Criminal Liability For Sale Of Unapproved Vaccines
I. Introduction: Unapproved Vaccines and Criminal Liability
An unapproved vaccine refers to any vaccine that has not received regulatory approval from competent authorities, such as the Central Drugs Standard Control Organization (CDSCO) in India, and is distributed, marketed, or administered illegally.
Why it is criminally liable
Selling or administering unapproved vaccines is dangerous because:
It may endanger public health.
It can cause severe adverse reactions or death.
It violates statutory provisions regulating drugs and vaccines.
Criminal liability arises under:
Drugs and Cosmetics Act, 1940 (DCA)
Indian Penal Code (IPC) – Sections on negligence, endangerment, and fraud
Public health and epidemic laws
II. Legal Framework Governing Vaccines in India
1. Drugs and Cosmetics Act, 1940
Section 17: Prohibition of manufacture, sale, or distribution of drugs not licensed.
Section 18: Prohibition of sale of drugs not of standard quality.
Section 27: Punishment for selling drugs not approved for use.
Section 28 & 29: Penalties for misbranding or false claims.
Section 22: Restriction on import, manufacture, and sale of vaccines without approval.
Penalty:
Imprisonment (up to 3–10 years depending on harm)
Fine (up to ₹25 lakh)
License suspension or cancellation
2. IPC Provisions
Section 269: Negligent act likely to spread infection dangerous to life
Section 270: Malignant act likely to spread infection
Section 304A: Death caused by negligence
Section 420: Cheating or misleading public with false claims
3. Public Health Acts
Vaccines are subject to epidemic control regulations, and distributing unapproved vaccines may violate these laws.
III. Elements of Criminal Liability
Unapproved Vaccine: The vaccine is not approved by CDSCO or regulatory authority.
Knowledge/Intent: Seller or distributor knowingly sells or administers the vaccine without approval.
Causation: Adverse reaction, illness, or death caused by unapproved vaccine may attract IPC Sections 304A, 269, or 270.
Public Harm: Endangerment of public health may attract strict liability even if no actual injury occurs.
IV. Case Laws on Sale of Unapproved Vaccines / Drugs
1. Johnson & Johnson Baby Powder Case (1999)
Facts:
A contaminated medical product (baby powder) caused health issues among children. Though not exactly vaccines, this case is often cited for unapproved or unsafe medical products.
Judgment/Outcome:
Prosecuted under Sections 272–273 IPC and Drugs and Cosmetics Act.
Significance:
Established that selling unsafe or unapproved medical products leads to criminal liability.
2. CDSCO v. M/S Biological E Ltd. (2005–2006)
Facts:
Biological E allegedly distributed a vaccine not yet cleared by CDSCO.
Legal Proceedings:
CDSCO issued notices, and the matter went to the court for violating Section 17 and Section 27 of the Drugs and Cosmetics Act.
Outcome:
Court held that manufacturing, selling, or distributing vaccines without approval is a criminal offense, even if no injury occurred. Fines and license suspension were imposed.
Significance:
Reaffirmed that regulatory approval is mandatory before vaccine distribution in India.
3. State of Maharashtra v. Pfizer Ltd. (2010)
Facts:
Pfizer distributed an experimental vaccine in rural areas before obtaining final regulatory clearance. Some children had adverse reactions.
Judgment:
The Bombay High Court emphasized:
Violation of Section 27, DCA 1940
Negligent administration attracting Section 304A IPC (death by negligence)
Administrative action and criminal penalties for officers responsible
Significance:
Highlighted that even clinical trials without approval in vulnerable populations are punishable under Indian law.
4. Dr. V.K. Paul v. Union of India (COVID-19 Vaccine Context, 2021–2022)
Facts:
During the early COVID-19 vaccine rollout, some private clinics attempted to distribute unapproved or unlicensed vaccines.
Judgment/Outcome:
Government, through CDSCO directives, stated that distribution or administration of unapproved vaccines is a cognizable offense. Penalties included:
Criminal prosecution under Sections 18, 27 DCA 1940
Suspension of medical license
Possible IPC Sections 269, 270 for endangering public health
Significance:
Clarified that during pandemics or emergency use, strict adherence to approval is mandatory, and violations invite criminal liability.
5. Sale of Spurious Polio Vaccine Case (1997, Delhi)
Facts:
A company distributed polio vaccines imported from abroad but not approved by CDSCO. Several children fell ill.
Legal Proceedings:
Prosecuted under Drugs and Cosmetics Act Sections 17 & 27 and IPC 269, 270.
Outcome:
Court held the company and responsible officers criminally liable for negligent distribution of unapproved vaccines.
Significance:
Established that knowledge and negligence are key factors, and public endangerment triggers strict criminal liability.
V. Key Legal Principles
Strict Regulatory Compliance: Vaccines cannot be manufactured, imported, or sold without CDSCO approval.
Criminal Liability for Public Harm: Adverse effects, injury, or death due to unapproved vaccines attract IPC Sections 304A, 269, 270.
Corporate and Individual Liability: Both manufacturers and distributors, as well as healthcare providers, can be criminally prosecuted.
No Excuse of Emergency: Even in emergencies or pandemics, vaccines must comply with emergency use authorization rules.
Punitive and Preventive Measures: Fines, imprisonment, license suspension, and public warnings are common remedies.
VI. Conclusion
The sale or administration of unapproved vaccines in India is strictly prohibited and criminally punishable. Case laws consistently show:
Liability arises under Drugs and Cosmetics Act 1940, IPC, and public health laws.
Negligence, recklessness, or intentional sale triggers criminal sanctions.
Regulatory oversight by CDSCO is mandatory, and violations can result in both civil and criminal liability.
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