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It is mandatory to obtain an AYUSH license from the Ministry of Ayush if you are interested in the manufacturing of Ayurvedic or herbal products in India. I will try and cover all categories of ayurvedic medicine businesses and business plans in this article, including ayurvedic medicine shops, ayurvedic distribution, ayurvedic clinics, ayurvedic franchise concepts, ayurvedic pharmacy licenses, ayurvedic medicine marketing company, ayurvedic manufacturing unit, and investment & cost needed to launch, among others. I will answer Most of questions from google search query about ayurvedic medicine, such as how to open an ayurvedic medical store, what licenses are required to sell ayurvedic medicines, do we need a drug license to sell ayurvedic medicine, what qualifications are required to open an ayurvedic medical store, what licenses are required to sell herbal products in India, and so on.
The board term of Ayurveda: covers all that has to do with human wellbeing and Ayurveda is made up of two words: Ayur (Life) and Veda (Knowledge). The Ministry of Ayush regulates Ayush Licenses, and the Commissioner of the Ayush Department approves the Ayush License application. The Department of Indian System of Medicine and Homeopathy (ISM & H) was established in 1995. On November 9, 2014, the department's name was changed to the Ministry of Ayush. Ayurvedic medicines are gaining popularity because they have no or few side effects compared to synthetically prepared medicines and products.
How To Start Ayurvedic Medicine Business?
- To begin selling Ayurvedic medicines, you will need a legal business registration and GST Certificate, and trade license, and In India, the AYUSH Retail License is required for the sale of Ayurvedic/Unani medicines
- To open an Ayurvedic shop, all manufacturers must first obtain a license from the State Drug Controlling Authority(further requirements given below)
- A drug license is required if you want to sell ayurvedic medicines in India.
- If you deal in food products, you'll need an FSSAI registration/license.
Ayurvedic Business List:
Categorized ayurvedic businesses will gradually go through each form of ayurvedic business to start in detail. The Ayurvedic company I'm talking about here is also included.
- Manufacturing of Ayurvedic Medicine
- Marketing Agency for Ayurvedic Medicine
- Distribution and Wholesale of Ayurvedic Medicine
- Ayurvedic Retail Pharmacy and Ayurvedic Medicine Store
- Selling Ayurvedic Goods Online
- Panchkarma and Ayurvedic Clinic
- Ayurvedic Consulting Company
- Ayurvedic medicine Business Franchise
- Business of direct selling and multi-level marketing
- Export of Ayurvedic Products
Types of Licenses Required to Sell Ayurvedic Medicine
- License for retail: A Retail License is required to sell ayurvedic or herbal products as a retailer. Even so, this license is required to operate an Ayurvedic retail shop in India.
- License for wholesale sales: Second, if you are a wholesaler of Ayurvedic medicines, you will need this license. As a result, this wholesale license is granted to an organization or an individual who specifically engages in Ayurvedic drugs and medicines wholesale.
- Manufacturing permit: When an individual or an organization manufactures these ayurvedic/herbal medicines in India, a Manufacturing License is required. If you want to become an ayurvedic drug manufacturer, you must first establish a manufacturing unit and obtain a license. If you apply for an AYUSH manufacturing license, you must meet all of the state specifications provided by the AYUSH state authority.
- AYUSH loan authorization: When a Third Party Manufacturing Firm manufactures the products, AYUSH Loan License is given. As a result, in such situations, no applicant is permitted to own this manufacturing facility. Furthermore, to apply for an AYUSH loan, manufacturers must have a GMP certification. This loan license can only be given by the person who is using the premises.
- Contracts for AYUSH and third-party production licenses: If the manufacturer does not have a manufacturing unit or a license, the contract involves a marketing aspect that a third party or contract manufacturer performs. This license is used to obtain approval from the concerned authorities.
AYUSH Manufacturing License
This license can be obtained by anyone who wishes to establish a manufacturing unit or develop a proper manufacturing and marketing plan.
