Evidence for Ayurvedic products’ efficacy: The devil is in details

On and off, scientists and clinicians question non availability of scientific information, data to prove the efficacy of Ayurvedic products. In 2016, many dignitaries including the Prime Minister of India pointed to the need for validation of efficacy of Ayurvedic products. The department of Ayurveda, in the Ministry of Health, India has reported its intention to amend the Indian Drugs Regulations to introduce definition and description of what it considers “New Ayurvedic Drug” (which includes currently those ayurvedic medicines that are licensed as proprietary Ayurvedic medicines). For such new ayurvedic drugs the amendment of the regulation proposes to prescribe mandatory human clinical trials before any benefit claims are approved. This amendment describes various provisions to be enforced by the state licensing authorities