AYUSH License - An Overview
Are you a manufacturer, retailer, or wholesaler dealing in AYUSH products in India? If so, you're in the right place. Our experts help entrepreneurs like you secure the AYUSH license effortlessly.

What is AYUSH?
AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy—ancient medical systems that have been integral to India's healthcare practices for centuries. However, until the Ministry of AYUSH was established in 2014, these products and practices were largely unregulated. Since then, a robust legal and regulatory framework has been put in place to support the manufacturing, sales, marketing, and export of AYUSH products.

Are You Looking to Legally Manufacture and Sell AYUSH Products?
If you are ready to obtain the legal authority to manufacture and sell AYUSH products, Fastzeal's AYUSH license consultants can assist you in securing your AYUSH license. We help ensure that you gain customer trust and access to immense market opportunities.

Regulations Governing AYUSH License
The regulatory guidelines for issuing AYUSH licenses to manufacture Ayurvedic, Siddha, and Unani medicines are outlined in Rule 158-B of the Drugs and Cosmetics Rules, 1945. For the issuance of licenses to manufacture Homoeopathic medicines, the guidelines are mentioned in Rule 85(A to I) of the same set of rules.

Benefits of Obtaining AYUSH License Online
An AYUSH license is crucial for businesses engaged in the manufacturing, retailing, and trading of Ayurvedic, Unani, Siddha, and Homeopathy products. Whether you're seeking an AYUSH manufacturing or retail license, it is essential for legal operations in India. Here are the key benefits of obtaining an AYUSH license:

1. Legal Authorization
   The AYUSH license grants legal authorization to manufacture and sell Ayurvedic, Siddha, Unani, and Homeopathy products in compliance with the Drugs and Cosmetics Act, 1940.

2. Enhanced Credibility
   An AYUSH manufacturing license boosts a business's credibility, builds consumer trust, attracts customers, and fosters business collaborations. It reflects a commitment to product quality and authenticity.

3. Regulatory Compliance
   With an AYUSH license, businesses comply with all government standards for manufacturing, marketing, and exporting traditional medicine, ensuring smooth and hassle-free operations.

4. Global Market Access
   The AYUSH license opens the door for businesses to enter international markets, allowing them to legally export products and tap into the growing global demand for Indian traditional medicines.

5. Consumer Trust
   The AYUSH license assures customers of the product's quality and safety, increasing consumer confidence in your business.

6. Business Expansion
   An AYUSH license supports business expansion, enabling companies to explore new markets and territories while maintaining compliance with legal and operational frameworks.

7. Tax Benefits
   Businesses holding an AYUSH manufacturing license can benefit from government schemes, including tax incentives, reducing operating costs and increasing profitability.

8. Simplified Operations
   The online process for obtaining an AYUSH license streamlines operations by reducing paperwork, offering quicker approval times, and making the entire process more efficient.

9. Quality Assurance
   The AYUSH license mandates compliance with Good Manufacturing Practices (GMP), ensuring that products are of the highest quality and meet regulatory standards.

10. Market Recognition
    Obtaining an AYUSH license enhances your business's reputation and credibility in the market, building trust among consumers and business partners alike.

Types of AYUSH Licenses in India
In India, various AYUSH licenses are issued for different purposes. These licenses ensure that businesses comply with regulatory standards while operating legally. The types of AYUSH licenses include:

1. AYUSH Manufacturing License
   Required for businesses involved in manufacturing Ayurvedic, Unani, Siddha, or Homeopathy products. It ensures compliance with GMP standards.

2. Unani Manufacturing License
   For businesses manufacturing Unani medicines, which focus on holistic healing. This license ensures legal compliance and product quality.

3. Siddha Manufacturing License
   For businesses manufacturing Siddha medicines, a system that focuses on holistic health. This license ensures adherence to manufacturing and quality standards.

4. AYUSH Retail License
   Required for businesses that sell Ayurvedic, herbal, or homeopathic medicines and cosmetics. This license ensures compliance with safety and quality standards.

5. AYUSH Wholesale License
   Issued to wholesalers or distributors of AYUSH products. It ensures compliance with regulatory standards for storage, handling, and distribution.

6. AYUSH Export License
   For businesses exporting AYUSH products to international markets. This license ensures products meet international standards and legal requirements.

7. AYUSH Product Approval License
   Required to launch new Ayurvedic, Unani, Siddha, or Homeopathy products. It ensures the product’s safety and regulatory compliance.

8. AYUSH Clinic License
   Mandatory for businesses offering treatments based on Ayurveda, Unani, Siddha, or Homeopathy. This license ensures qualified staff and adherence to healthcare standards.

9. AYUSH Loan License
   For businesses that outsource the manufacturing of AYUSH products. The license allows collaboration with GMP-certified manufacturers and ensures product approval.

Eligibility Criteria for AYUSH Manufacturing License Online
Businesses involved in manufacturing or marketing AYUSH products must meet specific eligibility criteria to obtain the AYUSH manufacturing license. These include:

1. Business Type
   Businesses involved in manufacturing, trading, or marketing Ayurvedic, Homeopathy, Siddha, or Unani products are eligible.

