Start Your Ayurvedic Pharma Unit: Complete Licensing Process Explained

To get an Ayurvedic medicine manufacturing license in India, you need to follow the rules and guidelines laid out by the AYUSH department (Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy), under the Ministry of AYUSH, Government of India

Types of AYUSH Manufacturing Licenses

• Complete Manufacturing License: For businesses setting up their own manufacturing unit to produce and market Ayurvedic medicines.
• Loan License: For those using the premises and equipment of an existing licensed manufacturer (requires Good Manufacturing Practices [GMP] certification).
• Contract/Third-Party Manufacturing License: For businesses outsourcing production to a licensed manufacturer while handling marketing.

Eligibility Requirements

To apply for an Ayurvedic manufacturing license, you must meet the following criteria:

• Business Registration : Register your business as a sole proprietorship, partnership, or private limited company with the Government of India.
• Qualified Staff : Employ competent technical staff, including at least one full-time employee with:
  • A degree or diploma in Ayurveda, Ayurvedic Pharmacy, Siddha, or Unani from a recognized university or institution; OR
  • A graduate degree in Pharmacy, Pharmaceutical Chemistry, Chemistry, or Botany with at least 2 years of experience in manufacturing Ayurvedic drugs; OR
  • A registered Vaid or Hakim with at least 4 years of experience in manufacturing Siddha or Unani drugs; OR
  • A qualified pharmacist with at least 8 years of experience in manufacturing Ayurvedic, Siddha, or Unani drugs.
• Premises : For a complete manufacturing license, the manufacturing unit must:
  • Be located in an industrial area.
  • Have a minimum area of 1200 sq. ft. for one category of drug (additional space for more categories, e.g., 400 sq. ft. extra for Unani medicines).
  • Include specific areas: 100 sq. ft. for office space, 150 sq. ft. each for raw material and finished goods storage, 150 sq. ft. for a laboratory, 100 sq. ft. for rejected drugs, and 200 sq. ft. for a churn room.
• GMP Certification : The manufacturing unit must comply with Good Manufacturing Practices (GMP) as per Schedule T of the Drugs and Cosmetics Act.
• Machinery and Equipment : Provide all necessary manufacturing and packaging machinery (e.g., stainless steel tanks, P.P. cap sealing machines) as per the production volume and dosage form (tablets, liquids, powders, etc.).

Steps to Obtain the License

1. Prepare the Manufacturing Unit :
   • Set up the facility in an industrial area with the required space and partitions for different sections (e.g., tablet/capsule section: 100 sq. ft.; liquid section: 150 sq. ft.).
   • Ensure compliance with GMP standards, including proper ventilation, lighting, and hygiene.
   • Equip the unit with necessary machinery and a testing laboratory (or arrange for testing at a government-approved lab).
2. Gather Required Documents :
   • Application Form: Download Form 24-D (for complete manufacturing) or Form 24-E (for loan license) from the Ministry of AYUSH website or the state AYUSH department portal.
   • Business Documents :
     • Proof of business registration (e.g., Memorandum and Articles of Association, partnership deed, or proprietorship documents).
     • PAN card and Aadhaar card of the proprietor/director.
     • Proof of premises ownership or rent agreement.
   • Technical Staff Documents:
     • Appointment letter and biodata of the full-time technical supervisor.
     • Attested copies of academic qualifications and experience certificates.
     • Passport-size photos of the proprietor and technical supervisor.
   • Product Details :
     • List of medicines to be manufactured, including formulations, ingredients, quantities, uses, and references to authoritative texts (for classical drugs) or clinical trial reports for proprietary drugs (tested on at least 30 patients).
     • Draft labels for sales packaging.
   • GMP and COPP :
     • GMP certificate for the manufacturing facility.
     • Certificate of Pharmaceutical Product (COPP) if exporting products.
   • Other Documents:
     • Affidavit of non-resemblance with other products (name, formulation, packaging, labeling).
     • Treasury challan or proof of application fee payment (e.g., ₹2,000 for Ayurvedic drugs, ₹3,000 for up to 10 proprietary drugs).
     • Self-addressed envelope with sufficient postal stamps.
   • Layout Plan: Blueprint of the manufacturing unit as per Rule 157 (GMP requirements).
3. Submit the Application :
   • Apply online through the Ministry of AYUSH portal or the state AYUSH department’s website (e.g., in Delhi, the AYUSH Department is located at Tibbia College, Karol Bagh).
   • Upload all required documents and pay the application fee (varies by state, typically ₹2,000–₹3,000).
   • For third-party or loan licenses, include a legal agreement with the GMP-certified manufacturer specifying product ownership and manufacturing charges.
4. Inspection :
   • The state AYUSH licensing authority (e.g., Director of Ayurveda/AYUSH) will review your application and conduct a site inspection to verify compliance with GMP and other requirements.
   • Drug inspectors will periodically inspect the premises post-licensing.
5. License Approval :
   • If the application and inspection are satisfactory, the license will be issued. Since October 1, 2021, AYUSH licenses are perpetual (lifetime validity) with an annual self-compliance declaration, subject to GMP certificate validation every 5 years.
   • If rejected, the authorities will provide reasons, and you can address deficiencies and reapply.

Additional Notes

• State-Specific Requirements: Each state may have slightly different requirements (e.g., Delhi requires 1200 sq. ft. for one drug category). Check with the state AYUSH department.
• Loan License Requirements: For a loan license, you need a minimum of three rooms (raw material storage, finished goods storage, and office) in the same state as the manufacturer. No Ayurvedic experts or pharmacists are required for this license.
• Third-Party Manufacturing: You don’t need a manufacturing unit or license; the third-party manufacturer handles compliance and product approvals. A legal agreement is required to clarify product ownership.
• FSSAI Not Required: Ayurvedic medicines require an AYUSH license, not an FSSAI license, unless you’re selling food supplements alongside medicines.
• Clinical Trials: For proprietary Ayurvedic drugs, submit clinical trial reports on at least 30 patients, conducted by qualified practitioners
• Costs: Application fees range from ₹2,000–₹3,000, but total costs (including setup, GMP certification, and legal fees) may range from a few thousand to tens of thousands of rupees, depending on the state and scale.
• Export: For exporting Ayurvedic products, obtain a Certificate of Pharmaceutical Product (COPP) from the Central Drugs Standard Control Organisation (CDSCO).

Recommendations

• Consult Experts: Engage with AYUSH license consultants or legal advisors (e.g., Corpseed, FinacBooks, or Navayur Herbals) for guidance on state-specific processes and documentation.
• Online Application: Use the Ministry of AYUSH’s online portal for a streamlined, transparent process.
• Compliance: Ensure ongoing adherence to GMP and Drugs and Magic Remedies Act (DMR) standards to avoid penalties or license suspension.

By following these steps and ensuring compliance with AYUSH regulations, you can successfully obtain an Ayurvedic medicine manufacturing license in India. For further details, visit the Ministry of AYUSH website (www.ayush.gov.in) or your state’s AYUSH department portal.

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