The Ayurveda, Unani, Siddha and Homoeopathy (Ayush) manufacturers indulge in unethical business practices mainly due to the absence of a formal protocol on how traditional drugs should be tested for their safety, according to a market study conducted by the Chennai-based Centre for Traditional Medicines and Research Centre (CTMR).

Even if certain companies are willing to stand by the mandatory rules of clinical trials before their products hit the market, they are unable to proceed for the process as there has been no hospital identified so far as approved centre, says the study report.

This kind of appalling phenomenon is mainly seen in Tamil Nadu where most of the Siddha, Unani and Homoeopathy medicines and a good quantity of Ayurveda products are produced and exported. The department of Ayush had two years ago made it mandatory that all new traditional medicines had to undergo clinical trials before they were brought on to the market for sale and for export purpose.

Lack of protocols further results in the violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act (DMROA) 1954 which controls advertising of drugs in the country. Taking this serious situation in view, CTMR has wanted the department of Ayush to frame the protocols for clinical trials as early as possible, or else, the manufacturers’ exploitation over the public will continue.  Since the rule is connected with exports of products, the concerned authorities should act accordingly, said Dr T Thirunarayanan, secretary of the Centre. He said a host of Ayush companies in Tamil Nadu and in Kerala are engaged in unprincipled business practices because of CCIM’s delay in framing the protocols.

According to him, a large number of fake products under Ayush labels are being advertised in the media, especially in visual media for their promotion. This happens because of absence of proper rules to be adhered to while marketing the products. So, the government agencies should also monitor the marketing system adopted by these manufactures.

“The CCIM has to develop a set of protocols for safety testing as demanded by the Ayush department and strict enforcement should be carried out with regard to advertisements in media, both print and visual media. CCIM ethical committee should meet at regular intervals to inquire about patients’ complaints on ‘adverse drug reactions’ based on pharmacovigilance reports and serious adverse effect reports on wrong treatment. A strict monitoring and control should be made on the violation of the DMROA”, he says.