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Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire an AYUSH License controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9th November 2014, before it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was made in March 1995.AYUSH License in India is provided to the companies or businesses that want to venture into the field of Ayurveda, Unani, or Siddha drugs. Chapter four of the Drug and Cosmetic Act, of 1940 talks about the concept of Ayurveda, Unani, or Siddha drugs. The provisions relating to Ayurveda, Unani or Siddha drugs start from Section 33B. AYUSH License is provided by the Central Government under the Ministry of AYUSH.
(1) The individual or entity, after obtaining the AYUSH License, can function in any state regardless of the location of the manufacturing company.
(2) The individual or entity who has applied for the AYUSH License only looks after the marketing part of the product; the rest of all the compliance necessary for the product is being taken care of by the manufacturing company.
(3) The use of Ayurvedic and herbal medicine is most preferred in Indian culture, and to regulate and restrict the improper use of Ayurvedic medicine, one must get the AYUSH License.
(4) The government, with its approach of “go local”, is also encouraging entities and consumers to rely on home production, i.e., Ayurvedic and herbal medicines.
(5) The medicines produced by natural herbs and ayurvedic resources have a low risk of side effects, and the AYUSH license helps in enhancing the trust of the users.
(1) Application filing.
(2) Application assessment.
(3) Inspection of facility.
(4) Grant of ayush certificate.
(1) Details of the applicant.
(2) Details of company (MOA or AOA). If applicable.
(3) Manufacturing License copy as issued by the state government.
(4) List of products applied for.
(5) Issuance of Certificate of a Pharmaceutical Product.
(6) Site Plan Master file.
(7) Master manufacturing formula and the manufacturing process.
(8) Process validation report for 3 batches.
(9) Validation report of the analytical method.
(10) List of technical staff along with their qualification, experience and approval status.
(11) Manufacturing Plant layout.
(12) Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
(1) What is Ayush License?
(2) How to get ayush license & certificates?
(3) How to get ayush license for manufacturing herbal products?
(4) Who can sell ayurvedic medicines?
