India, Sep 05 : India’s drug regulator has flagged a batch of the Abhayrab rabies vaccine after testing found that the sample did not meet required potency standards, prompting an investigation into whether the product could be spurious.
According to a government document reviewed by Reuters, the Central Drugs Laboratory in Kasauli found that batch KE25012 failed its potency test. The sample reportedly passed other checks, including tests for sterility, moisture and identity.
However, investigators also identified discrepancies involving the product’s labelling, QR codes and packaging when compared with a reference sample. The findings have led authorities to examine the batch under provisions of India’s Drugs and Cosmetics Act.
The investigation is significant because Abhayrab is extensively used for rabies prevention in India. More than 210 million doses of the vaccine have reportedly been supplied in India and more than 40 other countries.
The latest case also follows an earlier counterfeit-related concern involving the same vaccine. In January 2025, Indian Immunologicals Ltd reported counterfeit Abhayrab vaccines in the market, prompting health authorities to issue international travel-related alerts.
Authorities have yet to establish the extent to which the flagged batch may have entered the wider distribution network. It also remains unclear whether doses from the batch were exported.
The development highlights the importance of stringent quality testing and traceability for vaccines, particularly those used to prevent fatal diseases such as rabies.
India continues to face a substantial rabies burden, making reliable access to effective post-exposure vaccination a critical component of public health efforts. The investigation is expected to determine whether the issue was confined to the tested batch or points to a broader supply-chain problem.