After almost eight years of discussion on the subject, the Department of Ayush has finally issued a notification approving the use of additives, preservatives, antioxidants, flavouring agents, sweeteners, chelating agents, etc in the Ayurveda, Siddha and Unani (ASU) drugs. Though the department had given the in-principle approval some time back, it issued the formal notification on last October 23 in this regard.

The notification will provide the much needed clarity on the use of additives, preservatives, antioxidants, flavouring agents, sweeteners and chelating agents in the ASU drugs. As of now, the use of these items in ASU drugs are neither allowed nor banned by the government. In the absence of a clear law in this matter, the drug authorities and the manufacturers have been at constant loggerheads as both of them interpreted the use of these items differently.

In the wake of harassment by the authorities in different states, the industry associations have been making representations to the department of Ayush to give clarity on the use of additives, preservatives, antioxidants, flavouring agents, sweeteners and chelating agents in the ASU drugs.

Given this background, the notification will prove to be beneficial to thousands of ASU drug manufacturers in the country as it will save them from the harassment of the licensing authorities in the states due to the absence of a law which approved the use of additives, preservatives, antioxidants, flavouring agents, sweeteners and chelating agents in the ASU drugs.

In the notification, the Ayush department said that these excipients will be allowed to use in the permissible limits as prescribed in the Indian Pharmacopoeia, Prevention of Food Adulteration Act, 1954, Food Product Order and Bureau of Indian Standard Act, 1986 and the manufacturers should comply with the respective quality specifications, not exceeding any specified limits of usage therein and except hydrogenerated vegetable oil.

However, if any excipient or additive or preservative, etc referred in the Indian Pharmacopoeia, Prevention of Food Adulteration Act, 1954, Food Product Order and Bureau of Indian Standard Act, 1986 is deleted at a particular point of time, this will also be deleted simultaneously from the use in ASU drugs.