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Grant or Renewal of Manufacturing Loan Licenses

This document lists the 16 documents that must be submitted along with an application for a grant or renewal of a manufacturing loan license. These include a covering letter introducing the applicant, the application form with fee payment receipt, documents proving ownership and addresses, consent letters, equipment lists, staff consent letters, copies of licenses held, GMP certificates, and technical documents regarding manufacturing and quality control procedures for bulk drugs and formulations. In total, it requires a comprehensive set of documents to demonstrate legal ownership, manufacturing capabilities and quality standards.

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Mulayam Singh Yadav
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129 views4 pages

Grant or Renewal of Manufacturing Loan Licenses

This document lists the 16 documents that must be submitted along with an application for a grant or renewal of a manufacturing loan license. These include a covering letter introducing the applicant, the application form with fee payment receipt, documents proving ownership and addresses, consent letters, equipment lists, staff consent letters, copies of licenses held, GMP certificates, and technical documents regarding manufacturing and quality control procedures for bulk drugs and formulations. In total, it requires a comprehensive set of documents to demonstrate legal ownership, manufacturing capabilities and quality standards.

Uploaded by

Mulayam Singh Yadav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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

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