AYUSH Licence: Starting an Ayurvedic Products Business

Ayurveda sells — and regulators know it. Ayurvedic medicines are 'drugs' under the Drugs & Cosmetics Act, licensed by state AYUSH/drug authorities under their own chapter: their own GMP schedule, their own formulation rules, their own claim boundaries. Whether you're reviving a family formulation or building a modern wellness brand, here is the licensing architecture for ayurvedic (and Siddha/Unani) products in India.

First, classify your product honestly

• Classical (Shastriya) medicines: formulations exactly per the scheduled authoritative texts (Ayurvedic Formulary etc.) — licensed by reference to the text; no proof of efficacy needed beyond conformity
• Patent or Proprietary (P&P) ayurvedic medicines: your own combinations of ayurvedic ingredients — licensed with formulation details, rationale from ayurvedic principles, and safety/label scrutiny
• Not medicines at all: many 'wellness' products are legally foods — herbal supplements under FSSAI's nutraceutical/Ayurveda Aahara regimes; cosmetics with herbal ingredients under Cosmetics Rules. The claim you make decides the regulator you meet

This classification is the strategy decision: an amla candy sold as immunity food (FSSAI) versus an amla rasayana sold as medicine (AYUSH licence) are different businesses with different rulebooks.

The manufacturing licence

Manufacture of ayurvedic medicines requires the state AYUSH licensing authority's licence — with GMP compliance under Schedule T: premises sized and separated for processes (raw herb stores, processing, finished goods), machinery per your dosage forms (churnas, asavas, tablets, oils each have needs), hygienic construction, and technical staff — the rules require qualified persons (Ayurvedic degree holders/pharmacists as prescribed) supervising production and quality. A quality-control arrangement (in-house or approved lab agreement) covers raw material identity and finished-product testing. The loan licence route mirrors cosmetics/pharma: your brand, formulations and regulatory standing; manufacturing at an existing GMP-licensed unit — the standard entry path for brands without factories.

Application and timeline

• Apply to the state AYUSH directorate (increasingly via e-portals) with premises plans, equipment and staff proofs, product list (classical references or P&P dossiers), and fees
• Inspection against Schedule T; compliance of observations
• Grant — with the product list endorsed; every new product extends the licence formally (P&P additions get scrutinised each time)
• GMP certification (Schedule T) issues alongside/for export needs; WHO-GMP is a separate, higher bar for regulated-market exports
• Plan 3–6 months for a new unit; loan licences at clean host facilities move faster

Labels, Bhasmas and the modern channel stack

Labels must carry the licence number, ingredients with quantities (per formulation rules), batch/manufacturing details, dosage and anupana where applicable, and prescribed cautions (metal-containing preparations like bhasmas carry specific warning requirements). Heavy-metal testing expectations attach to relevant categories — export markets test rigorously and domestic surveillance increasingly does. The channel stack for a modern brand: AYUSH licence (or loan licence) + GST + trademark + Legal Metrology + EPR packaging + marketplace dossier (platforms ask for licences on medicine listings). E-pharmacy and quick-commerce listings add their own verification layers.

How Aidwish helps

Aidwish structures ayurvedic ventures end to end — product classification strategy (medicine vs food vs cosmetic), state AYUSH applications and Schedule T readiness, loan-licence arrangements, claim and label review — so tradition scales with its paperwork intact.