The Department of Ayush has launched a process to overhaul the system of determination of shelf-life of ASU drugs based on the recommendations of the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) to improve the overall quality of these drugs in the market.
The method of revision of shelf-life of ASU drugs, being finalised, is part of a number of measures initiated by the department to improve the quality of ASU drugs in the country. The revised list of drugs with expiry and shelf-life will be notified soon, sources said.
Provision of Retail Sale license for ASU drugs containing hazardous raw materials (as per Schedule E-1) has also been initiated on the recommendation of ASUDTAB. Making regulatory provision for mandatory compliance to Good Clinical Practice (GCP) for clinical trials on ASU drugs was another measure being initiated on the recommendations of the ASUDTAB.
The department also has initiated steps to develop and notify model laboratory practices for testing of ASU drugs. Amendment of the lists of authoritative texts of Ayurveda, Siddha and Unani is initiated under the First Schedule of the Drugs & Cosmetics (D&C) Act is another move underway, also on the recommendation of ASUDTAB, sources said.
Listing out the measures taken during the current year, a senior official of the department said, the duties of six technical officers appointed under Drugs & Cosmetics Rules 160 E and 160 F were redefined for inspection of institutions carrying out testing of ASU drugs.
“Notification of Rules regarding the mandatory mention of botanical names and plant parts on the labels of ASU medicines has been finalised. Good Clinical Practice (GCP) guidelines for ASU drugs finalized for publication as a guiding document to the researchers. As on date 44 Drug Testing Laboratories are approved as per the provisions of Drugs & Cosmetics Rules 1945 for testing of Ayurveda, Siddha, Unani and Homoeopathic drugs. Pharmacopoeial standards of 600 ayurvedic single drugs and 152 compound formulations have been developed and published in the ayurvedic pharmacopoeia,” he said.