India’s central drug regulatory agency has neither disclosed whether it investigated an alleged counterfeit anti-rabies vaccine nor named the companies or products involved in 694 other quality-related enforcement actions against drug makers.
Doctors and industry executives say this lack of disclosure by the Central Drugs Standard Control Organisation (CDSCO) reflects a broader pattern of regulatory opacity that extends beyond the alleged counterfeited vaccine to cough syrups and drug-makers that failed quality checks.
They have also questioned the absence of any public alert during the 74 days between the warning on January 13, 2025, about a counterfeited batch from vaccine maker Indian Immunologicals Limited (IIL) to the CDSCO and the Delhi drugs department’s public notice on March 28.
Rabies is a viral infection that attacks the central nervous system, particularly the brain, and is almost always fatal if not prevented. The vaccine is used to prevent infection after exposure to the virus, not to treat the disease once symptoms appear.
“The silence on something as critical as a rabies vaccine is shocking,” an industry executive familiar with drug regulatory affairs told The Telegraph. “People exposed to the rabies virus have only a short time window to protect themselves with a vaccine. Ethics demanded a public alert as early as possible.”
Queries sent by this newspaper to the CDSCO and the IIL about the 74-day gap have not received a response. But an official who requested anonymity said the CDSCO sent letters to all state drug regulators seeking follow-up action. The Delhi drugs department’s public notice cited the CDSCO’s letter.
Doctors say thousands of dog-bite victims across the country would have received anti-rabies shots during the two months when regulators knew about the counterfeited batch but the public did not.
With an estimated 2.3 million people in India receiving anti-rabies shots annually and the affected vaccine accounting for 40 per cent of the market, over 2,500 people receive doses of that vaccine each day.
Public health experts say the CDSCO’s silence represented a failure of basic regulatory responsibility.
“This was a lapse,” Omesh Bharti, principal epidemiologist at the State Institute of Health and Family Welfare in Shimla, Himachal Pradesh, told this newspaper. “A public alert should have been issued as soon as they came to know of it.”
Experts say the silence was all the more striking because the CDSCO continued to issue monthly alerts on drugs that failed quality tests during routine sampling between January and March — 379 drugs and two other medicines declared spurious. But those lists did not mention the alleged counterfeited rabies vaccine.
The IIL had also asked the CDSCO to work with law enforcement to investigate the counterfeiting operation. The agency has not confirmed whether any investigation took place, leaving the scale, impact and perpetrators unclear. Queries to the CDSCO and the IIL about the investigation have gone unanswered.
“A prompt public alert and disclosure of the investigation are clearly in public interest,” said Prashanth Reddy, a lawyer who specialises in intellectual property and co-author of The Truth Pill: The Myth of Drug Regulation in India. “The gap in information reflects the near-zero transparency in how our drug regulators function.”
Concerns about opacity have also emerged from the CDSCO’s replies to Right to Information (RTI) requests seeking details of 694 enforcement actions — including stop-production orders and licence cancellations or suspensions — against errant drug makers since 2023.
Central and state regulators began risk-based inspections of drug makers’ facilities in 2023 after authorities linked child deaths in the Gambia and Uzbekistan to toxin-contaminated cough syrups made in India, prompting a call for inspections from the World Health Organisation.
K.V. Babu, an ophthalmologist in Kerala and RTI activist, had requested information on the drugs, products, and companies involved in the 694 regulatory actions and updates on investigations or prosecutions, if any, against the two companies implicated in the Gambia and Uzbekistan incidents.
In replies dated November 28 and December 26, the CDSCO cited exemptions under the RTI Act, said state regulators hold licensing and enforcement authority and directed Babu to obtain details of companies or products from states.
“The CDSCO appears to be stonewalling public-interest questions and shielding identities of drug-makers facing regulatory actions,” Babu said. “The public needs to know the nature and scale of violations and who was punished for what. Without disclosure, there is no way for the public to know whether enforcement is meaningful.”
Health authorities in the US, the UK and Australia flagged the counterfeited rabies vaccine between October and December 2025 in advisories for travellers. Only after those alerts did the IIL announce through a media release that one batch had been counterfeited. The company also stated that it had received no complaints about the affected batch.
The industry executive quoted earlier said the IIL’s silence on the counterfeiting case until December 25 was conspicuous in contrast to the actions of certain other companies that encountered trouble with their batches.
The Hyderabad-based Bharat Biotech, for instance, had voluntarily recalled the entire remaining batch of 95,000 vaccine vials three years ago after its shipping company reported about 5,000 stolen vials.
In August 2025, the CDSCO itself had issued a public alert for doctors and consumers listing three batches of insulin and three batches of the anti-diabetic drug semaglutide reported stolen by pharmaceutical firm Novo Nordisk — a contrast that health experts say underscores how transparency is applied selectively.