Nisha Pandey

Abhayrab Rabies Vaccine Batch Found Misbranded, ‘Not Of Standard Quality’: DCGI Alerts States

India’s drug regulator has flagged a batch of <span>Abhayrab</span>, a widely used <span><a href="https://www.healthandme.com/health/rabies">rabies</a> vaccine</span>, as “Not of Standard Quality” and misbranded after vaccine samples seized from an unlicensed premises in Delhi failed to meet potency test. 

The development has raised concerns that the vials could be counterfeit, because the vaccine manufacturer, <span>Indian Immunologicals Ltd</span> (IIL), says the samples tested by authorities were not manufactured by the company.

The vaccine samples, carrying batch number KE25012, were seized on April 22 from an unlicensed residential premises in Mukherjee Nagar, Delhi, during an enforcement operation by the Delhi Crime Branch and Drugs Control Department.

<span>CDSCO</span> officials carried out legal sampling, and the samples were sent to the <a href="https://www.healthandme.com/health-wellness/the-difference-between-zoonotic-non-zoonotic-and-reverse-zoonotic-diseases-article-151134152" data-type="tilCustomLink">Central Drugs Laboratory</a> (CDL), Kasauli, for testing. CDL subsequently classified the product as “misbranded” and “Not of Standard Quality.”

The laboratory report found that the sample failed the potency requirement, although it passed tests for sterility, moisture, thermostability and identity. It also identified 17 differences between the seized product and the genuine retention sample of the same batch, including differences in labelling, artwork, QR-code verification, cap colour, licence details and packaging text.

Also read: <a href="https://www.healthandme.com/health-news/us-petting-zoo-visitors-warned-after-4-goats-test-positive-for-rabies-why-rabies-is-almost-fatal-without-treatment-article-156016071" data-type="tilCustomLink">US Petting Zoo Visitors Warned After 4 Goats Test Positive For Rabies: Can You Get Rabies Without A Bite?</a>

<h2>Manufacturer Says Seized Samples Were Counterfeit</h2>

IIL has denied manufacturing the vials that were seized in Delhi. In a statement released on September 4, the company said the laboratory had found 17 differences between the seized vials and its genuine retention samples. 

“On that basis, the vials examined are not a product manufactured by <a href="https://www.healthandme.com/health-news/british-woman-dies-of-rabies-after-being-scratched-by-puppy-in-moroccowhy-should-you-avoid-petting-strays-article-152125754" data-type="tilCustomLink">Human Biologicals Institute</a>,” the company said.

The company also said the genuine batch had been independently tested and released by CDL, Kasauli, with 83,370 vials supplied through its authorised distribution channel. It said no market complaint had been received for batch KE25012.

Also read: <a href="https://www.healthandme.com/health-news/bat-encounter-while-sleeping-why-you-shouldnt-ignore-the-risk-of-rabies-article-156020124" data-type="tilCustomLink">Bat Encounter While Sleeping: Why You Shouldn’t Ignore The Risk Of Rabies</a>

The Drugs Controller General of India (<span>DCGI</span>) has asked state drug regulators to closely monitor the movement and distribution of batch KE25012.

In its August 27 statement , the <a href="https://www.healthandme.com/health-wellness/australian-man-dies-from-an-extremely-rare-rabies-like-infection-after-a-bat-bite-article-152206252" data-type="tilCustomLink">DCGI</a> directed officials to maintain “strict vigilance” over the batch and take regulatory action where necessary.

A government notice issued on September 5 said the action was part of ongoing efforts to detect “unauthorized manufacturing and distribution activities and prevent the circulation of misbranded and spurious medicines.”

Four people have been arrested by Delhi Police in connection with the case, while further investigation is underway. The government has also confirmed that no part of the concerned batch was exported to another country.

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<h2>What Does This Mean For People Who Took Abhayrab?</h2>

The current alert concerns vials seized from an unlicensed premises, which the manufacturer says were not its genuine product.

IIL has said vaccines administered through hospitals, clinics, government healthcare facilities and licensed pharmacies reach patients through the authorised supply chain and are not affected by this matter.

