Pharmaceutical Jurisprudence and Management: Indian Drug Law and Inventory Control
Pharmaceutical Jurisprudence and Management in GPAT tests Indian drug law, regulatory schedules and basic management tools used in pharmacy practice. Exact schedule letters and statutory years are high-yield.
Statutes and schedules
- Drugs and Cosmetics Act 1940 and Rules 1945; CDSCO is the central regulator.
- Pharmacy Act 1948 established the Pharmacy Council of India; NDPS Act 1985 controls narcotics.
- Schedule H: prescription-only; Schedule X: narcotic/psychotropic drugs with separate licence and stricter records; Schedule M: GMP; Schedule Y: clinical trials; Schedule F: blood banks; Schedule P: shelf life; Schedule N: pharmacy premises.
- DPCO 2013 fixes ceiling prices for scheduled formulations.
Management
ABC analysis ranks inventory by annual consumption value; VED ranks by criticality. EOQ balances ordering and holding costs.
Worked example
A retail pharmacy holds a Schedule X drug. It must possess a separate licence for that drug, sell only against a prescription, and retain prescriptions and records for two years. A Schedule H drug also requires a prescription and records, but does not need the separate Schedule X licence. The distinction turns on the schedule letter, not on the drug's therapeutic class.
Traps
Confusing Act year (1940) with Rules year (1945); swapping Schedule M (GMP) and Schedule N (premises); assuming Schedule H and X records have different retention periods; treating DPCO as a voluntary code.