Countries Raise Concern About ‘Fake Rabies Vaccine’ in India

Syllabus: GS2/Issues Related Health; GS4/Ethics

Context

• Recently countries like the UK, US, and Australia have issued an advisory about the counterfeit batch of Abhayrab, a rabies vaccine manufactured by government-owned Indian Immunologicals Limited (IIL). 

About Abhayrab Counterfeit Controversy

• Abhayrab is a cell‑culture rabies vaccine manufactured by Indian Immunologicals Limited (IIL), in use since 2000 in India and over 40 countries.
• It reportedly holds around 40% of India’s human rabies vaccine market and is widely used in government programmes, private hospitals, and for travellers.
• Indian Immunologicals Limited (IIL) stated that in January 2025, it detected one counterfeit batch with altered packaging.
• Later, the company stated that the batch was identified internally, following which regulatory and enforcement agencies were informed, and that the product was no longer available for sale.

Understanding Rabies and Its Risks

• Rabies is a viral infection transmitted through the saliva of infected animals such as dogs, cats, bats, and monkeys. 
• It typically spreads through bites, scratches, or saliva entering open wounds.
• Symptoms may include Fever, headache, and nausea; hallucinations and fear of water (hydrophobia);
• Post-exposure vaccination, given promptly after a potential exposure, is the most reliable way to prevent infection.
• According to India’s National Rabies Control Program, 6,644 suspected human rabies cases and deaths were reported between 2012 and 2022.
  • However, the WHO estimates a far higher toll, at around 18,000–20,000 deaths annually, with up to two-thirds of victims under age 15.
    • India alone accounts for 36% of global rabies deaths.
• The issue of rabies is particularly serious because it is almost 100% fatal once symptoms appear.

Ethical Perspectives of Abhayrab Controversy

• Public Health Ethics: The fake vaccine is a violation of the principle of non-maleficence(‘do no harm’) from a public health standpoint.
  • Public health systems have an ethical duty to ensure the safety, efficacy, and authenticity of all vaccines.
  • Distributing fake vaccines breaches public trust and undermines future vaccination drives.
• Professional Ethics in Medicine: Medical professionals who administered vaccines without verifying authenticity acted under compromised ethical conditions.
  • However, many doctors were victims themselves, relying on state-supplied vaccines, a failure of institutional ethics, not individual negligence.
• Corporate and Manufacturing Ethics: Pharmaceutical suppliers and intermediaries falsified batch numbers and expiry dates, violating business ethics and legal obligations under the Drugs and Cosmetics Act, 1940.
  • Ethically, it is an act of deliberate deception risking lives for profit.
• Regulatory Ethics: The Central Drugs Standard Control Organization (CDSCO) and state drug regulators failed to exercise due diligence.
  • It exposes a moral lapse in oversight, echoing ethical negligence in governance, comparable to the Ranbaxy data falsification case (2013).

Broader Implications

• Trust Erosion: Communities may resist future vaccination campaigns (e.g., rabies, polio, COVID-19 boosters).
• Systemic Reform Need: Experts from AIIMS and ICMR have called for blockchain-based traceability and third-party audits for all vaccine batches.
• Moral Responsibility: Ethical accountability must extend beyond punishment to institutional reform and restoration of public trust.

Source: IE