In summary
- An AYUSH licence covers the manufacture, marketing, and distribution of AYUSH products.
- An AYUSH manufacturing licence is required for businesses with their own facilities.
- An AYUSH loan licence allows manufacturing at another licensed manufacturer’s premises.
- The application process may include GMP certification, COPP certification, form submission, document verification, and approval.
- An AYUSH licence supports legal compliance, product quality, business credibility, and market access.
What is an AYUSH license in India?
An AYUSH license is a mandatory licence under Section 33B of the Drugs and Cosmetics Act, 1940, for entities manufacturing, selling, promoting, or exporting Ayurvedic, Unani, Siddha, Homeopathic, or herbal products in India.
The AYUSH Ministry, established in 2014, oversees the development and regulation of India’s traditional systems of medicine. Businesses dealing with AYUSH products must comply with the applicable licensing and quality requirements.
An AYUSH license is also the license required for ayurvedic medicine and other eligible traditional medicinal products, helping regulate their manufacture and distribution.
What are the different types of AYUSH licenses?
The main types of AYUSH license include four categories, based on the nature of manufacturing, distribution and export activities involved.
| License Type | Who Needs It | Key Requirement | Form No. |
|---|---|---|---|
| AYUSH Manufacturing License | Businesses manufacturing AYUSH medicines and products at their own premises | Must meet AYUSH manufacturing license requirements, including applicable facility and quality standards | Form 24D |
| AYUSH Loan License | Businesses manufacturing products using another licensed manufacturer’s facilities | Requires access to an eligible licensed manufacturing facility | Form 25E |
| AYUSH Wholesale License | Businesses involved in the distribution and wholesale supply of AYUSH medicines | Must meet applicable requirements for the storage and distribution of AYUSH products | Applicable state requirements |
| AYUSH GMP and COPP Certificate | Manufacturers exporting eligible AYUSH products | Must comply with Good Manufacturing Practices and applicable export certification requirements | Applicable certification process |
Documents required to apply for AYUSH license
To apply for an AYUSH license, the following documents are typically required:
| S.No | Document Required for AYUSH License |
| 1 | Copy of the Manufacturing License (if the applicant is involved in the manufacturing of AYUSH products) |
| 2 | Layout of the manufacturing facility site |
| 3 | Details of the manufacturing formula and process |
| 4 | Finished product specification report |
| 5 | List of applied and approved products for COPP certification |
| 6 | Process validation report for at least 3 batches |
| 7 | Details of technical staff, including their names, qualifications, and experience |
| 8 | List of equipment used in the manufacturing process |
| 9 | Diagrams of the water and HVAC systems |
| 10 | Proof of safety and effectiveness as per Rule 158B of the Drugs & Cosmetics Rules, 1945 |
| 11 | Undertaking confirming the absence of non-herbal ingredients (for herbal products) |
| 12 | Undertaking for compliance with the Drugs and Cosmetics Act, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and corresponding rules (for herbal products only) |
| 13 | KYC details of the applicant |
| 14 | Address proof of the premises (e.g., rent agreement) |
| 15 | Constitutional documents of the business |
Key considerations before applying for an AYUSH License in India
Before applying for an AYUSH license, check five critical aspects: the applicable legal provisions, business premises, qualified staff, required documents and the correct online application process.
- Check Section 33B: Confirm that your proposed manufacturing activity falls within the licensing requirements under Section 33B of the Drugs and Cosmetics Act, 1940.
- Verify premises: Ensure the manufacturing facility, equipment, storage areas and other infrastructure meet applicable AYUSH requirements.
- Arrange qualified staff: Check that the required technical experts and pharmacists are available for the proposed manufacturing activity.
- Prepare documents: Keep product details, facility plans, staff credentials, business documents and other supporting records ready.
- Apply online: Complete the ayush license registration process through the applicable online portal and submit the required information and documents.
Operating without a valid licence is illegal; the license required for ayurvedic medicine and other regulated AYUSH products must be obtained before commencing operations, as non-compliance can result in fines, product bans and prosecution under the Drugs and Cosmetics Act, 1940.
How to apply for an AYUSH manufacturing license online in India?
Applying for an AYUSH Manufacturing License involves several steps to ensure compliance with regulatory standards. The process includes:
Step 1 - Documentation
The first step in applying for an AYUSH Manufacturing License is gathering all necessary documents. This includes proof of premises (rent/lease agreement or ownership document), a detailed manufacturing layout plan, a list of machinery and equipment, and qualifications and details of technical staff. These documents ensure that the applicant has the proper infrastructure and expertise to produce AYUSH products in compliance with regulatory standards. Proper documentation is crucial for a smooth application process and timely approval.
- Gather proof of premises, layout plans, and staff details.
- Ensures compliance with regulatory requirements.
Step 2 - Apply for GMP certificate
The next step is to apply for a Good Manufacturing Practice (GMP) certificate. This certificate is essential as it verifies that the manufacturing processes adhere to quality and safety standards set by regulatory authorities. GMP certification involves an inspection of the manufacturing facilities to ensure they meet the necessary hygiene, equipment, and procedural standards. Obtaining a GMP certificate is crucial for maintaining product quality and gaining approval for the AYUSH license.
- Obtain GMP certification to ensure quality standards.
- Involves inspection of manufacturing facilities.
Step 3 - Apply for COPP certificate, if applicable
If you plan to export AYUSH products, you will need to apply for a Certificate of Pharmaceutical Product (COPP). The COPP certificate is required for international trade and ensures that the products meet the quality standards of both the country of manufacture and the importing country. This step involves submitting the necessary documents and undergoing additional inspections to comply with international regulations.
- Necessary for exporting AYUSH products.
