The most consequential early decision in this industry is which regulatory route your product takes, because it changes the label format, the permitted wording, the approval process and the timeline. It is also the decision most new brands make by accident. This page sets out the landscape plainly, and is explicit about where you need a regulatory consultant rather than a manufacturer's opinion.
The two main routes
Food supplement under FSSAI: the route for vitamin and mineral products, protein, and herbal products positioned as nutritional supplements. Labelling follows food rules, claims are constrained to nutrition and general wellness, and the process is generally faster and simpler.
Ayurvedic proprietary medicine under the relevant state AYUSH or drug authority: the route for formulations built on classical Ayurvedic herbs where you want to use traditional-use language. Different label format, different permitted wording, and a different approval process. Classical formulations with recognised texts behind them sit naturally here.
What you need as a brand owner
A company or firm registration and GST registration. An FSSAI licence in your own name as a marketer or brand owner, ours covers our manufacturing, not your marketing. A trademark application on the brand name, started before you print. And product approvals or product-level registrations as required by your chosen route.
For an Ayurvedic route you may also need a loan licence or a marketing arrangement documented appropriately with us, depending on the state and the structure. This is one of the places where state-level variation is real and a consultant earns their fee.
What our licences do and do not cover
Our manufacturing licence, FSSAI licence, GMP certification and any AYUSH licence cover how and where the product is made. You may legitimately state that your products are manufactured at a GMP-certified, FSSAI-licensed facility.
They do not cover you as a brand owner, they do not make a claim on your label permissible, and they do not substitute for your own registrations. A manufacturer who implies otherwise is doing you no favours.
Export adds another layer
Destination markets have their own requirements: specific labelling, certificates of free sale or phytosanitary certificates, wider contaminant testing, and frequently organic certification. Some registrations require real-time stability data rather than accelerated, which takes months and cannot be compressed.
Several ingredients permitted in India are restricted elsewhere, bhasma preparations and classical iron-containing formulations are the common problems. Confirm destination requirements before fixing a composition, not after a consignment is held.
Where you genuinely need a consultant
Any new export market. Any unusual ingredient or claim. Anything filing as an Ayurvedic proprietary medicine where state-level practice varies. And any situation where you are unsure which route applies, because choosing wrong means redoing artwork, approvals and sometimes the composition.
We will give you our view and supply every manufacturing-side document you need. We are not a substitute for regulatory advice and we will say so rather than let you assume otherwise.