An AYUSH Manufacturing License is mandatory for manufacturing Ayurvedic, Siddha, Unani, or Homoeopathic medicines in India. The license is regulated by the Ministry of AYUSH, Government of India, and issued through State AYUSH Drug Licensing Authorities.
This Saving Mantra blog explains the step-by-step process for obtaining an AYUSH manufacturing license in India, including eligibility, documents, plant requirements, timelines, and compliance—crafted to rank higher on Google and support entrepreneurs entering the traditional medicine sector.
What is an AYUSH Manufacturing License?
An AYUSH Manufacturing License is a statutory approval required to manufacture medicines under:
- Ayurveda
- Yoga & Naturopathy (products)
- Unani
- Siddha
- Homoeopathy
The license ensures medicines are produced as per Good Manufacturing Practices (GMP) and AYUSH pharmacopoeia standards.
Who Needs an AYUSH Manufacturing License?
The license is mandatory for:
- Ayurvedic medicine manufacturers
- Herbal and classical formulation units
- Proprietary AYUSH medicine manufacturers
- Homoeopathic drug manufacturers
- Startups and MSMEs producing AYUSH products
Benefits of AYUSH Manufacturing License
- 🌿 Legal authorization to manufacture AYUSH medicines
- 🌿 Eligibility for government schemes and tenders
- 🌿 Increased market trust and brand credibility
- 🌿 Export eligibility with additional approvals
- 🌿 Compliance with drug safety standards
Step-by-Step Process for AYUSH Manufacturing License in India
Step 1: Company / Firm Registration
First, establish a legal entity such as:
- Proprietorship
- Partnership / LLP
- Private Limited Company
Step 2: Premises & Infrastructure Setup
- Separate manufacturing area
- Adequate space as per AYUSH norms
- Storage for raw material and finished goods
- Quality control area
📌 Premises must comply with GMP standards.
Step 3: Appointment of Technical Staff
- Qualified Ayurvedic / Unani / Siddha / Homoeopathic expert
- Full-time technical supervisor approved by AYUSH authority
Step 4: Documentation Preparation
Prepare documents including:
- Manufacturing layout plan
- List of products to be manufactured
- Equipment list
- Raw material details
Step 5: Application Submission
- Apply online/offline to the State AYUSH Drug Licensing Authority
- Pay prescribed government fees
Step 6: Inspection by AYUSH Authority
- Physical inspection of manufacturing unit
- Verification of infrastructure, staff, and records
Step 7: Grant of AYUSH Manufacturing License
Upon successful inspection:
- AYUSH Manufacturing License is issued
- License mentions approved product categories
⏳ Timeline: 60–90 days (state dependent)
Documents Required for AYUSH Manufacturing License
- Entity incorporation documents
- Premises ownership / rental agreement
- Site & layout plan
- GMP compliance declaration
- Qualification certificates of technical staff
- Product formulations & labels
Validity & Renewal
- License validity: 5 years (varies by state)
- Renewal required before expiry to continue operations
Common Mistakes to Avoid
- ❌ Inadequate manufacturing space
- ❌ Unqualified technical staff
- ❌ Non-compliance with GMP norms
- ❌ Manufacturing unapproved products
Why Choose Saving Mantra for AYUSH License?
- ✔ End-to-end AYUSH license support
- ✔ GMP-compliant documentation
- ✔ Inspection readiness assistance
- ✔ Faster approvals with expert handling
Frequently Asked Questions (FAQs)
Q1. Is AYUSH manufacturing license mandatory for herbal products?
Yes, if products fall under AYUSH drug definitions.
Q2. Can startups apply for AYUSH manufacturing license?
Yes, startups and MSMEs can apply if requirements are met.
Q3. Is GMP certification mandatory?
Yes, GMP compliance is compulsory for manufacturing units.
Q4. Can AYUSH medicines be exported?
Yes, with additional export registrations and approvals.
Disclaimer
This blog is for informational purposes only and does not constitute legal or regulatory advice. AYUSH rules, state procedures, and documentation requirements may change over time. Readers are advised to consult professionals or authorities before proceeding.