A Parliamentary Panel has recommended that the Ministry of Ayush should immediately enhance the regulatory mechanism for reporting adverse drug reactions (ADR) and post-marketing surveillance of Ayush medicines. The recommendation comes amid growing concerns about the safety and efficacy of such traditional medicines, especially due to high metal levels in some of these products.

Key Highlights:
Call for Action on Adverse Drug Reporting:

• The Department-Related Parliamentary Standing Committee on Health and Family Welfare, in its 162nd report, has requested the Ministry to give information on action taken to enhance ADR reporting systems.

• The Committee has requested a detailed status note on action taken for stricter quality control of Ayush drugs.

Post-Marketing Surveillance Suggestions:

• The panel has emphasized periodic post-marketing surveillance to observe the real-world safety and efficacy of Ayush medicines.

• Collecting data on an ongoing basis is recommended to identify potential safety concerns and permit corrective action at the right time.

International Collaborations and Standardization Initiatives:

• The Ministry has collaborated with the World Health Organization (WHO) to make Ayush possible globally, including efforts like the WHO Global Centre for Traditional Medicine (GTMC) in Jamnagar, India.

• A proposal to establish an ISO Technical Committee for Ayurveda and Yoga has been made and is under consideration.

• The Bureau of Indian Standards (BIS) has also collaborated with ISO to standardize Ayush quality standards at the global level.

Ministry's Present Response:

• The Ministry informed the panel that it has directed the National Pharmacovigilance Coordination Centre (NPCC) to provide data on ADRs and herb-drug interactions.

• The Ministry emphasized collaboration with WHO on developing benchmark documents and tools like the WHO M-Yoga App.

Statements of Leaders or Officials:
Prof. Ram Gopal Yadav, Member of Rajya Sabha and Panel Chair:
"The Ministry of Ayush should take a more proactive role in strengthening the regulatory mechanism for reporting adverse effects and post-marketing surveillance of Ayush medicines."The recommendations of the panel point to the imperative necessity of strict regulatory control over Ayush medicines for their safety and efficacy. By improving adverse drug reaction reporting systems, conducting regular post-marketing surveillance, and adherence to international quality standards, India can raise the credibility and international acceptability of its traditional medicines. The Ministry's continuous interactions with WHO and ISO are considered positive trends, but active and open regulatory measures are still required.