“Do I need my own licence?” is the first regulatory question most Shilajit brand founders ask. The honest answer is that it depends on the product, the route it is made under and the market. This guide explains the roles in general terms, so you know what to ask.
The basics
Ayurvedic and Unani medicines in India are regulated under the Drugs and Cosmetics Act, 1940 and its Rules. Manufacturing is licensed by the state licensing authority, and the licence lists the products or categories approved for the premises. Labels must carry the particulars the Rules require.
Who may hold what
In a contract manufacturing arrangement there are two parties: the manufacturer, who holds a manufacturing licence for its premises, and the brand owner, whose name appears on the pack. Depending on the arrangement and the state, the brand owner may need to hold a permission of its own so that the product can be made for it. The exact name of that permission, the forms involved and the timelines vary by state and change as the Rules are amended.
What to confirm
- Which licence the manufacturer holds, and whether your product category is covered
- Which permissions, if any, you need as the brand owner
- Whose name and licence number go on the label
- How the product is classified, and which reference supports the formula
- Whether you plan to export, which brings additional requirements
Claims are a separate question
A licence does not decide what you may say. Advertising is controlled by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Claims about sexual capacity or performance, and claims to treat listed diseases, are not allowed.
Get it confirmed for your product
Rules change, and the position for your product depends on the details. Use this guide to prepare questions, then confirm the answers with the licensing authority or a regulatory adviser. At the start of every project we explain the route we expect to apply, and you can send us your brief to begin that conversation.