- Ensures compliance with international quality standards.
Step 4 - Download the form for the AYUSH license certificate
The next step is to download the application form for the AYUSH License Certificate from the official website of the Ministry of AYUSH. This form is crucial as it captures all necessary details about the applicant, the manufacturing facility, and the products to be manufactured. Ensure that you download the correct form and follow the instructions provided.
- Download the application form from the Ministry of AYUSH website.
- Ensure you have the correct form for your application type.
Step 5 - Fill out & submit the application
Once you have gathered all the necessary documents and downloaded the application form, fill out the form with accurate and complete information. Ensure that all required fields are correctly filled and attach the necessary documents. Submit the completed application form along with the documents to the respective AYUSH department. This step is crucial as incomplete or incorrect information can lead to delays or rejection of the application.
- Fill out the application form with accurate details.
- Submit the form along with the required documents.
Step 6 - Verification by AYUSH department’s commissioner
After submitting your application, the AYUSH department's commissioner will review and verify the documents. This process involves a thorough examination of the provided information and possibly an inspection of the manufacturing facilities. The verification ensures that all regulatory requirements are met and that the applicant is capable of maintaining the standards for AYUSH product manufacturing.
- The AYUSH department verifies submitted documents.
- May include an inspection of the manufacturing facilities.
Step 7 - AYUSH license granted
Upon successful verification, the AYUSH department will grant the license. The AYUSH license allows the holder to legally manufacture and distribute AYUSH products in compliance with regulatory standards. This step concludes the application process, and the licensee can now begin operations.
- License granted after successful verification.
- Legal permission to manufacture and distribute AYUSH products.
How long is an AYUSH license valid?
An AYUSH license is valid for a lifetime under the Drugs (4th Amendment) Rules, 2021, which came into force on 1 October 2021, replacing the earlier fixed-period validity. No fixed five-year renewal is required to keep the licence valid.
However, licence holders must continue meeting applicable regulatory and GMP requirements. They must also submit an annual self-compliance declaration online as part of ongoing compliance and the ayush license registration framework.
The GMP certificate and facility require re-validation every five years to confirm continued compliance with prescribed manufacturing standards.
What is the cost of an AYUSH license?
The government fee for an AYUSH license in India starts at ₹2,000 for standard applications. The fee structure was revised under the Drugs (4th Amendment) Rules, 2021, which increased the standard fee from Rs. 1,000.
| License/Application Type | Government Fee |
|---|---|
| Standard application for Ayurvedic, Unani or Siddha drugs/cosmetics | Rs. 2,000 |
| Up to 10 proprietary ASU drugs | Rs. 3,000 |
Additional costs may apply for ayush license registration, including documentation preparation, GMP inspection and professional or consultancy services. These charges can vary based on the state, licence type and scale of operations.
What are the benefits of an AYUSH license in India?
An AYUSH license offers six key benefits, including legal recognition, wider market acceptance, enhanced credibility, business diversification, holistic healthcare opportunities and greater access to employment opportunities.
| Benefit | What It Means for Your Business |
|---|---|
| Legal recognition | Provides regulatory recognition and supports compliant operations; ayush license registration helps establish the required legal framework for eligible activities. |
| Market acceptance | Enables businesses to serve the growing market for traditional systems of medicine across India. |
| Enhanced credibility | Demonstrates compliance with applicable standards, helping build customer confidence and strengthen brand reputation. |
| Business diversification | Allows eligible businesses to expand their product portfolio and explore opportunities across different AYUSH categories. |
| FDI eligibility | 100% FDI is permitted for AYUSH businesses in India, making a valid AYUSH licence essential for attracting foreign investment. |
| Growth and employment | Supports opportunities to expand operations, create jobs and serve customers through eligible AYUSH products and services. |
What is the difference between an AYUSH manufacturing license and a loan license?
| Aspect | AYUSH Manufacturing Licence | AYUSH Loan Licence |
|---|---|---|
| Meaning | Permits an entity to manufacture AYUSH medicines at its own approved manufacturing premises. | Allows an entity to manufacture AYUSH medicines using the facilities of another licensed manufacturer. |
| Manufacturing facility | The licence holder owns or operates the approved manufacturing premises. | The applicant uses the premises and facilities of an existing licensed manufacturer. |
| Infrastructure requirement | Requires compliant premises, equipment and manufacturing infrastructure. | Reduces the need to establish an independent manufacturing unit. |
| Manufacturing responsibility | The licence holder directly manages the manufacturing process. | Manufacturing takes place through the approved facility of another manufacturer. |
| Regulatory compliance | Must comply with applicable AYUSH regulations, quality standards and manufacturing requirements. | The applicant and manufacturing facility must comply with applicable AYUSH regulations and quality standards. |
| Best suited for | Businesses with their own manufacturing infrastructure and facilities. | Businesses seeking to manufacture products without setting up a complete manufacturing facility. |
Which authority issues AYUSH licenses in India?
The State Licensing Authority (SLA) is the primary authority responsible for issuing an AYUSH license, while the Ministry of AYUSH provides central oversight and policy guidance for AYUSH regulations. Applicants can complete the ayush license registration process online through the e-Aushadhi portal, where applicable, by submitting the required application and supporting documents. The specific licensing procedure, authority and additional requirements may vary by state, so applicants should also check the requirements of their respective State AYUSH Department and State Licensing Authority.
In conclusion, obtaining an AYUSH license is crucial for ensuring the quality, safety, and efficacy of traditional medicinal products. By following the outlined steps and understanding the requirements, businesses can streamline the application process and maintain compliance with regulatory standards. For healthcare professionals seeking financial support, consider exploring a doctor loan or professional loan to manage your practice and expand your services.
