An AYUSH licence is the manufacturing licence that a State Licensing Authority grants under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 (Chapter IVA) to produce Ayurvedic, Siddha, Sowa-Rigpa and Unani medicines for sale. You apply on Form 24-D and receive the licence on Form 25-D after the State inspects the premises and your Good Manufacturing Practice arrangements. This page covers who needs the licence, the qualification routes, the documents, fees as reported, and the practical steps from file preparation to inspection.
What is an AYUSH licence?
AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy. When people talk about an AYUSH licence for a factory, they usually mean the licence to manufacture Ayurvedic, Siddha or Unani (ASU) medicines, which is issued by the State Licensing Authority under Chapter IVA of the Drugs Rules, 1945. Homoeopathic medicines have their own licensing forms under the same Act. The Ministry of AYUSH formulates policy, but it does not issue the manufacturing licence in an ordinary case.
The Rules treat ASU medicines in two broad groups. Classical medicines are those made from the authoritative texts listed in the First Schedule, such as Ayurvedic formulations from recognised classical books. Patent or proprietary medicines are formulations that are not in those texts, and for them the applicant has to submit proof of safety and effectiveness under Rule 158B. This difference matters because it changes the documents you must file with Form 24-D.
A manufacturing licence is tied to a named premises, a list of products and a qualified technical person. The inspector checks the building, equipment, raw material handling, quality control and the technical staff against the Good Manufacturing Practice requirements in Schedule T of the Drugs Rules. Once granted, the licence remains in force without annual renewal, provided the retention fee is paid every five years and the licence conditions are met.
AYUSH licensing is distinct from other approvals your business may need. Herbal supplements sold as food may fall under the FSSAI regulations instead of the Drugs Rules, depending on how they are presented. A drug licence is for sale of allopathic drugs, and a cosmetic licence covers cosmetics. Classify the product before you apply.
Who needs an AYUSH manufacturing licence?
Any person or company manufacturing Ayurvedic, Siddha or Unani medicines for sale or distribution needs a licence for the manufacturing premises. Typical applicants include:
- Ayurvedic pharmacies producing classical formulations such as churna, vati, asava, arishta, taila and bhasma
- Unani and Siddha manufacturers of tablets, syrups, ointments and other dosage forms
- Herbal wellness brands making medicinal products with therapeutic claims
- Brand owners who use a contract manufacturer and need a loan licence arrangement
- Exporters of ASU medicines who need a licensed Indian site and GMP certification for foreign buyers
- Start-ups launching proprietary Ayurvedic formulations that need Rule 158B evidence
Benefits of AYUSH Manufacturing Licence
Legal right to manufacture and sell
Manufacturing ASU medicines without a licence is an offence under the Act. A licence lets you supply distributors, hospitals, pharmacies and government institutions openly.
Credibility with buyers
Distributors, e-commerce platforms and institutional buyers ask for the licence number and a GMP certificate before they list a product.
Foundation for export
Overseas buyers and regulators commonly ask for a certificate of GMP and a certificate of free sale issued on the basis of your licence.
Structured quality system
Schedule T GMP pushes you to document raw material testing, process control and batch records, which reduces variation between batches.
Low maintenance burden
Since the licence does not need annual renewal, the compliance effort after grant is largely the five-yearly retention fee and routine records.
Eligibility, premises and qualified person
The Rules focus on the competence of the technical person who supervises manufacture and on whether the premises can support GMP. Check each item before filing.
- A technical person in charge of manufacture who falls in one of the qualification routes below
- Degree in Ayurveda, Ayurvedic pharmacy, Siddha or Unani from a recognised university or council
- Diploma in Ayurveda, Siddha or Unani from a State Government or recognised institution
- Graduate in pharmacy, pharmaceutical chemistry, chemistry or botany with at least two years of manufacturing experience in these medicines
- Registered Vaid or Hakim with at least at least four years in manufacturing Siddha or Unani drugs
- Premises with adequate area, separation of processes, clean utilities, storage and a quality control arrangement as per Schedule T, with the minimum area and equipment as prescribed by the Rules and the State
- Constitution of the applicant clearly defined, with a responsible person named for the business
Documents required
Applicant and constitution documents
- Application in Form 24-D with the fee receipt
- Certificate of incorporation, partnership deed or proprietorship proof, with identity and address proof of directors or partners
- PAN and GST registration of the entity
- Affidavit and undertakings as required by the State, such as non-conviction
Premises and technical staff documents
- Ownership proof or registered lease or rent agreement for the manufacturing premises
- Site plan and layout of manufacturing, storage and quality control areas with dimensions
- Qualification certificates, experience letters and appointment letters of the technical staff
- List of machinery and equipment, and details of the quality control laboratory
- Pollution control consent or NOC where applicable to the process
Product and quality documents
- List of products proposed to be manufactured with formulations and the authoritative text reference for each classical medicine
- For patent or proprietary medicines, proof of safety and effectiveness under Rule 158B
- Schedule T GMP compliance documents, standard operating procedures and, where available, the GMP certificate
- Label drafts and details of raw material sourcing and testing
Step-by-step process
Procedures differ in detail between States, but the sequence below describes the usual route.
