Are you finding the correct answer for whether you require a Drug License to Sell Ayurvedic Medicine or not? Also want to know 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 questions or doubts related to a Drug License.
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Selling Ayurvedic medicines in India can be done through a physical store, online retail, or as a component of an all-encompassing health & wellness company. Vendors should not assume that Ayurvedic medicines fall within the same guidelines or procedural expectations as generic cosmetics or health and supplement items.
As far as Therapeutic Claims go, Ayurvedic Products are subject to regulation under the Drugs and Cosmetics Act (1940) and applicable provisions. To legally sell products with therapeutic claims, vendors must obtain the appropriate Ayurvedic or Drug License from Central or State authorities, depending on whether they will manufacture, wholesale or sell retail, and whether the product is classified as an Ayurvedic Medicine or Nutraceutical, or Cosmetic/Food item through the AYUSH licensing system.
Since the growth of the AYUSH industry is expanding rapidly, regulation is NOT only about legal compliance, but is also a way to build confidence and trust among customers and trading partners.
Key Legal Facts to Sell Ayurvedic Medicines
- The AYUSH sector of India’s pharmaceutical industry was specifically created under the Indian Drugs and Cosmetics Act of 1940 to recognize that drugs produced from ayurveda, siddha, unani and homeopathy systems of medicine are not excluded from drug regulations. Press Information Bureau
- The AYUSH sector is experiencing a rapid increase in growth as evidenced by reports estimating the AYUSH and wellness market to be valued in the tens of billions of USD, with continued growth anticipated through 2030. Regulations and compliance with regulatory requirements have allowed companies in this sector to create scalable business models and as a result, expand to export. India Brand Equity Foundation
- The presence of an online business does not exempt an e-commerce vendor from licensing requirements. E-commerce vendors wishing to sell ayurvedic products must be licensed either as retail marketers or wholesale distributors and must also comply with all regulatory requirements when establishing their supply chain. Corpbiz
- Exporters of AYUSH products may be required to submit additional documentation (e.g., certificate of pharmaceutical products and export clearance) and comply with the laws of the importing country. Legal Corner
Do We Need a Drug License to Sell Ayurvedic Medicine?
The answer is Yes, you need a 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 cleared by the competent authority before starting commercial manufacturing.
- It is mandatory to have an Ayush Retail license for the sale of Ayurvedic /Unani / Siddha medicines or any product related to Ayurvedic in India.
- Without an Ayush License, there are Government Penalties for selling Ayurvedic / Unani products.
Why The Licence Matters: Legal Safety and Market Access
A license serves three important functions in this practical way: to demonstrate compliance with regulations; to assure that quality control expectations (GMPs, testing, labeling, etc.) have been met; and to establish the legality of selling and distributing products in both domestic and export markets. In addition, violations of laws may result in confiscation of the products, fines and or incarceration; therefore, the government has taken recent enforcement actions against Ayurvedic manufacturers for advertising and/or production violations, indicating an increasing level of activity within the regulatory system.
Which Licence Do You Need?
- Manufacturing for Sale – To produce drugs for sale, you will need either a licence under the Drugs and Cosmetics Act (Forms 24D/24E) or an AYUSH manufacturing licence from your State AYUSH authority. GMP certification and quality testing are generally required.
- Wholesale/Distribution: To distribute drugs at wholesale levels, you will need a Wholesale Drug Licence from your State Drug Control Authority. Proper documentation and storage are very important.
- Retail Sale (Pharmacy / Online): In most cases, obtaining a Retail Drug Licence from your State Drug Control Authority is a requirement for selling products that fall under the category of drugs. Selling products via an online store also requires proper licences and generally has to include a registered pharmacist on the record.
- Cosmetics / Food like Herbal Products – If a product is labelled and sold solely as a cosmetic or food supplement, it has to adhere to either FSSAI (Food Safety and Standards Authority of India) regulations regarding foods or Cosmetics Regulations. In addition, it must comply with all applicable CDSCO regulations, if needed. Classifying a product as either a Food and Drug or Cosmetic will determine the applicable regulations that must be followed based on its origin and intended use, etc.
