Here below you can find GOVERNMENT OF KARNATAKA (SEVA SINDHU) – Renewal of License – Application Process and full details.

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

Drugs Control Department

Renewal of 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 FORMS

3.FEES

4.ADDITIONAL INFORMATION SHEET FOR RENEWAL

5.ADDRESS PROOF OF APPLICANT QP OR CP

6.AFFIDAVITS ON BIOMEDICAL WASTE DISPOSAL AFFIDAVIT UNDER TAKING(IF NOT GIVEN ALREADY)

7.XEROX COPY OF LICENSES LAST RENEWAL FORM 21C QP OR CP LAST APPROVAL LETTER

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Application Fee : http://drugs.kar.nic.in/node/206.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 3.00 Superintendent

3 PRELIMINARY PROCESSING 5.00 Assistant Drug Controller

4 INSPECTION REPORT 11.00 Inspector

5 FINAL PROCESSING 4.00 Assistant Drug Controller

6 PREPARATION OF RENEWAL CERTIFICATE 3.00 Superintendent

7 DISPATCH 2.00 Case Worker

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Here below you can find GOVERNMENT OF KARNATAKA (SEVA SINDHU) – Renewal of Drug Manufacturing License – Application Process and full details.

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

Drugs Control Department

Renewal of 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: http://drugs.kar.nic.in/node/49.html

Application Fee : http://drugs.kar.nic.in/node/206.html

Service Charge (Free for Online Submission) : NA

Delivery Time (Days) : 210 Working Days

Procedure for applying:

Step Description No. of Days Designation

1 RECEIPT OF APPLICATION 2.00 Superintendent

2 INWARD PROCESSING 1.00 Superintendent

3 ALLOCATION OF FILE 2.00 Drug Controller

4 PRELIMINARY PROCESSING 5.00 Inspector

5 PRELIMINARY PROCESSING 5.00 Assistant Drug Controller

6 PRELIMINARY PROCESSING 5.00 Deputy Drug Controller

7 PRELIMINARY PROCESSING 4.00 Additional Drug Controller

8 PRELIMINARY PROCESSING 4.00 Drug Controller

9 INSPECTION REPORT 15.00 Inspector

10 FINAL PROCESSING 3.00 Inspector

11 FINAL PROCESSING 3.00 Assistant Drug Controller

12 FINAL PROCESSING 3.00 Deputy Drug Controller

13 FINAL PROCESSING 3.00 Additional Drug Controller

14 FINAL PROCESSING 3.00 Drug Controller

15 DISPATCH 2.00 Case Worker

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Here below you can find GOVERNMENT OF KARNATAKA (SEVA SINDHU) – Name Change – Application Process and full details.

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

Drugs Control Department

Name Change

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.Existing licenses

3.Xerox Copy of licenses /Form 21C/ QP or CP Last Approval letter

4.Affidavit of the applicant for name change and on Biomedical Waste disposal Affidavit/Under taking (if not given already)

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Application Fee : NA

Service Charge (Free for Online Submission) : NA

Delivery Time (Days) : 07 Working Days

Procedure for applying:

Step Description No. of Days Designation

1 RECEIPT OF APPLICATION 1.00 Assistant Drug Controller

2 INWARD PROCESSING 1.00 Superintendent

3 PRELIMINARY PROCESSING 2.00 Inspector

4 FINAL PROCESSING 1.00 Assistant Drug Controller

5 PREPARATION OF CHANGES 1.00 Superintendent

6 DISPATCH 1.00 Case Worker

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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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Here below you can find GOVERNMENT OF KARNATAKA (SEVA SINDHU) – Change in Premises and Constitution – Application Process and full details.

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

Drugs Control Department

Change in Premises and Constitution

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

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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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