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Prakash Kakani Director, PNS EV HubAn 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.
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.
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 |
It is a mandatory certification for businesses manufacturing, distributing, or selling Ayurvedic, Siddha, Unani, and Homeopathy products.
Manufacturers, distributors, and retailers of AYUSH medicines and products.
Typically valid for five years and requires renewal.
No specific capital requirements, but sufficient resources must be shown for manufacturing and quality assurance.
Yes, with proper local registration and adherence to Indian regulations.
The business may face fines, product seizures, or cancellation of operations.
Yes, qualified pharmacists or chemists are required for quality assurance.
Yes, proprietary formulations can be approved subject to regulatory compliance.
A single license covers all AYUSH systems, but specific approvals may be required for each.
Penalties include fines, license suspension, or legal action.