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Industry vehemently opposes Ayush dept’s new draft rule providing additional detail on labels of ISM

MUMBAI (PB): The Ayurveda, Siddha and Unani (ASU) industry has strongly opposed the provisions enlisted in the draft rule 161 issued by the Department of Ayush which requires all the ASU manufacturers to provide additional details on the labels of Indian Systems of Medicine (ISM) covered under the patent or proprietary ASU therapies.

Expressing concern over the draft, the Ayurvedic Drug Manufacturers’ Association (ADMA) pointed out that the whole idea of adopting this provision is not only pointless but also will lead to unnecessary confusion within the industry. The industry has expressed its concern to the department at a joint meeting held on June 13.

As per the draft notification, issued in March this year, all the ASU manufacturers will have to compulsorily 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 on the label.

According to Chandrakanth Bhanushali, general secretary, ADMA, “It is not possible for us to incorporate both scientific as well as official name on a single label along with all the ingredients which can range from 60 to 90 at times based on the products. Most importantly, to incorporate all of them in a single label we will be forced to reduce the font size which will further lead to violation of weight and measurement act. In our representation, we have clearly explained our position to the Ayush department which has agreed to have further discussion on this matter.”

He pointed out that the industry does not want the government to make this rule mandatory as they fear that if implemented it will have strong implications on the growth prospect of the industry.

“We really appreciate the sentiment of the government which is aimed at sensitising the patients at large. However it must be understood that the demand they are making should also be reasonable and feasible as well. We strongly believe that this move will neither help the industry nor consumer as it will only create more confusion among all, due to the congestion on the label. Moreover if this rule comes into force, not only will the industry suffer as it will be required to adopt lot of changes in the labelling of ASU drugs but even the consumers will not have any benefit out of it,” Bhanushali pointed out.

Having said so, ADMA stressed that their only point of contention is that this rule should not be made mandatory. He assured that the industry is open to other options and will incorporate the botanical name of the drug along with the official name ‘wherever possible’ provided that there is enough space for the same. The department of Ayush has agreed to have a detailed discussion on the same with the stakeholders to get final opinion and is expected to meet industry again in mid-July to finalise the matter.

Industry is hopeful that the government will consider their request and take a stance that is in the best of the interest of the industry at large. It is understood that the government had earlier also tried to implement this rule some 10 years back which was later scrapped after facing strong objection from the industry.

Discussion

One thought on “Industry vehemently opposes Ayush dept’s new draft rule providing additional detail on labels of ISM

  1. Rule 161 deals with the labeling packing and limit of alcohal has clear provision for the medicines which has the large number of ingredients in that pericular formulation in its second paragraph.Hence the statement is totally misleading.
    The argument of ADMA is not palatable due to the reasons that the API which is the only publiction of standards and appears at Sl.No.54C&54D of the firest schedule and adopted for the testing of ingredients present in the formulation claimed at label of the product, does not deal with the plant as a whole but provides the standerds of the individual parts of the plant required to be used in the product.AFI mentioned at Sl.No.54A of the first schedule deals with the details of manufacturibg method also does not deal with the planrt as a whole and clearly mentions the part of the plant required to be used in peticular formulation.Rule 161 very clearly desires to have the true list of ingredients on the label.Unless the parts of the plants uaed in the product is mentioned on the label it is impossible for an analyst to identify the presence of that peticular substance present in that part of the plant , in the formulation claimed at the label .For example Elaichi seeds and ealaichi plant will not have the same chemical standerd.Unless it is mentioned on the label that the perticular syrup contains the seeds of elaichi, standerd mentioned for the leaf of elaichi will make that syrup pass for the presence of elaichi if tetsed for its chemical standerds despite of the fact that it may not be containing its seed.
    First schedule of the drugs and cosmetics Act itself needs scruitiny as the names of the standered books appearing in the schedule does not have any mention of its publcation details.It may not be out of context to mention that these bokks are originally in indian languages including sanskrit and they have difference in their publication,translation and iterpretations despite of the fact that the name of the book is the same but published by various publishers based on the available manuscripts found in different libraries in differnt places.
    Therefore the governance is required to consider the general welfare of the common man and make the drugs of ASU with reproducible pharmacopoeial standereds and prevent the profit makers taking shelter in the loopholes of law by introducing further more strict provisions.This will not only allow to reamain the genuine and honest industry of Ayurveda,Siddha,Unani(ASU) into the market but also gain the global credibility of the ASU drugs.

    Posted by Janardan panday | June 30, 2012, 7:23 pm

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