Application to get Manufacturing License

DOCUMENTS / INFORMATION REQUIRED TO GRANT THE DRUG MANUFACTURING LICENSE.

I). Application duly completed in the Form 1 prescribed along with the pro forma form and all other required documents according to Annex A of the Drug Rules (Licenses, Registration and Advertising) 1976. The FORM 1 prescribed see Drugs (Licenses, Registration and Advertising )) The 1976 Rules are reproduced below:

FORM 1

1. I / we …………… of ………………… hereby request the granting of a license to manufacture Drugs through ………………. At the facilities located in …………… ...

2. The medicine (s) or class (s) of medicines intended to be manufactured: -

(I) Drug class (s)

(II) Drug dosage form (s).

(III) Name of the drug (s).

3. Attachment: -

I. Details on the legal status of the applicant (that is, in the case of the property, the names of the owners and their addresses, in the case of the company, the name and names and addresses of their partners and, in the case of the company, the name and address of the company and its directors).

ii) Details of the facilities, including the factory distribution plan.

iii) Details of the equipment and machinery section for manufacturing and quality control.

iv. Names and qualifications of the Production Manager and Quality Control Officer to supervise the manufacturing processes and the Quality Control Department, and other technical personnel working in these departments.

4. The facilities and plant will be ready for inspection on ……………… .. or are ready for inspection.

Dated ……………………… Signed ………………………………

Place ……………………… Name, designation and address …… ..

ii). Pro-form according to Annex A mentioned above.

iii) Copy of Challan of Fee in original duly retained by the DRAP Statistical Officer according to the following schedule to be deposited under the following account manager

A / C No. 0010008463-100018 Allied Bank Limited

I. Rs share 100,000 / - for the concession of DML through the formulation.

ii) Fee of Rs. 30,000 / - for the concession of DML through the basic and semi-basic formulation.

iii) Rs share. 60,000 / - for the DML concession as a repackaging.

iv. Rs share 5,000 / - for Medicines specified in Annex D for repackaging.

iv). All documents submitted must be duly accredited.

Format:

Form 1

[See rule 5 (/)]

APPLICATION FORM GRANTING A LICENSE FOR MANUFACTURING BY FORMULATION / BASIC MANUFACTURING / SEMI-BASIC MANUFACTURING 

I / We ........... of ......... hereby request the granting of a license to manufacture through ........... in

local located in ...................

2. The medicine (s) or class (s) of medicines intended to be manufactured: -

(1) Class (s) of drugs.

(2) Drug dosage form (s).

(3) Name of the drug (s).

3. Attachment: -

(i) Details on the legal status of the applicant (that is, in the case of the property, the names) of the owners and their addresses, in the case of the signature, the name and names and addresses of their partners and in the case of the company, name and address of the company and its directors).

(ii) Details of the facilities, including the factory distribution plan.

(iii) Details of the equipment and machinery section for manufacturing and quality control.

(iv) Names and qualifications of the Production Manager and the Quality Control Manager to supervise the manufacturing processes and the Quality Control Department, and other technical personnel working in these departments.

4. The facilities and the plan will be ready for inspection or ready for inspection.

Dated .................. Signed ……………………

Place ....................
Name, designation and address ........................

PROFORMA

SIGNATURE DETAILS

Company name ............... Type of property (company, property, limited public,

Private limited, etc.)

Name (s) of Owner (s) / Director (s) / Partner (s). Foundation date.

Initial investment (and details of actions). Current investment (and details of actions).

Profit and loss statement according to the audited accounts of the last five years:

Year Investment turnover Profit before tax Percentage 1% before taxes for the Central Research Fund percentage of profit Calculated paid investment Rotation

Note: Copies of the balances that will be attached to the application