After dilly dallying on the issue for a long, the Department of Ayush has finally approved the use of additives, preservatives, antioxidants, flavouring agents, sweeteners, chelating agents, etc. in Ayurveda, Siddha and Unani (ASU) drugs.

The Ayush department's decision in this regard will prove to be beneficial to thousands of ASU drug manufacturers in the country. It will save them from harassment of licensing authorities in states in the absence of a regulation approving the use of additives, preservatives, antioxidants, flavouring agents, sweeteners and chelating agents in ASU drugs.

As there is no rule permitting the use of these items, the drug control authorities and the manufacturers have been at constant loggerheads with both interpreting their uses differently.

The Ayush department has made it clear that these ingredients will be allowed to use in 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.

Only natural colouring agents as permitted under Rule 26 of Prevention of Food Adulteration Rules 1955 will be used for ASU drugs and additionally colours permitted under Rule 127 of Drug and Cosmetics Rules 1945 shall be used for proprietary ASU drugs as defined in sub clause (i) of clause (h) of section 3 of Drugs and Cosmetics Act, 1940, not exceeding any specified limits of usage therein.

Preservatives and colouring agents shall be mentioned on the label for the information of the consumers as required under rule 161 of the Drugs and Cosmetics Rules, 1945. Additives used in various processes and in formulating dosage forms shall be mentioned clearly with quantities used, in the application for licenses and the record for the same shall be maintained by the manufacturers.

Manufacturers should be responsible to ensure rationality, safety and quantity of various excipients used in the formulation. 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 for use in ASU drugs.