In a bid to ensure strict implementation of GMP requirements in alternative medicine segment, the Department of Ayush, Ministry of Health has asked all state drug-licensing authorities to cancel the manufacturing licenses of all Ayurveda, Siddha and Unani drug units if they are not GMP compliant.
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 along 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 of good manufacturing practices is essential.