AYUSH License Registration
Manufacture and market AYUSH products with complete legal compliance. An AYUSH License is mandatory for any business manufacturing, selling, or distributing Ayurvedic, Unani, Siddha, and Homoeopathic medicines in India — ensuring your products meet the prescribed quality, safety, and regulatory standards under the Drugs and Cosmetics Act, 1940.
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What is an AYUSH License?
An AYUSH License is a regulatory approval required for the manufacture of products falling under the Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) systems of medicine. Manufacturing licenses are generally issued by the respective State Licensing Authorities under the provisions of the Drugs and Cosmetics Act, 1940 and the related rules, establishing the legitimacy of the manufacturing operation.
The licensing framework ensures that AYUSH products are manufactured in facilities that comply with prescribed standards, including Good Manufacturing Practices (GMP) and quality-control requirements. For businesses engaged in producing, marketing, or distributing traditional medicine, the licence provides the legal foundation to commercialise formulations across India and to pursue export approvals and additional certifications where applicable.
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Key Benefits of an AYUSH License
Legal Authorisation to Manufacture
An AYUSH License permits the lawful manufacture and marketing of AYUSH medicines and wellness products in India.
Regulatory Compliance
Ensures your operations meet the requirements prescribed under the Drugs and Cosmetics Act, 1940 and applicable AYUSH regulations.
Enhanced Market Credibility
Licensed manufacturers are viewed as more reliable and trustworthy by consumers, distributors, and business partners.
Improved Consumer Confidence
Registration demonstrates adherence to recognised quality and safety standards, strengthening buyer trust in your products.
Facilitates Product Commercialisation
A valid licence lets your business legally introduce and market AYUSH formulations across India through varied commercial channels.
Supports Brand Development
A compliant, licensed manufacturing setup strengthens the reputation and long-term value of your AYUSH brand.
Eligibility for Further Certifications
Licensed entities may pursue additional approvals such as GMP Certification and export-related registrations where applicable.
Access to Wider Markets
Proper licensing facilitates expansion into domestic and international markets while reducing regulatory and enforcement risks.
Eligibility & Requirements
How to Obtain an AYUSH License
AYUSH manufacturing licence applications are filed with the respective State Licensing Authority (State AYUSH / Drug Control Department) under the Drugs and Cosmetics Act, 1940 and the related rules.
1Step 1: Identify Licence Type and Authority
Determine the applicable licence — manufacturing, loan, wholesale, or retail — and the State Licensing Authority governing your facility.
2Step 2: Prepare the Premises
Ensure the manufacturing premises comply with GMP standards, covering layout, plant and machinery, and a quality-control laboratory.
3Step 3: Appoint Technical Staff
Appoint a qualified BAMS / BUMS / BHMS professional or pharmacy graduate as the technical person-in-charge of manufacturing.
4Step 4: Submit the Application
File the prescribed form (Form 24D for Ayurvedic, Siddha, and Unani drugs) with complete documentation and applicable fees.
5Step 5: Premises Inspection
A Drug Inspector inspects the manufacturing facility for GMP compliance and submits a report to the Licensing Authority.
6Step 6: AYUSH Licence Issued
On satisfactory inspection, the State Licensing Authority grants the manufacturing licence in the prescribed form.
The process typically takes 30–60 days. Premises inspection is the key milestone — ensure full GMP compliance before the Drug Inspector visits to avoid delays.
Documents Required
Applicant Documents
- PAN Card of the applicant / entity
- Address proof
- Passport-size photographs
- Constitution documents of the business
Premises Documents
- Ownership deed or registered rental agreement
- Layout plan of the manufacturing premises
- List of plant, machinery, and equipment
- GMP compliance details
Technical Staff
- Qualification certificates of the technical person-in-charge
- Appointment / consent letter
- Experience certificates
- Identity and address proof
Post-Registration Compliance
GMP Compliance
Maintain Good Manufacturing Practices at all times across premises, equipment, processes, and staff standards.
Licence Renewal
Renew the AYUSH manufacturing licence periodically as prescribed by the State Licensing Authority to keep it valid.
Product Quality Testing
Test each batch in an approved laboratory and maintain proper batch and testing records before dispatch.
Label Compliance
Ensure all product labels comply with the Drugs and Cosmetics Rules — ingredients, dosage, batch number, and expiry.
Common Questions
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