Procedure to Get AYUSH License From the Ministry of Ayush & Various Types of Licenses Required by Manufacturers to Manufacture Ayurvedic Herbal Products
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Procedure to Get AYUSH License From the Ministry of Ayus
The manufacturer who is dealing with the Ayurvedic or Herbal products in India has to obtain the license from AYUSH regulated by the Ministry of AYUSH. On 9th November 2014 the ministry of AYUSH was formed.
Types of AYUSH Licenses required by manufacturers
- Ayush Manufacturing License.
- Ayush Loan License.
- Contract Manufacturing / Third party manufacturing / Product to Product manufacturing.
Types of AYUSH Licenses
A. Complete Manufacturing License
Complete Manufacturing license is obtained when the applicant desires to obtain the license has planned for manufacturing and marketing, both of the products. The manufacturer has to set up his own manufacturing unit in this case.
The state requirement for such manufacturing set up differs from state to state. One needs to comply with all the requirements stated by the state authority of AYUSH.
In Order To Take AYUSH Manufacturing License, The Requirement To Obtain AYUSH Manufacturing License Under AYUSH Act Are As Follows
- The manufacturing unit should belong to industrial area.
- For one category of the drug only, the minimum size of 1200 sqft. should be there .
- One needs to add more space in case more than one drug is required, and add more categories.
- The manufacturing unit to be GMP certified is mandatory.
- 2 Ayurvedic experts and 2 Pharmacies have to form the part of your team.
- All the manufacturing and packaging machinery has to be available with you.
- Drug Inspectors shall do regular inspection of the premise.
B. Ayush Loan License
In case of Ayush Loan License, the manufacturing unit is not owned by the applicant. Third party manufacturers manufacture the products. Such Loan license has to be applied with a GMP certified manufacturer and thereafter Applicant Company will issue it. Thereafter the product approval is to be obtained from the authorities.
In Order To Take The Above-Stated License, Requirement To Be Obtained Under AYUSH Are As Follows
- The manufacturing belongs to an industrial area.
- The premise should have minimum three rooms as per the description as given below:
- One room for raw material storage;
- One for storage of finished material and;
- One for office.
- One should do Renewal of Loan License regularly
- It is must for Drug inspectors to visit on regular basis for inspection of premises.
- No need of Ayurvedic experts and Pharmacist.
- The company registration and the manufacturing set up have to be the same.
C. Ayush Contract / Third-Party Manufacturing License
In case of Ayush Contract / Third-Party Manufacturing License , neither the person has the license nor has the manufacturing set of his own, only the contract / third – hand manufacturing do the manufacturing part , in that case, manufacturer shall take care of all compliance and liaison work .
GMP certification: Good manufacturing practice
Good manufacturing practice (GMP) is a system whereby it is ensured that the products are consistently produced and controlled according to quality standards as prescribed in line with the WHO. The intent behind such certification is to minimize the risks involved in any pharmaceutical production.
COPP: Certificate of a Pharmaceutical Product (COPP)
The COPP is the legal document that certifies that the manufacturing company having this certificate is legally allowed to sell their pharmaceutical product in the country they are producing.
Following Documents Are 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.
- Products list 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.
- Products List for which the firm has already availed the COPP.
- Evaluation of stability study 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.
- Safety and effectiveness proof 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 i.e Applicable in case of herbal products .
- Undertaking regarding compliance with the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules there under, 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 need to visit the individual sites of the required state and check the required documents.
This is a state law, the required documents, application format, information seeking, the manufacturing company area so defined, the number of rooms, and such other stuff may vary from state to state, hence before application, one needs to visit the individual state sites of the required state and check the required documents, compliances, notification, circulars anything of that sort of issue in this regard, thereafter shall proceed for the next step of applying under AYUSH.