AYUSH LICENSE is mandatory for all such manufacturer who is dealing with the Ayurvedic or Herbal products in India.
AYUSH LICENSE
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HIGHLIGHTS
OVERVIEW
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. The Ministry of AYUSH was formed on 9th November 2014, earlier it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was created in March 1995.
Types of AYUSH Licenses
Following are the manufacturing licenses that are issued by AYUSH:
- Ayush Manufacturing License.
- Ayush Loan License.
- Contract Manufacturing / Third party manufacturing / White label Manufacturing / Product to Product manufacturing.
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.
Prerequisite of AYUSH Manufacturing license 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.
Prerequisite of AYUSH Loan license to be obtained under AYUSH Act:
- 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.
REGISTRATION PROCESS
1. Identify
Find the state website of AYUSH
2. Preparation
Download the Application & List of Documents
3. Application
Apply for AYUSH License
4. Audit
On Site Audit by Ayush officer
5. License
Grant of License
DOCUMENTS REQUIRED FOR GMP & iCOPP
- 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).
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FREQUENTLY ASKED QUESTIONS
1. What is COPP (Certificate of a Pharmaceutical Product) ?
The COPP is the legal document that certifies the manufacturing company having this certificate is legally allowed to sell their pharmaceutical product in the country they are producing. In cases where the pharmaceutical product is to be registered under the overseas, the government body in charge of approving the application will ask for COPP to ensure that the product is being sold as a commercial finished product in the country that is producing it.
2. What is the role of Loan License holder?
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.
3. In case of Loan License, What if the manufacturer is required to be changed?
The license holder is required to apply for a Loan license again with a new GMP certified manufacturer.
4. 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.
5. What are all charges charged by the manufacturer in third party manufacturing?
- 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.
6. In case of Loan License, 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.
7. In case of Contract Manufacturing, What will be displayed on product?
The Product Label will display that the product is manufactured by the manufacturer company and marketed by you.