EU likely to revise guidelines for imports of Indian herbal drugs

EU likely to revise guidelines for imports of Indian herbal drugs

Mumbai: The European Union (EU) is looking into its norms to allow marketing of Indian herbal drugs in its member countries, following prolonged negotiations between the India and European regulatory authorities.

D.C. Katoch, deputy adviser Ayurveda, department of Ayurveda, yoga, Unani, Siddha and homeopathy (Ayush), says he is hopeful of a speedy resolution to the issues brought up by the government.

“We have had several rounds of discussions with the authorities and many things (concerning herbal medicines manufactured in India) have been cleared."

Last week, a working committee appointed by the EU convened to study the matter. Representatives of the Indian government were also present at the meeting to put forward India’s point of view on the subject. The working committee will submit its report shortly and subsequently a decision is likely to be taken.

In 2004, the EU issued a directive stating that companies wanting to export traditional herbal medicines to the EU must submit evidence to prove that the product has been in “medicinal" use for at least 30 years preceding the date of application, including 15 years within Europe.

The directive was issued in an attempt to ensure only products that met stringent quality parameters would be sold in EU countries.

Given that the EU did not allow the import of herbal products (except supplies to individual patients following face-to-face consultation) prior to this directive, herbal drug producers are unable to meet this requirement of “15 years in use within the EU".

And many of the herbs used in these products are not indigenous to Europe.

“We call this a trade barrier against producers of herbal medicines in other countries," says Ranjit Puranik, chief executive officer of herbal drug maker Shree Dhootapapeshwar Ltd and honorary general secretary of the Ayurvedic Drug Manufacturers Association.

“It also denies consumers the right to have products of their choice," adds Puranik.

Herbal drug manufacturers here say that safety concerns about products manufactured in markets such as India have been overplayed.

“Look at the Indian industry’s presence in the US. If we can meet quality standards set by the US Food and Drug Administration for pharmaceutical products, can’t we extend the same to herbal drugs as well?" asks Puranik.

Ravi Prasad, president and chief executive officer of Himalaya Drug Co., a major producer of herbal medicines in India, expects the EU to develop an alternative route for manufacturers of herbal medicine who cannot meet the 15-year usage in the EU ­criterion.

The Indian herbal drug industry believes that the only way around these issues would be the creation of a common technical document with quality standards. “The guidelines need to be harmonized internationally to facilitate quicker registration of herbal medicines and should be based on proving validity, efficacy and safety (of herbal medicines) through rigorous scientific tests," says Prasad.

Earlier this year, a high-level committee from the EU visited India and started a review process in a bid to address the Indian government’s and industry’s concerns.

The delegation visited the Maharishi Ayurveda Products manufacturing unit in the New Delhi suburb of Noida, the regional research laboratory of the Council for Scientific and Industrial Research in Jammu and Arya Vaidyasala at Kottakkal in Kerala to examine standardization and quality control of Ayurveda products in India.

Both the industry and the government are hopeful that after the visit and the recent expert committee meetings, the concerns of the Indian industry are resolved, opening up the European market for Indian ­players. “There is a huge market for herbal medicines in Europe. With the change in regulation, we will be able to enter these markets and offer the medical fraternity access to effective complementary and alternative medicines," says Himalaya’s Prasad.

There are currently about 123 herbal manufacturers who are registered with the Pharmaceuticals Export Promotion Council. However, India currently accounts for less than 2% of the global herbal products market, which is estimated to be worth more than $71 billion (Rs2.8 trillion).