Deputy Drug Controller of Regulatory Wing is responsible to:
-
Coordinate, assist & facilitate Board members/Inspection committees in conducting
inspections of pharmaceutical firms
- Liaise with Director operations about his operational activities.
- Monitor routine activities of his wing.
- Collect and submit Inspection report before the Secretary PQCB.
- Maintain track record of GMP Inspection of each firm.
-
Highlight GMP Compliant & non-compliant firms and actions taken against non-compliant
firms.
-
Supervise the scrutiny of Test/analysis reports of DTLs and investigation reports of the Drug Inspectors.
-
Supervise the preparation of show cause & personal hearing notices to the accused
persons.
-
Supervise brief of cases to be placed at agenda for the PQCB meeting.
- Supervise the preparation of draft orders as per minutes/directions of the PQCB.
- Integrate and update information with Information Management Unit.
- Perform any other task assigned by Senior Management.
Pharmacist of Regulatory Wing is responsible to:
-
Coordinate, assist & facilitate Board members/Inspection committees in conducting
inspections of pharmaceutical firms.
-
Maintain the records of GMP inspections conducted by 3rd party or Primary and Secondary Healthcare Department.
- Collect and submit Inspection report before the Secretary PQCB.
-
Highlight GMP Compliant & non-compliant firms and actions taken against non-compliant
firms
- Scrutinize the Test/analysis reports of drug samples issued by respective DTL
- Scrutinize the investigation reports of the Drug Inspectors
-
Correspondence with the Drug Inspectors: In case of any legal flaws/deficiency,intimate
the same to the concerned DI & get it rectified.
- Prepare show cause & personal hearing notices to the accused persons
- Prepare brief of cases to be placed at agenda for the PQCB board meeting
- Present cases in PQCB board meeting
- Prepare brief summary of PQCB board meeting
- Prepare draft minutes of PQCB meeting
- Prepare draft orders as per minutes/directions of the PQCB
- Prepare performance report of Regulatory Wing for review meeting
- Integrate and update information with Information Management Unit
