AYUSH License – Types, Eligibility, Documents, and Procedure

AYUSH License – Types, Eligibility, Documents, and Procedure. In India, the AYUSH License is a regulatory requirement for individuals and businesses involved in the manufacturing, marketing, sale, and export of traditional medicines under the AYUSH systems. AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy. These traditional systems have been widely practiced across India for centuries, offering holistic treatment and promoting wellness. However, until 2014, the manufacture and sale of AYUSH products remained largely unregulated. With the establishment of the Ministry of AYUSH in 2014, a well-structured regulatory framework was introduced. The AYUSH License has since become mandatory for businesses intending to deal in Ayurvedic, Unani, Siddha, or Homeopathy (ASU&H) drugs or cosmetics.
What is AYUSH License?
The AYUSH License is a mandatory authorization issued by the respective State Licensing Authorities under the Ministry of AYUSH to businesses engaged in the manufacture, trade, or export of AYUSH products. This license ensures that the products are manufactured in accordance with the safety, efficacy, and quality standards laid down by the Drugs and Cosmetics Act, 1940 and its Rules.
The license allows legal recognition and ensures that businesses operate within the permitted legal and regulatory boundaries. It is applicable to a wide range of activities—from the manufacturing of drugs and cosmetics to the setup of clinics and retail businesses dealing in AYUSH products.
Types of AYUSH Licenses in India
There are multiple types of AYUSH Licenses issued depending on the nature and scope of the business activity. Each type of license has its specific purpose and eligibility criteria.
AYUSH Manufacturing License
This license is issued to businesses that manufacture AYUSH products using their own manufacturing units. To be eligible, the business must own a facility located on industrial land. The manufacturing area should have a minimum of 1200 sq. ft. for a single product. For multiple products, the area requirement increases accordingly. Additionally, the unit must be GMP certified, equipped with proper machinery, and must employ at least two Ayurvedic experts and two pharmacists.
AYUSH Loan License
A loan license is granted to businesses that do not own a manufacturing facility but intend to use another manufacturer's infrastructure. The loaned facility must already have a valid AYUSH manufacturing license. It must be located on industrial land and include separate rooms for raw material storage, finished goods, and office operations. There is no requirement for technical staff under this license, as the actual manufacturing is handled by the primary license holder.
AYUSH Retail and Wholesale License
Interestingly, businesses engaged solely in retailing or wholesaling AYUSH products are not required to obtain a specific AYUSH Retail or Wholesale License. As per Section 33A of the Drugs and Cosmetics Act, 1940, Chapter IVA of the Act only applies to the manufacture of AYUSH products and not to retail or wholesale activities.
AYUSH Export License
For businesses planning to export AYUSH products, an export license is required. This license ensures compliance with international safety and quality standards. The Certificate of Pharmaceutical Product (COPP) is generally a prerequisite for such businesses.
AYUSH Clinic License
Clinics or wellness centers that offer AYUSH-based treatments must acquire an AYUSH Clinic License. This is mandatory to ensure that qualified practitioners offer safe and legitimate healthcare services under the AYUSH system.
Benefits of AYUSH License in India
Obtaining an AYUSH License offers numerous benefits that extend beyond legal compliance:
1. Legal Recognition
The license provides businesses legal approval to manufacture and sell AYUSH products. This helps them avoid penalties and comply with regulatory norms. It strengthens their position in the industry as recognized and lawful operators.
2. Market Trust
Customers tend to trust businesses that are licensed by government authorities. An AYUSH license builds credibility for your brand and product range. It helps in winning long-term loyalty from consumers.
3. Regulatory Compliance
With a valid license, businesses align themselves with the Drug and Cosmetics Act and Rules. It ensures they follow good practices and avoid legal troubles. This also sets the base for quality assurance and transparency.
4. Export Opportunity
An AYUSH License allows you to apply for COPP and other certificates needed for export. It opens up access to global markets for traditional Indian medicine. This increases business opportunities and profit margins.
5. Business Expansion
Holding a license makes it easier to collaborate with retailers and distributors. It helps businesses to enter new markets and scale up operations. The license also facilitates smooth product registrations in different states.
6. Government Incentives
Licensed entities become eligible for government grants, subsidies, and schemes. These incentives support AYUSH-based businesses in growth and innovation. They also reduce the cost of doing business.
7. Consumer Confidence
Certified products give assurance of safety and effectiveness to users. Consumers are more likely to trust products that meet official standards. This improves brand loyalty and repeat sales.
8. Operational Efficiency
The online license process reduces manual paperwork and time delays. It helps businesses function smoothly with faster approvals. Renewal and compliance declarations are also streamlined.
9. Quality Assurance
A valid license requires regular inspections and adherence to GMP. This ensures that only high-quality products reach consumers. It enhances the brand’s reputation in domestic and global markets. 
Eligibility Criteria for AYUSH Manufacturing License
To obtain an AYUSH Manufacturing License, businesses must meet the following requirements:

