May 25, 2012

Dept of Ayush issues draft rules notification to list all ingredients with botanical names & quantity on labels


Nandita Vijay, Bengaluru
Thursday, May 24, 2012, 08:00 Hrs  [IST]
Department of Ayush’s guidelines on draft rules notification issued by the Drugs Consultative Committee dated March, 22, 2012 [GSR 249 (E)] has sought to provide the additional details to be mentioned on the labels of ISM  medicines covering Patent or Proprietary Ayurveda, Siddha and Unani (ASU) therapies.

The labelling as per the draft notification would need to list all the ingredients with official and botanical names for herbal ingredients along with parts used and form of ingredient, in which, it is used in the formulation, with its quantity.

The Association of Manufacturers of Ayurveda Medicines (AMAM) has taken serious objection to this move in a representation made on May 15, 2012. “Even if the manufacturers implement the same it may become impractical since the space on the label is just sufficient to comply with the current requirement of Rule 161 of the Drugs & Cosmetics Rules”, stated Pradeep Multani, Hon. Gen. Secretary, AMAM.

“While we appreciate the intent of the government to make the consumers more informed, there is a serious practical issue to include these details which the department of Department of Ayush needs to consider,” he added.

Most of the formulations in the Ayurveda texts are multi-ingredient. Even the Ayurvedic Formulary of India has provided that Analysis of Ayurvedic Formulations covered in Active Pharmaceutical Ingredient (API) Vol. I & II covering solids, semi solids and liquids has detailed the percentage of product containing up to 10 and above 20 ingredients, pointed out AMAM.

The label of Dashmularishta bottle falls short of writing the 62 ingredients and being a glass bottle, it is not possible to provide such a big bottle in a carton. “We fail to understand the necessity of this amendment to provide information on the label which is already submitted to the Licensing Authority during submission of manufacturing license application. The additional requirement regarding ingredients being asked for through this amendment is more of academic value to the subject expert and the consumers may not benefit from it. On the contrary, consumer know common names more than botanical names,” pointed out the Hon. Gen. Secretary, AMAM.

Classical ayurvedic products have limited f manufacturers. The industry is apprehensive on the amendment which is currently circulated as draft notification to seek comments.

In order to further, convince the Department of Ayush, the Association in its representation has insisted to give up or cancel the notification. It also went on to enclose a sample of the label for Mahasudarshan Churna as per the existing Rule 161 and modified one.

MahaSudarshan Churna manufactured by Dabur India Limited provided the Book Reference as ‘Ayurveda Sar Samgraha’. Besides providing details of the indications for which the churna, there was information on dosage, net weight, MRP, batch number, storage and shelf life along with a long list of over 100 herbs.

The Association views that the move to add extra information on the label would become counterproductive and may not serve the purpose.

“It is possible that this move is aimed to satisfy consumers needs and right to information. Providing additional on the label would add to cost and cause logistical problems. Creative solutions are needed to handle the issue. A viable move would be to make it mandatory for manufacturers to provide all details on their websites and mention this on the label,” said Dr DBA Narayana, an eminent pharmacist and regulatory expert.


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