Ayush License

A. Complete 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. One has to comply with all the requirements stated by the state authority of AYUSH.

In case you wish to take AYUSH Manufacturing license following is the requirement to be obtained under AYUSH Act:

•             The manufacturing unit should be an industrial area.

•             The minimum size of 1200 sqft. should be there, for one category of the drug only.

•             In case more than one drug is required, and add more categories, you need to add more space.

•             The manufacturing unit is mandatorily required to be GMP certified.

•             2 Ayurvedic experts and 2 Pharmacies must form the part of your team.

•             All the manufacturing and packaging machinery should be available with you.

•             Regular inspection of the premise shall be done by the Drug Inspectors.

B. 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.

How is the Loan License holder involved in it?

The Loan License holder can provide the raw materials and packaging material or manufacturer can arrange it from own sources also. The manufacturer converts such raw material into finished products and thereafter provides the finished product.

What if the manufacturer so appointed is required to be changed?

The license holder is required to apply for a Loan license again with a new GMP certified manufacturer.

What are all charges charged by the manufacturer on the Loan license holder?

Conversion charges are charged by the manufacturer i.e. the cost for manufacturing the desired product in his manufacturing unit or premises.

Will such a product display anything about the manufacturer?

No, the Product label will not display anything about the manufacturer, rather it will display that the product is both manufactured and marketed by the License holder company. It will not mention anything about the manufacturer who has been seasoned with by the license holder.

In case you wish to take the above-stated license following is the requirement to be obtained under AYUSH:

•             The manufacturing unit should be an industrial area.

•             The premise should have minimum three rooms according to the description as given below:

•             One room for the storage of raw material;

•             One for finished material storage and;

•             One for the office.

•             Renewal of Loan License should be done  regularly

•             Visit of Drug inspectors on regular basis for inspection of premises is a must.

•             No Ayurvedic experts and Pharmacist are required.

•             The company registration and the manufacturing set up should be the same.

C. Ayush Contract / Third-Party Manufacturing License

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.

The manufacturing license of the manufacturer shall be used; the manufacturer will have to get approval for your product from the concerned authorities.

However, you can provide the raw materials and packaging material or manufacturer can arrange it from his own sources.

What will the product display?

The Product shall display that the product is manufactured by the XYZ manufacturer and marketed by you.

What are all charges charged by the manufacturer on the Loan license holder?

•             Conversion charges are charged by the manufacturer i.e. the cost for manufacturing the desired product in his manufacturing unit or premises.

•             The product approval fees are also charged to you by the manufacturer.

•             A legal document is required to be drafted between the manufacturer and your details about the fact that you own the product. The Legal document so drafted should be strong enough to safeguard your rights in case of any dispute. It should include a clause that your company remains the owner of the product.

The benefit of such Contract Manufacturing:

•             The marketing company can operate in any state irrespective of the location of a manufacturing company.

•             Only the marketing portion is to be taken care rest all compliances is to be to be done by the manufacturer.

•             This modus oprandi is trending nowadays; many big companies are doing this.

General Documents required

Documents required for making an Application for GMP certification* & issuance of COPP*.

•             Details about the applicant like Name, address, telephone, fax, e-mail etc.

•             Manufacturing License copy.

•             List of products applied for issuance of COPP & their composition.

•             Site Master file.

•             Master manufacturing formula along with the manufacturing process.

•             Method of Analysis and finished product specification.

•             List of approved products.

•             List of products for which the firm has already availed the CoPP.

•             Stability study evaluation batch wise, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug etc

•             Process validation report for 3 batches. (Applicable in case of herbal products)

•             Validation report of the analytical method.

•             List of technical staff along with their qualification, experience and approval status.

•             List of equipment and instruments used or to be used.<>

•             Manufacturing Plant layout.

•             Water system diagram.

•             HVAC system diagram.

•             Export data for the last 2 years,  wherever re-validation of  CoPP is  applicable

•             Product summary sheet.

•             Actual labels of the products which are required to be applied for WHO-CoPP.

•             Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.

•             Certificates of Analysis for three batches of each product. (Applicable in case of herbal products), (Applicable in case of herbal products).

•             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).

•             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).

NOTE: However the list of documents may vary from state to state, one needs to visit the individual sites of the required state and check the required documents.