Premises: The facility must be on industrial land with a minimum area of 1200 square feet. Additional space is required for manufacturing multiple products.

Good Manufacturing Practices (GMP): The facility must be certified under GMP standards, which regulate product quality, cleanliness, and safety.

Technical Staff: At least two Ayurvedic or Unani practitioners (with BAMS or BUMS degrees) and two pharmacists (with D. Pharm or B. Pharm degrees) must be employed.

Machinery and Infrastructure: The premises must have appropriate machinery for the production and packaging of AYUSH products.

Compliance: All relevant laws, including the Drugs and Cosmetics Act, 1940 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 must be adhered to.

Documents Required for AYUSH License Application
Applicants need to gather and submit a set of essential documents. These documents play a crucial role in the verification and approval process:

Copy of existing manufacturing license (if any)

Site layout of the manufacturing facility

Manufacturing formula and process details

Product specification reports

List of products for COPP certification

Validation reports for at least three product batches

Technical staff details with qualifications

Equipment list for manufacturing

Diagrams of water and HVAC systems

Proof of product safety and efficacy under Rule 158B

Declarations for non-herbal ingredient absence (if applicable)

Compliance undertakings with applicable acts

KYC of applicant (PAN, Aadhaar)

Address proof of premises (rent agreement or ownership documents)

Business constitution documents (Partnership Deed, Certificate of Incorporation, etc.)

