FSSAI and AYUSH: navigating India's dual regulatory framework for health products

India presents one of the most structurally distinct regulatory environments for health products globally. It operates two parallel frameworks: FSSAI for food and nutraceuticals, and AYUSH for traditional medicine systems. The classification of your product between the two has profound implications for timelines, claims, and distribution.

FSSAI: the food and nutraceutical framework

The Food Safety and Standards Authority of India (FSSAI) regulates food products, dietary supplements, and nutraceuticals under the Food Safety and Standards Act 2006 and its various regulations. What falls under FSSAI: vitamins and mineral supplements, protein supplements and meal replacements, functional foods and fortified foods, probiotic and prebiotic products, sports nutrition products, and herbal products positioned as food supplements (not therapeutic).

FSSAI introduced a dedicated nutraceuticals regulation in 2022 that significantly updated the framework for health supplements.

Key FSSAI requirements for imports: products must be registered or imported under a valid FSSAI import approval, ingredients must comply with FSSAI's permitted lists and maximum levels, labels must meet FSSAI requirements including FSSAI logo and licence number, claims are restricted to those permitted under FSSAI regulations (disease claims are not permitted), and the Indian importer must hold a valid FSSAI import licence.

AYUSH: the traditional medicine framework

The Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) regulates traditional medicine systems under the Drugs and Cosmetics Act 1940. What falls under AYUSH: Ayurvedic formulations using ingredients from classical texts or proprietary blends, Unani and Siddha products, homoeopathic preparations, and products making therapeutic claims using traditional medicine frameworks.

AYUSH registration allows products to carry therapeutic claims within the AYUSH framework, claims that would not be permitted under FSSAI's food/supplement rules. For foreign brands, AYUSH product registration is complex and typically requires a local manufacturer or licensed partner.

The classification decision

Ingredients. Products containing ingredients from Ayurvedic pharmacopoeia in traditional combinations may be classified as AYUSH products. Some botanical ingredients commonly used in international supplements (ashwagandha, brahmi, triphala) exist in a classification grey zone in India.

Claims. Products making therapeutic or medicinal claims are likely AYUSH territory. Products positioning as dietary support without disease claims are FSSAI territory.

Format. Classical Ayurvedic dosage forms are clearly AYUSH. Capsule and tablet formats of botanical extracts are more ambiguous.

Common issues for foreign brands entering India

Restricted ingredients. FSSAI maintains positive and negative lists for ingredients in health supplements. Some ingredients freely available in Australian, US, or European supplements are restricted or require prior approval in India.

Labelling. FSSAI labels require the FSSAI licence number and logo, and must comply with the Food Safety and Standards (Labelling and Display) Regulations. Net quantity must be in metric units. Country of origin declaration is mandatory.

Import process. All food imports into India require FSSAI import approval. The importer must hold a valid import licence from FSSAI. Products are subject to testing at port of entry.

2025 FSSAI updates. FSSAI proposed restrictions on high-risk food category registrations and updated requirements for specific supplement categories in 2025. Brands planning India entry should confirm current requirements rather than relying on older guidance.

Taama's India coverage is on our roadmap, covering FSSAI nutraceutical compliance and AYUSH pathway classification for brands planning India entry. See our India page