The clarification comes in the backdrop of requests received by the Ministry from companies seeking approval to manufacture products under both Ayush and FSSAI in the same manufacturing premises, said the Ministry in an office memorandum.
The Ministry said that there is no specific prohibition to use combined set up of manufacturing line and equipment for manufacturing products licensed under ASU and FSSAI in Drugs and Cosmetics Act, 1940 and Rules made thereunder.
Besides, it observed, there is no direction issued by FSSAI, which is under the Ministry of Health and Family Welfare (MoHFW), for restricting the manufacturing of food products under FSSAI licence or registration norms, at premises where Ayush products are being manufactured.
“…it is to state that ASU facilities can be utilised for manufacturing food products licensed under FSSAI provided, the manufacturing company should have due precautions to avoid cross contamination as per the Schedule T of Drugs and Cosmetics Act, 1940,” said the Ministry.
It may be noted that the Ministry of Ayush and FSSAI, in May last year, announced formulation of regulations on safety & quality standards for food products under ‘Ayurveda Aahara’ category.
The comprehensive initiative was launched to ensure manufacturing of quality Ayurveda food products and help in expanding the international market for Make in India products.
According to the regulation, manufacturing and marketing of ‘Ayurveda Aahara’ products will adhere to strict Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, rules and will be available in market only after licence/approval from FSSAI. A special logo has been created for “Ayurveda Aahara” category, which will enable easier identification and reinforce quality in Ayurveda food products.
According to the regulations, all food prepared in accordance with the recipes/ingredients/processes described in the authoritative books of Ayurveda will be considered as “Ayurveda Aahara”. Food recipes and ingredients for promoting health, specific physiological needs, and foods specified for consumption during or post specified diseases, disorders referred as Pathya in Ayurveda are covered under these regulations.
The labelling of ‘Ayurveda Aahara’ shall specify the intended purpose, the target consumer group, recommended duration of use and other specific requirements. Health claims and disease risk reduction claims for the different categories of ‘Ayurveda Aahara’ and their approval process shall be in accordance with the requirements specified in regulations.
However, ‘Ayurveda Aahara’ will not include Ayurvedic drugs or proprietary Ayurvedic medicines and medicinal products, cosmetics, narcotic or psychotropic substances and herbs. Further, Ayurveda Aahara is also not recommended to young children below the age of two years.
‘Ayurveda Aahara’ needs prior approval, the same shall be in accordance with the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulations, 2017.
FSSAI has been assigned to constitute an Expert Committee under the Ministry of Ayush consisting of relevant experts including representatives of FSSAI for providing recommendation on approval of claims and products and the committee shall also empower to address concerns regarding registration or licensing or certification or laboratory accreditation or testing or quality issues related to ‘Ayurveda Aahara’.