Who Can Manufacture Ayurvedic Medicine?

1. Who Can Manufacture Ayurvedic Medicine? Due to its natural origins, the popularity of Ayurvedic medicine has increased in recent years. Experts anticipate a further increase in demand for these Ayurvedic medicines due to the absence of any negative side effects. As a result, the number of Ayurvedic medicine manufacturing units in India has steadily increased, and it is now required to obtain an AYUSH license to sell Ayurvedic medicines. Do you intend to launch a distribution company for Ayurvedic medicines? If so, continue reading to learn how to apply for an Ayurvedic medicine license. Which ayurvedic medicine licenses are available? To manufacture Ayurvedic medicines in India, you are required by law to possess an Ayush license. Moreover, the same holds for the production and manufacture of Unani and Siddha medicines. In India, four primary types of Ayurvedic medicine manufacturing licenses are therefore issued: 1. Retail License: Permits the owner to operate a business selling ayurvedic medicines. 2. Wholesale License: Permits owners to engage in the wholesale distribution of Ayurvedic products. 3. Manufacturing License: Permits the manufacture of ayurvedic drugs and medicines 4. Loan License: For those who use the premises and equipment of someone who has an Ayurvedic medicine manufacturing license. (Requires GMP Certification) 5. Contractual or ayurvedic third party manufacturing License: Required if the original manufacturer lacks an AYUSH license. What authorization is required to sell Ayurvedic medicine in India? If you wish to only sell Ayurvedic products, you will only need a retailer license. This license is required for both online and offline sales of these substances. Nonetheless, the company must first register under the Companies Act to obtain such a license. In addition, the owner cannot apply for an AYUSH retail license until the business has been incorporated in India. After that, they will be required to open a business bank account and complete tax registrations. If you wish to establish a manufacturing facility, you must obtain an Ayurvedic medicine manufacturing license from the State Drug Controlling Agency.

2. How to begin selling Ayurvedic medicinal products in India 1. Initially, you will have to look for a suitable location to open a store. 2. To ensure that your customers can easily locate you, the location must be easily accessible and popular. 3. Depending on your needs, you will be required to choose the type of business entity you wish to incorporate as. The following step is to check the availability of a name and register it for your shop. 4. After submitting the required application form and supporting documents, you must complete the incorporation procedure. Then, you can apply for your AYUSH license. 5. After incorporation, you must open a bank account for your business and apply for a PAN and TAN. 6. Subsequently, if your annual revenue exceeds the predetermined limit of INR 20 lakhs, you must apply for GST registration. 7. You will also need to find a reliable source for your products and begin implementing an efficient supply chain to begin selling your products. Required AYUSH license application documentation The following is a summary of the documents required to obtain an Ayurvedic medicine sale license, either for retail or wholesale, from the Department of AYUSH. 1. Articles of Association and Memorandum of Association 2. Also, proof of the address of the premises 3. If the property is rented, a copy of the lease and the owner’s NOC 4. ID proof of Directors/Partners/Owner 5. Specifics about the utilized refrigerator 6. Affidavit assuring conformity with MPD 2021 7. Qualifications Document 8. Registration with the Ayurveda Council of Delhi 9. The director’s appointment letter 10. The director’s biography

3. In addition, the following is a list of the supporting documents necessary to obtain an ayurvedic third party manufacturing company license. 1. Two copies of the layout of the premises with machinery and equipment. 2. Two copies of ownership or rental documents that have been attested 3. Statement in the form of an Affidavit-I from the Director/Partner/Owner 4. Two authenticated copies of the MOU and AoA/Partnership Agreement 5. A comprehensive list of necessary equipment. 6. Appointment letter for a permanent technical supervisor 7. Form for a certificate of experience and certified copies of academic credentials 8. Technical Staff Declarations with Photographs 9. Compilation of Shastric Medicines 10. Xerox reproductions of references signed by FTS 11. Two passport-sized photos of the FTS and the Director/Partner/Proprietor. 12. Sales pack draught labels 13. Clinical trial reports from three Ayurvedic practitioners on at least 30 patients. 14. 1200 square feet is the minimum required space. 15. The premises must comply with the regulations outlined in Schedule T of the Food, Drug, and Cosmetic Act. How to acquire a license in Ayush 1. Each state has a separate AYUSH website. Entrepreneurs are required to visit the state’s AYUSH website. 2. Download the application form for an AYUSH license from the website and the required GMP and COPP affidavits. 3. The next step is to fill out all the application forms, attach the supporting documents, and submit them to the commissioner of the AYUSH Department for review. 4. Following verification, approval will be granted within 15 days if the commissioner is satisfied. 5. The AYUSH license will then be sent to you by mail.

4. How Vakil Search will assist Our team of experts can advise you on the licenses and registrations your business will need. We can make suggestions on the type of business entity to incorporate based on your particular needs. Our team will also help you with all necessary documentation for incorporation and other registrations. We can also help you draught legal documents, such as the Memorandum and Articles of Association. Moreover, our team can manage your tax responsibilities, allowing you to file your annual tax returns on time.