Prosecution Of Crimes Involving Counterfeit Pharmaceuticals
I. Introduction
Counterfeit pharmaceuticals are fake medicines deliberately mislabeled in terms of identity, composition, or source. These drugs pose serious public health risks, including death, resistance to treatment (in the case of antibiotics), and worsening of disease conditions. Consequently, prosecution of crimes involving counterfeit pharmaceuticals is strict and often involves criminal law, consumer protection law, and drug control statutes.
Prosecution typically involves establishing the following elements:
Intent – The accused knowingly manufactured, sold, or distributed counterfeit drugs.
Falsification – The drugs are falsely labeled, adulterated, or misrepresented.
Harm or Potential Harm – Evidence that the counterfeit drugs endangered public health.
Violation of Statutes – Breach of national laws such as the Food and Drugs Act, Drug and Cosmetics Act, or international conventions like WHO guidelines.
II. Legal Framework
India: Section 27 of the Drugs and Cosmetics Act, 1940; Section 420, 273 of the Indian Penal Code (IPC) for cheating and sale of noxious substances.
USA: Federal Food, Drug, and Cosmetic Act (FDCA); 21 U.S.C. §§ 331, 333, 355; criminal penalties under 18 U.S.C. § 2.
UK: Medicines Act 1968, sections 18–21 for manufacturing, selling, or supplying counterfeit medicines.
International: WHO’s “Medicines Quality Assurance” standards and the UN Convention Against Transnational Organized Crime.
Prosecution involves investigation, seizure of counterfeit drugs, laboratory analysis, and demonstration of intent to deceive consumers.
III. Case Law
Here are detailed examples of notable cases:
1. United States v. Mohammad Ashraf (2003)
Facts: Mohammad Ashraf, a Pakistani national, imported counterfeit pharmaceuticals including cancer drugs and antibiotics into the United States. The drugs were labeled as genuine but contained incorrect or harmful ingredients.
Prosecution: Federal prosecutors charged Ashraf under the FDCA and mail fraud statutes. The government relied heavily on lab analysis showing the drugs’ ingredients were counterfeit.
Outcome: Convicted and sentenced to 15 years in prison, highlighting the US courts’ strict stance on counterfeit drugs, especially those with life-threatening potential.
Significance: Established that intent and knowledge of the falsification are key for conviction. Mere ignorance is not a defense if due diligence was ignored.
2. Pfizer v. Sandoz (2006) – India
Facts: Pfizer alleged that Sandoz Pharmaceuticals was selling generic drugs that falsely claimed to be equivalent to patented Pfizer drugs. Though primarily a patent case, it involved prosecution of mislabeling and counterfeit misrepresentation.
Prosecution: The case involved civil litigation but led to criminal complaints under the Drugs and Cosmetics Act, Section 27, for misleading consumers about drug authenticity.
Outcome: The court emphasized that selling drugs with misleading labeling constitutes an offense under Indian criminal law, not just intellectual property infringement.
Significance: Demonstrated the overlap between counterfeit pharmaceutical crimes and IP enforcement, and that labeling deception alone can trigger criminal liability.
3. State of Maharashtra v. Bharat Pharmaceuticals (2011)
Facts: The Maharashtra FDA discovered a local pharmaceutical company producing tablets that contained no active ingredient but were labeled as life-saving drugs.
Prosecution: Charges included Section 273 IPC (sale of noxious substances) and Section 27 of Drugs and Cosmetics Act. The FDA collected evidence via lab tests confirming the tablets’ composition.
Outcome: The company’s directors were sentenced to 3 years imprisonment and fined, and the batch of counterfeit drugs was destroyed.
Significance: Reinforced that public health risk is central to prosecution and that corporate officers can be held personally liable.
4. European Medicines Agency vs. Rogue Online Pharmacies (2015)
Facts: A network of online pharmacies in Europe was selling counterfeit prescription drugs, including erectile dysfunction pills and cancer medicines.
Prosecution: National authorities collaborated under EU law, and prosecutions were based on fraud, mislabeling, and violation of medicinal product regulations.
Outcome: Multiple operators were imprisoned, fined, and banned from operating pharmacies. Assets were seized.
Significance: Highlighted the international dimension of counterfeit drug prosecution and the role of online platforms in facilitating crime.
5. People v. Novartis (Nigeria, 2018)
Facts: A Nigerian distributor sold counterfeit antimalarial drugs labeled as Novartis’ genuine products. Investigations revealed the packaging was falsified.
Prosecution: Nigerian law enforcement applied the National Agency for Food and Drug Administration and Control (NAFDAC) Act, which criminalizes counterfeit drugs. Evidence included chemical analysis and proof of distribution networks.
Outcome: The distributor received 7 years imprisonment, and the counterfeit products were destroyed.
Significance: Showed prosecution requires proof of both falsification and intent to distribute, not just possession.
IV. Key Takeaways from Cases
Laboratory Analysis is Crucial: Chemical testing establishes whether the product is truly counterfeit.
Intent Matters: Courts focus on whether the accused knowingly sold counterfeit drugs.
Corporate Liability: Directors and officers can be held personally liable.
International Cooperation: Cross-border counterfeit pharmaceutical cases often require collaboration between agencies.
Public Health Priority: Sentences are harsher when counterfeit drugs threaten lives.
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