BENGALURU:
Karnataka Ayurveda industry sees need for more clarity from the Union government about the latest instruction on its mandate for pilot studies over clinical trials. It should specify the features of the pilot study for herb and plant-based medicine so that industry can comply accordingly.
According to DBA Narayana, herbal regulatory expert and consultant, the circular issued is legally acceptable. While the Ministry of Ayush has managed to take a stand, to omit the need for clinical trials and focus on pilot studies is a misnomer.
It is a fact that such pilot studies would not be expensive compared to a clinical trial. Nevertheless now the ministry should issue broad guidelines on what kind of pilot studies data would be acceptable to support the claims of drugs. Hence the regulation should be amended to say that for a proprietary preparation, the industry would need to produce a claim support data. Now if this is considered, industry should be relieved because consumers can be convinced that there is a certified claim support data for the products in the market and the new drugs. The reality is that conduct of clinical trials for Ayurveda is skewed in many of the cases as it is not done in the right manner except for some companies that have been transparent during the conduct of human studies for their herbal formulations, Dr. Narayana told Pharmabiz.
The government after this circular should constitute an expert committee comprising of cross section of knowledgeable personnel to develop a guideline indicating what all kinds of pilot studies need to be done to support the claims, he added.
“So long the government had not prescribed a protocol for clinical trials for Ayurveda drugs. The product approvals were at the discretion of the licensing authorities. Now the insistence for pilot studies are also not the answer, pointed out, JSD Pani, chairman, Ayurpark Health Care Limited, RTI and social activist focussing on Ayush department.
There is no doubt that a herbal or plant-based medicine backed by proper clinical trials is the need of the hour. The human studies are conducted in the interest of the patients and for the recognition of the Indian Ayurveda industry, added Pani, stating that for proprietary drugs applications will not be accepted if it is not backed by data of clinical trials.
“We at The Himalaya Drug Company believe in conducting clinical trials to evaluate the safety and efficacy of each and every product we launch. This is the hallmark of Himalaya. Through this, we establish the acceptability and credibility of our products amongst consumers. Although this is not mandatory now, we will continue this practice,” stated Philipe Haydon, CEO, The Himalaya Drug Company.
