Ayush Manufacturing License Online

Standards for Traditional Healing

Apply for Ayush manufacturing registration. Expert guidance for herbal and Ayurvedic product manufacturers on factory setup, testing, and licensing.

Obtain the mandatory license to manufacture Ayurvedic, Siddha, Unani, or Homeopathic (Ayush) medicines and herbal products in India.

The future of wellness. Get licensed by the Ministry of Ayush to manufacture and market Ayurvedic, Unani, and Homeopathic medicines legally in India.

The manufacturing of Ayurvedic, Siddha, Unani, and Homeopathic (AYUSH) medicines is regulated by the Ministry of Ayush and governed by the Drugs and Cosmetics Act, 1940. Every manufacturer must obtain a license from the State Licensing Authority (Ayush) to produce and sell these traditional medicines.

The licensing process involves a thorough inspection of the manufacturing unit to ensure compliance with Schedule T (Good Manufacturing Practices for Ayush). This includes norms for hygiene, raw material storage, production area, and quality control testing. Both classical (scriptural) and proprietary (modern research-based) formulations require approval.

QuickTaxperts provides expert assistance for Ayush manufacturing licenses, helping entrepreneurs set up GMP-compliant factories and managing the complex product approval process with the state drug controller.

• Category: Health & Medical
• Separate licenses for full-fledged manufacturing and 'Loan' licenses.
• Requires a well-equipped quality control laboratory for testing herbs and finished products.
• Mandatory appointment of qualified experts (BAMS/BUMS/B-Pharma Ayush).
• Essential for exporting herbal supplements and Ayurvedic medicines globally.
• Mandatory for all Ayurvedic, Unani, Siddha, and Homeopathic drugs
• Registration under the Drugs and Cosmetics Act, 1940 (Schedule T)
• Requires compliance with Good Manufacturing Practices (GMP)
• Covers proprietary medicines and classical formulations

Ayush License Types

Defining your manufacturing model.

• Full Manufacturing: For units that own the factory and manufacture their own products.
• Loan License: For companies that use the facility of another licensed unit to produce their brand.
• Proprietary Medicine: For unique formulations developed by the manufacturer based on research.
• Classical Medicine: For traditional medicines formulated exactly as per ancient texts.

Documents required

Document requirements vary by entity type, state, premises, and authority. These are the usual groups we verify before submission.

• Ayush Checklist: Manufacturing unit layout plan (blueprints).; Ownership or rental proof of the factory premises.; Qualification and registration of the technical staff (Physicians/Pharmacists).; Detailed list of machinery and lab equipment.; List of products to be manufactured with ingredients (Master Formula).; NOC from the Pollution Control Board.; Self-declaration for Good Manufacturing Practices (GMP).

Process and timeline

• Factory Setup: Designing and building the manufacturing unit as per Schedule T (GMP) norms.
• Technical Hiring: Appointing the mandatory technical experts with BAMS or Ayush Pharmacy degrees.
• Application Filing: Submitting the online/offline application to the State Ayush Licensing Authority.
• Factory Inspection: The Ayush drug inspector visits the unit to verify machinery, hygiene, and lab setup.
• Product Approval: Getting the specific formulations (labels and master formulas) approved by the authority.
• License Grant: Receipt of the Ayush Manufacturing License and GMP Certificate.

Expert review

Ayush Manufacturing License Online content is reviewed by QuickTaxperts Ayush Compliance Team, Traditional Medicine Consultants.

• Checklist-led review
• Document pre-verification
• Authority-specific next steps

Frequently asked questions

These quick answers cover common planning questions before you request a checklist or quote.

• What is an Ayush License?: It is a mandatory permission to manufacture Ayurvedic, Siddha, Unani, or Homeopathic medicines in India.
• Can I manufacture herbal cosmetics with this license?: Ayush covers medicinal products. For purely cosmetic items, a separate cosmetic license from CDSCO/State is usually needed.
• What is Schedule T?: Schedule T specifies the Good Manufacturing Practices (GMP) for Ayush manufacturing units.
• Can I start without owning a factory?: Yes, you can apply for a 'Loan License' to manufacture your products at an existing licensed Ayush factory.
• What is a 'Proprietary' Ayurvedic medicine?: It is a medicine where the ingredients are from classical texts, but the exact formulation/ratio is unique to the manufacturer.
• How long is the license valid?: The license is permanent, subject to the payment of license retention fees every 5 years.
• Is testing mandatory for herbs?: Yes, manufacturers must test raw materials for purity and heavy metals in an in-house or recognized lab.
• How long does the process take?: The entire process, including factory audit and product approval, usually takes 2 to 4 months.