In a recent development, the Ministry of Ayush has provided clarifications regarding the utilization of Ayurveda, Siddha, and Unani (ASU) manufacturing facilities for the production of food products licenced under the purview of the Food Safety & Standards Authority of India (FSSAI), subject to specific conditions.
This clarification comes as a response to requests received by the Ministry from companies seeking approval to manufacture products under both Ayush and FSSAI regulations within the same manufacturing premises, as conveyed in an official memorandum from the Ministry.
The Ministry has affirmed that there is no explicit prohibition against the use of a combined setup of manufacturing lines and equipment for the production of items licenced under ASU and FSSAI within the framework of the Drugs and Cosmetics Act, 1940, and its corresponding rules.
Furthermore, the Ministry has pointed out that FSSAI, which operates under the aegis of the Ministry of Health and Family Welfare (MoHFW), has not issued any directives restricting the manufacturing of food products under FSSAI licencing or registration norms at facilities engaged in the production of Ayush products.
In its statement, the Ministry asserted, “ASU facilities can be utilized for manufacturing food products licenced under FSSAI, provided the manufacturing company takes due precautions to avoid cross-contamination as per Schedule T of the Drugs and Cosmetics Act, 1940.”
It’s worth noting that in May of the previous year, the Ministry of Ayush and FSSAI jointly introduced regulations concerning safety and quality standards for food products falling under the “Ayurveda Aahara” category. This comprehensive initiative aimed to ensure the production of high-quality Ayurvedic food products and promote their acceptance in the international market as part of the “Make in India” campaign.
According to the regulations, the manufacturing and marketing of “Ayurveda Aahara” products must adhere to the stringent Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, and can only enter the market following licencing or approval from FSSAI. A special logo was introduced for the “Ayurveda Aahara” category to facilitate easier identification and reinforce quality standards for Ayurvedic food products.
The regulations cover all food items prepared in accordance with the recipes, ingredients, and processes described in authoritative Ayurvedic texts, categorizing them as “Ayurveda Aahara. These include food recipes and ingredients designed to promote health, address specific physiological needs, and support consumption during or following specified diseases or disorders, as referred to in Ayurveda as “Pathya.”
Labelling for “Ayurveda Aahara” products is required to specify the intended purpose, the target consumer group, the recommended usage duration, and other specific requirements. Health claims and disease risk reduction claims for different “Ayurveda Aahara” categories, along with their approval procedures, must align with the regulations’ stipulated requirements.
However, it’s important to note that “Ayurveda Aahara” does not encompass Ayurvedic drugs, proprietary Ayurvedic medicines, medicinal products, cosmetics, narcotic or psychotropic substances, or herbs. Additionally, it is not recommended for young children under the age of two.
For products requiring prior approval, the process aligns with the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulations, 2017. FSSAI has been entrusted with establishing an Expert Committee under the Ministry of Ayush, composed of relevant experts, including FSSAI representatives. This committee is tasked with offering recommendations regarding claims and product approval, and it possesses the authority to address concerns related to registration, licencing, certification, laboratory accreditation, testing, and quality issues pertaining to “Ayurveda Aahara.”