
In a coordinated enforcement operation targeting the illicit pharmaceutical trade, the Crime Branch of Delhi Police alongside drug inspectors from the Drugs Control Department, Government of NCT of Delhi, seized an unauthorized batch of the human rabies vaccine Abhayrab from an unlicensed residential location at Indra Vikas, Mukherjee Nagar, Delhi. Four individuals have been arrested in connection with the racket as comprehensive investigations and legal proceedings proceed under the Drugs and Cosmetics Act.
Laboratory Analysis and Regulatory Findings
Following the seizure, Central Drugs Standard Control Organisation (CDSCO) officials collected statutory samples of the confiscated product—bearing Batch No. KE25012—and forwarded them to the Central Drugs Laboratory (CDL) in Kasauli for detailed analytical examination.
The Government Analyst’s evaluation officially designated the sample as “Not of Standard Quality” (NSQ) and “Misbranded”. The testing revealed significant discrepancies:
- Analytical Evaluation: While the seized sample passed routine assays for sterility, moisture content, identity, and thiomersal content, the product failed standard potency benchmarks required to establish adequate protective antibody responses.
- Packaging & Physical Discrepancies: A forensic comparison against the genuine manufacturer’s retained control samples uncovered at least 17 distinct differences. These included alterations in font sizes, the alignment and position of the registered trademark (®) symbol, product name formatting, warning-box text, company logo coloration, QR code verification errors, vial cap colors, and seal holograms.
- Artwork & Licensing Codes: The fraudulent vials displayed artwork number
PLM0395/07/22instead of the genuinePLM0395/08/24, alongside unauthorized diluent manufacturing license notations and an incorrect weight-by-weight notation for preservative concentration.
Manufacturer Verification & Nationwide Regulatory Alert
Indian Immunologicals Ltd. (IIL), which manufactures authentic Abhayrab through its Human Biologicals Institute division, confirmed that the seized vials were not produced by the company. The firm clarified that genuine batches of Abhayrab are released into commercial supply strictly following individual lot testing and batch-release certification issued by CDL, Kasauli. The manufacturer further verified that no part of the affected batch had been exported abroad.
Prompted by the findings, the Drugs Controller General of India (DCGI) issued an urgent directive on August 27 to State and Union Territory Drugs Controllers. State regulatory inspectorates have been instructed to maintain intensified market surveillance over hospital and pharmacy supply chains to prevent any potential circulation of Batch No. KE25012 and ensure the integrity of critical rabies post-exposure prophylaxis.
