Manufacturing Ayurveda, Siddha or Unani medicines requires a licence from the State Licensing Authority (AYUSH) under the Drugs and Cosmetics Act, 1940 and Rules, 1945. Applicants need a factory complying with Good Manufacturing Practices under Schedule T, qualified technical staff, quality control arrangements, and product formulations based on authoritative texts or approved as patent and proprietary medicines.
Who needs it
- Manufacturers of classical and proprietary ASU medicines
- Loan licensees using another's facility
Requirements
- Schedule T compliant premises
- Machinery and quality control lab or tie-up
- Technical staff with prescribed qualifications
- Product list with references
Process
- Apply online to the state AYUSH licensing authority.
- Submit plans, staff and product details.
- Inspection of premises.
- Grant of licence.
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Follow labelling rules, maintain batch records and renew or retain the licence as required.
Frequently asked questions
Can AYUSH products be sold without a licence?
No. Manufacturing ASU drugs without a licence is prohibited.
Is FSSAI needed for ayurvedic food products?
Products marketed as food, such as ayurveda aahara, fall under FSSAI rules.
What is a loan licence?
A licence allowing manufacture at another licensed facility.
Is export possible?
Yes, with applicable export documentation and destination approvals.
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