In a recent development, the Ministry of Ayush has issued a significant clarification regarding the utilization of Ayurveda, Siddha, and Unani (ASU) manufacturing facilities for the production of food products licensed under the Food Safety & Standards Authority of India (FSSAI). This clarification comes in response to requests from companies seeking approval to manufacture products under both Ayush and FSSAI in the same manufacturing premises.
The Ministry’s office memorandum emphasized that there is no specific prohibition against using a combined setup of manufacturing equipment and production lines for items licensed under ASU and FSSAI within the framework of the Drugs and Cosmetics Act, 1940, and its associated regulations. Furthermore, there are no directives from FSSAI, which operates under the Ministry of Health and Family Welfare (MoHFW), that restrict the manufacturing of food products under FSSAI licenses or registration norms in facilities where Ayush products are being produced.
The Ministry clarified, “ASU facilities can be utilized for manufacturing food products licensed under FSSAI provided the manufacturing company takes due precautions to avoid cross-contamination, as per the Schedule T of Drugs and Cosmetics Act, 1940.”
Notably, the Ministry of Ayush and FSSAI jointly announced the formulation of regulations governing safety and quality standards for food products falling under the ‘Ayurveda Aahara’ category in May of the previous year. This initiative aims to ensure the production of high-quality Ayurveda food products and expand the international market for Indian-made goods.
According to these regulations, the manufacturing and marketing of ‘Ayurveda Aahara’ products must adhere to stringent Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, and can only enter the market after receiving approval or a license from FSSAI. A distinct logo has been introduced for the “Ayurveda Aahara” category, simplifying identification and reinforcing quality standards for Ayurveda food products.
The regulations define “Ayurveda Aahara” as all food prepared following the recipes, ingredients, and processes outlined in authoritative Ayurvedic texts. This category encompasses food recipes and ingredients intended to promote health, cater to specific physiological needs, and address foods recommended for consumption during or after specified diseases or disorders, referred to as Pathya in Ayurveda.
Labels on ‘Ayurveda Aahara’ products must specify their intended purpose, target consumer group, recommended duration of use, and other specific requirements. Health claims and disease risk reduction claims for various ‘Ayurveda Aahara’ categories and their approval process must adhere to the stipulated regulations.
However, it’s important to note that ‘Ayurveda Aahara’ excludes Ayurvedic drugs or proprietary Ayurvedic medicines, medicinal products, cosmetics, narcotic or psychotropic substances, and herbs. Additionally, it is not recommended for young children below the age of two years.
For products in the ‘Ayurveda Aahara’ category that require prior approval, the process will align with the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017.
FSSAI has been entrusted with the responsibility of forming an Expert Committee under the Ministry of Ayush, comprising relevant experts, including FSSAI representatives. This committee will provide recommendations for the approval of claims and products and will also address concerns related to registration, licensing, certification, laboratory accreditation, testing, and quality issues pertaining to ‘Ayurveda Aahara’.
This clarification by the Ministry of Ayush offers greater flexibility to manufacturers in the ASU sector, facilitating the production of a wider range of high-quality food products while maintaining strict quality and safety standards.