Relax ban on Indian Medicine, herbal drugs

India is not taking European Union's ban on the sale of its over-the-counter Indian Medicine and herbal drugs across Europe from May 1 lying down. A delegation of officials from India's department of Ayush and commerce visited Brussels in end-January to persuade EU to relax its decision by another 10 years. According to EU's Traditional Herbal Medicinal Products Directive (THMPD), companies making herbal products will have to provide clinical data to demonstrate its safety through use of those products within the EU for a minimum of 30 or 15 years within the EU, and 30 years outside the Union.  

A senior Ayush official told TOI, "We've asked EU to change the clause into 30 years of use anywhere in the world or country of origin. In this way, we can show how Indian Medicine products have been used in India for hundreds of years, and are both safe and efficacious." 

India has also urged EU to accept ayurveda, siddha, unani and homeopathy Pharmacopoeia's specifications and quality parameters. 

An official said, "Pharmacopoeias are official government publications. It is a comprehensive database on Indian plants in use for their health benefits, which is endorsed by the Union government. It should be recognised by EU." India has also asked EU to extend the scope of THMPD to include non-herbal ingredients. At present, it deals exclusively with medicinal plants. "In ayurveda, we are also using non-herbal components like honey and ghee. We have asked EU to incorporate non-herbal materials as they are safe for use," the official said. 

He added, "We have told the EU that Indian monographs should be reviewed as an authentic source of information for evidence when assessing applications. Good Manufacturing Practice certificates issued by India should be recognised by EU. We've also asked for a separate legislative framework for Ayush medicines. EU should put in place a simplified application dossier for registration of traditional Ayurveda products." 

THMPD came into force in 2004, but was given a transition period till April 30, 2011. Under this regulation, all herbal medicinal products are required to obtain an authorisation to market within EU. Previously, there was no formal authorisation procedure across EU. Consequently, each EU member regulated these types of products at the national level. 

The only herbal medicines that are exempted from the provisions of THMPD are those unlicensed remedies that are made up for a patient following a consultation with a herbalist. 

India, however, has been negotiating with EU since 2004 on THMPD. Department of Ayush has been raising its "concern on the inappropriateness and unworkable nature of the THMPD to regulate the traditional medicinal products." India made a presentation on ayurveda to European Medicine Evaluation Agency (EMEA) in London in May 2006 on quality control of ayurvedic medicines. 

Subsequently, a three-member EU commission team visited R&D and manufacturing facilities of ayurveda in Delhi, Jammu and Kottakal, Kerala, in 2007. It presented its report in May, 2007, acknowledging that there was a regulated infrastructure of ayurveda in India in terms of qualified practitioners, hospitals, dispensaries and manufacturing facilities. 

News Courtesy: Times of India

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