About Government Pharmacy College Banglore 

Key Drugs Control Processes

The organizations for Drugs Control exist at two levels i.e, at the Central and State Government level:

The Central Drug Control Standard Organization (CDSCO)

It is generally concerned with policy & making of laws and rules and management of committee such as Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC). It deals in 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, It deals with licensing of both manufacturing and sales premises of drugs & cosmetics. Its most important mandate is to ensure the supply of quality drugs at the price fixed by GOI (NPPA) to the people of the State.

Drugs Control Department, Karnataka has its beginning with the appointment of 4 Drugs Inspectors in the erstwhile Mysore in the Directorate of Health and Family Welfare Services. The Drugs and Cosmetics Act, 1940 and Rules,1945 were implemented in Karnataka state with effect from 01-04-1957

Drugs Control Department in Karnataka State is the State prime organization to ensure consumer gets quality drugs at price fixed by Govt of India - National Pharmaceutical Pricing Authority (NPPA)

Today the Drugs Control Administration in Karnataka is an independent department under the Ministry of Health and Family welfare in the Government of KARNATAKA headed by Drugs Controller Sri. Bhagoji T. Khanapure as its Administrative head who will be reporting to Secretary to Governement, Health and Family Welfare Department.

The Present Building of Drug Control Department in Karnataka was established in 1965 and has three wings:

·         Enforcement wing

·         Drugs Testing Laboratory

·         Education in Pharmacy:

·         Govt.College of Pharmacy imparting education at the level of diploma, degree, post-graduation and doctorate

·         Board of examining authority to conduct examination and declaring results of students of all Diploma Pharmacy colleges in the state as per guidelines of Pharmacy Council of India

Head Office and Bangalore Drug Testing Laboratory are housed in three-storied building with built up area of 9773 Sq.mtrs located in the center part of the Bangalore - Capital city of Karnataka and is surrounded by the Ministerial Government Offices of the central and State Government and is very close to the Vidan Soudha.

Regional Deputy Drugs Controller Officesare at Bangalore, Mysore, Hubli, Bellary and Gulbarga are headed by Deputy Drugs Controllers. and each District office in Karnataka is called as circle which is headed by Assistant Drugs Controller.

Regional Drug Testing Laboratories are also located at Hubli with built up area of - - - - - Sq.mtrs at - - - - - & Bellary with built up area of - - - - - Sq.mtrs at- - - - -

Education wing has separate infrastructure.

It has dedicated professionals working to protect, promote and enhance the health of people of the Karnataka and country by proper implementation and regulation of the Drugs and Cosmetics Act, 1940 to uphold safety standards, and protects consumers.

Enforcement Wing:

Enforcement wing deals with licensing of Drugs / Cosmetics / Blood banks / Medical Devices manufacturing establishments, sales establishments, inspections of manufacturing & sales establishments and drawl of samples for test and analysis, investigation of complaints, launching of prosecution against the defaulters etc.

It functions in Three-tier system

·         Head office

·         Circle office

And Level Of Officers are :

• Drugs Controller
• Addl. Drugs Controller
• Deputy Drugs Controller
• Asst. Drugs Controller
• Drugs Inspector

Drugs & Cosmetics Act, 1940 and Rules recognizes mainly three Functionaries-

Inspector:

The State Government by notification in the Official Gazette appointed Drugs Inspectors to be Inspectors under Section 21 of Drugs and Cosmetics Act, 1940 for areas assigned to them.

Licensing Authority:

Drugs Controller is Licensing Authority for manufacturing / sales Establishments. However, with the approval of state government, he has delegated the powers of Licensing Authority in respect of sales establishments to Asst Drugs Controllers working at Circle offices

Controlling Authority:

Drugs Controller is controlling authority. All inspectors are officially sub-ordinate to Controlling Authority.

Head Office Functions

• Overall administration of the entire organisation
• Grant / renewal of Manufacturing licenses for Drugs & Cosmetics, Approval of laboratories, Blood Banks and Blood components, Blood Storage Centers,
• Approval to Recognized Medical Institutions for transport, possession and use of Oral Morphine for palliative care in cancer patients.
• Inspections of manufacturing units of Drugs, Cosmetics, Approved laboratories, Blood banks and Blood Storage Centers and medical devices.
• Investigation of complaints.
• Drawl of samples from manufacturing establishments
• Issue of certificates such as GMP (Good Manufacturing Practices) certificate, Free Sale Certificate, Tender purpose Certificate, Export Registration Certificate etc.,
• Overall administration of the entire organization.
• Three deputy Drugs Controllers placed at Hqs will also be minitoring the administration and functioning of officers working at 6 circles of Bangalore urban district.

Regional Offices Functions:

Eleven Regional Offices headed by Deputy Drugs Controller are situated at Bangalore, Belgaum, Davanagere, Mysore, Hubli, Bellary,Tumkur,Mangalore and Gulbarga for 36 circles (other than circles of Bangalore Urban district) of entire state and they are overall incharge of all circles coming under justification which is mentioned in the below table

Other functions are:

• Overall administration of the entire jurisdiction assigned
• Blood Bank / Blood Storage Centers Inspections
• Collection and dissemination of information gathered during intelligence work
• Inspections of sales / manufacturing establishments whenever required
• Drawl of samples from sales premises / Drugs stores attached to Govt. hospital for test and analysis
• Investigation of complaints
• Any other work assigned by higher ups.

Information compiled from: Government Pharmacy College Banglore Website