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Clinical trials not mandatory for licensing ASU drugs, says govt; researchers warn of fraud, textual data manipulation

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Arun Sreenivasan    09 July 2018

The Central government’s new directive to all state drug regulators to issue licences for patented or proprietary Ayurvedic, Siddha and Unani (ASU) products without insisting on clinical trial or safety study reports would seriously harm the credibility of these alternative systems of medicine and help fraudsters flourish, industry experts and medical professionals have warned.

Of late, drug regulators in many states have been invoking provisions of Rule 158B of the Drugs and Cosmetics (D&C) Rules to make clinical trial reports mandatory for obtaining licences for patented ASU products. However, in a circular issued on July 4 to all state licensing authorities for ASU drugs, the Union Ayush ministry made it clear that the term ‘clinical trial’ was not mentioned in the ASU drug-related provisions of the D&C Rules. “Experience or evidence of effectiveness of the ASU drug based on textual rationale, published literature and pilot study is required in support of the claim of indication or use for issue of licence in accordance with the provisions of Rule 158B. Proof of effectiveness in the form of pilot study may be required for intended ASU drug if the textual rationale, published literature and authoritative book-based indications are not furnished to support the claim of use or indication,” the circular reads.

The decision is detrimental to the efforts of many state governments and Ayush medical professionals to weed out ineffective and potentially harmful drugs from the market. “Terms like textual rationale and published literature are vague and open to interpretation. For instance, many of the ancient and classical texts speak of numerous magical cures. It is true that obtaining clinical trial reports is a tough task in holistic systems of medicine. But licensing a proprietary drug without even a safety study will only hurt the ASU sector and blight its universal acceptability,” Sanjay Srivastav, Director of Maharishi Ayurveda Products, a Delhi-based Ayurvedic drug manufacturer and exporter, told Pharmabiz.

The circular further states that there is no provision to designate, authorise or notify a particular institution or centre for conducting such pilot studies on ASU drugs. According to researchers and scientists, this clause will go against all attempts to meaningfully integrate ASU and modern systems of medicine.

“Human trials are important for the alternative medical field to gain acceptance in the international community. But simultaneously, we have to create the required infrastructure to conduct such trials. Banaras Hindu University in Varanasi, for instance, has facilities to conduct clinical trials in Ayurvedic products. We need more such centres. Watering down regulations might help manufacturers in the short term, but would eventually boomerang on them,” said Dr Sadath Dinakar, the newly elected general secretary of Ayurveda Medical Association of India.

A few years back, the Kerala government had identified three Ayurveda colleges, the government Ayurveda colleges in Thiruvananthapuram and at Thrippunithura and VPSV Ayurveda College at Kottakkal for conducting trials. But, according to sources, these centres lack manpower or resources to conduct such extensive trials.

The Ayush ministry’s new step is learnt to be triggered by numerous complaints from the industry over inordinate delay in granting or renewal of licences. “It’s a Catch-22 situation. The problem is genuine, but diluting regulations is not a solution to it,” Srivastav opined.

Though the Ayush ministry has been allocating funds for trials and research in alternative medicines, many researchers complain that their proposals are frequently getting rejected by the institutes on flimsy grounds. The five autonomous bodies under the ministry, the Central Council for Research in Ayurveda, Central Council for Research in Siddha, Central Council for Research in Unani, Central Council for Research in Homeopathy and Central Council for Research in Yoga and Naturopathy, are also reluctant to give permission for human trials, they say.

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