Despite the restrictions on the imports of herbal products imposed by the European Union on India, India's leading Ayurveda major, The Himalaya Drug Company has not been affected at all. The company continues to export to Europe, Philipe Haydon, CEO, Pharmaceuticals, The Himalaya Drug Company told Pharmabiz in an email interaction.

“While the Traditional Herbal Medicinal Product Directive (THMPD) has come into effect in May 2011, national competent authorities in the member states of the EU have been given one year to observe the directive. One year later, the national competent authorities will address the concerns at the national level towards implementing THMPD. After that, the member states will share their feedback with the European Commission (EC). The EC will take a final call on further compliance at its discretion. However, the EC has already made the directive effective in EU from May 2011. Since the national authorities have been given one year by the EU to work out a process, we will continue to export in the region,” he added.

When it comes to how Himalaya would be able to continue its presence in the region, it goes back to its safe, efficacious and scientifically validated products that are currently under the ‘well-established use’ category in the Europe. For example, Liv. 52 has been registered as a ‘speciality drug’ in Switzerland from 1991! Moreover, our products are manufactured in an EU-Good Manufacturing Practice (GMP)-compliant facility, which is one of the major criteria for a product’s quality, safety and efficacy standard under the new EU law for herbal products, pointed out Haydon.

Himalaya presently reaches out to customers in over 82 countries. Liv. 52 and Cystone are its fastest growing pharmaceutical products. Further, these are also faring extremely well in Russia, the Middle East and CIS countries.

In the wake of the ban by the EC, Ministry of Commerce has called upon herbal drug manufacturers to look at tapping opportunities in the markets of Africa and Asia. Himalaya forayed into South East Asia in 2003, and opened its first office in Singapore. Since then, the company has expanded operations to Cambodia, Malaysia, Mongolia, Sri Lanka and Fiji Islands and recently entered Indonesia. It has plans in pace to tap markets of Vietnam, Thailand and Philippines soon.

Globally, there is an increasing interest in complementary and alternative medicine. There is considerable interest evinced in natural therapies to treat diabetes, hypertension and obesity. As a result, demand for herbal product are gaining momentum. In countries of South East Asia, the use of herbs for medicinal purposes already exists. But any form of traditional medicine is not accepted on face value. Customers are seeking well-researched and credible alternative medicine. This is where Himalaya comes in as its development process and herbal pharmaceuticals undergo years of research. The drugs are formulated adhering to allopathic protocols, which include mutagen and toxicity texts and clinical trials, stated Haydon.

In order to be able to sell proprietary medicine in any country, a company needs to apply for license and adhere to present regulations. The application is a long process, which requires the company to submit product and clinical trial reports on every drug. Moreover, the licensing application fee is extremely high, which is often a constraint. The company’s team of experts in the International Regulatory Affairs department ensure that the company required licenses are in place to market our products in particular regions.