Pharmabiz
 

STANDARDS FOR AYURVEDA

P A FrancisWednesday, April 5, 2006, 08:00 Hrs  [IST]

Ayurveda as a system of medicine has been in practice in India for centuries but its growth as an industry has commenced only a few years ago. This was mainly on account of the inherent weaknesses of this system of medicine and lack of initiative by its practitioners. Because of this, there are just a dozen Ayurveda companies which follow somewhat good manufacturing practices while there are thousands indulging in traditional ways of producing these medicines. At the same time, there is a sudden spurt in demand for Ayurvedic products from the US and Europe, two major markets, in recent years. Indian Ayurveda industry is not able to cash in on this international opportunity as the regulatory authorities in these countries are insisting on standardisation of raw materials and dosage forms as in the case of modern medicine. Absence of a basic manufacturing standard in this sector is another handicap. A recent report in the Journal of American Medical Association regarding high toxic metal contents in some of the Indian Ayurvedic preparations has highlighted this dilemma. Absence of adequate scientific documentation is, probably, the fundamental problem and most serious limiting factor faced by this sector from the very beginning. The recent initiative by the Union health ministry is the first serious attempt to address this issue. The Department of AYUSH has initiated elaborate studies, mainly toxicity and metal content analysis, of about 5000 herbal raw materials commonly used by the country's ayurveda units. Currently, these raw materials with no uniformity in quality are procured from divergent sources resulting in sharp variations in product efficacy. The study which may take two to three years, will be carried out by four designated centres in different parts of the country. The government has sanctioned an assistance of Rs 10 lakh per year to each of these centres and the centres will analyze about 500 samples every year. The Department has also commenced a programme to lay down standards for herbal extracts with the help of ISM industry. Initial target is to prepare standards for 30 herbal extracts to be completed during this year and three leading Ayurveda companies are associated with this project. Another interesting project is to identify Material Safety Data Sheet of natural solvent systems. The objective is the standardisation of water and hydro alcoholic extracts in drugs and the target is to standardise 50 drugs in an year starting from 2007. The health ministry's plan to standardise 100 fast moving Ayurveda products will give another big push to this sector. A problem confronted by the exporters of Ayurveda products is absence of herbal monographs in Indian Pharmacopoeia. The decision by the health ministry last year to include 10 herbal drug monographs in the new edition of Indian Pharmacopoeia, 2006 is yet another step in the right direction. All these regulatory support from the government will have meaning only if the medium and small players also adhere to quality concerns of the government.

 
[Close]