How to Apply for AYUSH Manufacturing License in India?
The application process for obtaining an AYUSH Manufacturing License is completely online and involves multiple steps. Here’s a step-by-step explanation:
1. Preparation of Documents
Before starting the application, ensure all documents are ready and updated. Errors or missing details can result in the rejection of the application.
2. Apply for GMP Certificate
Businesses must apply for a GMP certificate through the State Drug Controller. This certification confirms that the manufacturing practices adhere to prescribed standards.
3. Apply for COPP Certificate
Required mainly for exporters, the Certificate of Pharmaceutical Product (COPP) can also be obtained from the State Drug Control Department. It confirms that the product is quality-compliant for international markets.
4. Download the AYUSH License Form
Forms 24D (for AYUSH Manufacturing License) and 25E (for AYUSH Loan License) are prescribed under Rule 153 of the Drugs and Cosmetics Rules, 1945. These can be downloaded from the official state portals, such as e-Aushadhi.
5. Submit the Application
Fill the downloaded form with accurate details and submit it along with scanned copies of all required documents and application fees through the state AYUSH portal.
6. Inspection by the AYUSH Department
After submission, the licensing authority will verify the documents and inspect the manufacturing premises. The inspecting officer submits a detailed report for approval.
7. Grant of License
If the inspection and verification are satisfactory, the AYUSH License is issued in Form 25D. The average processing time is 60 days.
Validity and Renewal of AYUSH License
Earlier, the AYUSH license was valid for five years. However, post the implementation of the Drugs (4th Amendment) Rules, 2021 (effective from October 1, 2021), AYUSH Licenses now have lifetime validity. Businesses are only required to submit an annual self-compliance declaration. The GMP Certificate, however, must be renewed every five years following an inspection.
Conclusion
The AYUSH License is an important legal requirement for any business aiming to manufacture or deal in traditional Indian medicinal products. With an increasing demand for natural and holistic treatments globally, the AYUSH sector has seen exponential growth in recent years. By obtaining an AYUSH Manufacturing License, businesses not only become legally compliant but also position themselves as credible and trustworthy players in a highly competitive market.
If you're looking to apply for an AYUSH License, make sure you have the required infrastructure, technical staff, documents, and compliance mechanisms in place. Still you need any help in getting AYUSH License, then you can connect with Compliance Calendar’s experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. Who needs an AYUSH License in India?
Ans. Any individual or business engaged in the manufacturing, sale, or export of Ayurvedic, Unani, Siddha, or Homeopathy (ASU&H) products must obtain an AYUSH License. This includes those using their own manufacturing units or outsourcing production under a loan license.
Q2. Is an AYUSH License required for retail or wholesale of AYUSH products?
Ans. No, AYUSH Retail or Wholesale License is not mandatory. As per the Drugs and Cosmetics Act, the requirement of a license applies only to the manufacturing of AYUSH products, not their retail or wholesale distribution.
Q3. What is the validity period of an AYUSH License?
Ans. AYUSH Licenses issued after October 1, 2021, have lifetime validity. However, businesses must submit an annual self-compliance declaration, and the GMP certification needs renewal every 5 years.
Q4. What is the difference between an AYUSH Manufacturing License and an AYUSH Loan License?
Ans. An AYUSH Manufacturing License is issued to businesses with their own production facility. A Loan License is for businesses using a third-party manufacturer’s licensed facility to produce AYUSH products on their behalf.
Q5. How long does it take to get an AYUSH Manufacturing License?
Ans. Typically, it takes around 60 days to process the AYUSH Manufacturing License application, subject to successful verification and inspection of the premises by the licensing authority.
Q6. Can I export AYUSH products without a license?
Ans. No, to export AYUSH products legally, you must obtain an AYUSH Manufacturing License along with a Certificate of Pharmaceutical Product (COPP) as per WHO guidelines. This ensures product quality for international markets.
Q7. What is the minimum area requirement for obtaining an AYUSH Manufacturing License?
Ans. The minimum area required is 1200 square feet for manufacturing a single product. If more products are to be manufactured, the area must be increased proportionately, and the premises should be located on industrial land.

In India, the AYUSH License is a regulatory requirement for individuals and businesses involved in the manufacturing, marketing, sale, and export of traditional medicines under the AYUSH systems. AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy. These traditional systems have been widely practiced across India for centuries, offering holistic treatment and promoting wellness. However, until 2014, the manufacture and sale of AYUSH products remained largely unregulated. With the establishment of the Ministry of AYUSH in 2014, a well-structured regulatory framework was introduced. The AYUSH License has since become mandatory for businesses intending to deal in Ayurvedic, Unani, Siddha, or Homeopathy (ASU&H) drugs or cosmetics.

What is AYUSH License?

The AYUSH License is a mandatory authorization issued by the respective State Licensing Authorities under the Ministry of AYUSH to businesses engaged in the manufacture, trade, or export of AYUSH products. This license ensures that the products are manufactured in accordance with the safety, efficacy, and quality standards laid down by the Drugs and Cosmetics Act, 1940 and its Rules.

The license allows legal recognition and ensures that businesses operate within the permitted legal and regulatory boundaries. It is applicable to a wide range of activities—from the manufacturing of drugs and cosmetics to the setup of clinics and retail businesses dealing in AYUSH products.

Types of AYUSH Licenses in India

There are multiple types of AYUSH Licenses issued depending on the nature and scope of the business activity. Each type of license has its specific purpose and eligibility criteria.

AYUSH Manufacturing License

This license is issued to businesses that manufacture AYUSH products using their own manufacturing units. To be eligible, the business must own a facility located on industrial land. The manufacturing area should have a minimum of 1200 sq. ft. for a single product. For multiple products, the area requirement increases accordingly. Additionally, the unit must be GMP certified, equipped with proper machinery, and must employ at least two Ayurvedic experts and two pharmacists.

AYUSH Loan License

A loan license is granted to businesses that do not own a manufacturing facility but intend to use another manufacturer's infrastructure. The loaned facility must already have a valid AYUSH manufacturing license. It must be located on industrial land and include separate rooms for raw material storage, finished goods, and office operations. There is no requirement for technical staff under this license, as the actual manufacturing is handled by the primary license holder.

