In the wake of deteriorating quality of ayurveda drugs, the Drugs Control Department has decided to tighten the clinical study on new products before issuing licences.
As part of making the licencing procedures strict, the government has now given sanction to conduct clinical study in Thiruvananthapuram and Tripunithura Govt Ayurveda Colleges, the Toxicity and Safety Study Centre in Koratty and VPSV Ayurveda College in Kottakkal. State Drugs Controller P Hariprasad confirmed that sanction had been accorded to conduct clinical studies of ayurveda products in the ayurveda medical colleges.
The Centre had already made it mandatory to conduct clinical and safety studies of ayurveda products before issuing licence.
The government gave the sanction after the Deputy Drugs Controller (Ayurveda, Siddha and Unani) gave a proposal to the government to conduct clinical study on new patents and proprietary products in ayurveda.
Though certain studies were conducted earlier, the govt has now intensified the procedure after ayurveda manufacturing units mushroomed in the state.
Moreover, the commercialisation of ayurvedic drugs have resulted in the deteriorating quality. The guidelines for conducting the clinical study was prepared by the Deputy Drugs Controller in consultation with the Ayurveda Medical Education Director and principals of ayurveda medical colleges.
As per the guidelines, the manufacturer has to submit the trial drug to the licencing authority for pre-approval of the formula before the clinical study is conducted.
Once the formula is approved, the manufacturer should produce a trial batch of the product for administering to patients.
After the clinical studies, if the products contain ingredients specified in Schedule E1, safety and toxicity study will also be conducted.
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