BARRIERS TO HERBAL EXPORT.

Indian exports to the western countries are being increasingly threatened with various non tariff barriers raised by the regulatory bodies of these nations. Pharmaceutical exports from India to the US, Europe, Africa and Latin America are already in trouble on account of the entry barriers imposed by the European and US governments during last two years. Now, India's ayurvedic exports to Europe are going to get hit quite badly from 2011 if the European Union is successful in enforcing the Traditional Herbal Medicinal Products Directive (THMPD). The directive is expected to take effect from April 2011 and can seriously bring down the Indian herbal exports to these countries. 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 procedure.

The demand for herbal products and ayurveda system of treatment have been on the rise in Europe and North America mainly because of the growing Indian population. A large number of ayurvedic preparations are being thus exported to these countries over the years. These exports were never subjected to strict regulatory scrutiny for several years in these developed countries as they were regarded as food supplements and nutraceuticals. But after detection of certain substandard herbal and ayurvedic products with heavy metal contents in recent years, the regulatory authorities in these countries have become cautious. THMPD was framed after such quality problems were noticed. India lacked quality guidelines for herbal products for long and there are thousands of small and tiny units manufacturing these products but observe no standards in procuring raw materials and in manufacturing. This approach needs to be changed and manufacturers of these products have to adopt modern scientific practices if they have to remain in the market and sell their products abroad and in India. National Medicinal Plants Board under the Department of Ayush, in collaboration with the WHO's Country office for India, has issued a comprehensive guideline on Good Field Collection Practices for India. The Department has also started an 'Ayush' certification as a mark of quality standard approved by the Quality Council of India. These are positive initiatives by the Central government and the units of all sizes have to fall in line sooner than later if they have to survive in the competitive environment.

Source : pharmabiz.com