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The Parliamentary Panel on Health and Family Welfare has sought the Ministry of Ayush to promote a Clinical Trial Management System (CTMS) as a single window platform for all autonomous bodies and research councils under the ministry, in order to improve documentation of clinical research in Ayurveda, Yoga, Unani, Siddha, and Homoeopathy (Ayush) systems of medicines.
The Department-related Parliamentary Standing Committee on Health and Family Welfare in the 168th report on action taken by the government on the recommendations the Panel has made in the 165th report on Demands for Grants 2025-26 of the Ministry of Ayush, has also recommended that adequate budgetary provisions should be allocated for clinical trials and scientific validation of medicinal plants to boost evidence-based research.
The Panel, in its previous report, has suggested implementation of a robust CTMS for Ayush clinical research, and various autonomous bodies and research institutes, including the Central Council for Research in Ayurvedic Sciences (CCRAS) and Central Council for Research in Siddha (CCRS) responded in favour of creation of such a system.
Noting the response, the Panel said that it is in agreement with the submission of the CCRS that an effective CTMS in Ayush will be of importance for integrating traditional knowledge to current scientific validation, increasing research outcomes and making Ayush-based interventions universally acceptable and scalable.
"Since, a well-integrated CTMS will allow multicenter trials, facilitating global acceptance of Ayush-based interventions and positioning India as a leader in integrative medicine research, the Committee recommends the Ministry of Ayush to encourage all its autonomous bodies and research councils to bring-forth clinical trials and related activities onto single platform i.e. Clinical Trial Management System (CTMS) which would significantly improve documentation efficiency and mandatory compliance in Ayush clinical research," said the Panel headed by Prof. Ram Gopal Yadav, in the report presented in the Rajya Sabha recently.
A CTMS assures systematic documentation, protocol compliance, and data integrity in preparation for regulatory clearances. A CTMS ensures real-time data capture, validation and safe storage while decreasing human error and bias. It aids in automating critical trial processes such as patient recruiting, randomization, monitoring, and reporting in a successful manner, it opined.
CCRS, in response to the Panel's previous recommendation, said that a CTMS assures systematic documentation, protocol compliance, and data integrity in preparation for regulatory clearances. A CTMS ensures real-time data capture, validation and safe storage while decreasing human error and bias. It aids in automating critical trial processes such as patient recruiting, randomization, monitoring, and reporting in a successful manner.
The Council added that AI-driven analytics in Siddha for supporting data-driven decision-making, ancient Siddha literature content analysis, and better tracking of adverse events and treatment outcomes will be undertaken.
Concurring with the suggestion of the Panel, CCRAS said that the CTMS has a potential to strengthen the clinical research ecosystem in the Ayush sector.
At present, the data of clinical research projects conducted by CCRAS are recorded in structured Case Record Forms (CRFs) and e-CRFs. These mechanisms enable systematic data capture and provide restricted access to safeguard patient confidentiality and data integrity, but do not support advanced automation or analytics capabilities. Institutes can develop project-specific CTMS, adaptable to the specific needs of each type of project, it added.
In continuation with its previous recommendations to strengthen awareness and promotion of Ayush sector in the country, and in other countries, the Panel suggested that the Ministry should provide adequate budget to scientific validation of medicinal plants.
"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.
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