Karnataka Ayush industry with over 170 manufacturers is upset over the recent 5th amendment to the Drugs & Cosmetics (D&C) Rules. On November 26, 2012, the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) revised the D&C Rules and referred it as the 'D&C 5th Amendment Rules 2012'. It calls for inclusion of certain additional details of ingredients used on the labels of all formulations.

Now the industry in Karnataka view these amendments as unnecessary leading to greater confusion and chaos.

"The 5th amendment is impractical. There was no reason for the modification and the effort is futile. Though it would be useful from the consumer point of view, for the industry it is creating major difficulties. The revision will be implemented  only in November 2013 and therefore we expect some rethinking on the art of the government on this matter," said JSD Pani, president, Karnataka Indian Medicine Manufacturers Association.

Of the 170 Ayush drug units almost 90 per cent are in the small and medium sector and these rules have added to more anguish, Pani added.

"The government has done it again despite all the recommendations presented by experienced professionals. We are not clear about the government's intention for  new labelling norms. There should have been adequate consultation with the stakeholders to look for a creative solution to accommodate additional details. A viable solution would be if the label stated 'for detailed compositions of herbs to visit the company website'.”

It would then be the onus of the industry to update information as per the 5th Amendment. In no way is the industry against the Amendment but it is now seeking for an alternative option to the labelling norm, pointed out a senior ayurveda expert.

"As label is the primary source of information for any product before a consumer takes a call in selecting it, we only need to mention the minimum details. While the department's move is for increasing the clarity among consumers, many manufactures may resist in mentioning details with botanical names, parts used,   true quantity and form of ingredients used in the formulation basically due to lack of space in the primary label as the products are composed of multiple ingredients either of patented/proprietary ASU or classical medicines," stated Dr Baidyanath Mishra, Head-Regulatory Affairs, Natural Remedies.

"Under Rule 161 of the D&C Rules, 1945, the true list of all ingredients along with its botanical names, root, part of leaf and bark along with the form in which it is used needs to be mentioned on labels of all herbal formulations. But ayurvedic formulations often have multiple herbal ingredients. There is no space on the label to accommodate additional information,” said Dr Vijendra Prakash, senior manager - Domestic Regulatory Affairs, The Himalaya Drug Company.

Moreover, when product license applications are issued after stringent scrutiny of herbs used which is closely examined and approved by technical experts at the department of Ayush, incorporating all these details on the label again seems insignificant. If customers need find out about the part of the herb used in a particular formulation, they could always get in touch with the company, added Dr Prakash.