Loan license is just like renting a whole plant and its machinery. According to drug and cosmetic act,” A loan license means a license which a licensing authority may issue to an applicant who doesn’t have its own arrangement of manufacturing but who intent to avail himself of the manufacturing facilities of licensee.
Read in detail about Loan License here
List of Documents required for Loan License Manufacturing Approval:
List of Documentation for Application for Grant of Loan License in Form 25-A, 28-A and 32-A
- Covering Letter
- Challan for the required amount under the Head of Account.
- Statutory Forms: Form Fees
- Declaration of the Proprietor/Partners/Directors etc., in Affidavit-I along with Attested copies of Partnership Deed/Memorandum of Articles.
- Affidavit-II (Format enclosed) Attested by Notary regarding the name, address and other details of the person responsible to the day to day affairs of Company and for the conduct of business alongwith his Photograph duly attes ted.
- Copy of Ration Card/Passport/Electoral Card etc., in support of proof of residential address of responsible person.
- Consent letter from the parent firm declaring the facilities available and the details of Licences possessed indicating the category of drugs and No.of Loan Licences already held.
- Declaration of Technical Staff for manufacture and for Analysis
- Declaration to the effect that whether the firm is already having any manufacturing Licence for their own Unit/Loan Licence, and if so, the details of such Licences and declaration stating the same formulations now applied were not earlier permitted either on the same brand name or under any other brand names.
Required Documentation for Formulations Application:
- Consolidated list of formulations with packing particulars.
- Specimen Labels.
- Labels of similar products for non-pharmacopial drugs.
- Method of Test/analysis for the finished products and also for the ingredients which are not specified in any Pharmacopiea or any official compendia of Drugs Standards.
- Copies of monograph in respect of those drugs which are not official in I.P.
Required Documentation for Bulk Drugs Application:
- Brief Manufacturing procedure and flow charts along with consumption co-efficient and effluents generated and their treatment for the drugs applied for, along with the methods/procedure of Test/Analysis.
Hope above information is useful to you…
Please find the documents needed for loan licensing
I Need complete information about a Loan License Procedure with excise procudure for pharm raw materials i.e. API’s
Excise duty always imposed at Maximum retail price of any product whether it is Finished product or Raw Material. Read in detail about Excise Duty Here