Consistent inaction and misdirected effort by the government of India together with the lack of co-ordination amongst Ayush industry stake holders has left the Indian traditional medicine sector in the lurch with the imposition of the European Union's Directive on Traditional Medicine Product Directive (TMP).

“The government and the industry have not been able to propagate the credibility of the ayurveda. The big issue is that the government, despite several efforts, was unable to bring the industry stake holders to carry out a meaningful exercise in adhering to the required EU requirements,” Ranjit Puranik, chairman, Pharmaceutical Export Promotion Council for Ayush and managing director, Dhoot Pappeswar told Pharmabiz.

“Just like the information technology industry which ran into a crisis in the US market a few months ago, we saw a consensus across associations and the  industry that  helped the government of India to take a stand to solve the issue. In the case of Ayush industry, the attempt was mired in arguments instead of being able to arrive at a consensus. Now that EU has defined parameters, Ayush industry needs to look at ways to find pathways to market the products in the region, adhering to the stringent norms of the EU TMP directive,” they said.

“Meeting market requirements in terms of product quality and safety are  crucial for Ayush industries to be successful in the future. Right now there is no approval mechanism in place to address the EU needs. While the EU insists on information categorized on a ‘product’ basis, Indian Ayush sector operates on a  ‘system’ basis for its 2,000 formulations. Every product needs a safety clearance with labels certifying quality norms. There cannot be a compromise,” stated Puranik.

According to  Raghuvir Singh Rathore, Head—International Regulatory Affairs, The Himalaya Drug Company, the ban came into effect from May 1, 2011, seven years since the issuance of the directive. The industry will be affected. One of the parameters states that herbal products need to be in traditional use outside EU for 30 years and 15 years within the EU, before they can be marketed in these countries. “However, we believe that duration of use alone does not guarantee safety and efficacy. Empirical evidence that monitor the quality of the product can determine its safety and efficacy. These include product clinical trials, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) certifications, all of which determine that only safe and efficacious products are reaching the market.”

“Moreover EU has never claimed to have understood ayurveda. Therefore the industry had every chance along with the Union government to prove its practices in production was ethically correct. Indian industry should have geared up to convince the EU panel that its traditional medicine did not follow a product approach but viewed it has a holistic science. For instance, Ashwaganda and Amla are combined in Chyawanprash which claims on its  label that it could be used to prevent and treat several diseases for different age-groups. This was objected by the EU. Instead they insisted on clearances  for every batch of herbs used in the drug. When we see such kind of barriers which widens the gap to convince and communicate, it becomes difficult for the industry to work in such markets. Therefore the  government and the industry opted to issue licenses to ayurveda physicians for associating with the industry to provide more clarity on the science of ayurveda,” Puranik said.

If the government of China could engage working groups on Traditional Chinese Medicine, India failed to put in place such a mechanism for the EU to have a better understanding of safety and quality in the Ayush drugs, pointed out Puranik.

Viewing the EU directive as a major trade barrier for the herbal medicines, Dr DBA Narayana, Consultant, Regulatory Issues, said that this move leaves the herbal medicine sector in a crisis.

Several efforts were made by the Karnataka Indian Medicine Manufacturers Association (KIMMA) has urged the Department of Ayush to convince the European Union Directorate about the quality and image of India’s herbal and Ayurvedic products to dissuade them from going ahead with the ban on the sale of Indian Ayurvedic and other herbal medicines.“We should now work together to ensure that the European Directive is revised,” stated JSD Pani, president, KIMMA.