New Delhi: India's central drug testing laboratory has declared a batch of Bio-Med Pvt. Ltd's human rabies vaccine "not of standard quality" after it failed key safety tests, according to official documents reviewed by Mint.
The Central Drugs Laboratory (CDL), Kasauli, found that a batch of Bio-Med's rabies vaccine—SURE RAB I.P. (Lyophilized)—for human use meant for test and release failed bacterial endotoxin and bovine serum albumin tests and informed the Drugs Controller General of India (DCGI), according to a 30 June letter.
Bacterial endotoxin and bovine serum albumin are critical quality parameters that assess the purity and safety of the vaccine, ensuring it is free from harmful bacterial contaminants and excessive residual animal proteins from manufacturing.
Public health concern
The finding assumes significance because India reports an estimated 3.71 million dog-bite cases and 54 suspected human rabies deaths annually. Rabies, though almost entirely preventable through timely vaccination, remains nearly 100% fatal once symptoms appear. India also has an estimated 15.3 million stray dogs, according to the 2019 Livestock Census.
In the letter to Bio-Med's Ghaziabad manufacturing facility, the laboratory said the batch, R011125, manufactured in November 2025 and valid until October 2028, “does not comply” with the bacterial endotoxin and bovine serum albumin testing specifications.
CDL said, "This report is based on bacterial endotoxin, bovine serum albumin test and scrutiny of production and testing protocol as per test and their results detailed therein by the manufacturer."
Though the batch size is not mentioned, the document lists the volume distribution per vial, noting that a 1.0 ml volume contains a single dose for intramuscular use, while a 0.1 ml volume yields 10 doses for intradermal use.
The sample was tested as part of the mandatory test-and-release process before commercial distribution, meaning the batch was identified during routine regulatory quality checks and was not released into the market.
Bio-Med managing director S.P. Garg said, “The issue is related to only one batch. We produce at least 15 batches per month, and all others have passed. This specific batch has already been discarded as per the law… These manufacturing technologies are extremely difficult and not easy.”
Queries sent to the health ministry, CDL Kasauli, and the DCGI office on Monday remained unanswered till press time.
Rabies is primarily transmitted through dog bites, which account for nearly 96% of human infections in India. The remaining cases result from bites by cats, monkeys, mongooses, wild cats and cattle.
India's rabies vaccine market is estimated at about ₹125 crore, according to pharmaceutical market research agency Pharmatrac. Other domestic manufacturers include Serum Institute of India, Bharat Biotech and Indian Immunologicals.
Public health expert Dr Rajeev Jayadevan said the failed batch demonstrated that India's vaccine surveillance system was functioning as intended.
"The finding points to a possible quality-control issue that regulators should investigate. It does not mean vaccines available for public use are unsafe," he said, adding that prompt vaccination after a dog bite remains critical because rabies is almost always fatal once symptoms develop.
Earlier, Mint reported that the Centre mandated all hospitals to stock anti-rabies vaccines, which stimulate long-term antibody production, and rabies immunoglobulin, which provides immediate, short-term passive protection for post-exposure management.