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, according to a Pharmabiz report.
Expressing its reservations 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, noted the report.
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, the report pointed out.
Chandrakanth Bhanushali, General secretary, ADMA said: “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, the report informed.
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, the report added.