AYUSH Retail and Wholesale License

Interestingly, businesses engaged solely in retailing or wholesaling AYUSH products are not required to obtain a specific AYUSH Retail or Wholesale License. As per Section 33A of the Drugs and Cosmetics Act, 1940, Chapter IVA of the Act only applies to the manufacture of AYUSH products and not to retail or wholesale activities.

AYUSH Export License

For businesses planning to export AYUSH products, an export license is required. This license ensures compliance with international safety and quality standards. The Certificate of Pharmaceutical Product (COPP) is generally a prerequisite for such businesses.

AYUSH Clinic License

Clinics or wellness centers that offer AYUSH-based treatments must acquire an AYUSH Clinic License. This is mandatory to ensure that qualified practitioners offer safe and legitimate healthcare services under the AYUSH system.

Benefits of AYUSH License in India

Obtaining an AYUSH License offers numerous benefits that extend beyond legal compliance:

1. Legal Recognition

The license provides businesses legal approval to manufacture and sell AYUSH products. This helps them avoid penalties and comply with regulatory norms. It strengthens their position in the industry as recognized and lawful operators.

2. Market Trust

Customers tend to trust businesses that are licensed by government authorities. An AYUSH license builds credibility for your brand and product range. It helps in winning long-term loyalty from consumers.

3. Regulatory Compliance

With a valid license, businesses align themselves with the Drug and Cosmetics Act and Rules. It ensures they follow good practices and avoid legal troubles. This also sets the base for quality assurance and transparency.

4. Export Opportunity

An AYUSH License allows you to apply for COPP and other certificates needed for export. It opens up access to global markets for traditional Indian medicine. This increases business opportunities and profit margins.

5. Business Expansion

Holding a license makes it easier to collaborate with retailers and distributors. It helps businesses to enter new markets and scale up operations. The license also facilitates smooth product registrations in different states.

6. Government Incentives

Licensed entities become eligible for government grants, subsidies, and schemes. These incentives support AYUSH-based businesses in growth and innovation. They also reduce the cost of doing business.

7. Consumer Confidence

Certified products give assurance of safety and effectiveness to users. Consumers are more likely to trust products that meet official standards. This improves brand loyalty and repeat sales.

8. Operational Efficiency

The online license process reduces manual paperwork and time delays. It helps businesses function smoothly with faster approvals. Renewal and compliance declarations are also streamlined.

9. Quality Assurance

A valid license requires regular inspections and adherence to GMP. This ensures that only high-quality products reach consumers. It enhances the brand’s reputation in domestic and global markets.

Eligibility Criteria for AYUSH Manufacturing License

To obtain an AYUSH Manufacturing License, businesses must meet the following requirements:

Premises: The facility must be on industrial land with a minimum area of 1200 square feet. Additional space is required for manufacturing multiple products.
Good Manufacturing Practices (GMP): The facility must be certified under GMP standards, which regulate product quality, cleanliness, and safety.
Technical Staff: At least two Ayurvedic or Unani practitioners (with BAMS or BUMS degrees) and two pharmacists (with D. Pharm or B. Pharm degrees) must be employed.
Machinery and Infrastructure: The premises must have appropriate machinery for the production and packaging of AYUSH products.
Compliance: All relevant laws, including the Drugs and Cosmetics Act, 1940 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 must be adhered to.

Documents Required for AYUSH License Application

Applicants need to gather and submit a set of essential documents. These documents play a crucial role in the verification and approval process:

Copy of existing manufacturing license (if any)
Site layout of the manufacturing facility
Manufacturing formula and process details
Product specification reports
List of products for COPP certification
Validation reports for at least three product batches
Technical staff details with qualifications
Equipment list for manufacturing
Diagrams of water and HVAC systems
Proof of product safety and efficacy under Rule 158B
Declarations for non-herbal ingredient absence (if applicable)
Compliance undertakings with applicable acts
KYC of applicant (PAN, Aadhaar)
Address proof of premises (rent agreement or ownership documents)
Business constitution documents (Partnership Deed, Certificate of Incorporation, etc.)

