At the Drugs Control Department, we recognize the enormous challenges posed by spurious /adulterated /not of standard quality drugs, excess pricing of drugs, misleading advertisements by different manufacturers and dealers. It is right here in Drugs Control Department, where we are equipped to meet the challenges.
As statutory body, we play a vital role in supporting healthcare service regulations, serving the administration of justice and enhancing safety of our community.
We are responsible for the quality ,safety, efficacy and rational use of drugs at controlled prices, monitoring the collection and supply of safe blood and blood components, scrutinizing the misleading advertisements to safeguard the interests of the unwary people.
We also draw the samples of Drugs &Cosmetics for the purpose of test or analysis to ascertain its quality ,purity and safety. To undertake the analysis we have a well equipped statutory laboratory.
We have a dedicated work force who are known for their skill, knowledge, and professional integrity.
In parallel with this continuity in service, we also represent change.
I invite you to click further chapters to discover how we approach professionalism, processes and people, working hand in hand with our stakeholders to establish the need to build a safer today and a better tomorrow.
Yours sincerely
Dr. B.Sripati Rao
Drugs Controller
Introduction
Today the Drugs Control Administration is a separate department under the Ministry of Health and Family welfare in the Government of KARNATAKA headed by a full time Drugs Controller as its Administrative head. Under him three wings function, which are :
- Enforcement wing,
- Drugs Testing Laboratory headed by Superintendent (Administration),
- College of Pharmacy headed by Principal imparting education leading to Diploma, Degree, Post-graduation and Doctorate in six different faculties.
The Drugs Control Administration in the State is implementing the following Central Legislations throughout the State.
- The Drugs and Cosmetics Act, 1940 and Rules 1945
An Act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics in the country. The main object of the act is to prevent substandard in Drugs & Cosmetics. To ensure the quality of drugs manufactured and sold in the state, drug samples are taken from manufacturing units, hospitals and sales outlets and their quality is assessed after conducting test/analysis in the Drugs Testing Laboratory of the Drugs Control Administration.
- Drugs (Prices Control) Order, 1995 is issued by the Government of India under Section 3 of the Essential Commodities Act 1955 (10 of 1955):
In this order, prices of 74 Bulk drugs and their formulations are fixed by the Government of India (National Pharmaceutical Pricing Authority under the Ministry of Chemicals and Fertilizers, Government of India) so as to make these drugs available to the public at affordable prices. The enforcement wing of the Drug Control Administration implements the provisions of the Drugs (Prices Control) Order 1995 in respect of the current prices of Bulk drugs and their formulations as fixed by the National Pharmaceutical Pricing Authority. The drugs Control administration assists the National pharmaceutical Pricing Authority in realization of the excess prices charged by the errant manufacturers besides taking legal action against the erring manufacturers and dealers.
- The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules there under
The above Act is an important piece of legislation, enacted with a view to prevent objectionable and misleading advertisement in order to discourage self medication and self treatment and to control the advertisement of drugs in certain cases, to prohibit the advertisements for certain purpose of remedies alleged to possess magic qualities and to provide punishment for matters connected therewith. The enforcement wing of Drugs Control Administration scrutinizes the labels, advertisements and other materials for possible misleading and objectionable advertisements and the violators are prosecuted in the Courts of law.
- Narcotic Drugs and Psychotropic Substances Act,1985 and Narcotic Drugs and Psychotropic Substances (Karnataka) Rules 1985
As regards to Drugs Control Department , Karnataka, is concerned, quota of Narcotic Drugs and Psychotropic substances is allotted to the formulation manufacturers engaged in the manufacture of Narcotic Drugs and Psychotropic formulations.
Further, under Narcotic Drugs and Psychotropic Substances (Karnataka) Rules 1985, approval is given to the hospitals/ nursing homes etc. as Recognised medical institution for the purpose of possession, sale, import interstate, export interstate, or use of Morphine for the palliative care for cancer patients.
Under Karnataka Poisons Rules 1966, license is granted for the stock and sale of Poisons listed under the said rules. Inspections are also carried out to ascertain whether the licensees are complying with the provisions of the above statute are not.