Do we need Drug license to sell Ayurvedic Medicines..???

- Dr Akhil Manoj

Avācīna™ Group of Concern

"Greetings to all our readers of this first edition of our blog series"

The answer is Yes, you need some of the Drug license to sell Ayurvedic Medicines.

• You need the simple legal business registration and a current bank account to sell Ayurveda Products.

• Manufacturers have to take a prior license from the State Drug Controlling Authority for running an Ayurvedic Pharmacy.

• Formulations whether classical or patent proprietary have to be got clear from the competent authority before starting commercial manufacturing.

• It is mandatory to have Ayush Retail license for sale of Ayurvedic medicines or any product related to ayurvedic in India.

• Without Ayush License, there are Government Penalties to sell Ayurvedic products.

Types of Ayurvedic licenses

There are different types of Ayurvedic licenses issue by the Department of Ayush are as follows:

1. Retail license

One needs to obtain a retail license in case you want to sell the ayurvedic or herbal products as a retailer. This License is issued to run and sell ayurvedic medicines/products in India.

2. Wholesale license

One needs to obtain a wholesale license in case you want to sell the ayurvedic or herbal products as a wholesaler. Wholesale License is issued to persons or agencies who are directly engaged in wholesale of Ayurvedic drugs and medicines

3. Manufacturing license

Manufacturing License is issued to persons or agencies engaged in the manufacturing of ayurvedic drugs and medicines. In case one is planning to manufacture herbal or ayurvedic drugs and medicines, you need to set up your own manufacturing unit and obtain an Ayush license for the same. Any person who wants to apply for Ayush manufacturing license needs to comply with all the state requirements issued by the Ayush state authority.

4. Ayush loan license

Ayush loan license is issued in case the products are manufactured by third party manufacturers. In such cases, the manufacturing unit is not owned by the applicant. This loan license should apply with a GMP certified manufacturer and later issued to the applicant company. Loan License is issue to a loan licensee/person using the premises, equipments, and staff of another ayurvedic drug licensee having a manufacturing license.

5. Ayush contract/ third party manufacturing licenses

In this case, neither the manufacturer has his own manufacturing set up or nor the license. This contract only consists of the marketing part which is to be done by the contract/ third party manufacturing. The manufacturer takes care of all the compliance & liaison work. The manufacturer license is use and the manufacturer will get approval from the concerned authorities for your product.

Supporting Documents required for Ayush Manufacturing License

1. Plan and layout of the premises showing the installation of Machinery and Equipment – 2 Hardcopies

2. Attested copies of documents relating to the ownership/rent/lease – 2 Hardcopies

3. Declaration of the Proprietor/Partnership/Director etc., in Affidavit-I (enclosed with an online form), attested Partnership Deed/Memorandum and Articles of Association – 2 Hardcopies

4. A detailed list of Manufacturing and Analytical Equipment as required for formulations applied. – 2 Hardcopies

5. Appointment letter to full-time Technical Supervisor – 2 Hardcopies

6. Attested copies of certificates of academic qualification, experience certificate from Ayurveda/Unani and declarations of Technical Staff in the prescribed proforma with photo duly attested – 2 Hardcopies

7. List of Classical Medicines and Xerox copies of concerned pages of references duly signed by F.T.S with samples. – 2 Hardcopies

8. Passport size photos each of the proprietor and F.T.S – 2 Hardcopies

9. Sales pack draft labels for each drug as per D & C Rules with different sizes, if any – 2 hardcopies

10. A self-addressed envelope with sufficient postal stamps for registered post – 2 hardcopies

11. Clinical trial reports from (3) institutionally qualify Ayurvedic Practitioners as the case may be, on at least 30 patients for each drug uses orally as per the proforma guidelines – 2 hardcopies

12. Drug information in the following lines for Anubhutha Yogas (patent drugs) duly signed by the proprietor

• Name of the Product

• The formula shall contain Classical name, Part used and quantity

• The detailed method of preparation

• Purification of drugs wherever required

• Indications (In Ayurveda Terminology)

• Dosage schedule in details

• Side effects

• Anti-dotes – 4 hard copies

Process of obtaining AYUSH License

The process of obtaining AYUSH license is as follows –

• Every state has a different website for Ayush. Visit your own state website of Ayush.

• In the second step, download the application form, attachment, list of documents including affidavits & other certifications such as GMP and COPP (Apply for GMP & COPP, if applicable)

• The third step is to fill your application form and send the same for review along with the documents to the commissioner of the Ayush department.

• In the fourth step, the commissioner will review your application along with the required documents. If the commissioner of the Ayush department feels satisfied after checking your application. The application will be processe within 15 days.

• In the fifth step, after processing of the application, Ayush license is grant to the company.