Ayush to give data for herbal drugs exports

The Department of Ayurveda, Siddha, Unani and Homeopathy (Ayush) of the Central Government will soon provide safety and efficacy data of all the herbal drugs exported from the country to various drug regulatory agencies around the world, to solve the recurring issue of ban imposed on India's herbal drugs citing lack of adequate safety and efficacy profile.

The Department of Ayush will submit comprehensive data on each of the exported drugs to the International Regulatory Cooperation on Herbal Medicines (IRCH), a recent initiative of the world health organisation(WHO) to develop and implement common technical guidelines and standards for herbal and complimentary medicines sold in WHO member countries.

IRCH will dissseminate the data to all the regulatory agencies in various WHO member countries. These countries will have to consult the respective importing destination, in issues such as imposing ban for safety and efficacy issues.

The Department of AYUSH has asked the exporters to furnish details such as composition of the exported drug, details of extract(s), solvents, ratio of extract to RM, heavy metal content, pesticide residue, microbial contents in a prescribed format. The Department will soon pass on the data to IRCH, which will create an electronic mechanism to disseminate data to the regulatory agencies in various countries.

" The move is helpful in allaying the concern of the Western world over the contents of Ayurveda, Siddha and Unani drugs exported from India. In the recent past, our herbal exports were affected due to the adverse propoganda on higher levels of metal contamination in some of our products. We have asked all our members who export their products to furnish details at the earliest to the Department of Ayush" said Ranjit Puranik, general secretary, ayurveda drugs manufacturers association (ADMA).

A few days ago, the department of health and ageing therapeutic goods administration of Australia (ADRAC) had published a warning notice to its citizens to be careful while purchasing herbal drugs imported from India and China, as it could contain unsafe levels of metal content. In February, last year, the health sciences authority (HAS), Singapore banned four Indian ayurvedic medicines manufactured by the Bangalore-based herbal major Himalaya, allegedly for containing harmful amounts of lead and mercury.

Following the Singapore authority, the medicines and healthcare products regulatory agency (MHRA) of the UK also issued a warning to its citizens. Health Canada and the UK, MHRA had banned a few ayurvedic products from India for the same reasons in the recent past, citing an adverse study report published in a reputed medical journal, the Journal of the American Medical Association (JAMA). Some of the drugs manuactured by India's leading herbal drug makers such as Dabur India, Himalaya and Zandu Pharmacuticals were banned by the regulatory agencies citing high metal content. Following this, the Government made it mandatory to test metal content in herbal drugs for exports.

Sources said India exports about Rs 600 crore worth herbal products every year, mainly herbal extracts. India's share in the global $60 billion herbal market is very low, since it is difficult for the manufacturers to standardise and develop quality and safety parameters and the data through clinical trials for herbal drugs, as done in the case of pharmaceutical formulations.