The Drugs Control Administration, Telangana is making efforts to improve efficiency.
One of the important steps in this direction is the Restructuring of the Manufacturing Regulatory set up.
Old Set Up:
DCA is divided into 3 Wings - sales, manufacturing & Laboratory.
The Sales & Manufacturing Wings were divided Area Wise i.e. geographically.
Re-Structuring
The major division into Sales, Manufacturing &Laboratory continues.
However, the Manufacturing Wing has been restructured into the following 6 verticals:
Drugs (Including APIs)
Cosmetics
Blood & Biologics
Vaccines
Medical Devices
Animal & Vet Products
This restructuring is the result of discussions held with International regulators & Industry titans to ensure that the DCA is in consonance with the best practices followed worldwide. A similar Setup is followed by the US FDA.
The orders for restructuring were issued on 30.9.15 and Drug inspectors posted to these verticals as Incharges. These Incharge inspectors will undergo trainings and field visits to ensure they are aware of Inspection protocols and prepare SOPs for Regulatory processes in their Vertical.
The process of setting up physical Infrastructure is underway and will take 1 month. In the meanwhile, the New wings will function from the respective chambers of the Drug Inspectors posted there...
One of the important steps in this direction is the Restructuring of the Manufacturing Regulatory set up.
Old Set Up:
DCA is divided into 3 Wings - sales, manufacturing & Laboratory.
The Sales & Manufacturing Wings were divided Area Wise i.e. geographically.
Re-Structuring
The major division into Sales, Manufacturing &Laboratory continues.
However, the Manufacturing Wing has been restructured into the following 6 verticals:
Drugs (Including APIs)
Cosmetics
Blood & Biologics
Vaccines
Medical Devices
Animal & Vet Products
This restructuring is the result of discussions held with International regulators & Industry titans to ensure that the DCA is in consonance with the best practices followed worldwide. A similar Setup is followed by the US FDA.
The orders for restructuring were issued on 30.9.15 and Drug inspectors posted to these verticals as Incharges. These Incharge inspectors will undergo trainings and field visits to ensure they are aware of Inspection protocols and prepare SOPs for Regulatory processes in their Vertical.
The process of setting up physical Infrastructure is underway and will take 1 month. In the meanwhile, the New wings will function from the respective chambers of the Drug Inspectors posted there...
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