AYUSH

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

Manufacturing licence (Form 25D) and loan licence applications
Schedule T GMP compliance assessment and gap remediation
State Licensing Authority liaison and inspection readiness
Product approval and labelling compliance advisory
AYUSH Premium Mark and AYUSH certification scheme guidance
New drug approval and import permit support
Licence amendment, renewal and additional product endorsement

How It Works

1

Site Assessment

Evaluate manufacturing premises, equipment and quality systems against Schedule T GMP requirements.

2

Application Preparation

Prepare Form 24D/25D, technical dossier, GMP compliance statement and product list.

3

State Board Filing

Submit application to the State Licensing Authority; coordinate pre-inspection documentation.

4

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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