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Aims and Objectives of the Department

The important aims and objectives of the department are quality control of Drugs , consumer protection by exercising strict control and vigilance on the drugs which are being manufactured and /or marketed ,thereby ensuring drugs of standard quality, purity , strength, safety are available to the public at controlled prices. The enforcement wing is dealing with grant/renewal of manufacturing licenses, blood banks, sales licences, inspections of manufacturing, blood banks, and sales establishments. Investigation of complaints and launching prosecutions in case of breach of law, drawing of drug/cosmetics samples for the purpose of Test or analysis to ascertain its quality, purity and strength and safety.

Drugs Testing Laboratory is a statutory Laboratory that carries out testing and analysis of samples of Drugs & Cosmetics drawn by enforcement officers and samples sent by a purchaser. It is equipped to analyze all categories of drugs except Vaccines, Sera, Blood and Blood components and Diagnostic Kits. The laboratory is having library and animal house facilities. Drugs Testing Laboratory is situated in Drugs Control Department, Palace Road, Bangalore .

Pharmacy Education – Government College of Pharmacy is situated at Subbaiah Circle, Bangalore-27 imparting Pharmacy Education to Diploma, Degree, Post Graduate levels.

The Board of Examining Authority which is situated in the same campus is conducting the examination and valuation of Diploma in Pharmacy Course. This authority is entrusted with the responsibility of conducting Examination to students of Diploma in Pharmacy as per the Education regulations of Pharmacy Council of India, a statutory body to oversee the standard of education in Pharmacy in the country. For this purpose, the Govt. has constituted Board of Examining Authority with Principal ,Government college of Pharmacy, Bangalore as Chairman and Professor of the said college as Member Secretary.

Key Departmental Processes :

The organization for Drugs Control exist at two levels i.e, at the Central and State Government level. While the Central Drug Organization is generally concerned with making of laws and rules and management of committee such as Drugs Technical Advisory Committee (DTAB) and Drugs Consultative Committee(DCC), it also does some licensing work such as approval of licence meant for manufacture of Large Volume Parenterals, Vaccine & Sera, Blood Bank and Blood Components, Medical devices and products manufactured by Recombinant technology. It also deals with new drug clearance, clinical trials, import registration, import of drugs etc., and inspections. The State Drug Control Department on the other hand deals with licensing of both manufacturing and sales premises of drugs & cosmetics. Its most important mandate is to ensure the supply of safe and effective drugs at the right price to the people of the State.

The Drugs Control Department is working under the Ministry of Health & Family Welfare Department, Government of Karnataka. The organizations is headed by the Drugs Controller.

1) At the head office Drugs Controller is assisted by the following officers and office staff :

a) Additional Drugs Controller – 1

b) Deputy Drugs Controllers – 3

c) Assistant Drugs Controllers –2

d) Drugs Inspectors – 4

e) Office staff

2) At the field he is assisted by-

a) 4 Deputy Drugs Controllers meant for Blood Bank & Intelligence Wing. They are supported with Drugs Inspectors and office staff. Their offices are situated at Bangalore, Mysore, Hubli and Gulburga.

b) There is 1 Deputy Drugs Controller for Drugs Price Control Cell supported with Assistant Drugs Controllers and Drugs Inspectors and office staff. His office is situated in the Head Office.

c) There are 32 Circle Offices Headed by Assistant Drugs Controllers, in certain places supported by Drugs Inspectors and staff whereas, in certain places without Drugs Inspectors but by staff.

Nature of work

Head quarters

  1. Grant of fresh/renewal of manufacturing licences for Drugs & Cosmetics. Grant/Renewal of approval of approved laboratories. Grant/renewal of poisons licence. Grant/Renewal of Blood Banks and Blood components.
  2. Inspections of manufacturing units and Blood banks.
  3. Granting of permission to launch prosecutions
  4. Scrutiny of reports sent by enforcement officers pertaining to not of standard quality/adulterated/spurious/misbranded drugs. Investigation reports in respect of complaints.
  5. Issue of different certificates such as Good Manufacturing Certificates (GMP certificate), Free Sale Certificate, Market Standing Certificate, Export Registration Certificate etc., to the manufacturers for export purpose.
  6. Overall administration of the entire organization.
  7. Accounts & Establishments section
  8. Drawal of sample from the manufacturing establishments.

Blood Bank and Intelligence Wing:

  • Blood Bank Inspections in their respective jurisdiction.
  • Collection and dissemination of information gathered during intelligence work.
  • Inspection of sales establishments Drawl of sample from sales premises/hospital for test and analysis.
  • Launching of prosecution against the defaulters and follow up court cases.

Drugs Price Control Cell.

  • Inspection of sales establishments
  • Detecting of price control violation by manufacturers & dealers.
  • Drawl of samples from sales premises/Hospital for test & analysis.
  • Launching of prosecution against the defaulters & follow up court cases.

Assistant Drugs Controllers / Drugs Inspector’s at circles.

  • Grant / Renewal of sales establishments
  • Inspections of sales establishment and government hospitals
  • Follow up of court cases.
  • Investigation of complaints
  • Drawl of samples from sales/hospitals for test and analysis.
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