Ayush License: Learn Meaning, Types, Benefits, Application Process, and Required Documents to Apply

Learn about Ayush License meaning, types, application process, required documents & benefits in India. Get manufacturing & loan license details. Apply easily.
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3 min
10 December 2024

What is the AYUSH license?

An AYUSH license is a mandatory certification for manufacturers and traders involved in the production and distribution of Ayurvedic, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy products in India. This license ensures that the products meet the standards set by the Ministry of AYUSH, promoting safety, efficacy, and quality.

  • Ensures compliance with AYUSH regulations.
  • Mandatory for manufacturing and marketing AYUSH products

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 AYUSH manufacturing license in India?

Applying for an AYUSH Manufacturing License involves several steps to ensure compliance with regulatory standards. The process includes:

  1. Documentation: Gather all necessary documents such as proof of premises, manufacturing layout, and staff details.
  2. Apply for GMP certificate: Obtain a Good Manufacturing Practice (GMP) certificate, which is essential for ensuring product quality and safety.
  3. Apply for COPP certificate: If applicable, obtain a Certificate of Pharmaceutical Product (COPP) for international trade.
  4. Download the form: Download the Ayush License Certificate application form from the official website.
  5. Fill out & submit the application: Complete the application form and submit it along with the required documents.
  6. Verification by AYUSH department’s commissioner: The submitted application and documents are verified by the AYUSH department.
  7. AYUSH license granted: Upon successful verification, the AYUSH license is granted.

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.

Validity of AYUSH license

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.

Government fees for 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.

Benefits of obtaining AYUSH License in India

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

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.

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Frequently asked questions

What is AYUSH license certification?

AYUSH license certification is an official approval issued by the Ministry of AYUSH, allowing the production, marketing, and distribution of Ayurvedic, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy products. This certification ensures that products meet specific safety, quality, and efficacy standards set by regulatory authorities.

What are AYUSH certified products?

AYUSH certified products are those that have been approved by the Ministry of AYUSH after meeting stringent safety, quality, and efficacy standards. These products include medicines, supplements, and other health-related items derived from Ayurvedic, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy traditions, ensuring they are safe and effective for consumers.

How to become an AYUSH doctor?

To become an AYUSH doctor, one must complete a degree in any of the AYUSH disciplines from a recognised university or institution. This includes degrees like BAMS (Bachelor of Ayurvedic Medicine and Surgery), BHMS (Bachelor of Homeopathic Medicine and Surgery), BUMS (Bachelor of Unani Medicine and Surgery), or BSMS (Bachelor of Siddha Medicine and Surgery). After obtaining the degree, registration with the respective AYUSH council is required to practise legally.

What are the benefits of an AYUSH certificate?

The benefits of an AYUSH certificate include the legal authority to manufacture and sell AYUSH products, assurance of product quality and safety, and enhanced credibility in the market. This certification helps in gaining consumer trust, meeting regulatory requirements, and accessing broader market opportunities both domestically and internationally.

What is the cost of AYUSH certification?

The cost of AYUSH certification varies depending on the type of certification and the scale of manufacturing. For manufacturing AYUSH products, the government fees for AYUSH certification can range between ₹1,000 to ₹3,000. The fees can differ based on the specific products and the requirements set by the Ministry of AYUSH. Additional costs may include those for documentation, consultancy, and compliance with safety and quality standards. It’s important to factor in these expenses when planning for certification. Detailed fee structures are provided by the relevant authorities, and applicants should consult them for precise costs.

What is GMP Certification in AYUSH License?

GMP (Good Manufacturing Practice) certification in the AYUSH license is a requirement for ensuring that AYUSH products are manufactured consistently to high standards of quality. The certification is awarded to manufacturers who adhere to strict guidelines, ensuring the production of safe, effective, and high-quality products. This certification is internationally recognised, with standards often based on the World Health Organization's (WHO) guidelines. Obtaining GMP certification is crucial for AYUSH practitioners and manufacturers as it builds trust with consumers and ensures compliance with regulatory requirements. It also plays a key role in the export of AYUSH products.

What is a Certificate of Pharmaceutical Product in AYUSH License?

A Certificate of Pharmaceutical Product (COPP) is a document issued under the AYUSH license, verifying that the manufacturing facility produces pharmaceutical products in compliance with Indian and international standards. This certification is required for the export of AYUSH products to other countries. The COPP confirms that the product is safe, effective, and complies with the regulations of the importing country. It is particularly important for manufacturers involved in the global trade of AYUSH products, as it ensures that products meet international quality and regulatory standards, thus facilitating smoother export procedures.

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