Fix the product list and classification
Decide which medicines you will make, and mark each as classical (with the text reference) or proprietary (needing Rule 158B proof). Since the fee is charged by the number of products, list only what you will actually launch.
Prepare the premises for GMP
Arrange process areas, storage, water, drainage, equipment and a quality control corner as Schedule T requires. Do this before filing, because the inspection follows soon after the file is accepted.
Appoint the qualified technical person
Confirm that the person meets one of the qualification routes and prepare certificates and an appointment letter. Check whether the same person is named as technical staff elsewhere.
File Form 24-D online
Submit the application on the State licensing portal or on e-AUSHADHI with the documents and pay the fee as the portal directs.
Scrutiny and queries
The licensing office reviews the file and may issue queries on documents, products or premises. Reply in writing, pointing to the document that answers each query.
Inspection
The Licensing Authority or the inspector visits the premises and checks GMP, staff, equipment, raw material storage and records. Observations are recorded and you have to close them.
Grant of licence on Form 25-D
On satisfaction after inspection, the authority grants Form 25-D. Check the premises address, product list and technical staff named on it.
Commence manufacture and maintain records
Start batch records, labelling and testing, and set a calendar reminder for the retention fee.
Government fees
The Drugs Rules fix the licence fee, and States collect it through their portal or treasury. The figures below come from a consultancy summary and should be checked in the rule schedule and the State's current fee notification before you pay.
| Item | Amount | Note |
|---|---|---|
| Manufacturing licence (Form 24-D application), first ten products | ₹3,000 | As reported; State rules may vary. |
| Each additional product beyond ten | ₹2,000 | As reported. |
| Retention fee every five years | As prescribed under the Rules and the State | Amount and due date to be confirmed with the Licensing Authority. |
Professional charges are quoted separately after reviewing your case. Government fees are paid directly to the authority.
How long does it take?
There is no single statutory timeline that applies in every State. Time depends on how complete the file is, the date of inspection and the number of observations to be closed. Applications supported by a ready GMP-compliant premises and a consistent product list tend to move faster. We do not promise a fixed government timeline.
| Stage | Typical time |
|---|---|
| Premises preparation and document collection | Depends on the state of the plant |
| Scrutiny and query replies | Varies by State office |
| Inspection and closure of observations | Depends on inspector scheduling |
| Grant of Form 25-D | After satisfactory inspection |
Validity and renewal
A manufacturing licence for ASU drugs does not carry an expiry date. It stays in force if you pay the retention fee every five years and observe the conditions. If the fee is missed beyond the permitted period, the licence can be cancelled, and you would have to apply afresh. Adding products, changing the premises, the technical person or the constitution of the firm needs an application to the Licensing Authority. Keep the licence displayed at the premises and available for inspection.
Compliance after approval
- Maintain batch manufacturing records, raw material testing records and finished product test results under Schedule T
- Label each product with the licence number, composition, batch details and the other particulars the Rules require
- Retain samples and records for the period prescribed by the Rules and be ready for inspection and sampling by the drug inspector
- Follow the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and avoid claims to cure diseases that the law lists
- Pay the retention fee on time and apply before changing premises, products or technical staff
- Keep GMP certificates and pollution consents current where applicable
AYUSH licence vs related health licences
| AYUSH (ASU) manufacturing licence | Drug licence (allopathic sale) | Cosmetic licence |
|---|---|---|
| Covers manufacture of Ayurvedic, Siddha and Unani medicines | Covers retail and wholesale sale of allopathic drugs | Covers manufacture or import of cosmetics |
| Application on Form 24-D, licence on Form 25-D | Application on Form 19, licence on Forms 20, 21, 20B, 21B | Application on COS forms such as COS-5 or COS-1 |
| Granted by State Licensing Authority | Granted by State Drugs Control | State authority for manufacture, CDSCO for import |
| Technical person with ASU qualification | Registered pharmacist for retail | Premises and staff conditions per the Cosmetics Rules |
Common mistakes and rejection reasons
Technical person does not qualify
A degree or experience that does not fit any of the Rule's routes, or experience letters from an unlicensed unit, leads to rejection. Check the route against the actual certificates.
Premises not GMP ready at inspection
Applicants file first and renovate later. The inspector sees an incomplete plant and records major observations.
Products listed without references
Classical formulations without the text reference, or proprietary formulations without Rule 158B evidence, are returned with queries.
Inflated product list
Listing many products that you do not intend to make raises the fee and invites questions about equipment for each dosage form.
