AYUSH Licence
Licensing for Ayurvedic, Unani, Siddha and Homeopathic products under the Drugs & Cosmetics Act
Overview
Manufacturers and marketers of Ayurvedic, Siddha, Unani and Homeopathic (ASUH) drugs require a valid licence from the State Licensing Authority (SLA) under the Drugs & Cosmetics Act, 1940. The Ministry of AYUSH also mandates GMP (Good Manufacturing Practice) compliance under Schedule T. Estabizz provides end-to-end assistance for AYUSH drug licences — from site readiness to State Licensing Board applications and GMP certification.
What We Offer
How It Works
Site Assessment
Evaluate manufacturing premises, equipment and quality systems against Schedule T GMP requirements.
Application Preparation
Prepare Form 24D/25D, technical dossier, GMP compliance statement and product list.
State Board Filing
Submit application to the State Licensing Authority; coordinate pre-inspection documentation.
Inspection & Licence
Support during the SLA inspection; follow up for licence issuance and endorsement of approved products.
Documents Required
- Proof of premises (ownership/rent agreement)
- Manufacturing site layout and area calculations
- List of machinery and equipment
- Qualified Person / Technical Supervisor qualification proof
- GMP compliance statement
- Product list with formulae references (classical/proprietary)
- Certificate of Incorporation / partnership deed
Frequently Asked Questions
Is a separate AYUSH licence required for each product?+
No. The licence covers categories of products (e.g., tablets, liquids, external preparations). Individual products are endorsed on the licence.
What is Schedule T?+
Schedule T under the Drugs & Cosmetics Act prescribes GMP requirements for AYUSH manufacturing premises — covering plant layout, equipment, quality control and personnel standards.
Can an AYUSH manufacturer also sell under their own brand?+
Yes, but a separate loan licence or marketing arrangement may be needed if manufacturing and marketing are done by different entities.
AYUSH Licence — Start Today
Licensing for Ayurvedic, Unani, Siddha and Homeopathic products under the Drugs & Cosmetics Act
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