AYUSH License

Overview of AYUSH License in India

What is an AYUSH License?

AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. These are all ancient forms of medicine and treatments which have been quite popular in India since decades. Prior to 2014, these products and treatments were in extensive use but remained completely unregulated. However, since the establishment of a dedicated AYUSH Ministry under the Central and State governments, in the year 2014, AYUSH businesses have received a robust regulatory framework for manufacturing, sale, marketing, and export of products within and outside India.

AYUSH licenses are a significant part of this regulatory framework, whereby the Government prohibits unlicensed AYUSH businesses from operating in India. The AYUSH license is granted by the AYUSH Ministry of the state government, under the jurisdiction of which the AYUSH business operates. The license must be obtained by all businesses dealing in Ayurvedic, Unani, Siddha, herbal, and homeopathy, drugs / cosmetics, and other related treatments. As far as the application for the grant of license is concerned, the provisions for the same are mentioned in the Drugs and Cosmetics Rules, 1945.

Types of AYUSH Licenses

1. Manufacturing License: Necessary for businesses manufacturing their own AYUSH products using their facilities.

2. Wholesale & Retail License: Required for selling AYUSH products in wholesale or retail.

3. Loan License: For businesses that rent a manufacturing facility and do not own one.

4. Third-Party Manufacturing License: For those who outsource manufacturing to third-party entities.

Application Process

Step 1: Gather all required documentation.

Step 2: Apply for a GMP Certificate from the World Health Organisation to ensure compliance with manufacturing standards.

Step 3: If applicable, obtain a COPP Certificate to meet export quality standards.

 Step 4: Download and fill out the appropriate AYUSH License application form from the e-aushadhi portal.

Step 5: Submit the completed application online along with necessary documents and fees.

Step 6: A physical inspection of the premises by AYUSH Department officials.

Step 7: Issuance of the AYUSH license upon approval.

Requirements for AYUSH License

a)  Ownership of a compliant manufacturing facility or retail space.

b) Necessary qualifications and staff such as Ayurvedic experts and pharmacists.

c)  Compliance with the National Building Code and other regulatory standards.

Benefits of Obtaining an AYUSH License

 Legal recognition and credibility in the traditional medicine market in India.

 Access to a broad market of consumers looking for traditional and holistic treatments.

 Opportunities for business expansion and diversification into various AYUSH treatments.

Regulatory and Financial Aspects

100% FDI is allowed for AYUSH-related businesses.

Businesses must comply with GMP guidelines to ensure the quality and safety of their products.

Documents Needed for Application

a)  Manufacturing license, site layout, and technical staff details.

b) Manufacturing process and formula documentation.

c) Safety, efficacy, and quality control reports.