Jurisprudence: Drugs and Cosmetics Act, Pharmacy Act and Allied Rules
What the domain tests
The legal framework governing pharmacy practice in India: the Drugs and Cosmetics Act 1940 with its Rules 1945, the Pharmacy Act 1948, and allied statutes such as the NDPS Act, DPCO and device and clinical trial rules. Items test schedule identification, licence conditions and definitions.
Core rules to hold
- Key definitions: drug, cosmetic, misbranded, adulterated and spurious drugs; misbranding concerns labelling, adulteration concerns contamination or substandard content, and spurious drugs are imitations or substitutes.
- Schedules of the Rules: A (application forms), B (licence fees), C and C1 (biological and special products), F (cosmetics), G (hormones and steroids), H (prescription-only drugs), H1 (special record-keeping), X (narcotic and psychotropic drugs needing a special licence and secure storage), J (notifiable diseases), M (GMP), N (minimum equipment for a pharmacy), P (life periods), S (cosmetic standards), U (labelling), V (physician samples), W (drugs marketed under generic names), Y (now replaced by the New Drugs and Clinical Trials Rules 2019).
- Pharmacy Act 1948: constituted the Pharmacy Council of India and State Pharmacy Councils; Section 42 restricts compounding and dispensing to registered pharmacists.
- Pricing and narcotics: DPCO 2013 fixes ceiling prices under NPPA; the NDPS Act 1985 controls narcotic drugs and psychotropic substances.
Worked example
A retailer sells an antibiotic without a prescription and keeps no record. Antibiotics fall in Schedule H, and the specified ones in Schedule H1, which require a separate register retaining entries for three years, a label in a red-bordered box and a caution that sale is only on the prescription of a registered medical practitioner. The sale breaches the Act and attracts penalties under the Drugs and Cosmetics Rules.
Traps that cost marks
Treating Schedule H, H1 and X as interchangeable - X needs a separate licence and locked storage; confusing Schedule M (GMP) with Schedule N (minimum equipment); recalling Schedule Y as still governing clinical trials.