Metal test must: the catch, only for global market

While the government mentioned unsatisfactory agricultural and cultivational practices and environmental pollution as the reason for testing the drugs in its October 2005 order, many believed it was prompted by the damaging study published by JAMA and conducted by Harvard Medical School. With the global ayurvedic products market touching $14.2 billion, there was reason enough for the government to take note of the Harvard report. In India, the market is estimated to be worth Rs 2,300 crore, with a 15 per cent annual growth rate.

Under the government order, manufacturers have to declare on medicine labels that the heavy metals present in the drugs are ‘‘within permissible limits’’. The manufacturers have to either set up in-house testing laboratories or get the drugs tested by approved laboratories.

But it is the fact that the same is not required of drugs being sold back home that shocks many. ‘‘Does it mean that we are guinea pigs? How is it different from foreign companies coming to India to experiment on us? We are treating ourselves as second-class citizens; it’s anti-national,’’ says Dr C M Gulati, WHO drug expert and editor, MIMS India.

When animal products and heavy metals are integral to ayurveda, why conceal the facts from consumers, asks Dr Vasanta Muthuswamy, Deputy Director General and Incharge of Alternate Medicine Research in Indian Council for Medical Research (ICMR).

The government, however, says ensuring safety in export products was a priority. ‘‘These are requirements of the importing countries, so we had to fulfill them,’’ says Shiv Basant, Joint Secretary, AYUSH. ‘‘But we have said in the order that the process of self-certification will be extended to the country in due course.’’ The government is not even ready to set a deadline for this, its reason being the size of the industry. ‘‘There are about 9,000 manufacturing units and some of them are so small they can’t afford to purchase Rs 25 lakh Atomic Absorption Spectrometer. We will have to do it in a phased manner. Maybe one or two years,’’ says Basant.

Besides, almost everything is sold under Brand Ayurveda, whether mystic ayurveda or massage ayurveda…‘‘Who is checking whether the formulations in the market conform to the 54 textbooks of ayurveda which have been listed in the Drug and Cosmetics Act. Classically there are 2,500 formulations, about 2,250 of which are herbal-based, 150 are of mineral origin and 50 of animal origin,’’ adds Dr Gulati.

Pure herbal formulations cannot have heavy metal content more than 10 parts per million (ppm) for lead, 0.30 ppm for cadmium, 10 ppm for arsenic and 1ppm for mercury. The permissible limits are as per WHO and FDA guidelines. In case of mineral-based drugs, the manufacturers have to follow rigorous purification or detoxification measures. ‘‘In classic text Sodan and Maran cleaning and purification is important. If not followed properly the steps can make metal harmful,’’ Basant explains.