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Policy Matters

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

Bengaluru (PB): 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.

 

Discussion

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

  1. I fail to understand the motive of this untrue and misleading statement.As per the present definition of ayurveda unani sidha drugs the drugs covered under the section 3(a) of the D&C Act needs only the reference from which it has been manufactured, as the parts used in the formulation is already mentioned in AFI which is published by the Govt. of India.The names of the books mentioned in the schedule of D&C Act required to be followed by the manufacturers is lacking the complete reference in respect to its publication and year of publication to pin point.As most of these books are in Sanskrit and, translators in different languages has made many plants controversial as the plants/drugs mentioned in Sanskrit are used differently in different agro- climatic and socio -linguistic zones/areas of our diversified Indian culture even the Sanskrit names are one not to mention that in the absence complete reference of schedule books of D&C Act any one is free to publish its own book by the same name as the more than one manuscripts by the same name is available in various libraries with various com entries and variations in shloka(Original verses) apart from our learned translators translates them in their own fashion in the absence of any authenticating authority for these Sanskrit books..However making formularies by the government is a good effort to pin point the scientific identity of these plants by fixing one botanical name and part to be used in particular formulation. hence it is important to have this name on label in order to facilitate the identification of the presence of these drugs scientifically in laboratory conditions for testing and preparation of their monographs for pharmacopoeial standards.Government has created the pharmacopoeial standards (for some and not all)and made it mandatory for testing of the products floated in market by pharmaceutical companies in order to ensure the availability of quality products to the users which is the primary duty of governance.Now the pharmacopoeial standerds of the plants/herbs used in the formulation available in the market varries as per the parts of the plant used in preparation.Root,stem, stem-bark,heart wood,flower fruit extracts (extracted by the chemicals suppose to produce serious health hazards) etc. of the same plant is not one in its quantitative chemical ingredient.Hence if the parts used are not mentioned on the labell the identification for the presence of that particular part of the plant in formulation can not be verified in laboratory and manufacturer will have the escape rout for its bogus medicines floated in the market for maximum profit.Government should not compromise with the regulation of these kind of activities under practice by any one in order to ensure the availability of high quality drugs to common man in market for which he pays the hard earned money.
    It is amazing that the persons who are traditionally protecting and always protected the credibility of the system are now seem to be hell bent to provide disgrace by escaping from standing to test their products and provide the true list of ingredients at label for few bucks.God may bless these people and provide some humor to protect the system in its originality naturality and scientifically proved on well accepted scientific parameters to stand the demand of time

    Posted by Janardan Panday | May 28, 2012, 4:59 pm

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