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Overview

AYUSH License (Ayurveda, Yoga, Unani, Siddha, and Homeopathy Certification)

An AYUSH License is a mandatory certification issued by the Ministry of AYUSH, Government of India, for businesses involved in the manufacturing, distribution, or retailing of Ayurvedic, Siddha, Unani, and Homeopathic medicines or products. The license ensures compliance with quality standards and regulations established under the Drugs and Cosmetics Act, 1940. It fosters trust in AYUSH products and promotes the growth of traditional medicine systems.

Importance

1. Legal Compliance : Ensures adherence to the Drugs and Cosmetics Act for AYUSH products.

2. Consumer Trust : Builds credibility and confidence in AYUSH medicines and practices.

3. Market Expansion : Facilitates the domestic and international trade of certified products.

4. Quality Assurance : Promotes standardization and safety in the production of AYUSH medicines.

5. Regulatory Support : Provides eligibility for government schemes and incentives.



Documents Required

For Indian Nationals


For Foreign Nationals




Features

Features & Benefits of AYUSH License (Ayurveda, Yoga, Unani, Siddha, and Homeopathy Certification)

Mandatory for AYUSH Products
Required for manufacturing and selling Ayurvedic, Unani, Siddha, and Homeopathy products.
Product Categories
Covers classical medicines, proprietary formulations, and OTC products.
Premises Compliance
Adheres to specific standards for space, equipment, and hygiene.
Quality Control
Requires in-house or third-party testing facilities.
Technical Staff Requirements
Must employ qualified pharmacists and chemists.

Ayush License

Pollution Control Measures
Ensures environmentally sustainable operations.
License Validity
Typically valid for five years, with periodic renewal.
Domestic and Export Eligibility
Supports businesses catering to both domestic and global markets.
Regulatory Oversight
Subject to inspections and audits by AYUSH authorities.
Access to Incentives
Eligible for government schemes promoting traditional medicines.



Comparison with FSSAI License

Feature AYUSH License FSSAI License
Purpose Manufacturing AYUSH products Food safety and standards
Issuing Authority State AYUSH Licensing Authority Food Safety and Standards Authority of India (FSSAI)
Scope Traditional medicines and therapies Food and dietary supplements
Technical Requirements Technical staff and lab facilities Food testing labs and safety measures
Renewal Period 5 years 1-5 years



Frequently Asked Questions

What is an AYUSH License?

It is a mandatory certification for businesses manufacturing, distributing, or selling Ayurvedic, Siddha, Unani, and Homeopathy products.

Who needs an AYUSH License?

Manufacturers, distributors, and retailers of AYUSH medicines and products.

What is the validity of the AYUSH License?

Typically valid for five years and requires renewal.

What are the capital requirements for AYUSH businesses?

No specific capital requirements, but sufficient resources must be shown for manufacturing and quality assurance.

Can foreign nationals apply for an AYUSH License in India?

Yes, with proper local registration and adherence to Indian regulations.

What happens if AYUSH products are sold without a license?

The business may face fines, product seizures, or cancellation of operations.

Is technical staff mandatory for obtaining the license?

Yes, qualified pharmacists or chemists are required for quality assurance.

Can proprietary formulations be registered under the AYUSH License?

Yes, proprietary formulations can be approved subject to regulatory compliance.

Are there separate licenses for different AYUSH systems?

A single license covers all AYUSH systems, but specific approvals may be required for each.

What are the penalties for non-compliance with AYUSH guidelines?

Penalties include fines, license suspension, or legal action.