Missing pollution consent
Processes involving boilers, effluent or solvents may need State Pollution Control Board consent, and a missing consent delays grant.
Labels with prohibited claims
Label drafts promising cures for listed diseases attract action under the advertisements law and inspection objections.
Penalties for non-compliance
Manufacturing ASU drugs without a licence, or manufacturing spurious or adulterated drugs, is an offence under the Drugs and Cosmetics Act, 1940 and can lead to imprisonment and fine, besides suspension or cancellation of the licence. We have not stated section-wise amounts here because they depend on the offence and the Act as amended; refer to the current text on India Code for a specific case.
Practitioner tips
- Ask the Licensing Authority for its current inspection checklist and build your plant plan around it. Offices differ in how closely they check area, floor finish and the separation of raw and finished goods.
- Keep qualification and experience certificates in a single file with attested copies, and check them against the qualification routes before the technical person signs the application.
- File classical medicines with the text name, chapter and formulation reference. The inspector often compares your master formula with the text.
- If you plan to export, design records and documentation to GMP certificate standards from day one so that you do not have to repeat work later.
- Start the pollution NOC enquiry in parallel if your process uses boilers, steam or effluent generating steps.
How Lawgical Guru helps
Eligibility and product review
We review your formulations, product claims and qualified-person details to confirm the licence route and the evidence needed.
Document preparation
We prepare Form 24-D, site plan checklist, product list and the supporting documents so they are consistent.
State portal filing
We file on the relevant State portal or e-AUSHADHI and track the application status with the office.
Inspection readiness
We prepare a premises and GMP checklist aligned to the Rules so that observations are fewer.
Related approvals
We support GST registration, pollution NOC, factory licence and trademark registration for the brand.
AYUSH Manufacturing Licence: frequently asked questions
Which form is used to apply for an AYUSH manufacturing licence?
Applications to manufacture Ayurvedic, Siddha and Unani drugs are made on Form 24-D to the State Licensing Authority, and the licence is granted on Form 25-D after inspection. The forms are part of Chapter IVA of the Drugs Rules, 1945. Homoeopathic medicines use separate forms.
Who issues the AYUSH licence?
The State Licensing Authority for Ayurvedic, Siddha and Unani drugs issues the manufacturing licence under the Drugs and Cosmetics Act. In many States this is the AYUSH or Ayurved department or the State Drugs Control office. The Ministry of AYUSH sets policy but is not the issuing authority.
What qualification does the technical person need?
The Rules allow several routes, including a degree or diploma in Ayurveda, Siddha or Unani, a science or pharmacy graduate with two years of manufacturing experience, or a registered Vaid or Hakim with at least four years in Siddha or Unani manufacture. Confirm the route with your State office.
What is Schedule T and why does it matter?
Schedule T of the Drugs Rules sets Good Manufacturing Practice requirements for Ayurvedic, Siddha and Unani drugs, covering premises, equipment, staff, raw materials, records and quality control. Inspectors use it to decide whether your plant can be licensed, so prepare the premises against it before filing.
How much is the government fee for an AYUSH licence?
A consultancy summary reports ₹3,000 for the first ten products and ₹2,000 for each additional product, but State rules can differ. Check the schedule and the State fee notification on the day you file. Professional charges are separate from the government fee.
Does an AYUSH licence need yearly renewal?
No. A manufacturing licence for ASU drugs remains valid indefinitely if the retention fee is paid every five years and the conditions are followed. If the retention fee is not paid within the permitted period the licence can be cancelled and a fresh application is needed.
What is Rule 158B?
Rule 158B deals with proof of safety and effectiveness for patent or proprietary Ayurvedic, Siddha and Unani medicines whose formulations are not in the authoritative texts. Applicants need to submit supporting evidence with the application. Classical formulations need the text reference instead.
Do I need a separate sale licence to sell Ayurvedic medicines?
Under the Drugs and Cosmetics Act the licence requirement for Ayurvedic, Siddha and Unani drugs applies to manufacture, and a separate sale licence is generally not prescribed for ASU drugs. State trade and GST requirements still apply, so confirm with your State office.
Can I get a loan licence for a contract manufacturer?
Yes, the Rules allow manufacture on loan licence arrangements where the brand owner uses the facility of a licensed manufacturer. The documents and conditions are set by the State, so check them with the Licensing Authority before signing the contract.
Is an AYUSH licence the same as AYUSH Premium Mark or GMP certification?
No. The licence is the legal permission to manufacture. GMP certification is a separate certificate issued on the basis of an inspection against Schedule T, and quality marks are voluntary schemes. Buyers and exporters often ask for the GMP certificate in addition to the licence.
Reviewed by Satyam Gupta, Company Secretary (CS) & Advocate
8+ years of industry experience. This page was last reviewed on 16 October 2026 against the official sources below. Rules and fees change — confirm on the official portal before you apply.