Ayurveda which literally means “The Science of Life” is one of the oldest healing science to have ever existed dating back almost 5000 years or more. Ayurveda originated from the ancient Vedic culture and is the basis of the principles of many of the natural healing systems now familiar in the West have their roots in Ayurveda, including Homeopathy and Polarity Therapy.
Every business engaged in the manufacture, Retail, Wholesale, or any other form of trade of Ayurvedic or Herbal Products should get an Ayush Licence. The Ayush Manufacturing Licence is issued by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy). The Ministry of AYUSH is responsible for the development, education, research, and growth of the alternative medicine system in India.
Points to consider to Get Ayush Mnufacturing Licence in India
1. No person in India may start or continue a drug or cosmetic business without obtaining an appropriate license for conducting such operation.
2. To conduct a drug or cosmetic business under the purview of the drug & cosmetic act 1940 all forms of drug or cosmetic business like allopathic, homeopathic, ayurvedic, or Unani drugs are protected.
3. To develop Ayurvedic medicines, one must obtain a license from the Ministry of Ayush for the manufacture of drugs.
4. Ayurveda is an ancient therapy for healing that improves longevity, it is also known as “Life Science.” Ayurveda is one of the world’s old surviving medical systems which started nearly 5000 years ago. The Ayurveda theory describes a set of mental structures marked by balance and chaos, well-being, and illness. It explains that the mental, emotional, and spiritual being of a person is all interconnected and that even a slight difference between them contributes to health disorders and disease.
Who requires Ayush license and Pre- requisite for Ayush Manufacturing Licence
a. Manufacturer
- Self Manufacturing
- Loan Manufacturing
- Third-party manufacturing
b. Retailer
c. Wholesaler
Following are the Mandatory Requirements for Ayurveda Manufacturing Licence
- Unit Location: The manufacturing unit should be situated in an industrial area.
- Minimum Size of Unit: Should have a minimum of three rooms (1 for Raw Material, 1 for Finished products and an Office Room)Certification:
- GMP Certificate is Mandatory (Click to get GMP Certification).
- Team Specifications: There is a professional required for the team.
- Inspection: Inspection by Drug Inspectors is one of the requisites for approval of the license.
- Loan Manufacturing Agreement should be signed between the two parties.
Criteria for different types of Ayush License
TYPES OF AYUSH MANUFACTURING LICENCE
SELF MANUFACTURING
To develop Ayurvedic medicines, one must obtain a license from the Ministry of Ayush for the manufacture of drugs.
The requirement for manufacturing of AYUSH Drug:
a. For Company/ Proprietary and other forms of business
- The manufacturing unit area will not be less than 1285 sqft
b. DMR act [The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954]
c. (DMR act compliances must be followed for manufacturing)
d. BMS Doctor (medical officer)
e. Professional executive (Technical officer) (BSC with Bio.)
f. Detail about the manufacturing drug (what will be the product going to be manufacture)
g. Manufacturing Product form [in what form (tablets/liquid/powder) product going to be manufacturing)
h. Directors (related to the herbal domain) will be more preferable
LOAN MANUFACTURING:
Under this form of set-up, the acquirer can acquire licenses without owning a production unit. The product will be manufactured by third parties. Loan license should be issued with GMP accredited manufacturer and consequently Applicant Company may face issues, and goods should be approved by authority.
A request for the grant or renewal of a loan license to produce any Ayurvedic (including Siddha) or Unani drugs for sale shall be sent to the Licensing Authority in Form 24-E along with a fee of six hundred rupees.
Explanation — For the purposes of this law, a loan license means a license granted by a licensing authority to an applicant who does not have its own manufacturing facilities but plans to take advantage of a licensed manufacturing facility in Form 25-D:
PROVIDED that in the case of renewal, the applicant may request that the license be renewed before its expiry or within one month of the expiry of the licence:
PROVIDED further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case the fee payable for the renewal of that license shall be six hundred rupees plus three hundred additional fees for rupees. (ii) a fee of one hundred and fifty rupees shall be payable for a duplicate copy of a license given under this Regulation;
THIRD PRTY MANUFACTURING
Under this you will have to use a third party manufacturer’s manufacturing license to manufacture the drug. You just have to sell the drug, so you don’t need to own a manufacturing unit and get any license in this as well. The supplier itself will execute all essential specifications and formalities with AYUSH office.
