Ayush License
AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. Before 2014, Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy treatments were widely used in India without any regulations. But in 2014, the government established the AYUSH Ministry to regulate these practices. AYUSH businesses now have a strong framework for manufacturing, selling, marketing, and exporting their products. To operate in India, AYUSH businesses need to obtain a license from the state’s AYUSH Ministry. This license is required for businesses dealing with Ayurvedic, Unani, Siddha, herbal, and homeopathy products, drugs, cosmetics, and related treatments. The application process for the license is mentioned in the Drugs and Cosmetics Rules, 1945.
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Which act governs the formation of AYUSH license registration?
The AYUSH license is registered under the provisions of the Drugs and Cosmetics Act, 1940. Ayush License Act provides the legal framework for regulating drugs, cosmetics, and medical devices in India. The AYUSH Ministry, under the state government’s jurisdiction, grants the license to ensure the safety, quality, and efficacy of Ayurvedic, Unani, Siddha, herbal, and homeopathy products and treatments.
What are the eligibility for AYUSH license ?
- Qualification: The applicant should have the necessary qualifications as specified by the AYUSH Ministry. This may include having a degree or diploma in Ayurveda, Unani, Siddha, or Homeopathy.
- Infrastructure: The business should have suitable infrastructure, including a manufacturing unit or treatment facility, as per the guidelines provided by the AYUSH Ministry.
- Good Manufacturing Practices (GMP): The applicant should comply with the Good Manufacturing Practices guidelines for the manufacturing, storage, and distribution of AYUSH products.
- Quality Control: The business should have a quality control system in place to ensure the safety, purity, and efficacy of the products or treatments offered.
- Compliance with Regulations: The applicant should comply with all the relevant regulations and guidelines set by the AYUSH Ministry, including labelling requirements, product registration, and advertising regulations
What are the benefits of AYUSH license ?
- Legitimacy: Obtaining an AYUSH license adds credibility and legitimacy to your business. It assures customers that your products or treatments meet the required standards and are backed by the government.
- Compliance: AYUSH license registration ensures that your business adheres to the regulations and guidelines set by the AYUSH Ministry. This helps in maintaining quality control, safety standards, and ethical practices.
- Market Access: With an AYUSH license, you gain access to a wider market. Many government institutions, hospitals, and healthcare facilities prefer to collaborate with licensed AYUSH practitioners and businesses.
- Consumer Trust: AYUSH license registration builds trust among consumers. They feel more confident in utilizing your products or services, knowing that they are backed by recognized authorities.
- Export Opportunities: AYUSH license registration can open doors to export opportunities. Having the necessary licenses and certifications makes it easier to comply with international regulations and expand your business globally.
- Government Support: Registered AYUSH businesses are eligible for various government schemes, incentives, and grants. This support can help in the growth and development of your business.
What is the process of AYUSH license ?
The process for obtaining an AYUSH license in India involves several steps that can vary slightly depending on the specific license type and your location. Here’s a general overview of the process:
- Determine Your License Type:
- Identify the category that best suits your activity: Manufacturing (Ayurvedic, Unani, Siddha), Sales (Ayurvedic, Unani, Siddha), or Practitioner Registration (Ayurveda, Yoga & Naturopathy, Unani, Siddha).
- Eligibility Criteria:
- Each license type has specific eligibility requirements. Ensure you meet the educational qualifications, experience (for practitioners), and any other criteria set by the authorities.
- Application Preparation:
- Obtain the application form, which can usually be downloaded from the website of the AYUSH department of your state government or the central Ministry of AYUSH
- Gather all the necessary documents as per the application checklist. These might include:
- – Business registration documents (if applicable)
– Educational certificates (for practitioners)
– Manufacturing facility details (for manufacturing licenses)
– Product information and formulations (for manufacturing licenses)
– Proof of address and identity
– Fee challan (payment receipt)
- – Business registration documents (if applicable)
- Application Submission:
- – Submit the completed application form with all the required documents to the designated authority, which is usually the AYUSH department of your state. You might be able to submit it online through a designated portal in some states.
- Inspection and Verification:
- – The authorities might conduct inspections of your premises, manufacturing facilities (if applicable), and practices to ensure compliance with regulations.
- – They might also verify your documents and qualifications.
- License Issuance:
- Upon successful verification and fulfilling all requirements, the AYUSH department will issue the license.
What are the required document list for Ayush license registration ?
