Prosecution Of Pharmacists Violating Drug Safety Rules
1. Overview: Prosecution of Pharmacists Violating Drug Safety Rules
In India, pharmacists and manufacturers are governed by:
The Drugs and Cosmetics Act, 1940 – regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Section 27: Punishment for manufacturing/selling adulterated drugs.
Section 18 & 19: Power to control manufacture, sale, and standards of drugs.
Section 21 & 22: Licensing requirements for pharmacists and drug manufacturers.
The Pharmacy Act, 1948 – regulates the profession of pharmacists.
Requires registration of pharmacists and adherence to ethical standards.
Indian Penal Code (IPC) Sections 270-272 – for acts likely to spread disease or adulteration leading to injury or death.
Types of Violations:
Selling spurious or adulterated drugs.
Operating without a license.
Negligence in storage or dispensing.
Misbranding or wrong labeling.
Unethical professional conduct.
Liability arises:
Criminal prosecution under Drugs and Cosmetics Act.
Professional disciplinary action under Pharmacy Council of India regulations.
Tort or civil liability if harm occurs to patients.
2. Landmark Case Laws
2.1 State of Maharashtra v. Natco Pharma (2007)
Facts: Natco Pharma was accused of selling spurious and misbranded drugs in violation of Sections 27 and 18 of the Drugs and Cosmetics Act.
Legal Issues:
Liability of corporate bodies and their managing directors for drug violations.
Whether mere possession or sale of misbranded drugs attracts criminal liability.
Judgment:
Court held that liability is strict under the Drugs Act. Corporate officers cannot escape liability by delegating responsibilities.
Conviction was upheld; fines and imprisonment were imposed.
Impact:
Reinforced strict liability principle for pharmaceutical companies and pharmacists.
Emphasized due diligence and internal compliance.
2.2 Kiran Kumar v. State of Kerala (2012)
Facts: A licensed pharmacist dispensed expired antibiotics, leading to adverse effects in several patients. Charges were framed under Sections 27 & 272 IPC.
Legal Issues:
Whether dispensing expired drugs amounts to criminal negligence or strict liability under Drugs and Cosmetics Act.
Judgment:
Supreme Court held that dispensing expired drugs violates safety standards and criminal provisions.
Imposed imprisonment and license suspension.
Impact:
Highlighted the importance of pharmacists’ professional responsibility.
Reinforced the role of regulatory inspections in preventing public harm.
2.3 Union of India v. Ramesh Pharma (2003)
Facts: Ramesh Pharma was operating without a valid license and selling prescription-only drugs over the counter.
Legal Issues:
Whether operating without a license constitutes a criminal offence under Sections 18, 21, and 27 of the Drugs Act.
Judgment:
Court held that unlicensed sale of prescription drugs is a serious offence.
Conviction confirmed; fine and imprisonment imposed.
Impact:
Strengthened regulatory compliance for pharmacists.
Emphasized importance of licensing for public health safety.
2.4 State of Tamil Nadu v. Gopal Krishna (2010)
Facts: A pharmacist sold misbranded and spurious drugs, claiming them to be genuine. Several patients suffered mild to severe adverse effects.
Legal Issues:
Scope of liability for misbranding and fraud in drug sale.
Whether knowledge of the spurious nature is required.
Judgment:
Court applied strict liability: proof of intent was not required.
Pharmacist convicted under Sections 27 & 272 IPC and relevant provisions of the Drugs Act.
Impact:
Reinforced that public health protection outweighs commercial defenses.
Set precedent for convicting negligent pharmacists even without intent.
2.5 Indian Drugs & Pharmaceuticals Association v. Union of India (2001)
Facts: The case involved non-compliance with quality control norms by several pharmaceutical manufacturers. Inspections revealed substandard manufacturing practices.
Legal Issues:
Whether non-compliance with Good Manufacturing Practices (GMP) attracts criminal liability.
Scope of liability for corporate officers and pharmacists in manufacturing units.
Judgment:
Court emphasized that non-compliance with statutory quality standards constitutes criminal negligence.
Companies were fined, and responsible officers faced imprisonment.
Impact:
Strengthened enforcement of GMP regulations.
Reinforced accountability of managing pharmacists in manufacturing units.
2.6 Dr. K. S. Bhaskar v. State of Karnataka (2015)
Facts: A pharmacist dispensed drugs containing unapproved chemical compositions. Complaints were lodged under the Drugs and Cosmetics Act.
Legal Issues:
Whether distributing unapproved formulations amounts to criminal offence.
How liability is shared between pharmacist and manufacturer.
Judgment:
Court held that both the pharmacist and manufacturer can be held liable under Sections 27 & 18 of Drugs Act.
Criminal proceedings were justified even if harm was potential rather than realized.
Impact:
Clarified that pharmacists are responsible not only for dispensing but also for ensuring drug safety compliance.
Encouraged rigorous verification of drug licenses and formulations.
Key Principles from These Cases
Strict Liability: Pharmacists and manufacturers are strictly liable for violations under the Drugs and Cosmetics Act, regardless of intent.
License Requirement: Operating without a valid license or dispensing prescription drugs illegally is a criminal offence.
Professional Responsibility: Pharmacists must ensure quality, validity, and labeling of drugs.
Corporate Accountability: Directors and managers cannot escape liability by delegating duties.
Public Health Priority: Courts prioritize public safety over commercial interests.
Penalty Spectrum: Convictions can include imprisonment, fines, and license suspension.
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