AYUSH Manufacturing Licence (Form 25-D)
To manufacture Ayurvedic, Siddha or Unani medicines for sale, you need a licence in Form 25-D from the State Licensing Authority, applied for in Form 24-D on the e-AUSHADHI portal. The rules ask the authority to decide within two months, and the licence stays valid perpetually once granted. We prepare the file, handle the portal and follow through to grant.
What it is
An AYUSH manufacturing licence is the State’s permission to make Ayurvedic, Siddha or Unani (ASU) medicines for sale at a named site. It covers classical formulations from the authoritative books as well as patent or proprietary medicines sold under your own brand. Every product you make must be approved on the licence.
Picture a family that has run an Ayurvedic dispensary in Faridabad for years and now wants to sell its own churna and pain oil across North India. The recipes exist. What they need is a licensed site, a qualified technical person and each product approved on a Form 25-D licence before the first pack goes out.
The law is the Drugs and Cosmetics Act, 1940 and Part XVI of the Drugs Rules, 1945. You apply under Rule 153 in Form 24-D and get a licence in Form 25-D. If you don’t own a plant and want another licensee to make your products, the route is a loan licence: Form 24-E for a licence in Form 25-E under Rule 153-A. Manufacturing must follow Schedule T, the GMP standard for ASU medicines. Homoeopathic medicines follow a separate set of rules and are not covered here.
Who it applies to
You are setting up an ASU plant
A company, LLP or firm setting up a plant for churnas, tablets, oils, asavas, arishtas or capsules. Small units can also take Udyam registration once set up.
You own a brand but no plant
A marketer who wants products made at a licensed third-party unit under its own name takes a loan licence in Form 25-E. Protect that name early with trademark registration, since the brand is the main asset you own.
You are launching new products
A licensed unit adding classical or proprietary products. New proprietary formulations need evidence of their ingredients and effectiveness under Rule 158-B.
Why it matters
Makes your products lawful to sell
Distributors, pharmacies and online marketplaces ask for the licence number, and it goes on every label.
Removes the renewal cycle
Under Rule 156 a Form 25-D licence remains valid perpetually, with a yearly self-declaration in place of renewal.
Earns a GMP certificate buyers trust
A Schedule T GMP certificate in Form 26E-1 is what institutional and export buyers usually ask to see.
Documents required
Entity and premises
- Incorporation certificate, LLP or partnership deed
- Authorisation for the signatory
- Ownership or lease papers for the premises
- Site plan and layout of manufacturing and storage areas
Plant and staff
- List of machinery and equipment by section
- Qualification and experience papers of the technical person
- Appointment letter and consent of the technical person
- Testing arrangement: own lab or approved laboratory
Products
- Product list with the reference book for classical items
- Composition and published literature for proprietary items
- Proof of effectiveness where Rule 158-B asks for it
- Draft labels with brand name
How it works
Classify every product
We split the list into classical and patent or proprietary items. Here is the catch: the fee and the evidence differ between the two, so a mixed list needs care. We also check each formulation’s reference.
Prepare Form 24-D on e-AUSHADHI
We register you on the e-AUSHADHI portal and build the application with premises, staff, equipment and product annexures.
Answer queries and host the inspection
The Licensing Authority reviews the file and inspects the site against Schedule T. We reply to queries; your technical team handles the floor.
Get the licence, then keep it current
Rule 154 asks for a decision within two months of the application or of compliance with queries. After grant we file your yearly self-declaration and track the GMP certificate.
Timelines
Two months to decide
Under Rule 154 the licence is to be issued within two months from receipt of the application, or from the date you comply with queries.
Self-declaration every year
Under Rule 156 you file a self-declaration of compliance every year, within three months of completing each year.
GMP retention every five years
The Form 26E-1 GMP certificate needs a retention fee of ₹1,000 before each succeeding five-year period ends.
What happens if you skip it
Manufacture without a licence
Making ASU drugs for sale without a licence breaks the Drugs and Cosmetics Act, 1940. Stock made that way cannot be lawfully sold.
Missed self-declaration
Perpetual validity under Rule 156 comes with the yearly self-declaration. Skipping it puts the licence at risk.
Products not on the licence
Say a Gurugram brand owner adds a new herbal capsule to its range but the host unit’s licence doesn’t list it. That product is made without a licence, even though the plant itself is licensed.
Frequently asked questions
Who issues an AYUSH manufacturing licence?
The State Licensing Authority for Ayurvedic, Siddha and Unani drugs issues it, through the e-AUSHADHI portal. In Haryana, ASU drug licensing sits with the AYUSH Department rather than the allopathic drugs wing. The Ministry of AYUSH sets policy at the centre; the licence itself is a State licence. We file on the portal, follow up on queries and coordinate the inspection for you.
What is the government fee for Form 24-D?
Rule 153 prescribes ₹2,000 for classical Ayurvedic, Siddha or Unani drugs. For patent or proprietary medicines, the fee is ₹3,000 for the first ten products, with a further fee for additional products. The same structure applies to a loan licence in Form 24-E under Rule 153-A. We work out the exact fee from your product list before filing.
How long does it take to get the licence?
Rule 154 asks the Licensing Authority to issue the licence within two months from receipt of the application or from the date you comply with its queries. In practice, the clock depends on a complete file and a site that is ready for inspection. We review every annexure before submission to keep queries few.
Does an AYUSH licence need renewal?
No. Under Rule 156 a licence in Form 25-D remains valid perpetually. In place of renewal, you submit a self-declaration of compliance with the licence conditions and the Act every year, within three months of completing each year. The GMP certificate separately needs a ₹1,000 retention fee every five years. We diarise both dates and file them for you on time.
What is a loan licence and when do I need one?
A loan licence lets you get your products made at another licensee’s plant, under your own name, without owning a factory. You apply in Form 24-E and receive a licence in Form 25-E under Rule 153-A, with fees on the same scale as Form 24-D. It suits a brand owner starting small. We help you document the arrangement with the host unit and file the application.
Who can be the technical person?
Rule 157 requires at least one full-time technical person with a recognised qualification, such as a degree in Ayurveda or Ayurvedic Pharmacy from a university, or certain other qualifications in the relevant system with at least two years of manufacturing experience. Siddha and Unani units need the equivalent qualification in that system. We check the papers against the rule before filing so the inspection doesn’t stall over staffing.
What extra is needed for a proprietary product?
Rule 158-B asks for published literature on the ingredients and, depending on the type of formulation, proof of effectiveness such as a pilot study or existing evidence. Classical formulations made exactly as in the authoritative books do not need this. The rule also covers categories such as Balya and Poshak wellness products and Aushadh Ghana extracts. We help assemble the evidence file from what your R&D team provides.
Is an AYUSH product the same as a food supplement?
No. An Ayurvedic medicine is licensed under the Drugs and Cosmetics Act, while a health supplement or nutraceutical falls under food law and needs FSSAI registration or licence instead. The same herb can sit on either side depending on the claim and the formulation. We look at your product and its label claims before filing, so it goes to the right regulator first time.
Do you test products or certify GMP?
No. Testing is done by your own lab or an approved laboratory, and GMP inspection and certification are done by the Licensing Authority. Our role is the application, the documents, the portal filing, liaison with the office and ongoing compliance such as the yearly self-declaration. We work with your technical person and consultants on the file.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fee under Rules 153 and 153-A: ₹2,000 for classical ASU drugs; ₹3,000 for the first ten patent or proprietary products, plus a further fee for additional products. GMP certificate retention: ₹1,000 every five years.
Ready to begin?
Send us your product list and site details, and we will tell you the licence route, the fee and what the file needs.