Any manufacturer of Ayurvedic or Herbal products or medicines in India is required to obtain a license from the Department of AYUSH which is established and regulated by the Ministry of AYUSH. How many types of Ayush Licence are prescribed by the Ministry of Ayush?
A) Ayush Manufacturing License.
B) Ayush Loan License.
C) Contract Manufacturing / Third party manufacturing / Product to Product manufacturing.
TYPES OF AYUSH LICENCE / AYURVEDIC MANUFACTURING LICENCE
A. Manufacturing License
➲ This licence is needed by a manufacturer of Ayush products who undertakes marketing as well as production of such products.
➲ For obtainment of Complete manufacturing Licence a manufacturing unit has to be mandatorily setup by the applicant.
➲ The Department of Ayush of the respective state may lay down additional requirement of provisions for allotment of such licence
➲ Mandatory Requirements for Ayurveda Manufacturing Licence
> Unit Location: Manufacturing unit should be situated in an industrial area.
> Minimum Size of Unit: 1200 sqft. for manufacturing single product. For more than one product additional space is needed
> Certification: GMP Certificate is Mandatory (Click to get GMP Certification).
> Team Specifications: A minimum of 2 Ayurvedic experts and 2 Pharma Graduates should be part of the team.
> Machinery: Manufacturing and packaging machinery should be procured before applying.
> Inspection: Inspection by Drug Inspectors is one of the requisites for approval of the licence.
Connect with us to understand any of these requirements for the Manufacturing Unit
B. Loan Manufacturing Licence
➲ A loan licence is to be applied when the applicant does not own the manufacturing facility himself.
➲ The products of the applicant are manufactured in the unit of such third party.
➲ The manufacturing unit of the third party shall be a GMP Certified Unit.
➲ Mandatory Requirements for Ayurveda Manufacturing Licence:
> Unit Location: Manufacturing unit should be situated in an industrial area.
> Minimum Size of Unit: Should have a minimum of three rooms for each of the following activities:
-Storage of Raw Material
-Storage of Finished products
-An office room
>Certification: GMP Certificate is Mandatory (Click to get GMP Certification).
>Team Specifications: There is professional required on the team.
>Inspection: Inspection by a Drug Inspectors is one of the requisites for approval of the licence.
>Loan Manufacturing Agreement should be signed between the two parties.
C. Ayush Contract / Third-Party Manufacturing License
➲ No Ayush Licence is needed for third party manufacturing.
➲ In this case, the applicant does not set up a manufacturing unit nor does his own products
➲ He uses the Ayush Licence of the manufacturer
➲ The applicant is merely marketing the product and has nothing to do with manufacturing
➲ The onus of compliance is on the manufacturer and not the applicant in this case.
What is the mandatory GMP & COPP certification required for AYUSH Licence
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
1. Name, address, telephone, fax, e-mail etc of the applicant
2. Copy of Manufacturing Licence (In case of loan licence or third party)
3. List of products their composition (For which COPP is availed and otherwise).
4. Master Plan of the site.
5. Master manufacturing formula along with the process of manufacturing.
6. Method of Analysis
7. Specification of the Final product.
8. Reports Required:
> Batch Wise Evaluation of stability, (should include the Date of manufacturing, Date of Expiry, stability study condition, Name of the drug etc)
> Process validation report of 3 batches for Herbal Products.
> Validation report of the analytical method.
9. Certificates of Analysis for three batches of each product. (Applicable in case of herbal products), (Applicable in case of herbal products).
10. List comprising of details of technical staff.
11. List of machinery, equipment and instruments (Used and to be used).
12. Layout of the Manufacturing Unit.
13. Water system diagram.
14. HVAC system diagram.
15. Export data for the last 2 years (wherever re-validation of COPP is applicable)
16. Final labels (which are to be printed) required for which WHO-COPP is to be obtained.
17. Proof of Safety and effectiveness as per the Rule 158B of Drugs & Cosmetic Rules, 1945.
18. 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.
19. 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 thereunder, (Applicable in case of herbal products).
** Documents may vary from state to state.
