AYUSH LICENSE

About Ayush License- All such manufacturer who is dealing with the Ayurvedic or Herbal products in India is required to obtain the license from AYUSH regulated by the Ministry of AYUSH.

Types of Ayush License for Manufacturers:-

1. Ayush Manufacturing License- It is obtained in the cases when the applicant is desirous of obtaining the license has planned for manufacturing and marketing, both of the products. In this case, the manufacturer has to set up his own manufacturing unit. The state requirement for such manufacturing set up varies from state to state.
2. Ayush Loan License- In this kind of set up the manufacturing unit is not owned by the applicant. The products are manufactured by the third party manufacturers. Such Loan license is to apply with a GMP certified manufacturer and thereafter it will be issued to the applicant company. Thereafter the product approval is required to be obtained from the authorities.
3. Contract Manufacturing / Third party manufacturing / White label Manufacturing / Product to Product manufacturing- In such arrangements neither the person has the license nor has the manufacturing set of his own, only the marketing part is done by the contract / third – hand manufacturing, in that case, all compliance and liaison work shall be taken care by the manufacturer. However, you can provide the raw materials and packaging material or manufacturer can arrange it from his own sources.

Requirements for obtaining Ayush Manufacturing License:-

1. The manufacturing unit should be an industrial area.
2. The minimum size of 1200 sqft. should be there, for one category of the drug only.
3. In case more than one drug is required, and add more categories, you need to add more space.
4. The manufacturing unit is mandatorily required to be GMP certified.
5. 2 Ayurvedic experts and 2 Pharmacies must form the part of your team.
6. All the manufacturing and packaging machinery should be available with you.
7. Regular inspection of the premise shall be done by the Drug Inspectors.

Requirements for obtaining Ayush Loan License:-

Procedure for the Incorporation of Private Limited Company

1. The manufacturing unit should be an industrial area.
2. The premise should have minimum three rooms according to the description as given below:
3. One room for the storage of raw material;
4. One for finished material storage and;
5. One for the office.
6. Renewal of Loan License should be done regularly
7. Visit of Drug inspectors on regular basis for inspection of premises is a must.
8. No Ayurvedic experts and Pharmacist are required.
9. The company registration and the manufacturing set up should be the same.

Procedure for obtaining Ayush License:-

1. Go to the individual state sites of AYUSH.
2. Download the requisite form, attachments, list of documents which may include affidavits and other certification such as GMP and COPP as the case may be.
3. Apply for GMP and COPP if applicable.
4. Submit it before the Directorate of the AYUSH, falling under the jurisdiction of that.

Documents required for Good Manufacturing Practice (GMP) Certification and Issuance of Certificate Of Pharmaceutical Product (COPP):-

1. Details about the applicant like Name, address, telephone, fax, e-mail etc.
2. Manufacturing License copy.
3. List of products applied for issuance of COPP & their composition.
4. Site Master file.
5. Master manufacturing formula along with the manufacturing process.
6. Method of Analysis and finished product specification.
7. List of approved products.
8. List of products for which the firm has already availed the COPP.
9. Stability study evaluation batch wise, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug etc

10. Process validation report for 3 batch
es. (Applicable in case of herbal products)
11. Validation report of the analytical method.
12. List of technical staff along with their qualification, experience and approval status.
13. List of equipment and instruments used or to be used.
14. Manufacturing Plant Plan & Layout showing the installation of Machinery and Equipment..
15. Water system diagram.
16. HVAC system diagram.
17. Export data for the last 2 years, wherever re-validation of COPP is applicable
18. Product summary sheet.
19. Actual labels of the products which are required to be applied for WHO-COPP.
20. Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
21. Certificates of Analysis for three batches of each product. (Applicable in case of herbal products), (Applicable in case of herbal products).
22. Undertaking regarding the absence of any non-herbal such as metals/ or minerals, etc. in the products applied for WHO-COPPs, (Applicable in case of herbal products).
23. Undertaking regarding compliance with the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under, (Applicable in case of herbal products).

Documents required for Ayush License:-

1. Plan and layout of the premises showing the installation of Machinery and Equipment- 2 Hard Copy
2. Attested copies of documents relating to the ownership/rent/lease- 2 Hard Copy
3. Declaration of the Proprietor/Partnership/Director etc., in Affidavit-I (enclosed with online form), attested Partnership Deed/Memorandum and Articles of Association- 2 Hard Copy
4. Detailed list of Manufacturing and Analytical Equipment as required for formulations applied- 2 Hard Copy
5. Appointment letter to full time Technical Supervisor- 2 Hard Copy
6. 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 - 2 Hard Copy
7. List of Shastric Medicines and Xerox copies of concerned pages of references duly signed by F.T.S with samples- 2 Hard Copy
8. Passport size photos each of the proprietor and F.T.S- 2 Hard Copy
9. Sales pack draft labels for each drug as per D & C Rules with different sizes, if any- 2 Hard Copy
10. Sample of each drug with sales pack draft labels with different sizes, if any- 2 Hard Copy
11. Self-addressed envelope with sufficient postal stamps for registered post- 2 Hard Copy
12. 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- 2 Hard Copy
13. Drug information in the following lines for Anubhutha Yogas (patent drugs) duly signed by the proprietor and F.T.S- 4 Hard Copy
a. Name of the Product
b. Formula shall contain Shastric/Tibbi Name, Part used and quantity
c. Detailed method of preparation
d. Purification of drugs wherever required
e. Indications (In Ayurveda/Unani Terminology)
f. Dosage schedule in details
g. Side effects
h. Anti-dotes
i. Diet restrictions, if any