To obtain an Ayush Manufacturing License, you must meet all of the following requirements:
- Manufacturing land should be a minimum of 1285 square feet.
- The installation of machinery and equipment is shown on a plan and layout of the premises.
- Attested copies of academic qualification certificates, Ayurvedic/Unani experience certificates, and declarations of Technical Staff in the prescribed proforma with photo duly attested
- Declaration of the Proprietor/Partnership/Director etc., in Affidavit-I (enclosed with an online form), attested Partnership Deed/Memorandum and Articles of Association.
- The manufacturing facility must be located in an industrial setting.
- The manufacturing unit should be certified according to GMP.
- Two pharmacies and two Ayurvedic experts should be on board.
- You have full access to all packaging and manufacturing equipment.
- Your manufacturing unit will be inspected regularly by the drug inspector.
Some Documents are the same for Unani and Siddha Manufacturing License.
Unani Manufacturing License:
This license is extremely popular among the general public due to the unique approach to preventing and curing diseases. Unani medicine is dedicated to the art and science of healing.
Siddha Manufacturing License
Siddha's treatment focuses on disease prevention rather than cure. It aids in the treatment of diseases such as skin, liver, and prostate.
What is the procedure in India for obtaining an AYUSH license?
The following is a step-by-step method for obtaining an AYUSH license in India:
- For AYUSH registration, visit the official websites of each state.
- Download the application form and insert all supporting documentation, including affidavits and other certificates such as CoPP and GMP, in some cases.
- If applicable, apply for GMP and CoPP (details are given below).
- Certification for Good Manufacturing Practices (GMP): This certification ensures that the goods are consistently manufactured and that the quality levels prescribed by the WHO. This qualification aims to reduce the risks associated with pharmaceutical manufacturing. A GMP certificate indicates that the pharmaceutical business has passed the inspection of a pharmaceutical regulatory body and is safe to export. It also guarantees that the commodity follows all of the World Health Organization's standards (WHO).
- Pharmaceutical Product Certification (CoPP): Any manufacturer with a Certificate of Pharmaceutical Product (CoPP) is permitted to sell pharmaceutical products in the country. Suppose the pharmaceutical item is to be registered outside of the country. In that case, the government body in charge of authorizing the application will require a Pharmaceutical Product (CoPP) certificate to ensure that the product can be delivered as a finished product country.
- Send the form, along with all appropriate documents, to the AYUSH Directorate.
Qualifications for Ayurvedic Medicine Manufacturing
The manufacturing of Ayurvedic (including Siddha) or Unani drugs must be done under the guidance and supervision of professional technical personnel, which must include at least one full-time employee with at least one of the following qualifications:
- A degree in Ayurveda, Ayurvedic Pharmacy, Siddha, or Unani system of medicine conferred by a University, a State Government, or Statutory Faculties, Councils, and Boards of Indian Systems of Medicine recognized by the Central Government or a State Government for this reason, or a degree in Ayurveda, Ayurvedic Pharmacy, Siddha, or Unani system of medicine conferred by a University, a State
- A recognized University graduate by the Central Government in Pharmacy, Pharmaceutical Chemistry, Chemistry, or Botany, with at least two years of experience in the manufacture of drugs related to the Ayurvedic, Siddha, or Unani medical systems.
- A certificate in Ayurveda, Siddha, or Unani medicine granted by a state government or an institution recognized by the Central Government for this reason, or
- A Vaid or Hakim who is listed in a State Registry of Indigenous Medicine Practitioners and has at least four years of experience manufacturing Siddha or Unani medicines, or
- Qualification as a Pharmacist in the Ayurvedic (including Siddha) or Unani systems of medicine, with at least eight years of experience in the manufacture of Ayurvedic, Siddha, or Unani medicines, as defined by the Central Government.
(Please Read Government Guidelines For proper Details about Qualifications)