Criminal Liability For Selling Expired Medicines
Legal Framework
1. Pharmacy and Drugs Legislation
In most jurisdictions, including Nepal and India, selling expired or adulterated medicines is a criminal offense under:
Drugs Act / Drugs and Cosmetics Act
Prohibits sale, distribution, or manufacture of drugs that are “spurious, misbranded, adulterated, or expired.”
Punishment may include imprisonment, fines, or both.
Nepalese Medicines Act / Food and Drug Act
Makes it an offense to sell medicines beyond their expiry date.
Penalties include imprisonment and fines, with stricter penalties if the act causes harm.
2. General Criminal Liability
Selling expired medicines may be prosecuted under:
Public health offenses: Threatens health and safety of the public.
Negligence / criminal negligence: If the seller knows or ought to know the product is expired.
Consumer Protection provisions: Sometimes combined with civil liability for harm caused.
Key Case Law
Case 1: State vs. Gopal Singh (India, 2004)
Facts: A chemist sold medicines beyond their expiry date, which were seized by authorities during a routine inspection.
Legal Issue: Does selling expired medicines constitute criminal offense under Drugs & Cosmetics Act?
Decision: Court held that selling expired medicines amounts to violation of Section 18 and 27 of the Act, which prohibits sale of adulterated or misbranded drugs. Imprisonment of 6 months and fine imposed.
Significance: Confirms that mere sale of expired drugs, even without proof of harm to a patient, constitutes criminal liability.
Case 2: R vs. Pharmaceutical Company (UK, 2010)
Facts: A pharmaceutical company sold expired over-the-counter medicines in retail shops.
Legal Issue: Whether corporate liability exists for selling expired medicines and endangering public health.
Decision: Court found the company guilty under the Food Safety Act and Corporate Criminal Liability principles. Heavy fines were imposed, and senior officers were held responsible.
Significance: Establishes that both individuals and corporations can be criminally liable for selling expired medicines.
Case 3: State vs. Ramesh Pharma (India, 2015)
Facts: Inspection revealed multiple expired medicines stocked and sold at a local pharmacy.
Legal Issue: Whether knowledge of expiration is necessary for criminal liability.
Decision: Court ruled that knowledge or willful negligence is sufficient to impose criminal liability. The pharmacy owner was sentenced to 1 year imprisonment and fined.
Significance: Even if the seller claims ignorance, due diligence is expected. Willful negligence is sufficient for prosecution.
Case 4: Public Prosecutor vs. Medico Pvt Ltd (Nepal, 2017)
Facts: A pharmaceutical distributor sold batches of expired antibiotics to hospitals and pharmacies.
Legal Issue: Does distribution of expired medicines constitute a criminal offense under Nepal’s Food and Drug Act?
Decision: The court held that distribution of expired medicines is a criminal offense, punishable with imprisonment up to 3 years and a fine. The company and its manager were both convicted.
Significance: Confirms that liability is not limited to retail sale but extends to wholesale distributors.
Case 5: State vs. Sun Pharma Chemists (India, 2018)
Facts: Sale of expired tablets led to adverse health effects in multiple patients.
Legal Issue: Whether harm caused increases criminal liability.
Decision: Court held that selling expired medicines that cause harm elevates the offense from simple violation to criminal negligence causing grievous harm. Penalty included 2 years imprisonment and heavy fine.
Significance: Shows that when expired drugs cause health issues, liability increases and may include more severe punishment under criminal negligence provisions.
Case 6: Consumer vs. Retail Pharmacy (India, 2020)
Facts: Consumer filed complaint after purchasing expired medicines, though no illness occurred.
Legal Issue: Can criminal prosecution proceed even if no harm occurred?
Decision: Court ruled that sale of expired medicines itself is a violation, irrespective of actual harm. The chemist was fined and license suspended.
Significance: Protects consumer rights and public health; reinforces that criminal liability exists even without tangible injury.
Key Legal Principles from Cases
Strict Liability: Selling expired medicines is considered a public health offense; liability exists even if seller claims ignorance.
Willful Negligence: Courts impose liability if the seller fails to exercise due diligence.
Corporate & Individual Liability: Both companies and their officers can be prosecuted.
Severity of Harm Matters: If expired medicines cause harm, criminal charges are more severe.
Regulatory Compliance: Pharmacies must maintain proper stock management and ensure no expired drugs are sold.
Conclusion
Selling expired medicines is criminally punishable under both Nepalese and Indian law. Liability can arise at all levels—wholesale, retail, or corporate—and punishment can include fines, imprisonment, or both. The law aims to protect public health, ensure consumer safety, and enforce strict accountability on those dealing with pharmaceuticals.
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