Ghaziabad firm faces crackdown for making substandard rabies vaccine

CDSCO has stopped Bio Med from making anti-rabies vaccines for human use after Sure Rab batches failed quality tests. The action followed a joint inspection and adds to scrutiny of vaccine quality in a high-rabies-burden country.Anti rabies vaccine is recommended for anyone bitten by dogs or other animals. India records 58 lakh animal bites every year, including 47 lakh dogbitesThe country's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has prohibited Ghaziabad-based biopharmaceutical company Bio Med from manufacturing anti-rabies vaccines for human use after some batches of its vaccine were found to be substandard in recent months, India Today has learnt.The company has been issued a stop-production order after at least three batches of its anti-rabies vaccine, Sure Rab, failed the Bacterial Endotoxin Test (BET), a critical quality-control procedure used to detect and measure fever-causing bacterial toxins, or lipopolysaccharides, in injectable vaccines and other sterile pharmaceutical products.India Today has reviewed copies of the test results for two batches of Sure Rab – R030126 and R011125 – issued by the Central Drugs Laboratory (CDL), Kasauli, under the CDSCO.Both batches failed to comply with BET parameters and were declared Not of Standard Quality (NSQ). One of the batches also failed on the parameter for bovine serum albumin, a major protein found in cow blood that is used during rabies vaccine manufacturing to support cell growth, increase virus yield and stabilise the final product. Its presence is permitted only within specified limits as a trace component.STOP-PRODUCTION ORDERSourceS in the CDSCO confirmed that following the test results, a joint inspection of Bio Med's manufacturing premises in Ghaziabad was carried out along with the Uttar Pradesh Food and Drug Administration (FDA). This was followed by the company, established in 2002, being directed to completely stop the production of anti-rabies vaccines. Bio Med is among five Indian manufacturers of anti-rabies vaccines. Other major players include Indian Immunologicals Limited (IIL), Bharat Biotech, Serum Institute of India and Cadila.India Today has reached out to Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), who heads the CDSCO, and S P Garg, founder and managing director of Bio Med. This copy will be updated if and when their responses are received.The latest action comes just days after Indian regulators flagged a suspected counterfeit batch of Abhayrab, IIL's rabies vaccine, which has the largest share of India's rabies vaccine market. The suspected counterfeit product was linked to an unauthorised premise in the national capital.The CDSCO had issued a public notice on the matter only after a media report first brought the issue into the public domain.EARLIER POLIO SCANDALBio Med, which manufactures several vaccines for human and veterinary use including vaccines for typhoid and varicella, has also been blacklisted from supplying polio vaccines since 2018 after its involvement in a major controversy over type-2 poliovirus contamination in its oral polio vaccine (OPV).Under World Health Organisation (WHO) guidelines, India had ordered the withdrawal and destruction of all trivalent OPV stocks by April 2016. Since then, all OPVs have been expected to be bivalent, containing only type-1 and type-3 polioviruses.Type-2 poliovirus was removed from OPVs worldwide after wild type-2 polio was declared eradicated. Continued use of the live type-2 vaccine strain had also become a concern because it was responsible for most new cases of vaccine-derived poliovirus.Because vaccines are high-risk biological products administered to large populations, any quality failure can trigger immediate regulatory and law-enforcement action under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.The concerns are particularly significant in a country with one of the world's highest rabies burdens. In July this year, Union Health Minister J P Nadda informed Parliament that India records around 58 lakh animal-bite cases annually, including about 47 lakh dog-bite cases.According to the last available figures, India records more than 5,700 rabies deaths annually, the highest globally.All patients exposed to dog bites and bites by cats or monkeys, are recommended for anti-rabies vaccination. In cases involving more severe exposure, rabies immunoglobulin may also be required. While the government has maintained that there is currently no shortage of rabies vaccines, concerns over their availability have continued to emerge periodically from different states.Rabies is transmitted through the saliva of infected mammals, usually through bites or scratches. Once symptoms appear, the infection causes severe inflammation of the brain and is almost always fatal.Veteran pharmacologist Dr Santanu Tripathi said quality failures in vaccines carry consequences that can extend far beyond an individual patient.“Substandard drugs should never be taken lightly, but the consequences of a substandard vaccine can be far more serious from a public health perspective. Vaccines are administered to large numbers of mostly healthy people, who may develop a false sense of security, believing they are protected when, in reality, they may have received inadequate or no protection at all,” he said.The latest episode comes amid the government's broader push to strengthen quality control of medicines and vaccines made in India. In recent years, Indian drug and vaccine manufacturers have faced scrutiny and criticism over major quality lapses reported both within the country and overseas.- EndsPublished On: Sep 10, 2026 12:22 IST