Food & AYUSH Licensing

AYUSH License Traditional & Modern

Complete regulatory licensing for Ayurvedic, Unani, Siddha, and Homeopathic (AYUSH) products under the Drugs & Cosmetics Act, 1940.

Service Overview

The AYUSH sector (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) is one of India's most vibrant traditional sectors, now transitioning into a modern, evidence-based industry. Governed by the Drugs and Cosmetics Act, 1940 and the subsequent Rules of 1945, AYUSH manufacturing is regulated at the state level by the State Licensing Authority (SLA).

Commercializing a traditional remedy requires a valid manufacturing license (Form 25-D) and strict adherence to Good Manufacturing Practices (GMP) as per Schedule T. Whether you are manufacturing 'Classical' medicines mentioned in authoritative texts or 'Patent & Proprietary' formulations, your facility must meet high hygiene and documentation standards to gain trust in both domestic and international markets.

MedRegX India provides deep expertise in the AYUSH regulatory framework. We help with site selection, blueprint approvals for GMP compliance, formulation documentation (AFI/API references), and the successful filing for manufacturing, loan, and marketing licenses.

End-to-end support for Schedule T GMP compliance and factory setup.
Expert assistance in drafting Formulation Dossiers (Patent & Proprietary).
Direct liaison with State AYUSH Licensing Authorities (SLA).
Scientific validation of classical references for traditional medicines.
Guidance on the 'AYUSH Standard' and 'AYUSH Premium' quality marks.
Detailed labeling reviews to prevent misleading claims as per Rule 161.
Support for Export Certificates (COPP) for international traditional markets.
Facilitating testing and stability reports from AYUSH-approved labs.

Required Documentation

Plan of the premises (Blueprint) showing the manufacturing and storage areas.
List of Machinery and Laboratory equipment as per Schedule T.
Documents of ownership/lease of the premises and property tax receipts.
Authenticated proof of technical staff (Ayurvedacharya/Pharma-D etc.).
Product formulation sheet with references from the Ayurvedic Pharmacopoeia.
Stability study data and toxicological reports for proprietary items.
Self-declaration for compliance with the Drugs and Magic Remedies Act.
NOC from the owner for manufacturing on a loan license basis (if applicable).

"Accurate documentation is 70% of the battle. Our experts pre-audit every file before submission."

Our Delivery Workflow

01

Unit Layout Approval

Getting your factory blueprint pre-approved by the state council to ensure it meets GMP requirements before construction.

02

Documentation & AFI Refs

Compiling the ingredients and finding the correct classical references in the Ayurvedic Formulary of India (AFI).

03

File Submission (Form 24-D)

Submitting the physical and digital application to the State Licensing Authority with requisite fees.

04

SLA Joint Inspection

Coordinating a site visit by the government inspector to verify the machinery, staff, and hygiene systems.

05

Grant of License

Issuance of the 25-D Manufacturing License and the subsequent approval of the individual product labels.

FAQ

Frequently Asked Questions

Have questions? Find direct, humanized answers about the regulatory approvals and timelines.

Schedule T under the Drugs & Cosmetics Act prescribes Good Manufacturing Practices for Ayurvedic, Siddha, and Unani drug manufacturers. Compliance with Schedule T is mandatory for obtaining and retaining an AYUSH Manufacturing License from the State Licensing Authority.
A Patent and Proprietary (P&P) medicine is an AYUSH formulation not listed in classical texts. P&P medicines require a separate license and a dossier demonstrating safety, efficacy, and rationale for the proprietary formulation, reviewed by the State Licensing Authority.
Requirements include: site layout plans complying with Schedule T, list of qualified technical staff, product formulation cards referencing classical texts or authoritative books, raw material validation reports, and laboratory equipment compliance. Our team prepares the full dossier.
A COPP is issued by the State Licensing Authority to certify that an AYUSH product is manufactured as per GMP and licensed for sale in India. It is required by importing countries for customs clearance. MedRegX assists in obtaining COPP certificates for all AYUSH product categories.

Launch Your Product In Record Time

Red tape shouldn't decide your launch date. We keep the paperwork moving and the queries answered, so approvals come through sooner.

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