India’s Ayush industry needs an entirely new regulatory model

Context: The present controversy of Patanjali’s claim to COVID cure necessitates new standards and regulatory model for AYUSH industry.

Need For tight regulations

• Bypassing Scrutiny:  promoted remedies for diabetes, malaria, dengue and rheumatoid arthritis without demonstrating any clinical proof of efficacy.
• Absence of documented process : Under Drugs & Cosmetics Act in 1964, there is no requirement for manufacturers to establish the therapeutic efficacy through a documented process.

• Lack of faith: the Ayush Ministry in 2018 amended India’s Drugs & Cosmetics Rules, 1945, to prohibit manufacturers of Ayush drugs from advertising their products. i.e. these products could no longer make therapeutic claims.

• The ban, is limited to “publication"; it does not address direct marketing to Ayush practitioners.

• Presence of heavy metals in Ayush concoctions: most of these contain detectable levels of lead, mercury and arsenic which produce harmful toxicological effects in humans.

• Patients have suffered severe liver damage after self-medicating themselves with Ayush based tonics.

Difference between Ayurvedic and pharmaceutical products: 

• Evidence-based medicine

• Pharmaceutical Drug: singular entity, whether chemical or biological is approved on the basis of clinical evidence. 

• Drugs are isolated and purified from naturally occurring plant species which help determine the right dosage and controls any adverse physiological effects.

• Ayurvedic Drug: is a concoction of two or more ingredients as it does not isolate its active ingredients from its plant-based sources; rather, it uses the entire leaf or herb or root in its concoction.

• It makes it impossible to understand the dose at which it will deliver its intended therapeutic benefits to a patient.

Way forward: 

• Safety of the Ayurvedic drugs: must be based on the understanding of the therapeutic dosage and data supporting longitudinal usage.
• Drug development: based on balance between safety and therapeutic efficacy.
• Evidence-based medicine: no reluctance in adopting the tools of modern science to validate the claims made by traditional texts.