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Grant or Renewal of Manufacturing Loan Licenses

 

DOCUMENTS TO BE SUBMITTED TO THE LICENSING AUTHORITY ALONG WITH APPLICATION FOR GRANT / RENEWAL OF LOAN LICENCES IN FORM 25A & 28A

1. Covering Letter. (Introduction of applicant with address of the Plant and Administration office and his requirement)

2. Application (statutory) in form- 24A with fee – Rs.7500
                                                          -
27A with fee  - Rs.7500/-

Duly signed by the Proprietor / Managing Partner / Managing Director/ Person declared as responsible under Sec.34 / Person Authorized by the Board of Directors accompanied by Company Board Resolution.

3.Challan in original remitting the required amount of fee in the Head of Account  0210    – Medical and Public Health
                                                                                                                      
04     – Public Health,
                                                                                                                     
104    – Fees, Fines etc
4. Attested copies of partnership Deed / Memorandum and Articles of Association

5. Declaration of the Proprietor / Partners / Directors etc. in Affidavit  (Format enclosed)

6. Attested Copy of Ration Card or Passport or Electoral Card / Bank Account Details in support of proof of residential address of the responsible person.

7. Letter addressed to the parent firm/Company requesting for consent for availing the manufacturing facilities.

8. Consent letter from the parent firm/Company enclosed with statement of spare capacity  (in prescribed Format)

9. Copy of licenses of the parent firm/Company with copy of approved list of the products ( attested by the M.D. / Director of Parent unit/company)

10. Site Master file of  the Parent firm

11.  List of equipment / Machinery (in prescribed Format)

12.  Consent letter of the Technical Staff ( Which contain the name of the applicant Unit, and the products ) – (in prescribed Format)

13. Copy of the Drug licenses in Form 20B, 21B of the applicant.

14. Copy of valid G.M.P/Who G.M.P of the Certificate or reference of compliance under revised Schedule “M”, if any, of Parent firm.

15. Technical Data in respect of the products for manufacture of:

           Technical Documents to be submitted for Bulk Drugs:

 i.      Manufacturing procedure of each product

ii.      Flow Chart with structural Formula of reactions as per Master Formula record and analytical procedure of each applied product with mode of procurement of official reference standards or working standards.

iii.      Official Monographs copies

iv.      Consumption coefficients of Raw Materials.(as per Format)

v.      Details of effluents generated and their treatment followed.

vi.   Specimen labels of all applied products             

         Technical Documents to be submitted for Formulations:

i. Consolidated list of Formulations with packing particulars separately Category wise Viz. Tablets, Capsules, Injectables etc.

ii. Manufacturing & Analytical procedure of each product.

iii. Specimen labels

iv. Labels of the similar products moving in the market for formulations not included in IP

v. Declaration regarding the Brand Names of the 

vi. Copies of monographs of drugs which are not included in IP