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 the AYUSH license?
AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. These are traditional systems of medicine that have been used in India for many years. Before 2014, these treatments were widely used, but there were no proper rules or government checks in place.
In 2014, the Central Government created a special AYUSH Ministry, and state governments followed suit. Since then, there have been clear rules for making, selling, promoting, and exporting AYUSH products both in India and abroad. One of the most important rules is that anyone who wants to run an AYUSH business must get a proper licence. This licence is issued by the AYUSH Ministry of the state where the business is based. It’s required for all businesses that deal with Ayurvedic, Unani, Siddha, herbal, or homeopathic medicines, cosmetics, or related treatments.
The process to apply for this licence is explained in the Drugs and Cosmetics Rules, 1945.
What are the different types of AYUSH licenses?
AYUSH licenses are categorised based on the nature of operations involved. The primary types include:
- AYUSH manufacturing license: For manufacturing AYUSH products.
- AYUSH loan license: For manufacturing AYUSH products at another manufacturer’s premises.
1. AYUSH manufacturing license
An AYUSH Manufacturing License allows a company to produce AYUSH medicines and products within its manufacturing facility. This license is essential for any entity looking to manufacture and sell AYUSH products.
- Required for setting up an AYUSH product manufacturing unit.
- Ensures adherence to AYUSH standards and regulations.
2. AYUSH loan license
An AYUSH Loan License permits a company to manufacture AYUSH products using the facilities of another licensed manufacturer. This license is ideal for businesses without their own manufacturing units.
- Allows manufacturing at third-party facilities.
- Suitable for businesses without manufacturing capabilities.
Who needs to apply for an AYUSH license in India?
Entities involved in the manufacturing, marketing, and distribution of AYUSH products must obtain an AYUSH license. This includes:
- Manufacturers of Ayurvedic, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy products
- Companies marketing AYUSH products
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
- A person or entity cannot start a business in the manufacturing or sale of cosmetics or drugs without obtaining the appropriate license from the relevant authority.
- To start a business in Ayurveda, Unani, allopathic, homeopathy, or cosmetics, one must comply with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
- These regulations ensure businesses maintain safety, quality, and compliance with legal standards.
- If a person’s business involves activities under Section 33B of the Drugs and Cosmetics Act, 1940, they are required to obtain an AYUSH License.
- The AYUSH License must be obtained from the Ministry of AYUSH before starting the business.
- This license ensures that Ayurvedic, Unani, or other alternative medicine products meet safety, quality, and efficacy standards.
- Compliance with these legal requirements is essential for anyone entering the manufacturing or sale of such products in India.
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?
The AYUSH license is typically valid for a period of five years. License holders must ensure compliance with regulatory standards throughout this period. Before the expiration of the license, it is important to apply for renewal to continue operations without any legal interruptions. The renewal process involves submitting updated documents and possibly undergoing another round of verification.
- Typically valid for five years.
- Renewal is required before expiration to continue operations.
What is the cost of an AYUSH license?
The government fees for obtaining an AYUSH license vary depending on the type of license and the specific requirements of the application. These fees cover the cost of application processing, inspections, and certifications. It is essential to check the latest fee structure from the Ministry of AYUSH’s official website or contact the respective department for accurate information.
- Fees vary based on license type and requirements.
- Covers application processing, inspections, and certifications.
What are the benefits of an AYUSH license in India?
- Legal recognition: An AYUSH license provides legal recognition to practice traditional medicine in India. It establishes a regulatory framework that ensures treatments are safe, effective, and compliant with established standards, offering credibility to practitioners.
- Wide acceptance: The AYUSH system of medicine enjoys widespread recognition and acceptance across India. With a long history of thousands of years, it remains a trusted and popular choice among the Indian population. Holding an AYUSH license allows you to tap into this extensive and ever-growing market.
- Enhanced credibility: Having an AYUSH license enhances your credibility as a practitioner. It signals to clients that you have met the required training standards and are authorized to practice traditional medicine in India, building trust in your services and boosting your brand reputation.
- Business diversification: An AYUSH license opens the door to diversifying your offerings. You can integrate traditional medicine alongside modern treatments, allowing you to cater to a broader patient base. This expansion can drive more business and increase your revenue.
- Holistic health benefits: AYUSH medicine is renowned for its holistic approach to health, focusing on prevention rather than just symptom treatment. As a licensed practitioner, you can offer patients comprehensive wellness benefits that promote long-term health.
- Job opportunities: With the rising demand for AYUSH professionals in both the public and private sectors, obtaining an AYUSH license can unlock various job opportunities, including positions in government and private hospitals, as well as self-employment options.
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 AYUSH license is issued at the central level under the Ministry of AYUSH, while the State AYUSH Department and the State Licensing Authority (SLA) handle licensing at the state level. Since AYUSH licences are governed under the Drugs and Cosmetics Act, the SLA of the respective state is responsible for issuing licences, in coordination with the central Ministry of AYUSH. Applicants can explore ayush license apply online options through the Ministry of AYUSH's online portal or the relevant State AYUSH Department's online system, where available.
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 to manage your practice and expand your services.
