Abstract

Concerns about side effects, safety, and the natural origin of Ayurvedic preparations marketed for sexual enhancement contribute to a rising global demand for these formulations. Research, however, has brought to light startling cases of adulteration of these products with the synthetic Phosphodiesterase-5 (PDE5) inhibitors sildenafil (Commonly known as Viagra), tadalafil, avanafil and vardenafil. The adulteration of a product with these compounds is a fundamental challenge to standardization, regulatory framework, and safety of the patient. This review describes the occurrences of adulteration, health challenges, regulatory frameworks, and the need for appropriate analytical techniques to determine the authenticity of these formulations and the trust of the patients in Ayurvedic sexual wellness preparations. The foremost issues in standardization of herbal medicines, in particular, the public health threat resulting from the undisclosed addition of sildenafil and other PDEs to Ayurvedic medicines are of special concern. The document unsupported inclusion of these ingredients in herbal products poses a significant threat to public health, and the recent surge in cross-border trade of Ayurveda and herbal medicines necessitates the enforcement of fundamental quality control and regulations. The adulteration on synthetic drugs, variability of herbal raw materials, and absence of appropriate analytical methodologies result in the unreliable description of Ayurvedic herbal medicines. The undocumented presence of sildenafil in herbal aphrodisiacs is alarming, as it poses serious health risks to the consumers and trust in herbal medicines. The major issues with standardization arise from variability in herbal materials, lack of consistent quality control, and clandestine adulteration with synthetic PDE5 inhibitors, all of which compromise efficacy and safety..

Keywords:Ayurvedic sexual wellness products; PDE5 inhibitors; Herbal medicine adulteration; Standardization and patient safety