The Union Ministry of Ayush (MOA) is set to amend regulations governing the retail sale of Ayurveda, Siddha, and Unani (ASU) drugs to enhance their safety, efficacy, and quality. A revision to the Drugs and Cosmetics Act of 1940 is on the horizon, and the Ministry is currently reviewing the recommendations of an expert committee before presenting the amendments in Parliament.
Once the amendments take effect, Ayurveda drug inspectors will be authorized to inspect ASU retail outlets and collect samples for testing, mirroring the practices of drug inspectors for modern medicines. Consumers will also be able to use traditional medicines sold through licensed pharmacies under medical supervision, with the assurance that ingredients are accurately listed on product labels. Any violations of regulations will be subject to reporting to drug control authorities.
The retail outlets selling ASU drugs will be designated as “Ayush Pharmacies,” with medicines dispensed by qualified professionals, such as Ayurveda pharmacists or doctors. In its most recent meeting, the ASU Drugs Technical Advisory Board (ASUDTAB) recommended forming a committee to establish a framework for the registration of these retail outlets. Retailers will be required to obtain sales licenses from the Ayush drug control department and report sales data of formulations containing substances listed under Schedule E (I) (Poisonous Substances) via the e-Aushadhi portal.
In line with these recommendations, the Ayush Ministry has appointed a committee to draft the necessary amendments to the Drugs and Cosmetics Rules of 1945. Once finalized, these amendments will be presented in Parliament for approval.
Currently, the sale of homoeopathic medicines is already regulated under the Drugs and Cosmetics Rules.
Industry representatives and traders have expressed strong support for these upcoming changes. Dr. P. Madhavan Kutty Varier, managing director of Kottakkal Aryavaidyasala, emphasized the need for sale licenses for Ayurveda retail outlets to ensure quality and safety. He also highlighted the importance of dispensing medicines through qualified professionals and advocated for ending the current practice of allowing unqualified individuals to run Ayurveda pharmacies. Dr. Varier welcomed the Ministry’s efforts to bring retail sales of Ayush products under legal regulation.
At present, there is no comprehensive regulatory oversight of retail outlets, making it difficult to track the number of such outlets or the sources from which they procure their products. It is estimated that there are approximately one million ASU&H retail shops operating across the country.
In addition to these regulatory changes, the MOA has introduced various measures to improve the quality of Ayush drugs. One such initiative is the Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY) for the period 2021-2026.
The scheme aims to strengthen Ayush pharmacies and drug testing laboratories, establish better pharmacovigilance systems for ASU&H drugs, monitor misleading advertisements, and enhance the regulatory framework at both the central and state levels.
As reported by pharmabiz.com, the initiative also supports the development of standards for Ayush products in collaboration with institutions like the Bureau of Indian Standards (BIS) and the Quality Control of India (QCI).