The Drug Technical Advisory Board (DTAB) for Ayurveda, Siddha & Unani (ASU) has proposed a separate set of procedures and guidelines for conducting clinical trials of patent and proprietary formulations in Indian systems of medicine in the Drugs & Cosmetics Act.
The proposal, mooted by Dr S K Sharma, member secretary, Department of Ayush, is in the wake of majority of the DTAB members' opinion that the Schedule Y, which is followed for the clinical trials of allopathic drugs, is not suitable for ASU drugs. At the same time, the DTAB is also of the view that some criteria for clinical trials for the proprietary drugs in the ASU sector is essential and should be made mandatory before licensing the drugs.
Keeping in view the extreme significance of this issue, the Board has now decided that an expert group including the Drug Controller General of India (DCGI), experts from Ayurveda, Siddha and Unani and an expert knowledgeable on drug development (clinical pharmacologist) is to be constituted for preparing a draft of the rule.
Though there was a draft prepared earlier by the former DTAB committee for the same purpose, the newly constituted Board has scrapped the same by saying that it is not feasible as it is a replica of Schedule Y, which has altogether different purpose and requirements.
However, the revised draft by the new experts group for making provisions for drug development research and clinical trials in the ISM sector is expected to be placed at the next meeting of the DTAB, which will be held within six months.