AYUSH Licence: Manufacturing Licence for Ayurvedic, Siddha and Unani Drugs
Manufacturing licence support for Ayurvedic, Siddha and Unani drugs from the State Drug Licensing Authority.
Get Started Today
An AYUSH licence, in the manufacturing sense, is the licence issued by the State Drug Licensing Authority under the Drugs and Cosmetics Act, 1940 and its Rules to a unit that makes Ayurvedic, Siddha or Unani medicines. It is needed by herbal and traditional medicine manufacturers, contract manufacturers and brands that plan to market classical or proprietary formulations. The licence is tied to the premises, the products and the qualified technical staff, and the unit must meet Good Manufacturing Practice requirements. Our team prepares the application, maps your formulations and premises to the rules, and supports you through inspection.
Who provides this service: our team of Company Secretaries and compliance specialists.
Who Needs AYUSH Licence?
- Manufacturers of Ayurvedic, Siddha or Unani medicines
- Brands that plan to get products made through a licensed contract manufacturer
- Entrepreneurs setting up a new herbal or traditional medicine unit
- Existing units adding new formulations or relocating to new premises
- Exporters who first need a valid domestic manufacturing licence
Key Benefits
- Product-wise formulation review so classical and proprietary medicines are applied for under the right category
- Premises and layout check against the GMP expectations for AYUSH manufacturing before the inspector arrives
- Technical staff documentation prepared so qualifications and appointment letters match what the authority asks for
- Clear separation of what this licence covers and what needs separate export, free-sale or marketing certificates
- Support with pollution, fire and local body clearances that sit alongside the drug manufacturing licence
- Renewal and amendment tracking when you add products, machinery or change premises
How It Works
Scope and product review
We list the medicines you intend to make, classify them as Ayurvedic, Siddha or Unani, and note whether each follows a classical text or is a proprietary formulation needing more documentation.
Premises and GMP gap check
We compare your building, layout, water supply, storage, equipment and hygiene arrangements with the GMP requirements prescribed for these drugs, and list changes needed before applying.
Technical staff and constitution papers
The licence requires qualified technical staff supervising manufacture. We prepare their qualification proofs and consent letters, along with incorporation or partnership documents and premises ownership papers.
Application to the State Licensing Authority
We file the application with the product list, formulation details, layout plan, machinery list and fee payment, following the format and portal used by your state drug authority.
Inspection and compliance responses
The licensing authority inspects the unit. We prepare your team for the visit, respond to observations and help rectify gaps so the inspection report supports grant of the licence.
Licence grant and post-licence upkeep
After grant, we explain conditions on labelling, batch records and record keeping, and track renewal and product additions so the licence stays aligned with what you actually produce.
Documents Required
- Application in the form prescribed by the State Licensing Authority
- Constitution documents of the applicant: incorporation certificate, partnership deed or proprietorship proof
- Proof of ownership or lease of the manufacturing premises
- Site plan, layout and blueprint of the manufacturing unit
- List of machinery and equipment with capacity details
- Educational qualification and experience proof of the technical staff, with consent letters
- List of products with formulation details and source reference where applicable
- Consent or clearance from the State Pollution Control Board, where applicable
- Fire safety and local body approvals, where applicable
- Water analysis and Udyam registration details, if available
Timeline and Fees
Indicative timeline: Typically a few weeks to a few months, depending on the State Licensing Authority, inspection scheduling and how quickly observations are closed.
Professional fee: Government fees are set by the state drug authority. Our professional fee depends on the number of products, the state, the condition of the premises and how much GMP gap work is required. Contact us for a scoped quote after a short review of your unit.
What Can Go Wrong if This Is Missed or Done Incorrectly
- Manufacturing medicines without a valid licence is an offence under the Drugs and Cosmetics Act and can lead to prosecution and seizure of stock
- Making products that are not listed on the licence can result in action against the unit and its products
- GMP lapses found during inspection can delay, suspend or cancel the licence
- Misleading labels or unsupported medicinal claims can attract regulatory action against the brand
Frequently Asked Questions
What is an AYUSH manufacturing licence?
It is a licence granted by the State Drug Licensing Authority that permits a unit to manufacture specified Ayurvedic, Siddha or Unani drugs at specified premises under the Drugs and Cosmetics Act, 1940 and Rules. It is issued to the unit and its products, not to the brand name alone.
Who grants the licence, the central or the state government?
Manufacturing licences for Ayurvedic, Siddha and Unani drugs are granted by the State Licensing Authority of the state where the unit is located. Central bodies set policy and standards, but the application, inspection and grant for a factory are handled at the state level.
Is GMP compliance compulsory for AYUSH manufacturers?
Yes, the Rules prescribe Good Manufacturing Practice requirements for units making these drugs, and the licensing authority checks the premises against them. Matters such as building, hygiene, storage, equipment, record keeping and quality control are examined, so a unit built without these in mind often needs rework.
Does this licence let me export AYUSH products?
Not by itself. The manufacturing licence is the base requirement, but export usually needs further documents, such as an importer-country registration, a certificate of free sale or a GMP certificate, issued by the relevant authorities. Treat export as a separate step and plan it with the buyer market in mind.
Can I sell Ayurvedic products without a licence if they are herbal?
Describing a product as herbal does not remove it from drug rules. If a product makes a medicinal claim, it is generally regulated as a drug. Food-type herbal products may fall under food safety rules instead. The classification depends on the claim and the composition, so confirm it before launch.
What usually delays an AYUSH licence application?
Common causes include premises that do not match the submitted layout, technical staff whose qualifications do not match the product type, incomplete formulation details and missing pollution or local body papers. Inspection observations that are not closed promptly also add weeks. A pre-application gap check removes most of these.
Official Sources
Rules, forms and fees change. Check the current position on the official portal:
Related Services
Related Guides and Articles
Ready to Get Started?
Speak with a qualified professional about your ayush licence: manufacturing licence for ayurvedic, siddha and unani drugs requirements.
Last reviewed: . Laws, fees and procedures change; check the official portal before you act.
Disclaimer: The information on this page is for general informational purposes only and does not constitute professional legal, tax or compliance advice. Requirements vary by situation. Please consult a qualified CA or CS for advice specific to your needs. Government fees and timelines are subject to change; verify with the relevant authority before proceeding.