ORDER

Whereas the Govt. Of India in the Ministry of Health and Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani , Siddha and Homoeopathy ( AYUSH) had issued an order of even number on October 10,2005 in exercise of the powers conferred under Section 33p of the Drugs and Cosmetics Act, 1940, Govt, of India in the Ministry of Health and Family Welfare, Department of Ayurveda. Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) directing the State Licensing Authorities of Ayurveda, Siddha and Unani (ASU) drugs to ensure full compliance by all ASU drug manufactures of the Provision of Rule 161 (1) and (2) relating to displaying on the label of the Container or Package of an Ayurveda, Siddha and Unani drugs, the true list of all the ingredients (official and botanical names) used in the manufacture of the preparation together with the quantity of each of the ingredients Incorporated therein.

Whereas representatives of Ayurveda , Siddha and Unani drugs manufactures have made a representation to the Central Government for modification in the above order to provide for printing of only the official names of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and dispense with the requirement of printing corresponding botanical names.

Whereas representatives of Ayurveda, Siddha and Unani drugs manufacture companies have also made a representation to Central Government that some grace period be provided to them to comply with the requirement of indicating the true list of all the ingredients together with the quantity of each of the ingredients incorporated therein so that the medicines already in the market are not adversely affected.

In view of the above representations, order issued by the Govt. of India in the Ministry of Health and Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) of even number dated October 10, 2005 is hereby modified to provide that State Drug Licensing Authorities of ASU drugs shall ensure full compliance by all ASU drug manufactures of Provisions of Rule 161 (1) and (2) relating to displaying on the label of the container or in a leaflet to be inserted in the package of ASU drugs. Both classical as well as patent Proprietary, official names of all the ingredients, used in the manufacture of that drug together with the quantity of each of the ingredients incorporated therein.
However, the manufactures shall continue to provide corresponding botanical names to the state Drug Licensing Authorities as part of the license application. Further that State Drug Licensing Authorities shall enforce the order in respect of all ASU drugs with affect from 1.7.2006. The remaining parts of the order of even number dated October 10, 2005 remain unchanged.

(SHIV BASANT)
Joint Secretary to Government of India