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Pharmexcil to focus on reviving exports to EU in the aftermath of THMPD enforcement

Suja Nair Shirodkar, MumbaiTuesday, October 9, 2012, 08:00 Hrs  [IST]

In an attempt to revive poor exports of ayurvedic products to the European Union (EU), the Pharmaceutical Export Promotion Council of India (Pharmexcil) will soon be taking a delegation of select ayurvedic manufacturers to Europe. Through this initiative the council aims to provide a platform to the Indian exporters for advocating their cause with respect to the Traditional Herbal Medicinal Products Directive (THMPD) with the regulatory officials and other EU based companies.

The meeting, which is expected to be held early next year, comes at a crucial time when the industry is struggling to sustain its market in Europe, in the aftermath of the implementation of the THMPD in the EU since May 1 this year. According to Pharmexcil, the ayurvedic and herbal exports to Europe has adversely affected after the enforcement of the THMPD.

Under the THMPD, 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 to apply for a product for traditional use, the company should provide sufficient data to prove that it has been in use for a minimum period of 30 years and 15 years within the EU. However, a transition period of seven years is 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.

Dr P V Appaji, director general (DG), Pharmexcil pointed out that dwindling exports to EU nations is a matter of great concern that needs to be taken care of. “We need to review our strategies and press upon the regulators to ensure them that the products that are manufactured in India are of highest quality. In the light of the stagnant growth of the ayurvedic exports to Europe, there is an urgent need to find a middle ground to address this matter soon so that the ayurvedic export industry is not affected,” he said.

Dr Appaji further informed that as of now most of the companies are selling the ayurvedic products as either nutraceuticals or food supplements to escape the directive which is slowly but effectively killing the ayurvedic exports.

 
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