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Know More About AYUSH Herbal Product License Registration
Introduction and Its Compliance
AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy. The AYUSH License is issued by the Ministry of AYUSH, Government of India, for the manufacturing and marketing of traditional Indian systems of medicine, including Ayurveda, Unani, Siddha and Homeopathy as well as Herbal Products which is a mandatory requirement of law. A special ministry for AYUSH was created by the Central Government in the year 2014 and was followed by the State Governments. Under this ministry the rules for making, selling, promoting exporting AYUSH products have been laid. Any individual or company that wishes to produce or distribute AYUSH products must obtain a license from the respective State AYUSH Department.
Lawfinity India Private Limited offers complete assistance in acquiring AYUSH licenses, ensuring full compliance with applicable laws, including infrastructure setup, documentation, regulatory inspections and necessary approvals.
Why It Is Needed
The demand for Ayurvedic and herbal wellness products has increased exponentially in recent years, both in domestic as well as in international markets. An AYUSH license is legally required to ensure that the products meet traditional formulation standards and safety requirements. It enables businesses to manufacture, market and export AYUSH based products, while ensuring public health and consumer confidence. Additionally, it also allows participation in government tenders and ecommerce platforms where licensing is mandatory.
Benefits and Advantages
- Legal Authorization for Herbal Product Manufacturing An AYUSH License legally permits the manufacturer to produce and distribute herbal, Ayurvedic and Unani products while staying compliant with Indian regulations.
- Access to Global Markets With an AYUSH License, businesses can export products internationally, as the certification is recognized by many countries interested in traditional Indian medicine.
- Increased Market Trust Consumers trust licensed herbal and Ayurvedic brands more, improving brand reputation and marketability.
- Government Scheme Eligibility Licensed AYUSH businesses are eligible for financial grants, R&D support and incentives under the AYUSH Mission and similar schemes.
- Competitive Advantage Obtaining an AYUSH license adds value to the brand and gives a competitive edge in the booming herbal product sector.
Eligibility Criteria
Eligible Applicants
- The applicant must be a registered company, LLP or proprietorship with manufacturing or marketing intent.
- Manufacturing premises must meet Good Manufacturing Practices (GMP) prescribed under Schedule T of the Drugs and Cosmetics Act.
- The business must employ a qualified AYUSH practitioner or pharmacist, such as BAMS, BUMS or equivalent degree holders.
- For marketing companies (loan license), a tie-up with a GMP-certified manufacturer is required.
Documents Required
- Company registration certificate or partnership deed
- Identity and address proof of the directors/partners/proprietor
- Premises proof (ownership/lease agreement)
- Site plan/layout of the manufacturing unit
- Qualification and appointment letter of the technical person
- List of machinery and manufacturing equipment
- Product formula and labelling details
- Affidavit of non-conviction
- NOC from the Pollution Control Board (if required)
- GMP and COPP (if applying for export)
Steps for Getting Registration
- Select Type of License: Manufacturing, loan license or contract manufacturing based on business needs.
- Infrastructure Setup: Establish or tie-up with a GMP-compliant manufacturing unit.
- Document Collection: Gather necessary documents including technical personnel details and site layout.
- Application Filing: Submit application online or offline to the State AYUSH Licensing Authority.
- Inspection: The authority inspects the premises for hygiene, equipment, personnel and compliance.
- Grant of License: After approval, the AYUSH license is issued with a unique license number.
Penalties
- Non-Compliance Fines ranging from ₹20,000 to ₹1,00,000.
- Unauthorized Manufacturing or Sale Imprisonment for up to 2 years under the Drugs and Cosmetics Act.
- License Cancellation Cancellation or suspension of license.
- Product Recalls Product recalls and damage to business reputation.
Timelines
Manufacturing License
Typically granted within 45 to 60 working days after application and inspection.
Loan or Marketing License
May be processed faster, within 30 to 45 working days, provided the contract manufacturer is pre-approved.
Timelines may vary depending on document verification and government approvals.
Fee
Frequently Asked Questions
Because every great business starts with the right answers.
It is a mandatory license required to manufacture or market Ayurvedic, Unani, Siddha or herbal health products in India.
The license is issued by the State Licensing Authority under the Ministry of AYUSH.
Yes, for a manufacturing license. However, for a marketing company, you can partner with an approved manufacturer and apply under a loan license.
Good Manufacturing Practices ensure that manufacturing premises maintain hygiene, equipment standards and trained personnel.
Yes. You must also obtain a Certificate of Pharmaceutical Product (CoPP) and comply with the import regulations of the destination country.
Only if the products are based on Ayurvedic or Unani formulations. Pure cosmetics fall under separate licensing.
You need a qualified AYUSH medical practitioner or technical person, not a conventional pharmacist.
Most AYUSH licenses are valid for 5 years, subject to compliance and renewal before expiration.
Absolutely. Lawfinity India Private Limited offers end-to-end support across all Indian states for AYUSH and other health sector licensing.
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Anil Yadav
Shaperz India Grain Private Limited
“From FSSAI to Trade License, Lawfinity handled all our approvals efficiently. One-stop solution for all licensing needs.”
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