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