Types of Ayurvedic licenses
There are different types of Ayurvedic licenses issued 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 hard copies
- Attested copies of documents relating to the ownership/rent/lease – 2 hard copies
- 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 fothe r 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 the concerned pages of references duly signed by F.T.S. with samples. – 2 Hardcopies
- Passport-size photos of each of the proprietors and F.T.S. – 2 hard copies
- Sales pack draft labels for each drug as per D & C Rules with different sizes, if any – 2 hard copies
- A self-addressed envelope with sufficient postal stamps for registered post – 2 hard copies
- Clinical trial reports from (3) institutions qualify Ayurvedic /Unani Practitioners, as the case may be, on at least 30 patients for each drug used orally as per the proforma guidelines – 2 hard copies
- 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 the 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 detail
- Side effects
- Anti-dotes – 4 hard copies
Process Of Obtaining Ayush License
The process of obtaining an 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 out 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 granted to the company.
Quick Comparison Table: Licence Types at a Glance
| Activity | Typical licence required | Issued by | When needed |
| Manufacture (for sale) | AYUSH/Drug manufacturing licence (Form 24D/ 24E) | State AYUSH/State Drug Authority | For any indigenous manufacturing of Ayurvedic medicines. |
| Wholesale distribution | Wholesale Drug Licence | State Drug Controller | For large scale supply of Ayurvedic medicines to the dealers. |
| Retail sale (shop/online) | (Traffic) Retail Drug Licence (+registered pharmacist) | State Drug Controller | Necessary for the seller of drugs to final consumers in the case of therapeutically claimed products. |
| Cosmetic/personal care (herbal) | Cosmetic rules/ CDSCO/State authority | CDSCO/State bodies | If the product is considered a cosmetic (i.e. no therapeutic claims). |
| Food supplement/nutraceutical | FSSAI registration/licence | FSSAI | For ingestible wellness products categorized as food/supplement, not drugs. |
Conclusion
So, do you also require a drug licence to sell Ayurvedic medicine? Yes, in most cases — especially when products are advertised as treatments or preventive health care. The actual licence is dependent upon whether you are a manufacturer, wholesaler or retailer and how your product is classified. These rules are important for businesses and entrepreneurs to be aware of so they can steer clear of legal risks and develop a trustworthy image. We at Ayurvedic Pharma Companies feel that clear regulations lead to development. Proper licensing, transparent practices and quality compliance are the cornerstones of long-term success in India’s rapidly growing Ayurvedic market for both established and aspiring Ayurvedic Pharma Companies.
Frequently Asked Questions
Can I sell Ayurvedic medicines online without a license?
No. If you are selling Ayurvedic medicines online, your sale is going as an offline sale without a valid prescription of an authorized Ayurvedic practitioner, then it becomes territorially illegal, and the State department officials or their appointed regulators may be vigilant on this issue at any time. Online vendors must have the same retail or wholesale drug license as a bricks-and-mortar store and comply with all storage, labelling and pharmacist requirements.
Do we need a license to sell herbal or ayurvedic cosmetics?
Not always. If the item is sold as strictly a cosmetic and does not make claims of medical or therapeutic benefit, then it becomes regulated by the cosmetics rules rather than the drug laws. But you can still get in trouble for mislabeling or overstating the product.
Which license is necessary for manufacturing Ayurvedic drugs?
Manufacturers are required to obtain an AYUSH drug manufacturing licence from the state AYUSH authority. This also depends upon adherence to GMP, approved formulations and quality testing standards.
Are wholesalers and distributors also required to be licensed?
Yes. It is mandatory for practitioners and all those involved in the bulk supply/distribution of Ayurvedic medicines to have a valid wholesale drug licence from the State Drug Control Department.
Is FSSAI registration sufficient for Ayurvedic products?
Only food or dietary supplement products need to be registered with FSSAI. If you are making medicinal claims, then simply getting FSSAI approval is not good enough; you will need a drug licence to operate as well.
What will happen if I sell Ayurveda medicines without a license?
Selling without a valid licence can cause product seizure, monetary penalties, cancellation of commercial enterprise operations, and even legal prosecution under the Drugs and Cosmetics Act.
Is there a multi-state license available?
No. Typically, drug licences are state-based. (If you do business in multiple states, you may need additional licenses or approvals depending on the shape of your particular type of business.)
What is the time taken for a drug or AYUSH license?
It depends on the state, but typically this is 30 to 90 days, times verification of documents, inspections and compliance.
