Pharmaceutical Legislation and Ethics: Nepal regulatory framework
What legislation and ethics tests
This domain tests Nepal's drug regulatory framework and professional conduct: the Drugs Act 2035 (1978), Drugs Rules 2037 (1980), Nepal Pharmacy Council Act 2057 (2000), National Drug Policy 2058 (2002), licensing, registration, prescription-only status and pharmacy ethics. Expect scenario questions on lawful sale, record keeping and conflicts.
Core rules
- The Department of Drug Administration (DDA) regulates manufacture, import, export, sale, distribution, registration and quality of drugs. A drug must be registered before marketing, unless a specific exemption applies.
- Retail and wholesale drug sale require the appropriate licence; NPC professional registration is necessary but not sufficient to operate a drug outlet.
- Prescription-only medicines must be sold on a valid prescription; records must be kept and prescriptions retained as required.
- NPC registers pharmacists and pharmacy assistants, sets standards and handles professional discipline. Its code requires competence, confidentiality, honesty and avoidance of conflicts of interest.
- Narcotic and psychotropic drugs need special authorization, secure storage and register entries.
Worked example
A customer asks for amoxicillin capsules for a sore throat without a prescription. The pharmacy assistant should not sell them as a routine OTC item. Amoxicillin is a prescription antibiotic; dispensing without a valid prescription breaches drug law and encourages resistance. The correct response is to explain the need for prescriber assessment, refer for red flags, and offer symptomatic advice within scope.
Traps
Confusing DDA and NPC roles; assuming registration equals a sale licence; selling prescription medicines informally; and ignoring privacy or conflict-of-interest rules.