulation, 2004/24/EC. This new rule stipulates that a company intending to export its herbal medicines to EU needs to demonstrate the safety and efficacy of the same 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 and 15 years in use within the EU. A transition period of seven years is, however, given to companies to take necessary corrective measures to comply with the new EU norms as many of their products may not pass the new registration procedures.
One can say that by implementing THMPD, the EU is denying its citizens,especially Indians living there, access to an ancient system of healing. These medicines had helped millions in EU over past few decades for treating chronic disorders where modern medicine failed to produce results. A Research conducted for the Medicines and Healthcare Products Regulatory Agency in 2009 showed that 26 per cent of adults in the UK have been taking herbal medicine in the last two years from health food shops and pharmacies. The EU ban can be, thus, termed as a direct attack on patients’ right to seek alternative medicine. Be that as it may, absence of a standardized manufacturing system and scientific documentation are two fundamental drawbacks of this sector from the very beginning. The recent move by the Department of Ayush to conduct elaborate studies, mainly toxicity and metal content analysis, of about 5000 herbal raw materials commonly used by the country's Ayurveda units is thus a right initiative. Currently, these raw materials with no uniformity in quality are procured from divergent sources resulting in sharp variations in product efficacy. There are about 8000 small and tiny units spread across the country producing herbal drugs in the traditional ways. The most critical factor for the universal acceptability of herbal and plant medicines is to ensure their quality, safety and efficacy by way of clinical trials. Only that can build credibility of these drugs as it will scientifically prove their therapeutic benefits. It is in view of this, the Department of Ayush has come out with a set of draft guidelines for good clinical practices for Ayurveda, Siddha, Unani drugs and other traditional medicines. If the ayurvedic industry is serious about achieving a sustainable growth, the units have to adopt all these scientific norms in their manufacturing practises instead of crying over the EU ban.