The Indian healthcare landscape is rapidly transforming as Ayurvedic medicines are fast sweeping the nation, according to Vadya Devendra Triguna, president of the All India Ayurvedic Congress, and president of the National Academy of Ayurveda. In the aftermath of COVID-19 outbreak, exports of Ayurvedic medicines have increased by three to four times. Lets learn more about if you Need A License To Sell Ayurvedic Medicine In India.
In recent years, Ayurvedic medicine has increased demand due to its natural origins. Also, since these medicines produce no adverse side effects, experts expect the demand to continue to rise. As a result, there has been a steady rise in the number of Ayurvedic medicine manufacturing units set up in India. Obtaining an AYUSH license is mandatory to sell Ayurvedic medicine. If you plan to start an Ayurvedic medicine distribution company, read on to learn more about how to apply for an Ayurvedic medicine license.
What Are the Various Ayurvedic Medicine Licenses?
As per Indian law, you need an Ayush license to manufacture Ayurvedic medicines in India. Moreover, the same holds for the manufacture and production of Unani and Siddha drugs. Therefore, four significant types of Ayurvedic medicine manufacturing licenses issued in India are as follows:
- Retail License: Allows the owner to run a business that sells ayurvedic medicines
- Wholesales License: Allows owners to engage in wholesale distribution of Ayurvedic products
- Manufacturing License: Enables the manufacturing of ayurvedic drugs and medicines
- Loan License: For people using the premises and equipment of someone with an Ayurvedic medicine manufacturing license. (Requires GMP Certification)
- Contract or Third-Party License: Required if the original manufacturer does not have an AYUSH license.
What License Do You Need to Sell Ayurvedic Medicine in India?
A retailer license is all you need to sell only Ayurvedic products. Both online and offline dealers require this license. However, owners must register with the Companies Act to acquire such a permit. It is also necessary to incorporate as a legal business entity in India to apply for an AYUSH retail license. Ayurvedic medicine manufacturing license is required from the State Drug Controlling Authority if you wish to start a manufacturing unit. Following this, you must open a company bank account and register with the tax authorities.
How to Start Selling Ayurvedic Medicines in India
- First and foremost, you will have to search for a suitable place for setting up a shop. Therefore, the area must be accessible and popular to ensure your customers find you easily.
- Depending on your needs, you will then have to decide on what type of business entity you want to incorporate.
- Next, you will have to check for the availability of a name and register it for your shop.
- Afterwards, you will have to complete the incorporation process after submitting the required application form and supporting documents. You can then apply for your AYUSH license.
- Once incorporated, you will have to set up a bank account for your company and apply for a PAN and TAN.
- Next, you will have to apply for a GST registration if your turnover exceeds the preset limit of INR 20 lakhs annually.
- You will also have to locate a good source for your products and start implementing an efficient supply chain to start selling your products.
https://www.youtube.com/shorts/inBUrmjW7kw
Documents required to apply for an AYUSH license
Here’s a quick look at the documents you need to obtain an Ayurvedic medicine sale license, retail or wholesale, from the Department of AYUSH.
- Company’s Memorandum and Articles Of Association
- Address proof of the premises
- If rented, a copy of the rental agreement and the owner’s NOC.
- ID proof of Directors/partners/proprietor
- Details regarding the refrigerator used
- Affidavit ensuring compliance of MPD 2021
- Proof of Qualification
- Registration with Delhi Ayush Council
- Appointment Letter of the director
- Biodata of the director
Click Here For : FSSAI License Registration
Moreover, here is a list of the supporting documents required to obtain an Ayurvedic medicine manufacturing license.
- Two copies of the layout of the premises with machinery and equipment
- Two attested copies of ownership or rental documents
- Declaration in the form of Affidavit-I from the Director/Partner/Proprietor
- Two attested copies of the MoA and AoA/Partnership Deed
- A detailed list of equipment is required.
- Appointment letter for a full-time technical supervisor
- Experience certificate form along with attested copies of academic qualification certificates
- Declarations of Technical Staff with photos
- List of Shastric Medicines
- Xerox copies of references signed by FTS
- Two passport-size photos of the FTS and Director/Partner/Proprietor
- Sales pack draft labels
- Clinical trial reports from three Ayurvedic Practitioners on at least 30 patients
- The minimum area required is 1200 sq. ft.
- The premises must adhere to the rules specified in Schedule T of the Drug and Cosmetic Act.
Furthermore, the Full-Time Technical Supervisor you employ must have the following qualifications;
- BAMS for Ayurvedic Manufacturing Or
- Diploma or a Degree in Ayurveda or Ayurvedic Pharmacy Or
- Pharmacy graduation or be a graduate in Chemistry/Botany or Pharmaceutical chemistry with over two years’ worth of experience dealing with Ayurvedic medicines Or
- Registered Hakim or Vaid with over four years of experience in Ayurvedic manufacturing Or
- An Ayurvedic pharmacist with over eight years of experience in manufacturing
How to Obtain an Ayush License
- Every state has its own AYUSH website. Entrepreneurs must visit the AYUSH website of their concerned state.
- From the website, download the application form for an AYUSH license, along with the required GMP and COPP affidavits.
- Next, you will have to fill out the application form, attach the supporting documents, and send it for review to the AYUSH Department’s commissioner.
- After verification, if satisfied, the commissioner will grant their approval within 15 days.
- You will then receive the AYUSH license by post.
Conclusion
As we all know, it is necessary to acquire an Ayush license to sell Unani, ayurvedic or any ayurvedic pills. You should also be aware that you will be charged government penalties for selling such products without acquiring a license.With the help of our team of experts, we will be able to guide you on what licenses and registrations your business will need. We can also advise you on what type of entity to incorporate for your business. We can help you with all the documentation required to incorporate and register your company. We can also assist you in drafting legal documents, such as the Memorandum of Association and Articles of Association. Furthermore, our team can handle your tax obligations, allowing you to file your taxes on time each year.
FAQ
Is a license required to sell Ayurvedic medicine in India?
Yes, it is mandatory to have an AYUSH Retail License to sell Ayurvedic/Unani medicines in India. The license is issued by the Department of Ayush and is required for both online and offline dealers.
What are the regulatory requirements for selling Ayurvedic medicine in India?
The regulatory requirements for selling Ayurvedic medicine in India include obtaining an AYUSH Retail License, registering the business with the government of India, and incorporating as a legal business entity in India to apply for an AYUSH retail license.
Additionally, businesses must comply with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act of 1954, and its corresponding rules.
Do I need government approval to market Ayurvedic products in India?
Yes, you need government approval to market Ayurvedic products in India. An AYUSH license is mandatory for businesses dealing in Ayurvedic, Unani, Siddha, Homeopathy, and Herbal products, be it for manufacturing, sale, marketing, or exports.
What is the legal framework for selling Ayurvedic medicines in India?
The legal framework for selling Ayurvedic medicines in India includes the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act of 1954, and its corresponding rules.
Additionally, businesses must obtain an AYUSH Retail License and comply with the regulatory requirements set by the Department of Ayush.
Are there specific licenses or certifications needed for Ayurvedic medicine sales in India?
Yes, there are specific licenses needed for Ayurvedic medicine sales in India. These include the AYUSH Retail License, AYUSH Manufacturing License, AYUSH Wholesale License, and AYUSH Loan License.
The type of license required depends on the nature of the business.
Read more,
- Benefits of Obtaining a Drug License Certificate
- Who needs a trade license in India?
- Business License Number In India
