Union government is working towards mandating clinical trials, pharmacovigilance and post marketing surveillance for the Ayush sector. It is also working with the Vijnanabharati, an organization for the development of Swadeshi Sciences to create a network using information technology to compile clinicians data.
It will provide information of the Ayush physicians prescription recommend for treatments. These would be made available on a dedicated Ayush portal which is under development. A meta- analysis of the clinicians data will help to create a convincing aspects of evidence-based medicine in Ayush therapies.
Clinical trials, pharmacovigilance and post marketing surveillance and Ayush portal would require additional financial and human resources. Currently, the central budget available for the sector is less than 5 per cent of the total allocation towards healthcare. In order to take the first step in this direction, the Central Council for Research in Ayurveda and Siddha (CCRAS) has commenced nation-wide training across its 72 labs in the country in the areas of clinical trials which would automatically make the industry adopt standardized manufacturing system and scientific documentation. Once the industry professionals are trained, it would be much easier to have the process in place, Dr Geeta Krishnan, organizing secretary, 4th World Ayurveda Congress and head, department of integrative medicine, Medanta Medicity, told Pharmabiz.
One of the key features at the 4th World Ayurveda Congress, being held in Bangalore between December 9 and 13, 2010 is the presence of 300 international delegates of the total 4000 people from US, Europe, Sri Lanka, Australia and Japan among others. The Congress is bringing together 43 international buyers and Indian sellers who are leading Ayurveda formulation companies. “We expect this interaction to be converted into a business proposition with revenues being generated over 5- 6 years. Ayurveda belongs to India and therefore, we are preparing the small and medium enterprises an opportunity to enter the world markets. This would create the need for high quality and accurate documentation of production practices, going through the mandated clinical trials, pharmacovigilance and marketing surveillance, Dr Krishnan added.
Moreover these moves would help allopathy doctors to prescribe Ayurveda drugs. Although the Supreme Court has ordered that Ayurveda and allopathy physicians should refrain from prescribing each others drugs, yet there is a clause which allows independent state governments to take a call on this. Maharashtra and Punjab physicians prescribe both Ayurveda and allopathy medicines. In a few months, we could see more doctors from other states take on the same, he said.
A visible trend in the Ayush sector is the advent of the herbal food supplements which are developed with standardized multi ingredients.
However, the big challenge is the lack of evidence-based medicine in the Ayush sector. Herbal drug companies are unable to communicate to the community about the evidence-based research. This would be possible only if the Ayurveda industry goes for drug trials which could prove the safety and efficacy of medicines for particular disease conditions. Therefore the government of India should ensure that these human studies and pharmacovigilance are mandated at the earliest, pointed out Dr Krishnan.