Do We Need Drug License to Sell Ayurvedic Medicine – Are you finding the correct answer for whether you require Drug License to Sell Ayurvedic Medicine or not and how many drug licenses you require or what documentation you need to acquire drug licenses to sell your own Ayurvedic medicines. All the answers to your question are combined in a single blog. Read the blog of Ayurvedic Pharma companies for further information. You can also send us a query if you have any doubts related to Drug License.
Do We Need Drug License to Sell Ayurvedic Medicine?
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 /Unani / siddha medicines or any product related to ayurvedic in India.
- Without Ayush License, there are Government Penalties to sell ayurvedic / Unani 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.
However, you have the right to provide raw material & packaging material to the manufacturer or else the manufacturer can arrange the same from his own sources. For ex – ABC ltd. is the manufacturer but the goods are market by you as a third party manufacturer.
Supporting Documents required for Ayush Manufacturing License
- Plan and layout of the premises showing the installation of Machinery and Equipment – 2 Hardcopies
- Attested copies of documents relating to the ownership/rent/lease – 2 Hardcopies
- 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
- A detailed list of Manufacturing and Analytical Equipment as required for formulations applied. – 2 Hardcopies
- Appointment letter to full-time Technical Supervisor – 2 Hardcopies
- 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
- List of Shastric Medicines and Xerox copies of concerned pages of references duly signed by F.T.S with samples. – 2 Hardcopies
- Passport size photos each of the proprietor and F.T.S – 2 Hardcopies
- Sales pack draft labels for each drug as per D & C Rules with different sizes, if any – 2 hardcopies
- A self-addressed envelope with sufficient postal stamps for registered post – 2 hardcopies
- Clinical trial reports from (3) institutionally qualify Ayurvedic /Unani Practitioners as the case may be, on at least 30 patients for each drug uses orally as per the proforma guidelines – 2 hardcopies
- Drug information in the following lines for AnubhuthaYogas (patent drugs) duly signed by the proprietor and F.T.S a
- Name of the Product
- The formula shall contain Shastric/Tibbi Name, Part used and quantity
- The detailed method of preparation
- Purification of drugs wherever required
- Indications (In Ayurveda/Unani 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.
In this article, we have discuss that Do We Need Drug License to Sell Ayurvedic Medicine and other information related licensing. Hope this content is useful for our readers.