How to Apply for AYUSH Manufacturing License in India?

The application process for obtaining an AYUSH Manufacturing License is completely online and involves multiple steps. Here’s a step-by-step explanation:

1. Preparation of Documents

Before starting the application, ensure all documents are ready and updated. Errors or missing details can result in the rejection of the application.

2. Apply for GMP Certificate

Businesses must apply for a GMP certificate through the State Drug Controller. This certification confirms that the manufacturing practices adhere to prescribed standards.

3. Apply for COPP Certificate

Required mainly for exporters, the Certificate of Pharmaceutical Product (COPP) can also be obtained from the State Drug Control Department. It confirms that the product is quality-compliant for international markets.

4. Download the AYUSH License Form

Forms 24D (for AYUSH Manufacturing License) and 25E (for AYUSH Loan License) are prescribed under Rule 153 of the Drugs and Cosmetics Rules, 1945. These can be downloaded from the official state portals, such as e-Aushadhi.

5. Submit the Application

Fill the downloaded form with accurate details and submit it along with scanned copies of all required documents and application fees through the state AYUSH portal.

6. Inspection by the AYUSH Department

After submission, the licensing authority will verify the documents and inspect the manufacturing premises. The inspecting officer submits a detailed report for approval.

7. Grant of License

If the inspection and verification are satisfactory, the AYUSH License is issued in Form 25D. The average processing time is 60 days.

Validity and Renewal of AYUSH License

Earlier, the AYUSH license was valid for five years. However, post the implementation of the Drugs (4th Amendment) Rules, 2021 (effective from October 1, 2021), AYUSH Licenses now have lifetime validity. Businesses are only required to submit an annual self-compliance declaration. The GMP Certificate, however, must be renewed every five years following an inspection.

Conclusion

The AYUSH License is an important legal requirement for any business aiming to manufacture or deal in traditional Indian medicinal products. With an increasing demand for natural and holistic treatments globally, the AYUSH sector has seen exponential growth in recent years. By obtaining an AYUSH Manufacturing License, businesses not only become legally compliant but also position themselves as credible and trustworthy players in a highly competitive market.

If you're looking to apply for an AYUSH License, make sure you have the required infrastructure, technical staff, documents, and compliance mechanisms in place. Still you need any help in getting AYUSH License, then you can connect with Compliance Calendar’s experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. Who needs an AYUSH License in India?

Ans. Any individual or business engaged in the manufacturing, sale, or export of Ayurvedic, Unani, Siddha, or Homeopathy (ASU&H) products must obtain an AYUSH License. This includes those using their own manufacturing units or outsourcing production under a loan license.

Q2. Is an AYUSH License required for retail or wholesale of AYUSH products?

Ans. No, AYUSH Retail or Wholesale License is not mandatory. As per the Drugs and Cosmetics Act, the requirement of a license applies only to the manufacturing of AYUSH products, not their retail or wholesale distribution.

Q3. What is the validity period of an AYUSH License?

Ans. AYUSH Licenses issued after October 1, 2021, have lifetime validity. However, businesses must submit an annual self-compliance declaration, and the GMP certification needs renewal every 5 years.

Q4. What is the difference between an AYUSH Manufacturing License and an AYUSH Loan License?

Ans. An AYUSH Manufacturing License is issued to businesses with their own production facility. A Loan License is for businesses using a third-party manufacturer’s licensed facility to produce AYUSH products on their behalf.

Q5. How long does it take to get an AYUSH Manufacturing License?

Ans. Typically, it takes around 60 days to process the AYUSH Manufacturing License application, subject to successful verification and inspection of the premises by the licensing authority.

Q6. Can I export AYUSH products without a license?

Ans. No, to export AYUSH products legally, you must obtain an AYUSH Manufacturing License along with a Certificate of Pharmaceutical Product (COPP) as per WHO guidelines. This ensures product quality for international markets.

Q7. What is the minimum area requirement for obtaining an AYUSH Manufacturing License?

Ans. The minimum area required is 1200 square feet for manufacturing a single product. If more products are to be manufactured, the area must be increased proportionately, and the premises should be located on industrial land.