The Ayurvedic Drug Manufacturers' Association (ADMA) has urged the Department of Ayush to give more time to the Ayurveda, Siddha & Unani (ASU) drug manufacturers dealing with Patent and Proprietary (P&P) drugs to adopt the new regulations regarding safety studies. It has also requested the government to do away with the requirement of clinical trials completely as that will prove to be an added burden on the manufacturers.

This issue was raised by ADMA after the decision was taken by the Department of Ayush to impose provisions where the ASU manufacturers of the P&P drugs will have to undergo both safety studies and clinical trials soon. However the industry is apprehensive about this move since they feel that it is a great blow to the industry due to the huge expenses related to it.

Chandrakanth Bhanushali, general secretary, ADMA pointed out that the industry is open with the idea of undergoing safety studies of the P&P drugs. But he stressed that they need some time to prepare themselves for impending expenses that come along with it. However he pointed out that he is still not convinced about need for safety studies. “These may be okay for E1 drugs, but why are they needed for herbs of known safety,” he questions.

“The initiatives taken by the Department is appreciative but our industry has always had a traditional approach and this is new for us. We need at least two years from the government for understanding the concept of safety studies and whether they are needed for products made from herbs of proven safety. We also want the government to provide some kind of incentives and subsidy to the companies that undergo safety studies since it will be unaffordable for many ASU manufacturers due to high cost related to it.”

Although the industry is open towards the idea of safety study on case to case basis it is not that supportive of compulsory clinical trials. “Even though safety study is a good idea, having compulsory clinical trial for P&P drugs will be a big blow to the industry. Clinical trials need huge investment which will not be able to be borne by the ASU manufacturers. At present, our industry is still not organised enough to go for Good Manufacturing Practices (GMP) as has been observed during the implementation of Schedule-T, then how do you think will we be able to handle the complexity and expenses related to clinical trials,” Bhanushali points out.

Sources explained that P&P ayurvedic products are not like new molecules or New Chemical Entity (NCE) which warrants the need for a clinical trial due to their basic character. Rather, these are formulated from herbs of time tested efficacy and history of human usage.

Bhanushali suggested that the Department should restrict the implementation to only safety studies on a case to case basis that can be outsourced eventually at a reasonable price. However he insisted that clinical trial is not necessary and would only be an additional burden on the still growing ASU industry.