AYUSH Department

AYUSH Department- Department of Health, Medical & Family Welfare Name of Approval / NOC / License / ... (enclosed with online form), attested Partners...

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AYUSH Department- Department of Health, Medical & Family Welfare License for manufacture of ayurvedic, homeo, siddha, unani

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Name of Approval / NOC / License / Registration Competent Authority Stage Processing Timeline

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Approving Authority Supporting Documents required

Commissioner-AYUSH S. Item No .

AYUSH Department Pre-Operation 15 days

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Plan and layout of the premises showing the installation of Machinery and Equipment.

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Attested copies of documents relating to the ownership/rent/lease Declaration of the Proprietor/Partnership/Director etc., in Affidavit-I (enclosed with online form), attested Partnership Deed/Memorandum and Articles of Association. Detailed list of Manufacturing and Analytical Equipment as required for formulations applied. Appointment letter to full time Technical Supervisor. Attested copies of certificates of academic qualification, experience certificate from Ayurveda/Unani and declarations of Technical Staff in the prescribed proforma with photo duly attested

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List of Shastric Medicines and Xerox copies of concerned pages of references duly signed by F.T.S with samples.

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Passport size photos each of the proprietor and F.T.S

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Sales pack draft labels for each drug as per D & C Rules with different sizes, if any.

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Sample of each drug with sales pack draft labels with different sizes, if any

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Self-addressed envelope with sufficient postal stamps for registered post.

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Clinical trial reports from (3) institutionally qualified Ayurvedic /Unani Practitioners as the case may be, on at least 30 patients for each drug used orally as per the proforma guidelines.

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Drug information in the following lines for AnubhuthaYogas (patent drugs) duly signed by the proprietor and F.T.S

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a. b. c. d. e. f. g.

Name of the Product Formula shall contain Shastric/Tibbi Name, Part used and quantity Detailed method of preparation Purification of drugs wherever required Indications (In Ayurveda/Unani Terminology) Dosage schedule in details Side effects

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Fee and mode of payment Application Form

h. Anti-dotes i. Diet restrictions, if any Online payment through Single Desk system, fees as detailed in Annexure 1. Application to be filed online through Single Desk system at: https://www.apindustries.gov.in/APIndus/Index.aspx . Through Common Application Form for Pre-Operation available at: http://www.apindustries.gov.in/APIndus/Data/GO/G.O%20for%20AP%20Single %20Desk%20Policy.pdf and separate application form given in Annexure 2.

Annexure 1:

Annexure 2 License for Manufacturing Ayurvedic / Homeo / Siddha / Unani

No. Form-24-C Application for Grant or Renewal of a License to Manufacture for sale of [or for distribution] of Homeopathic Medicine or a License to Manufacture potentials preparation from back potencies by Licenses holding License in Form 20-C [Rule 85-B] 1. I/We.......................................................................... of ........................................................holder of License No…………………………………………in Form 20-C hereby apply for grant / renewal of License to manufacture under mention Homeopathic mother Tincture / potentised and other preparations on the premises situated at.................................................................................................................................................................................. ......................... 2. Name of the Homeopathic preparation. ............................................................................................ a. (each item to be separately specified) 3. Names, Qualifications and experience of technical staff employed for manufacture and testing Homeopathic medicines. 4. A fee of Rupees ........................................................................................... has been credited to Government under the Head of account.........................................................................................

Place: Date:

Signature of the Applicant

Note: 1) Delete whichever portion is not applicable 2) The application should be accompanied by a plan of the premises.

Form 24-D Application for Grant / Renewal of a License to Manufacture for sale of Ayurvedic/ Siddha or Unani drugs [Rule 153] 1. I/We ............................................................. of ....................................................hereby apply for grant / renewal of License to manufacture Ayurvedic/ Siddha or Unani drugs on the premises situated at .......................................................................................................................................... 2. Names of Drugs manufactured (with Details) ................................................................................... 3. Names, qualifications and experience of Technical Staff employed for manufacture and testing Ayurvedic/ Siddha or Unani drugs 4. A fee of Rupees .................................................................................................has been credited to Government under the Head of account .........................................................and the relevant Treasury Challan is enclosed herewith

Place : Date: Note: The application should be accompanied by a plan of the premises.

Signature of the Applicant

AFFIDAVIT-I DECLARATION 1. …………………………………………………………………………..Proprietor/Managing Director/ Managing Partner hereby declare that the words “Ayurvedic/Unani Proprietary medicine” shall be printed prominently one each label of Ayurvedic/Unani Medicine which will be manufactured by M/s…………………………………………………………………………………………………………. 2. Certified that there is no resemblance of the product of M/s ……………………………………….. b.

……………………………………………………with other drugs of any system of medicine and there is no

drug in the market with the same name and also does not bear any resemblance to any other brand name. 3. Certified that I will abide by the D & C Act., 1940 and D & C Rules 1945 and I will not violate the DMR & objectionable Advertisement Act. 1954 and I follow G.M.P Guidelines 4. Certified that, the information given in this application is true and correct to the best of my knowledge and I have not furnished any false information with a view to obtain Ayurvedic/Unani drug manufacturing license.

Signature of the Applicant