Expressing disappointment that the government has still not created a single, independent drug regulator for Ayush medicines, the Parliamentary Standing Committee on Health has once again urged the Centre to bring all Ayush drug standard-setting processes under one strong authority.
The Committee in its report tabled in Parliament recently also asked the Ministry to strengthen pharmacovigilance systems and encourage reporting of adverse drug reactions (ADR) to ensure safe use of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) medicines.
The Committee headed by Rajya Sabha MP Prof Ram Gopal Yadav said it was “dismayed” that the recommendation for a single Ayush drug controller had not yet been implemented. It reiterated that Ayush drug regulation should be unified under one independent authority, in line with the Drugs and Cosmetics Act, 1940.
To make this possible, the Ministry was advised to develop a coordinated mechanism that brings together all stakeholders to frame and update pharmacopoeial standards uniformly, ensuring better safety, quality and efficacy of Ayush medicines across the country.
The report emphasised that research bodies such as the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) and Ayush research councils including CCRAS, CCRUM, CCRS and CCRH should work in close coordination to promote research and standardisation in Ayush drug development.
Acknowledging the vital role of the Pharmacopoeia Commission in setting drug standards and curbing misleading advertisements, the Panel reiterated its earlier demand for creating a dedicated platform/body to exclusively oversee and monitor Ayush drug pharmacovigilance.
Noting that surveillance of Adverse Drug Reactions—including in traditional systems—is essential for public safety, the Committee underlined the importance of Intermediary and Peripheral Pharmacovigilance Centres and recommended strengthening the NPC-ISM network to increase ADR reporting.
In a separate set of concerns, the Committee pushed the Ministry of Ayush to operationalise a Clinical Trial Management System (CTMS) as a single-window digital platform for all autonomous bodies and research councils to improve documentation, protocol compliance and transparency in clinical research.
Reviewing responses to earlier recommendations, the panel noted support from CCRAS and CCRS for a unified CTMS to integrate traditional knowledge with modern scientific validation, enable multicentre trials and enhance global acceptance of Ayush-based interventions. A central CTMS would automate recruitment, randomisation, monitoring and reporting, reduce human error and improve data integrity.
CCRS informed the Committee that AI-driven analytics could strengthen Siddha research by improving tracking of treatment outcomes and adverse events. CCRAS added that while existing electronic Case Record Forms safeguard confidentiality and data capture, they lack advanced automation and analytic capacity, and institutes may need adaptable, project-specific versions of CTMS.
The panel again called for budgetary provisions to support clinical trials, scientific validation of medicinal plants and research infrastructure, arguing that investment will boost evidence-based practice, promote medical tourism and strengthen India’s position in integrative medicine, especially in regions rich in medicinal flora such as Kerala, Karnataka and the Northeast.
"Adequate budgetary provisions must be allocated for clinical trials and scientific validation centres to bolster evidence-based research and promote medical tourism in regions abundant in medicinal plants, such as Kerala, Karnataka, and the Northeast," it said.
