AYUSH Herbal Product License & Registration in India
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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.
Professionals Law 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.
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Documents Required
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.
FAQs
What is an AYUSH License?
Who issues the AYUSH License?
Is a manufacturing unit mandatory?
What is GMP in AYUSH Licensing?
Can I export AYUSH products with this license?
Is AYUSH license valid for cosmetics and personal care?
Do I need a pharmacist for AYUSH license?
How long is the AYUSH license valid?
Can Professionals Law help me get the AYUSH license anywhere in India?
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