To apply for an AYUSH license, you will generally need the following documents:
- Educational Certificates: Provide copies of your educational certificates related to Ayurveda, Unani, Siddha, herbal, or homeopathy treatments. These certificates should demonstrate your qualifications and expertise in the field.
- Identity Proof: Submit a valid identity proof document, such as a copy of your Aadhaar card, PAN card, or passport. This helps establish your identity and ensures that the license is issued to the correct individual.
- Address Proof: Provide a copy of a document that serves as proof of your address, such as a utility bill, bank statement, or rental agreement. This verifies your place of residence or business location.
- Business Registration Documents: If you are applying for a license for a business entity, include the necessary registration documents, such as the Certificate of Incorporation, Partnership Deed, or any other relevant documents based on the type of business structure.
- Manufacturing Unit Details (if applicable): If you are involved in manufacturing Ayurvedic or herbal products, you may need to provide additional documents related to your manufacturing unit, such as the manufacturing license, Good Manufacturing Practices (GMP) compliance certificate, and product formulation details.
- Other Documents: Depending on the specific requirements of the AYUSH Ministry or the state’s AYUSH department, you may be asked to submit additional documents, such as a list of products or treatments offered, quality control procedures, or any other documents specified in the application guidelines.
What are the different types of Ayush license ?
AYUSH licenses are categorized based on the nature of your operations within the traditional Indian medicine systems. Here’s a breakdown of the common types:
Manufacturing Licenses:
- Ayurvedic Manufacturing License: Required for businesses that manufacture and sell Ayurvedic medicines and products. This license ensures the facility meets safety and quality standards for production.
- Unani Manufacturing License: Needed for businesses manufacturing and selling Unani medicines, following specific formulations and ingredients based on Unani principles.
- Siddha Manufacturing License: Mandatory for businesses manufacturing and selling Siddha medicines, adhering to traditional Siddha practices and formulations.
Sales Licenses:
- Ayurvedic Sale License: Needed for businesses selling ready-to-use Ayurvedic medicines without any manufacturing involved. This license ensures proper storage and handling of these products.
- Unani Sale License: Required for businesses selling pre-prepared Unani medicines, focusing on proper storage and adherence to labeling requirements.
- Siddha Sale License: Mandatory for businesses selling pre-manufactured Siddha medicines, ensuring quality and compliance with regulations.
Practitioner Registration:
- Ayurvedic Practitioner Registration: Required for qualified practitioners offering Ayurvedic treatments and consultations. This registration verifies their educational qualifications and training.
- Yoga & Naturopathy Practitioner Registration: Needed for qualified Yoga and Naturopathy practitioners. It ensures they have undergone proper training in these disciplines.
- Unani Practitioner Registration: Mandatory for qualified Unani practitioners offering Unani-based treatment methods. This registration verifies their competency.
- Siddha Practitioner Registration: Required for qualified Siddha practitioners to offer Siddha-based treatments and consultations. It ensures they meet the necessary training standards.
What we offer ?
Black Tie Legal Services India LLP offer a variety of services to assist you with obtaining an AYUSH license in India.
Understanding License Requirements:
- Identifying the Right License: Black Tie can help you determine the specific AYUSH license type (manufacturing, sales, practitioner registration) that aligns with your business activity.
- Eligibility Assessment: Black Tie Legal Services India LLP review your qualifications (for practitioners) or business details to ensure you meet the eligibility criteria for the desired license.
- Staying Updated: Reputable company like Black Tie keep themselves informed about the latest AYUSH regulations and application procedures, ensuring adherence to current requirements.
Application Assistance:
- Form Completion: Black Tie Legal Services India LLP can guide you through the application form filling process, ensuring all sections are completed accurately and comprehensively.
- Document Gathering: We can help identify and collect all the necessary documents required for your specific license application, including business registrations, educational certificates, product information, etc.
Advanced Services:
- Liaison with Authorities: In some cases, Black Tie liaise with the AYUSH department on your behalf to clarify any queries or address potential issues during processing.
- Facility Inspections: For manufacturing licenses, Black Tie might assist in preparing your facility for inspections by the authorities to ensure compliance with safety and quality standards.
- Legal Support: Black Tie Legal Services India LLP offer legal consultations or collaborate with lawyers specializing in AYUSH licensing for complex situations.
Additional Services:
- Post-License Support: Black Tie offer guidance on license renewals or answer questions related to ongoing compliance with AYUSH regulations.
- Record-Keeping: Black Tie can help maintain records of your license and relevant documents for future reference.