The Hindu Business Line : `More testing, quality control needed in ayurvedic drugs'

Give the rise in popularity of Indian system of medicine, standardisation and quality control have to be brought in besides ensuring that therapeutic dosages do not contain toxic materials. This can be established through laboratory tests, which the Centre has already initiated.

Kochi , Jan. 10

BANNING of some preparations of herbal medicines from India by certain foreign countries seems to have been done without carrying out meticulous scientific evaluation and study and hence, is not backed by strong evidence, according to Dr K. Anil Kumar, Member of the National Council of Indian Medicines and National Joint Secretary, Ayurvedic Drug Manufacturers Association.

Speaking to Business Line, he said that such propaganda campaigns would have negative impact on the image of the ancient system of medicine besides adversely affecting those practising it.

While admitting that there is no system to establish the toxic levels in ayurvedic drug formulations where metals are a component, he said that the metals are used after removing toxicity and converting it into oxides and other forms.

In fact, there are seven to 101 stages of processing for shodhana (purification) and marana (conversion) depending upon the metal and its usage. All these processes are given in ancient ayurvedic texts/scriptures such as Rasarajatharangini and Rasaratnasamuchayam.

The use, volume to be used in the drug formulations, and the dosages are specified.

Administration of drugs containing metals such as mercury, iron, lead, and mica, depends upon the ailments and the dosage is clearly spelt out.

These drugs are given for short durations and by and large in combination with other medicines such as rasayana and ghritham, he said.

Therefore, if the drugs are prepared strictly as per the directions given in the ayurvedic texts and administered strictly adhering to the dosages specified, they would be safe, he added.

There is a saying in ayurveda that if "poison is given to a patient in a specified dosage by a physician it would act as a medicine, but when taken without the physician's advice it would function as a poison."

In most cases, people buy and consume ayurvedic medicines over the counter without the advice of the physicians. Often, such people land in trouble, he said.

Of late, with the increase in popularity of Indian system of medicine and the rise in demand following the shift towards the traditional system of medicine, drug-manufacturing units have mushroomed. Commercialisation has, thus, taken place on a large scale. This has resulted in compromise with the quality.

Given this scenario, standardisation and quality control have to be brought in besides ensuring that therapeutic dosages do not contain toxic materials.

This can be established through laboratory tests, which the Centre has already initiated, he said.

As most of the drug manufacturers do not have such facilities, they have been outsourcing it.

Most ayurvedic medicines are manufactured from medicinal plants and herbs.

Depending upon the soil characteristics and geographical conditions, heavy metal contents in these plants and herbs would vary. Therefore, this is an important area where studies have to be conducted, he said.

The industry and the Government will have to initiate research on these issues and studies have to be carried out to establish proper scientific data and documentation.

The industry is now gearing up to counter the current propaganda campaign by setting up testing facilities in their units. The modern Atomic Absorption Spectrum (AAS), costing around Rs 20 lakh, is being installed in the laboratories of the drug-manufacturing units for testing the presence of heavy metals, he said.

The Union Government has already made testing of all ayurvedic medicinal preparations mandatory. Unani and siddha medicines would also be tested before they are approved for export. The new system has come into force from January 1, he said.

In addition to testing, the drug manufactures would be required to specify the metal content clearly in the display label of the package.

A warning notice has to be included if the levels of heavy metals are above permissible levels.

It has also been proposed to label herbal medicines for heavy metal content meant for domestic use by Ahmedabad-based Consumer Education and Research Society (CERS), he added.