As the European Union and the government of UK introduced Traditional Herbal Medicinal Products Directive (THMPD), restricting unapproved traditional herbal medicines in the region, the most affected group is a few million users of the time tested Ayurveda drugs in Europe and also the growing Indian Ayurvedic industry. It is not the reservation against Ayurveda that created the catastrophe in Europe but the lack of proper understanding of this 5,000-year-old medical system of India, which is always confused with herbal medicine. So, the responsibility lies with the government of India to authentically present the case before the European authority to distinguish Ayurveda from herbal drugs. Unfortunately, government of India despite the fact that the country stands to lose on its Ayurveda exports with the Directive, could neither present its case in the right way nor explain the time-tested healthcare values of Ayurveda as its delegation representing local industry and the Department of Indian Systems of Medicines did not do their homework before leaving for Europe, laments Dr Vishal Gulati, chairman, International Ayurveda Foundation (IAF), in an exclusive interview to C H Unnikrishnan of Pharmabiz.com in London.

This is the first time an international forum has been constituted for Ayurveda, as there is an intense need to get the Indian healing system recognized in the European Union. In this context, could you elaborate on the real impacts of THMPD to Ayurveda use in Europe and how the Foundation plans to fight against this?

As the European Union's current draft of the Traditional Herbal Medicinal Products Directive (THMPD) is announced and going to be implemented, we feel that Ayurveda is one of the already-in-use medicinal systems in the UK that is going to be grossly affected. Although the Directive is targeting the traditional herbal products, a number of Ayurvedic products will be restricted in the European market as Ayurveda is often confused with herbal medicines. So, it is required to be clarified to the Authority here that the Ayurveda is a centuries old and time tested medicinal system to get the same exempted from the ambit of the Directive. Otherwise, it would ultimately result in denying the fundamental rights of Ayurveda users in the region to opt for their choice of medication.

As you are aware, the Ayurveda Foundation is a non-profit NGO, which has been established to promote contact between stakeholders of Ayurveda and various organizations like the government and regulatory bodies in the European countries, and hopefully round the world, where Ayurveda is being promoted actively. Though the Foundation has no intention to upstage anybody nor does it have any commercial interest, it has been doing considerable work in this area. Currently it is fighting the cause of recognition of Ayurveda by the European Union countries, especially the government of UK and the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Foundation is learnt to be of the view that current draft of the THMPD introduced by the European Union is fundamentally unjust in several respects. Could you elaborate on this?

Yes, it is true that the Foundation is opposed to the requirement for a product to demonstrate 15 years safe use within the European Union. According to the current draft of the Directive, no traditional herbal medicines can be registered in the EU unless the product is proven with safe use for at least 15 years in the European Union. Whilst we do not in anyway question the need of those seeking to register traditional medicines to show 30 years of safe use, we consider that the sole consideration should be the quality of the evidence presented and not the geographical region from which it is obtained.

We feel that this requirement could restrict the ability of producers to introduce medicines from traditional systems like Ayurveda, which might have been used safely by people for many years but not yet introduced into European markets. And this is also unfair to both practitioners and the many thousands of European citizens who benefit from the use of Ayurvedic therapies.

The Foundation has already represented in the Herbal Medicines Stakeholder Workshop on the draft Directive to give its view. How useful was this Workshop as far as your objective is concerned?

The participation at the stakeholders' workshop on the draft directive on Traditional Herbal Medicinal Products was helpful in clarifying a number of issues, the Foundation remains unconvinced about the requirement of evidence of product safety for registration based on a geographical region where it was obtained. However, we are currently in the process of preparing a response on the Directives to be sent to the MHRA and other concerned authorities. What is more surprising here is that as far as the UK government is concerned, introducing this Directive is an aberration from its stated stance that to seek maximum flexibility in taking account of evidence from outside the European Union. However, there needs a much more clear explanation about Ayurveda to make the EU and MHRA officials convinced on the strength of this medicinal system.

There was an official delegation representing government of India visited UK to negotiate with the concerned officials on the Directive. What was the outcome of their meeting with the MHRA and other EU officials?

The Indian team, comprises of senior officials form the Department of Indian Systems of Medicine & Homeopathy (ISM&H) and few Ayurvedic industry representatives, visited Europe in February with the purpose of negotiating with the officials in European Commission (EC) as well as UK MHRA to save the Ayurvedic exports from India, which would suffer severely due to the Directive.

Though the Indian delegation was supposed to argue the country's case to make the EU and government of UK officials convinced about the time tested and widely accepted efficacy of Ayurveda, on the contrary, received a set of fresh questions to take home. As the government of India representation including officials Dept of ISM as well as the Indian industry was completely unprepared to do their job effectively, they could not succeed on their mission and had to take the EU questions back to home.

Interestingly, the government of India is still not responded to those queries despite the fast approaching deadline for implementing the Directive.However, we have decided to fight the cause by promoting the fundamental values of Ayurveda, as it is a matter of healthcare for thousands of patients abroad.