Here below you can find GOVERNMENT OF KARNATAKA (SEVA SINDHU) – Grant of fresh drug manufacturing license – Application Process and full details.

GOVERNMENT OF KARNATAKA (SEVA SINDHU) Services & Online Application Process

Drugs Control Department

Grant of fresh drug manufacturing license

Online application Procedure

Eligibility: Any Person who is holding valid licenses issued under Part VI of the Drugs and Cosmetics Rules, 1945.

Supporting Document:

1.COVERING LETTER

2.STATUTORY FORM

3.FEES

4.CONSTITUTION DOCUMENT 5.ADDITIONAL INFORMATION SHEET FOR FRESH LICENSE.

6.QUALIFIED PERSON’S PROFORMA

7.OPTION AND APPROVAL FORM AS SPECIFIED UNDER D AND C RULES 65(3) AND 65(4) OF SAID RULE

8.AFFIDAVITS I.REGISTERED PHARMACISTS AFFIDAVIT II. AFFIDAVITS OF THE APPLICANT ON CONSTITUTION, TENANCY, AREA OF PREMISES ETC III. BIOMEDICAL WASTE DISPOSAL OR UNDER TAKING

9.PURCHASE INVOICE OR DECLARATION FOR OWNING REFRIGERATOR

10.ADDRESS PROOF OF APPLICANT

11.ADDRESS PROOF OF QP

12.PHOTO OF APPLICANT

13.PHOTO OF QP

14.RENT /LEASE DOCUMENT WITH LAND LORDS DECLARATION /LETTER

15.SKETCH OF THE PREMISES

16.SURRENDER OF EXISTING LICENCES- IF REQUIRED

17.XEROX COPY OF LICENCES / QP LAST APPROVAL LETTER- IF REQUIRED

18.DOCUMENT TO SHOW THE OWNERSHIP OF BUILIDING ( LATEST TAX PAID RECEIPT OR KHATA EXTRACT)

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Application Fee : http://drugs.kar.nic.in/node/214.html

Service Charge (Free for Online Submission) : NA

Delivery Time (Days) : 30 Working Days

Procedure for applying:

Step Description No. of Days Designation

1 RECEIPT OF APPLICATION 2.00 Assistant Drug Controller

2 INWARD PROCESSING 2.00 Superintendent

3 PRELIMINARY PROCESSING 3.00 Assistant Drug Controller

4 INSPECTION REPORT 15.00 Inspector

5 FINAL PROCESSING 3.00 Assistant Drug Controller

6 PREPARATION OF LICENSE 3.00 Superintendent

7 DISPATCH 2.00 Case Worker

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