By Praveen Prabhakar July 16, 2018

No Clinical trials required for licensing ASU drugs

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16 July, 2018 Praveen Prabhakar Ayurveda Medical Association of India, Ayurvedic, Banaras Hindu University, clinical trial, Dr Sadath Dinakar, Drugs and Cosmetics (D&C) Rules, Siddha and Unani

New Delhi: 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 recently 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 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.