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The Parliamentary Panel on Health and Family Welfare has recommended to the Ministry of Ayush to examine the feasibility of strengthening the Central regulatory mechanism for the regulation and laying down of uniform standards of enforcement of standardisation and efficacy of Ayush drugs.
The Parliamentary Standing Committee on Health and Family Welfare, in its 174th report on Demands for Grants 2026-27 of the Ministry of Ayush, observed that the enforcement of the Drugs and Cosmetics Act, 1940 lies within the purview of State Licensing Authorities (SLAs), which has resulted in delays and ineffective enforcement.
The Panel noted that regulatory provisions exist for the regulation of Ayush drugs under the Drugs and Cosmetics Act, 1940, which contains specific provisions for traditional systems of medicine.
"The Committee is of the view that, with the growing scope and global expansion of the Ayush sector, there is a need to further strengthen the regulatory legislative framework governing Ayush medicines. Moreover, the enforcement of the Act lies within the purview of State Licensing Authorities, which has often resulted in fragmented implementation, delays, and ineffective enforcement,” said the Panel headed by Member of Parliament Prof. Ram Gopal Yadav.
"The Committee, therefore, recommends that the Ministry examine the feasibility of strengthening the Central regulatory mechanism for the regulation and laying down of uniform standards of enforcement and enhancing coordination with State Drug Authorities to ensure better standardization, safety, and efficacy of Ayush drugs," it added.
Detailing the current regulatory framework for Ayush medicines, the Ministry of Ayush informed the Panel that the Drugs and Cosmetics Act, 1940 does not exclusively pertain to Ayush medicines and sought clarification regarding the status of establishing a separate regulatory mechanism for Ayush drugs.
The Ministry has informed that provisions relating to Ayurveda, Siddha and Unani drugs are contained in Chapter IVA and Schedule I of the Drugs and Cosmetics Act, 1940. Further, the Second Schedule of the Act provides standards for Homoeopathic drugs.
The Ministry also stated that a separate Ayurvedic, Siddha and Unani Drugs Technical Advisory Board and consultative committees exist under the current legal framework. In addition, State Governments and Union Territories appoint licensing authorities and drug inspectors for enforcement of regulatory provisions related to Ayush medicines.
It may be noted that the Panel has last year, while considering the Demand for Grants of the Ministry for 2025-26, recommended consolidation of all Ayush drug-related standard-setting processes under a single independent drug controller.
It recommended a simplified and standardised licensing process based on uniform parameters across all the states so that drug formulations do not vary from state to state.
It also called for a separate body to be created to implement and oversee the pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs including surveillance of misleading advertisements, among other activities, countrywide, it added.
"The Committee strongly recommends the consolidation of all Ayush drug-related standard-setting processes under a single authoritative body viz. an independent drug controller of Ayush, in alignment with the Drugs and Cosmetics Act, 1940, and its associated rules," said the panel in the previous year's report.
To achieve this, the Ministry should establish a streamlined and inclusive mechanism that actively involves stakeholders in the development of pharmacopoeial standards, ensuring greater efficiency and uniformity.
The Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) and Central Council for Research in Ayurvedic Sciences (CCRAS) may come together to coordinate and collaborate in this initiative to enhance the scientific testing and evaluation of a larger number of ASU&H drug samples to ensure safety, efficacy, and quality strengthening the foundation of research and standardization in the sector.
"The Committee is of view that the Ministry must have a standard licensing process based on uniform parameters across all the States so that drug formulations do not vary from state to state," it added.
A standardised approach will eliminate variations in drug formulations from state to state, thereby enhancing the quality, safety, and efficacy of Ayush medicines. This will prevent discrepancies in ingredient composition, dosage, and therapeutic claims, ensuring that Ayush drugs meet the same regulatory and scientific benchmarks nationwide.
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