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NPC B.Pharm study materials
NPC B.Pharm study resources

NPC B.Pharm: Pharmacy Legislation: Statutes, Authorities and Offences

NPC B.Pharm · Work through your exam, one topic at a time.

All guide sections

Pharmacy Legislation: Statutes, Authorities and Offences

This domain tests the statutory framework for drugs and pharmacy practice in Nepal: the Drug Act 2035 (1978) and its regulations, the Nepal Pharmacy Council Act 2057 (2000), the Narcotic Drugs (Control) Act 2033 (1976), and related consumer-protection provisions. Questions usually ask which authority does what, which licence is required, and what follows a breach.

Who regulates what

  • Department of Drug Administration (DDA) administers the Drug Act 2035: product registration, manufacturing/import/wholesale/retail licences, quality surveillance, recalls, and labeling/advertising control.
  • Nepal Pharmacy Council (NPC) regulates the profession and pharmacy education under the NPC Act 2057; it does not register products.
  • Narcotic Drugs (Control) Act 2033 adds licensing, record-keeping and security duties for narcotics and psychotropics.

Core rules

  • A drug must be registered with DDA before manufacture, import, sale or distribution unless a specific exemption applies.
  • Premises and persons need separate authorisations: an establishment licence is not a pharmacist registration, and vice versa.
  • Prescription-only medicines may be sold only on a valid prescription; storage must follow labeled conditions.
  • Breach can lead to seizure, suspension or cancellation of licence, fine and imprisonment; professional misconduct is handled separately by NPC.

Worked example

A retail pharmacy sells amoxicillin without a prescription and stores suppositories at 35 °C. Reasoning: (1) sale without a prescription breaches the Drug Act and the retail licence conditions; (2) storage outside the labeled temperature breaches quality and storage requirements; (3) DDA may inspect, seize stock and act against the licence; (4) if a registered pharmacist permitted the sale, NPC may also take disciplinary action. The two proceedings are independent.

Traps

Naming NPC as the product regulator; treating a manufacturing licence as permission to sell at retail; assuming expiry-date compliance alone satisfies storage rules; forgetting that penalties and professional discipline can run in parallel.