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