Ayush Certificate - A Certificate for Ayurvedic Products

Obtain an AYUSH Certificate for your herbal or Ayurvedic products with the assistance of Certifications Bay and enter the Indian market. Reach out to our consultants today to secure your AYUSH Certificate.

What is Ayush License or Ayush Certificate in India?

The Ayush License or AYUSH certificate is a government authorization required for conducting retail business of Ayurvedic, Unani, Siddha, or similar products in India. Failure to obtain this license can result in penalties imposed by the Ministry of AYUSH, established in 2014.

Ayurveda, the ‘science of long life’, is one of the world’s oldest forms of medicine, dating back thousands of years in India. Despite being criticized by some in scientific circles as pseudo-science, its popularity has spread globally. Canada, US, Russia and the European Union are among the top importers of Ayurvedic products from India. AYUSH License has facilitated the retail sale of Ayurvedic and related products in India and around the world.

What are the consequences if an applicant does not adhere to the conditions or undertakings of the AYUSH license?

Non-compliance with the conditions or undertakings specified by the Nodal agencies or other departments/agencies of the AYUSH license will result in conviction or punishment in accordance with legal provisions.

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Types of AYUSH Certificate

Complete Manufacturing License

To engage in the manufacturing and marketing of herbal products, a manufacturer must obtain a Complete Manufacturing License, which requires the establishment of a manufacturing unit. The following requirements must be fulfilled under the AYUSH Act:

  • The manufacturing unit must be located in an industrial area.
  • Regular inspections of the unit will be conducted by Drug inspectors.
  • The minimum size of the unit for a drug category is 12,000 square feet.
  • If manufacturing more than one drug, additional space will be required.
  • All necessary manufacturing and packaging machinery must be acquired.
  • The manufacturing unit must be GMP certified.
  • Two Ayurvedic experts and two Pharmacists must be included as team members.
 
AYUSH Third-Party Manufacturing/Contract License

The AYUSH manufacturing license of a third-party manufacturer is utilized for product manufacturing, as the name implies. The applicant need not own the manufacturing unit as they are only responsible for marketing the product.

In contrast, the manufacturer is accountable for fulfilling all necessary requirements and formalities.

AYUSH Loan License

A third party must obtain the AYUSH loan license, and it is important to note that the applicant is not responsible for medicine manufacturing, as it is completed by a third party. Additionally, the manufacturer must be GMP certified, and the license will be issued to the candidate/applicant.

The following requirements must be fulfilled under the AYUSH Act:

  • The manufacturing unit must be located in an industrial area.
  • The establishment should have an office, a storage room for raw material, and a storage room for finished products.
  • The loan license must be renewed as required.
  • Inspection of the establishment by the Drug Inspector is mandatory.
Unani Manufacturing License

Unani medicine is both a science and an art of healing that utilizes a unique approach to prevent and cure diseases. To offer such services, obtaining an AYUSH manufacturing license is necessary.

Siddha Manufacturing License

Siddha is a practice or treatment that focuses on maintaining a balance between the mind, body, and spirit system, and emphasizes equal importance to all three aspects in restoring psychological and physiological harmony of the body.

To provide such services, establishments must obtain a Siddha manufacturing license, which is issued with the goal of promoting equal importance to the mind, body, and spirit.

Basic Requirements to Fulfill Before Applying AYUSH Certificate

Establishments seeking an AYUSH license must meet certain requirements to ensure compliance with health and safety regulations. These requirements include:

  • Prohibiting the presence of open sewerage, drains, public lavatories, dust, and smoke in the establishment.
  • Obtaining a permit for drug production and maintaining hygienic conditions in the building, including keeping the premises free of cobwebs or insects and preventing dampness on the floors and walls.
  • Ensuring proper measures are taken to wash, clean, and dry containers used for storing products such as glass bottles and vials.
  • Providing pure and portable quality water, taking appropriate measures to wash the premises, and disposing of wastewater and laboratory residue after adequate treatment.
  • Having personal storage space for raw materials, packaged products, and final products in a well-ventilated room that is not damp.
  • Labeling containers used for storing products with appropriate identification, including the name of raw materials, source of supply, and status of raw materials.
  • Storing packaging materials in a clean and dry space.
  • Marking a specific area for quarantining finished products.
  • Moving finished products to an “approved finished goods stock” area after laboratory quality control and expert examination/testing.
  • Providing workers with proper uniforms, sanitation facilities, personal cleanliness facilities, medical facilities, and conducting medical exams at the time of employment and periodic checkups.
  • Ensuring availability of machinery and equipment required for production.
  • Maintaining records of batch manufacturing, distribution, and market complaints.
  • Obtaining all necessary licenses required for providing a section of the facility of quality control.

Documents Required For AYUSH Manufacturing Certificate

The following information and documents are required to be submitted:

  1. Name, address, email, and contact information.

  2. A copy of the manufacturing license.

  3. List of approved products.

  4. List of products for which COPP (Certificate of Pharmaceutical Product) is being applied for, along with their composition.

  5. Layout of the manufacturing unit or site master file.

  6. Details of the manufacturing process and manufacturing formula.

  7. Specification report of the finished product and the method of analysis.

  8. Process validation report of three batches.

  9. Stability study analysis based on a batch, including manufacturing date, expiry date, stability study condition, and drug name.

  10. Diagram of the water system and HVAC (Heating, Ventilation, and Air Conditioning) system.

  11. List of technical staff, including their experience, qualifications, and approval status.

  12. Export data of two years, wherever re-validation of COPP is applicable.

  13. Evidence of safety and effectiveness as prescribed in Rule 158B of Drugs and Cosmetic Rule,1945.

  14. Undertaking regarding compliance with the provisions of the Domestic Regulation Drugs and Cosmetic Act,1940.

  15. In the case of herbal products, an undertaking regarding the absence of non-herbal components (like metals, minerals, etc.) in the products for which WHO-CoPPs (World Health Organization Certificates of Pharmaceutical Products) are being applied for.

How to Obtain an AYUSH Certificate

  • The application form should include information about GMP and COPP certificates.
  • Once the information is entered, attach the necessary documents and send them to the relevant authorities.
  • After reviewing the documents, the certificate will be issued within 15 days.
  • The license will be delivered to the applicant via post.

Note: The commissioner has the authority to grant clearance to large industries. In contrast, the District Collector is responsible for granting clearance to MSMEs.

The Role We Play in AYUSH Registration

  • We promise to guide you on the process of obtaining the AYUSH license.
  • We assure you of complete support throughout the registration process.
  • Our team will provide assistance in the documentation process.
  • Our AYUSH license experts will help you fulfill the general requirements for registration.
  • We will liaise with the officials to ensure smooth coordination and timely completion of the registration.
  • Our consultants will keep you informed of every step of the registration process.
  • If you have any concerns, our experts will provide you with the best possible solutions.

Conclusion

Obtaining an AYUSH license can be a daunting task for any establishment due to the numerous general requirements that must be fulfilled, as well as the complexities involved in the registration and documentation processes. As a result, seeking the assistance of an experienced and knowledgeable consultant is crucial for obtaining the license.

Certifications Bay, guarantees to make the AYUSH license registration process hassle-free by providing 24/7 support to our clients.

Contact us now to learn more about how to obtain an AYUSH license.

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