<a href="https://www.healthandme.com/health-news/wyoming-health-officials-hunt-for-200-exposed-tourists-after-bat-infested-cabins-spark-rabies-scare-article-152478468" data-type="tilCustomLink">Rabies</a> is almost always fatal once symptoms develop. Timely post-exposure prophylaxis, including appropriate <span>rabies</span> vaccination after an exposure, is therefore critical. India’s National Rabies Control Programme describes rabies as 100% fatal once clinical disease develops if timely appropriate intervention is not provided.

As of now, authorities are tracing the source of the seized vials and investigating how products bearing the Abhayrab name and batch number entered an unauthorised supply chain.

Patients who suspect exposure must not to stop or delay rabies vaccination because of the alert. Anyone who has suffered a potentially rabid animal bite or exposure should seek medical care promptly and use vaccines obtained through authorised healthcare sources.

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Rabies Vaccine

DCGI

Central Drugs Laboratory

CDSCO

Indian Immunologicals Ltd

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India’s drug regulator has flagged a batch of Abhayrab, a widely used rabies vaccine, as “Not of Standard Quality” and misbranded after vaccine samples seized from an unlicensed premises in Delhi failed to meet potency test. The development has raised concerns that the vials could be counterfeit, because the vaccine manufacturer, Indian Immunologicals Ltd (IIL), says the samples tested by authorities were not manufactured by the company.Fake Batch Of Abhayrab SeizedThe vaccine samples, carrying batch number KE25012, were seized on April 22 from an unlicensed residential premises in Mukherjee Nagar, Delhi, during an enforcement operation by the Delhi Crime Branch and Drugs Control Department.CDSCO officials carried out legal sampling, and the samples were sent to the Central Drugs Laboratory (CDL), Kasauli, for testing. CDL subsequently classified the product as “misbranded” and “Not of Standard Quality.”The laboratory report found that the sample failed the potency requirement, although it passed tests for sterility, moisture, thermostability and identity. It also identified 17 differences between the seized product and the genuine retention sample of the same batch, including differences in labelling, artwork, QR-code verification, cap colour, licence details and packaging text.Also read: US Petting Zoo Visitors Warned After 4 Goats Test Positive For Rabies: Can You Get Rabies Without A Bite?Manufacturer Says Seized Samples Were CounterfeitIIL has denied manufacturing the vials that were seized in Delhi. In a statement released on September 4, the company said the laboratory had found 17 differences between the seized vials and its genuine retention samples. “On that basis, the vials examined are not a product manufactured by Human Biologicals Institute,” the company said.The company also said the genuine batch had been independently tested and released by CDL, Kasauli, with 83,370 vials supplied through its authorised distribution channel. It said no market complaint had been received for batch KE25012.Also read: Bat Encounter While Sleeping: Why You Shouldn’t Ignore The Risk Of RabiesGovernment's Action The Drugs Controller General of India (DCGI) has asked state drug regulators to closely monitor the movement and distribution of batch KE25012.In its August 27 statement , the DCGI directed officials to maintain “strict vigilance” over the batch and take regulatory action where necessary.A government notice issued on September 5 said the action was part of ongoing efforts to detect “unauthorized manufacturing and distribution activities and prevent the circulation of misbranded and spurious medicines.”Four people have been arrested by Delhi Police in connection with the case, while further investigation is underway. The government has also confirmed that no part of the concerned batch was exported to another country.      What Does This Mean For People Who Took Abhayrab?The current alert concerns vials seized from an unlicensed premises, which the manufacturer says were not its genuine product.IIL has said vaccines administered through hospitals, clinics, government healthcare facilities and licensed pharmacies reach patients through the authorised supply chain and are not affected by this matter.Rabies is almost always fatal once symptoms develop. Timely post-exposure prophylaxis, including appropriate rabies vaccination after an exposure, is therefore critical. India’s National Rabies Control Programme describes rabies as 100% fatal once clinical disease develops if timely appropriate intervention is not provided.As of now, authorities are tracing the source of the seized vials and investigating how products bearing the Abhayrab name and batch number entered an unauthorised supply chain.Patients who suspect exposure must not to stop or delay rabies vaccination because of the alert. Anyone who has suffered a potentially rabid animal bite or exposure should seek medical care promptly and use vaccines obtained through authorised healthcare sources.

abhayrab rabies vaccine batch found misbranded, ‘not of standard quality’: dcgi alerts states

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