The Department of AYUSH will soon form a technical committee to identify various pharmaceutical aids like preservatives and colouring agents that could be permitted in the manufacturing of Ayurveda, Siddha and Unani (ASU) drugs, by amending the Drugs & Cosmetic Rules 1945.

This decision follows a meeting held between representatives of the Ayurvedic drug industry and the government officials in New Delhi this week. Manufacturers had aired differing views on the required and permissible ingredients while reacting to the draft notification issued in this regard on August 10, 2004. The department would later decide further details of the technical committee, sources told Pharmabiz.

A long pending demand of the industry, the additives are considered essential to increase the shelf life and to improve the palatability of ASU drugs. As per the G.O. 907(e), the government intends to amend the rules for permitting use of pharmaceutical aids like preservatives, additives, anti-oxidants, colouring agents and flavouring agents in ASU drugs.

The amendment will also incorporate mandatory provisions on the part of the manufacturers to mention details of the preservatives and colouring agents on the label of the drugs, for information to the users. Other materials used in various processes and dosage forms shall also be required to be mentioned clearly with quantity in the flow sheets and records of the manufacturing units.

The notification had also mentioned that the manufacturers shall be responsible to ensure the rational and quantity of the various pharmaceutical aids used in the formulations.