Before launching a wellness product in India, one of the most important questions is: which regulatory category does it belong to? The answer decides the licence you need, how the label looks and which claims are allowed.
These are regulated under the Drugs and Cosmetics Act, 1940, with oversight from the Ministry of AYUSH and state licensing authorities. Classical and proprietary Ayurvedic medicines fall here.
These are regulated as foods by FSSAI under the Food Safety and Standards Act and its regulations for health supplements and nutraceuticals. Rules cover permitted ingredients, levels and labelling.
Products applied to the body for cleansing, beautifying or improving appearance are regulated as cosmetics, with their own manufacturing and labelling requirements.
Some products sit close to the boundary between categories. An experienced manufacturing partner can help you classify your product correctly. For final decisions, it is wise to consult a regulatory expert.
Marigold Wellness manufactures across Ayurvedic, nutritional and personal care categories. Talk to us about your product.