Does One Need a License to Sell Ayurvedic Medicine in India?

Last Updated at: Nov 17, 2022
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Ayurvedic medicine
Vaidya Devendra Triguna, president, All India Ayurvedic Congress, and president, National Academy of Ayurveda has claimed that Ayurvedic medicines are fast sweeping the Indian healthcare landscape. He said that Exports of Ayurvedic medicines have gone up by three to four times post the outbreak of COVID-19.  

 

The demand for Ayurvedic medicine has been on the rise in recent years due to its natural origins. Also, since they produce no adverse side-effects, experts expect the demand for such Ayurvedic medicine to rise even further. As a result, there has been a steady rise in the number of Ayurvedic medicine manufacturing units set up in India as well, and it is mandatory to obtain AYUSH license to sell Ayurvedic medicines. Are you planning on setting up an Ayurvedic medicine distribution business? If so, read on to find out more about Ayurvedic medicine licenses and how you can apply for the same.

  1. What are the various ayurvedic medicine licenses?
  2. What license do you need to sell Ayurvedic medicine in India?
  3. How to start selling Ayurvedic medicines in India
  4. Documents required to apply for an AYUSH license
  5. How to obtain an AYUSH License
  6. How VakilSearch can help

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 as well. Therefore, four major types of Ayurvedic medicine manufacturing licences issued in India are as follows:

  1. Retail License: Allows the owner to run a business that sells ayurvedic medicines
  2. Wholesales License: Allows owners to engage in wholesale distribution of Ayurvedic products
  3. Manufacturing License: Enables the manufacturing of ayurvedic drugs and medicines
  4. Loan License: For people using the premises, and equipment of someone who has an Ayurvedic medicine manufacturing licence. (Requires GMP Certification)
  5. 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?

If you only wish to sell Ayurvedic products, then you will only require a retailer license. Both the online and offline sale of such drugs requires only this trade license. However, to acquire such a permit, the business needs first to register itself under the Companies Act. Moreover, only after incorporating itself as a legal business entity in India, can the owner apply for an AYUSH retail license. Afterwards, they will need to open a company bank account and complete tax registrations. In case you want to start a manufacturing unit, you will need an Ayurvedic medicine manufacturing license from the State Drug Controlling Authority.

get company registered

How to start selling Ayurvedic medicines in India

  1. First and foremost, you will have to search for a suitable place for setting up a shop. Therefore, the area will have to be accessible and popular to ensure your customers find you easily.
  2. You will then have to decide on what type of business entity you want to incorporate as depending on your needs.
  3. Next, you will have to check for the availability of a name and register it for your shop.
  4. Afterwards, you will have to complete the process of incorporation after submitting the required application form and supporting documents. You can then apply for your AYUSH license.
  5. Once incorporated, you will have to set up a bank account for your company and apply for a PAN and TAN.
  6. Next, you will have to apply for a GST registration if your turnover exceeds the preset limit of INR 20 lakhs annually.
  7. You will also have to locate a good source for your products and start implementing an efficient supply-chain to start selling your products.

Documents required to apply for an AYUSH license

 Here’s a quick look at the documents you need to obtain an Ayurvedic medicine sale licence, either as retail or wholesale from the Department of AYUSH.

  1. Company’s Memorandum and Articles Of Association
  2. Address proof of the premises
  3. If rented, a copy of the rental agreement and the owner’s NOC
  4. ID proof of Directors/partners/proprietor
  5. Details regarding the refrigerator used
  6. Affidavit ensuring compliance of MPD 2021
  7. Proof of Qualification
  8. Registration with Delhi Ayush Council
  9. Appointment Letter of the director
  10. Biodata of the director
Moreover, here is a list of the supporting documents required to obtain an Ayurvedic medicine manufacturing licence.
  1. Two copies of the layout of the premises with machinery and equipment
  2. Two attested copies of ownership or rental documents
  3. Declaration in the form of Affidavit-I from the Director/Partner/Proprietor
  4. Two attested copies of the MoA and AoA/Partnership Deed
  5. A detailed list of equipment required.
  6. Appointment letter for a full-time technical supervisor
  7. Experience certificate form along with attested copies of academic qualification certificates
  8. Declarations of Technical Staff with photos
  9. List of Shastric Medicines
  10. Xerox copies of references signed by FTS
  11. Two passport size photos of the FTS and Director/Partner/Proprietor
  12. Sales pack draft labels
  13. Clinical trial reports from three Ayurvedic Practitioners on at least 30 patients
  14. The minimum area required is 1200 sq. ft.
  15. 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;
  1. BAMS for Ayurvedic Manufacturing OR
  2. Diploma or a Degree in Ayurveda or Ayurvedic Pharmacy OR
  3. Pharmacy graduation or be a graduate in Chemistry/Botany or Pharmaceutical chemistry with over two years’ worth of experience dealing with Ayurvedic medicines OR
  4. Registered Hakim or Vaid with over four years of experience in Ayurvedic manufacturing OR
  5. An Ayurvedic pharmacist with over eight years of experience in manufacturing

How to obtain an Ayush license

  1. Every state has its own AYUSH website. Entrepreneurs must visit the AYUSH website of their concerned state.
  2. From the website, download the application form for an AYUSH license, along with the required GMP and COPP affidavits.
  3. Next, you will have to fill the application form, attach the supporting documents, and send it for review to the AYUSH Department’s commissioner.
  4. After verification, if satisfied, the commissioner will grant his or her approval within 15 days.
  5. You will then receive the AYUSH license by post.

How VakilSearch can help

  1. Our team of experts will be able to guide you about what licenses and registrations your business will require.
  2. We can also advise you with regards to what type of business entity to incorporate according to your requirements.
  3. Our team will help with all the documentation required for incorporation and other registrations.
  4. We can also help you in drafting legal documents, such as the Memorandum and Articles of Association.
  5. Furthermore, our team can handle your tax obligations, enabling you to file your returns on time annually.

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