India
Non-Complying Ayurveda/Siddha/Unani Drug Producers To Lose License
By Ministry of Health and Family Welfare, India
Oct 25, 2005, 21:43

The manufacturers of Ayurveda/Siddha and Unani drugs now stand to lose their license in India if they fail to comply with good manufacturing practices notified under the Drugs and Cosmetics Rules 1945. The Department of AYUSH, Ministry of Health, India, while issuing the notification, directed all the State Drug Licensing Authorities of Ayurveda/Siddha and Unani, to take action against the non-complying manufacturers of these drugs, by revoking their licenses.

The State Licensing Authorities have also been asked to ensure full compliance by all manufacturers of these drugs to strictly follow Rule 161 (1) and (2) relating to display on the label of the container or package of Ayurveda/Siddha and Unani, the true list of all the ingredients (both official and botanical names) used in the manufacture of the preparation together with the quantity of each of the ingredients used. In case, the list of ingredients used is long and cannot be mentioned on the label, the same will have to be indicated in a leaflet to be inserted in the package.

Also the container of a medicine shall clearly display the warning i.e. �caution: to be taken under medical supervision�, if the list of ingredients contains any substance specified in schedule E(1) of the Drug and Cosmetics Rule 1945. If non-compliance is found, the State Authorities dealing with the licensing of these drugs will immediately cancel or suspend the license of the defaulting manufacturer, under Provision 159 of the Drugs and Cosmetics Rule 1945.

The Department has made it clear that adherence to good manufacturing practices is essential.

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