Drug Inspector syllabus: Goa

SYLLABUS FOR COMPUTER BASED RECRUITMENT TEST (CBRT) FOR THE POST OF DRUGS INSPECTOR UNDER DIRECTORATE OF FOOD AND DRUGS ADMINISTRATION

DI Goa Paper pattern

General English including Grammar – 10 marks

General Knowledge, Current Affairs and Events of National and International Importance – 10 marks

Logical Reasoning and Analytical Ability- 25 marks

Core:– 30 marks

Syllabus

Basic understanding of the objectives of various drugs & cosmetics-related legislations, which includes;
- Drugs & Cosmetics Act, 1940 and Rules 1945;
- Drugs and Magic Remedies (Objectionable Advertisements), Act, 1954 and Rules 1955;
- Drugs Price Control Order 2013;
- Narcotics and Psychotropic Substances Act, 1985 and Rules 1987;

Basic principles involved in the manufacture and testing of drugs, as well as those involved in the selling of drugs as regulated in the above drugs legislations, including the knowledge of various Schedules, appended to these legislations;
Basic concepts and principles involved in the categorization of drugs / cosmetics to the extent of various prohibitions envisaged in these legislations and the penal provisions attached to it;
Principles attached to the drugs process qualification, process validation, real time / accelerated stability studies, / packaging of pharma products / labeling of drugs, both for domestic & exports markets / validation / calibration / functional principles of essential analytical sophisticated equipment / instruments used in the testing of drugs;
Pharmaco-vigilance Program of India relating to the drugs inter-action / adverse drugs reaction, etc; concepts envisaged under the law relating to clinical trials of drugs;
Principles involved in the self-audit compliance / training calendar / importance of the technology usage in the maintenance of drugs manufacturing & selling documents / SOP ‘s / drugs master files / product approval / data integrity / quality-by-design;
Understanding of the principles involved in the drugs distribution / importance of drugs storage / supply chain monitoring /and product re-calls concepts;
Understanding of the principles involved in the advertisement of drugs as well as those in the pricing of drugs and its monitoring mechanism;
Understanding of the principles involved in the regulation relating to control over medicinal narcotics drugs, its labeling, storage, distribution and selling concepts to counter the mis-use / abuse of drugs or self-medication;