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Drugs Control Administration Clients Charter


 CLIENT’S CHARTER
Drugs Control Administration

I. Services offered by this department:

1. Grant of Manufacturing Licenses

2. Renewal of Manufacturing Licenses

3. Grant/Renewal of approval for Approved laboratories

4. Approval of Additional products

5. Approval of Technical Staff

6. Recommending for Grant/Renewal of Licenses to Central  Licensing Authority, Delhi with respect

    To Vaccines and Sera; Large Volume Parenterals; Blood Banks.

7. Effecting Changes in existing licenses

8. Issue of WHO GMP Certificate

9. Issue of free sale Certificate

10. Issue of Market Standing Certificate

11. Issue of GMP Certificate

12. Issue of Non-Conviction Certificate

13. Issue of Production capacity Certificate

14. Grant of Sales Licenses.

15. Renewal of Sale Licenses

16. Effecting Changes in existing sales licenses.

II.Our Service Standards (Maximum time frame):

 

S.No

Item of work targeted

Maximum Response time        ( In no. of working days)

1

Grant of manufacturing licenses

60

2

Renewal of Manufacturing licenses 

60

3

Grant/Renewal of approval for Approved  Laboratories

45

4

Approval of Additional products

21

5

Approval of Technical Staff

21

6

Recommending for Grant/Renewal of Licenses to Central Licensing Authority, Delhi with respect to Vaccines and sera; Large Volume parenterals:Blood

60

7

Effecting changes in existing licenses 

21

8

Issue of free sale Certificate 

7

9

Issue of Market  Standing Certificate

7

10

Issue of GMP Certificate 

15

11

Issue of Non-Conviction Certificate

7

12

Issue of Production capacity Certificate 

7

13

Issue of WHO GMP Certificate 

60

14

Grant of Sales Licenses

30

15

Renewal of Sale Licenses 

60

16

Effecting Changes in existing sales licenses 

30

17

Grant & renewal of NDPS-1 & NDPS-2 licenses 

20

18

Issue of test licenses

30