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Govt should strengthen regulatory framework & develop clinical research infra for Ayush: Parliamentary Panel
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Gireesh Babu, New Delhi
February 22 , 2024
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In order to gather a wider acceptance and implementation of the traditional systems of Indian medicine both in the country and internationally, the government should further strengthen regulatory frameworks through better adverse event reporting mechanisms and creation of data, according to a Parliamentary Panel.
The Department-related Parliamentary Standing Committee on Health and Family Welfare, in its 156th report on review of National Ayush Mission (NAM) earlier this month, also suggested various measures to develop clinical research infrastructure including establishing research networks, standardisation of protocols and interventions, among others.
The Committee observed that the quality of the medicines is essential as concerns have been raised over the high metal contents in the Ayush drugs, which damage people's health.
While acknowledging the measures taken by the Ministry in pharmacovigilance of the Ayush drugs, the panel headed by Rajya Sabha Member Bhubaneswar Kalita said, "To accentuate these measures, the Committee recommends that the Ministry further strengthen regulatory frameworks by developing user-friendly systems for healthcare professionals and consumers to report adverse events related to Ayush medicines."
"The Ministry should also conduct regular post-marketing surveillance of Ayush medicines to monitor real-world safety and efficacy. This provides ongoing data for continuous improvement of quality. The generated data may also help identify potential safety concerns and take prompt action," it added.
The Ministry may explore collaborating with the World Health Organization (WHO) and the International Organisation for Standardisation (ISO) to harmonise Ayush quality standards with international norms. This may facilitate global trade and recognition of Ayush products. The Ministry should also sign Mutual Recognition Agreements (MRAs) with other countries for regulatory compliance.
"The Committee is of the view that these steps may reduce duplicate testing and certification procedures, resulting in ease of the export and import of Ayush products," it added.
NAM intends to create an enabling environment for research and development in Ayush through various initiatives, programmes, and aspects of its implementation. The Committee opined that "Promotion of Research and Development" should be prominently included as one of the components of NAM. Similarly, the flexible component, which allows 25% flexible usage of funds, should include research and development as a supported activity.
The Committee further recommended various measures to develop clinical Research Infrastructure, including strengthening of manpower and training, establishing research networks, standardisation of protocols and interventions, community engagement and evidence recording.
Upgrading infrastructure and providing training opportunities for Ayush practitioners at health and wellness centres (HWCs) can enhance their research skills and capacity to participate in clinical trials. Collaboration among Ayush facilities and institutions can facilitate multicentric clinical trials and improve research quality.
Developing standardised protocols for Ayush interventions can ensure data consistency and enable robust clinical research. Engaging communities in research design and implementation through Ayush facilities can address their specific needs and ensure culturally relevant research outcomes.
Data gathered and generated in centres should be recorded and published. The clinically supported research and peer-reviewed articles should be placed in Ayush and allopathic medical colleges for better outreach, understanding, and coordination, added the Panel.
"The Committee believes that standardised data collection can pave the way for identifying biomarkers associated with specific Ayush interventions, opening doors for further research into mechanisms of action and personalised medicine," it said.
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