EU may revise guidelines for Indian herbal drugs
The European Union is looking into its norms to allow marketing of Indian herbal drugs in its member countries, reports Jeetha D'Silva.business Updated: Nov 01, 2007 22:48 IST
The European Union (EU) is looking into its norms to allow marketing of Indian herbal drugs in its member countries, following prolonged negotiations between Indian and European regulatory authorities.
DC Katoch, deputy adviser Ayurveda, department of Ayurveda, yoga, Unani, Siddha and homeopathy (Ayush), said he is hopeful about a quick resolution. "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 was convened to study the issue. Representatives of the government were also present at the meeting to put forward India's view. The working committee will submit its report shortly and 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 had 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 that 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 the "15-year usage in the EU" norm.
Moreover, most of the herbs used in the products were not indigenous to Europe.
"We call this a trade barrier against producers of herbal medicines in other countries," said Ranjit Puranik, CEO of herbal drug maker Shree Dhootapapeshwar and honorary general secretary of the Ayurvedic Drug Manufacturers Association.
"It also denies consumers the right to have products of their choice," Puranik added.
Herbal drug manufacturers here feel 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 them to herbal drugs as well?" asks Puranik.
Ravi Prasad, president and chief executive officer of Himalaya Drug, 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 harmonised 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," said Prasad.
Earlier this year, a high-level committee from the EU visited India and started a review process in a bid to address India's concerns.
India is hopeful that the concerns of Indian industry would be resolved, opening up the European market.