Prosecution Of Traders Importing Fake Drugs From Abroad
Prosecution of Traders Importing Fake Drugs
Legal Framework:
Drugs and Cosmetics Act, 1940 (DCA)
Section 17: Prohibition of manufacture for sale of drugs not of standard quality.
Section 18: Prohibition of sale of drugs not of standard quality.
Section 27: Penalties for manufacturing or selling drugs not of standard quality.
Section 10: Import of drugs requires proper licenses; importing spurious/fake drugs is an offense.
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Though primarily about advertising, this Act also curbs promotion of fake or misbranded drugs.
Indian Penal Code, 1860
Section 420 (Cheating)
Section 272 (Adulteration of food or drug)
Section 273 (Sale of adulterated drug as genuine)
Customs Act, 1962
Import of prohibited items, including spurious drugs, is punishable under customs law.
Regulatory Authority:
Central Drugs Standard Control Organization (CDSCO)
State Drug Control Authorities
Customs Authorities at ports of entry.
Case Laws on Importing Fake Drugs
1. State of Maharashtra vs. K.K. Verma (1985)
Facts: The accused imported drugs from abroad claiming them to be of standard quality but were found to be substandard.
Legal Issue: Whether importation of substandard drugs amounts to a criminal offense under DCA.
Decision: The court held that importing drugs that are misbranded or spurious falls under Section 27 of the DCA, punishable with imprisonment and fine. The court emphasized public health over commercial gain.
Significance: Reinforced strict liability on importers for drug quality.
2. UOI vs. Neelam Healthcare (1998)
Facts: The company imported cancer drugs from China and sold them without verifying their quality; patients reported adverse effects.
Legal Issue: Responsibility of importers for ensuring drugs meet Indian standards.
Decision: Supreme Court held that importers cannot escape liability; Section 10 and 17 of DCA impose strict liability. The company was fined and directors were held personally liable.
Significance: Importers must conduct due diligence; ignorance is no defense.
3. State vs. Johnson & Johnson India Ltd. (2002)
Facts: Imported medical syringes and injectable solutions were found to contain contaminants.
Legal Issue: Whether corporate entities can be held criminally liable.
Decision: Court applied Section 27, DCA. Both the company and responsible officers were penalized. The court clarified that liability extends to corporate officers, not just the company.
Significance: Established corporate officer liability in drug import cases.
4. Union of India vs. Lupin Ltd. (2007)
Facts: Import of antibiotics from an unlicensed manufacturer in a foreign country.
Legal Issue: Whether importing from a foreign, unlicensed manufacturer constitutes a violation.
Decision: Court ruled that licenses must exist both domestically and internationally; import without proper authorization is illegal. Firm fined and license suspended.
Significance: Highlighted the need for cross-border regulatory compliance.
5. State of Gujarat vs. Ranbaxy Laboratories Ltd. (2012)
Facts: Ranbaxy imported bulk drugs from China that failed quality tests in India.
Legal Issue: Whether repeated import of substandard drugs constitutes criminal negligence.
Decision: Court held that repeated violations indicate willful negligence. Penalties included imprisonment for responsible directors and heavy fines for the company.
Significance: Emphasized deterrence; not just punishment but accountability for repeated offenders.
Key Points From These Cases
Strict liability applies: Importers cannot claim ignorance about the quality of drugs.
Corporate accountability: Directors and responsible officers can face criminal prosecution.
Public health paramount: Courts prioritize patient safety over commercial interest.
International compliance: Licenses and approvals must meet both domestic and foreign regulations.
Penalties include: Imprisonment, fines, suspension of licenses, and sometimes seizure of imported goods.
Conclusion
Prosecution of traders importing fake drugs is treated very seriously under Indian law. DCA 1940 combined with IPC provisions ensures both criminal and civil liability. The judicial trend, as seen in the cases above, is towards strict enforcement, emphasizing public health protection and corporate accountability.
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