Drug Regulatory Affairs: The Drugs and Cosmetics Act and Rules
Drug Regulatory Affairs and Legislation is the highest-yield domain for the Drug Inspector post. It tests the Drugs and Cosmetics Act, 1940, the Rules, 1945, licensing, scheduled drugs and enforcement powers.
Core rules
- Definitions: drug (Section 3(b)), cosmetic (3(aaa)), misbranded (17), adulterated (17A), spurious (17B), patent or proprietary medicine (3(h)).
- Schedules: H (prescription drugs), H1 (antibiotics, anti-tuberculars and specified drugs with three-year record retention), X (narcotics and psychotropics, special licence, two-year prescription retention), G (caution label), M (GMP), Y (clinical trials and new drugs), P (life period), P1 (pack sizes), C and C1 (biologicals), F (blood products), K (exemptions), Q (colours), S (cosmetics standards), T (Ayurvedic GMP).
- Licences: Form 25/28 for manufacture; Form 20/21 for retail sale; Form 20B/21B for wholesale.
- Enforcement: Section 22 powers of inspectors, Section 23 sampling procedure, Section 25 Government Analyst report, Section 27 penalties for spurious and adulterated drugs, Section 27A for other contraventions, Section 28 for misbranded drugs.
Worked example
A tablet labelled 'Paracetamol 500 mg' is analysed and contains only starch. This is a spurious drug under Section 17B(d) - substituted wholly by another substance. If the same tablet contained 300 mg paracetamol, it would be not of standard quality (substandard), not spurious. If the label omitted the batch number or manufacturer's address, it would be misbranded under Section 17.
Traps
Do not equate substandard with spurious; do not confuse Schedule H with Schedule X; remember that Section 27 penalties were sharply enhanced in 2008; and do not forget that the Government Analyst's report must be supplied to the person from whom the sample was taken.