If you use manufacturer’s license, the manufacturer will have to receive permission from authorities for your product. In addition, the raw materials, packaging materials or supplier must organize the same from its sources. Finally, a producer must give you the finished / ready product. The product label will represent the name of the company which has manufactured and marketed the product.
The producer will charge for his service, i.e. the production costs of the product; the product approval fees will also be paid. Third party would be asked to create a legal document claiming they own the product. The legal document will also state that your business will remain the owner of the product in case of any conflict.
RETAIL LICENSE AND WHOLESALE LICENSE
If you want to sell the ayurvedic or herbal products as a retailer, you need to get a retail licence. This license is issued to run and sell Ayurvedic medicines / products in India and if you want to sell Ayurvedic or herbal products as a wholesaler, you will need to obtain a wholesale license. Wholesale License is given to individuals or organizations specifically engaged in the wholesale of Ayurvedic medicines and drugs
ADDITIONAL CONDITION FOR RETAIL AND WHOLESALE LICENSE
To apply for retail or wholesale:
· The area of the premises where you will build a shop should be 10 square metres. The height of the premises should correspond with the 2005 National Construction Code.
To apply for both retail and wholesale licenses:
· The premises will have a total area of around 15 metres. The height of the premises should be in line with the 2005 national Building Code.
Documents Required for Ayush Manufacturing Licence
1. MOA and AOA of the company or partnership deed
2. Proof of Occupancy or proof of address (Copy of the rent agreement) of the Manufacturing Unit
3. Photo ID proof of the Owner/proprietor/ Director/partner of the company.
4. Details pertaining to the refrigeration system
5. An affidavit confirming the compliance of MPD 2021
6. Proof of Qualification of the respective personnel
7. Registration of the state Ayush Council/department
8. Appointment Letter and detailed profile of the director/partners of the company.
9. Site Plan of the Manufacturing Unit
10 Detailed List of Products for which licence is being applied
11. List comprising of details of technical staff.
12. List of machinery, equipment and instruments (Used and to be used).
13. Proof of Safety and effectiveness as per the Rule 158B of Drugs & Cosmetic Rules, 1945
14. Undertaking regarding the absence of any non-herbal such as metals/ or minerals, etc. in the products applied for WHO-COPPs i.e Applicable in case of herbal products.
15. Detailed Information Dossier on the Product(s) for which the licence is being applied
Types of Ayurvedic Product Licences
AYURVEDIC DRUG LICENCE
Ayurveda which literally translates to the “Science of Life” the is the ancient art of healing focusing on enhancement of endurance. Millions of people have benefitted from Ayurveda and have achieved a healthy life. Ayurvedic Medicines are generally made of organic and pure ingredients found in nature like condiments, herbs and roots. Ayurvedic products are known to be free of any chemicals and dangerous ingredients.
AYURVEDIC HERBAL COSMETICS LICENCE
Ayurvedic Herbal Products are also formulated using ancient Ayurveda. These goods formulated from the composition of the extract of herbs and various other herbal components comprising of different types of woods turmeric and some condiments.
AYURVEDIC HERBAL HEALTH SUPPLEMENT LICENCE
Herbal supplements are a form of supplement that has plant or portion of herbaceous plants used for its own flavour, odour, or potential therapeutic properties.
UNANI DRUG LICENCE
Unani medicine is a system of alternative medicine which was originally practised ancient Greece but is now practised primarily in India. Unani system of medicine uses alternative therapies, herbal remedies and dietary practices to prevent and treat diseases.
HERBAL DRUG LICENCE
The system of Medicines which uses a herb or a plant or a part of a plant as medication or more likely as supplements are covered in Herbal Drugs. These medicines or drugs are mostly used to maintain a healthy lifestyle and increased wellbeing.
Ayurvedic Products Manufacturing Licence