2. Premises
   The manufacturing unit must comply with GMP standards and the Drugs and Cosmetics Rules, 1945.

3. Qualified Personnel
   Businesses must employ qualified technical staff, such as Ayurvedic or Unani practitioners, or certified pharmacists, as per Ministry of AYUSH regulations.

4. Equipment & Infrastructure
   The unit must have the necessary machinery and infrastructure to produce AYUSH products according to regulatory standards.

5. Documentation
   Required documents include proof of premises ownership or lease, site layout, GMP certification, product details, and staff credentials.

6. Compliance
   Businesses must adhere to all relevant laws and regulations issued by the Ministry of AYUSH and the respective state authorities.

Documents Required to Apply for AYUSH License Online
Individuals and businesses applying for an AYUSH drug license, including the AYUSH retail license, must submit several documents to meet eligibility criteria. These documents must be uploaded via the AYUSH license online portal or provided to AYUSH license consultants to ensure compliance and obtain the necessary permits for manufacturing and selling AYUSH products. The required documents include:

1. Application Form
   Duly filled application form, meeting all the mandatory guidelines.

2. Business Proof
   Title deed, sale deed, or lease agreement as proof of ownership for premises.

3. Site Layout
   Details of the manufacturing unit or retail premises layout.

4. Good Manufacturing Practices (GMP) Certification
   A compliance certificate is mandatory for manufacturing units.

5. Product Details
   Formulation and labels of all the products to be manufactured or sold.

6. Technical Staff Details
   Details, including educational qualifications, experience certificates, and appointment letters of qualified practitioners or pharmacists.

7. Identity Proof
   Documents such as PAN or Aadhaar cards to establish the applicant's identity.

8. Company Registration Certificate
   Incorporation or registration certificate to verify the business's identity.

9. Equipment List
   Information about machinery and equipment to be used for product manufacturing.

10. No Objection Certificate (NOC)
    NOC from local authorities (if required) to manufacture at the premises.

How to Apply for AYUSH License Online

Businesses involved in manufacturing or trading Ayurvedic, Unani, Homeopathy, or Siddha products must obtain an AYUSH license, such as the AYUSH manufacturing license or AYUSH retail license, to operate legally and smoothly in India. Each state in India has its dedicated AYUSH license application portal for a quick and efficient process. Follow these steps for a seamless application:

1. Visit the AYUSH Website
   Applicants must visit the state-specific AYUSH license application portal. They should download the relevant application form for the license required and submit an affidavit for Good Manufacturing Practices (GMP) and the Certificate of Pharmaceutical Product (COPP).

2. Submit the Application
   Fill out the downloaded form, attach the necessary documents like identity proof, proof of business, and product details, and then submit the application.

3. Approval by the Commissioner
   The submitted application will be reviewed by AYUSH department officials to verify its accuracy and validate the attached documents. If compliant, the commissioner will approve the AYUSH license within 15 days.

4. Receive the AYUSH License
   Once the application is reviewed and approved, the AYUSH license for manufacturing or retailing will be sent to the applicant by post.

5. Loan License Provision
   Loan license holders may supply raw materials and packaging to manufacturers, who then process these into finished products. Loan license holders can also reapply for a new AYUSH manufacturing license with GMP-certified manufacturers.

Charges Imposed by Manufacturer on Loan License Holder
Loan license holders should be aware that manufacturers charge conversion fees for producing products at their facilities on behalf of the license holder. These fees cover the costs associated with manufacturing the products. Additionally, loan license holders must pay the approval fees required by regulatory authorities.

Loan license holders are required to sign a legal agreement with the manufacturer of their AYUSH products to protect their rights. The agreement should clearly state that the ownership of the manufactured products belongs to the loan license holder, regardless of who or where the products are produced. The agreement should also include clauses to safeguard the license holder’s interests in case of a dispute, ensuring legal protection for all parties involved.

Timeline for Acquiring AYUSH License in India
The processing time to acquire an AYUSH license in India typically ranges from 20 to 30 days. However, in cases of regulatory delays, this timeline may extend to up to 60 days, depending on the workload of the Ministry of AYUSH.

Reasons to Trust Our AYUSH License Consultants
Here are the reasons why manufacturers, wholesalers, and retailers of AYUSH products trust AYUSH License Consultants at Fastzeal:

• Network of 100+ AYUSH License Consultants: Offering support in obtaining AYUSH licenses.
• 10+ Years of Experience: Expertise in managing AYUSH license requirements.
• Successful AYUSH License Application Filing: We handle the AYUSH license application process on your behalf.
• Saved 20 Lakh+ Hours: Helping AYUSH product manufacturers and sellers save valuable time.
• Dominating the Healthcare Industry: Holding a 75% market share in AYUSH licensing.
• Clear Communication: We maintain transparent communication with you throughout the application process.