|
Parliamentary Panel recommends single independent drug controller & uniform standards for Ayush
|
|
Gireesh Babu, New Delhi
March 17 , 2025
|
|
|
The Parliamentary Panel on Health and Family Welfare has recommended consolidation of all Ayush drug-related standard-setting processes under a single independent drug controller.
The Parliamentary Standing Committee on Health and Family Welfare, in its 165th report on Demands for Grants 2025-26 of the Ministry of Ayush, has 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 headed by Member of Rajya Sabha Prof. Ram Gopal Yadav, in its latest 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.
It will also strengthen consumer confidence by guaranteeing that all licensed Ayush drugs adhere to nationally recognised quality standards, ultimately fostering wider acceptance and integration of Ayush medicines in mainstream healthcare.
Observing the obscure and diverse pattern of licensing that creates hurdles for the manufacturer for seeking license for production of Ayush products, it recommends that arrangement be made to have simplified procedure for seeking uniform and standard license that will ensure ease of doing business for Ayush manufacturers thereby seeking the objective of Atma Nirbhar Bharat and Make in India mission.
"Moreover, the manufacturers will be encouraged to set up Ayush industry in the country for production of Ayush products that will ultimately promote Ayush sector in domestic as well as the global market," added the Panel.
In order to promote manufacturing of Ayush drugs in the country, it suggested that a separate body be created to implement and oversee the Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements etc countrywide.
"The Committee feels the need for strengthening of Central and state regulatory frameworks including Technical Human Resource & Capacity Building programmes for Ayush drugs for Manufacturing of quality medicine from state and private pharmacies and NABL accreditation of DTL," it added while looking at the progress of Ayush manufacturing in the country based on the scheme Ayush Oushadhi Gunvatta Evam Uttapadan Samvardhan Yojana (AOGUSY)
The Ministry should make concerted efforts to improve surveillance of adverse drug reactions through various existing initiatives and get the help of Bureau of Indian Standards, Quality Control of India (QCI) and other relevant scientific institutions and R&D centres to achieve the objectives of the Yojana.
It also strongly recommended that the Ministry must chalk out a strategic action plan to control misleading or objectionable advertisements that have arisen to 15,873 incidents during 2023-24 and 2024-25 (upto December 2024).
"If required penal provisions may be made to check/combat misleading advertisements that claim to cure lethal diseases within a short span of time," it added. It may be noted that the Supreme Court has earlier criticised the ministry of health and the regulators for not taking prompt action against misleading advertisements from herbal and Ayush drug manufacturers.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|