Ayush License

In India, an Ayush License is required for the manufacturing, sale, and distribution of Ayurvedic, Yoga, Unani, Siddha, and Homeopathy (AYUSH) products. The Central Drugs Standard Control Organization (CDSCO) is responsible for regulating Ayush products and granting licenses. The requirements and procedure for obtaining an Ayush License in India are as follows:

Business Entity: Establish a legal business entity such as a company, partnership firm, or proprietorship, depending on the legal structure allowed for Ayush products.

Qualified Person: Appoint a qualified person who holds a degree or diploma in Ayurveda, Siddha, Unani, or Homeopathy as per the specific requirements of the product category. This person will be responsible for manufacturing and quality control processes.

Premises and Infrastructure: Ensure that the manufacturing premises meet the specific requirements set by the CDSCO, such as adequate space, ventilation, sanitation, storage facilities, and equipment necessary for manufacturing Ayush products.

Formulation Approval: Obtain approval for the formulations of Ayush products that you intend to manufacture or sell. Submit the formulation details, including ingredients, proportions, manufacturing process, and therapeutic indications, to the appropriate Ayush authorities for review and approval.

Documentation: Prepare the necessary documents required for the Ayush License application. The required documents may include:

Proof of identity and address of the applicant and the qualified person.

Business registration documents.

Qualification certificates of the qualified person.

Manufacturing premises ownership or lease documents.

Product formulation details, including ingredients, proportions, and manufacturing process.

Standard operating procedures (SOPs) for manufacturing and quality control.

Test reports of raw materials and finished products.

Application Submission: Obtain the application form for an Ayush License from the respective Ayush authorities or the CDSCO. Fill out the application form with accurate information about your business, its premises, the qualified person, and the Ayush products.

Fee Payment: Pay the prescribed application fee along with any other fees or security deposits required by the CDSCO or the respective Ayush authorities.

Inspection: The CDSCO or the Ayush authorities may conduct an inspection of the manufacturing premises to ensure compliance with the prescribed standards, including infrastructure, equipment, quality control procedures, and adherence to Good Manufacturing Practices (GMP).

Approval Process: Once the application and all required documents are submitted, the CDSCO or the Ayush authorities will review the application, conduct necessary verifications, and evaluate the manufacturing facilities. If the application is approved, the Ayush License will be issued with specific conditions and validity period.

Compliance and Renewal: Ensure ongoing compliance with the terms and conditions of the Ayush License, including adherence to GMP, quality control procedures, labeling requirements, and any other specific requirements. Renew the license as per the prescribed renewal process and timelines.