Drug alert: This Typhoid Vaccine fails Quality Test – CDSCO

The sample of Typbar failed the quality test due to non-compliance with the O-acetyl content specification, as determined by the laboratory analysis.

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NSQ Drugs Substandard drugs Fail samples NSQ Samples Substandard samples
NSQ Drugs

NSQ Typhoid Vaccine

The Central Drugs Standard Control Organisation (CDSCO) has recently announced that a batch of Typbar, the typhoid polysaccharide vaccine manufactured by Bharat Biotech International Ltd, did not meet the standard quality requirements.

Quality Test Failure at CDL Kasauli:

The drug regulator issued a drug alert stating that the specific batch of Typbar, produced by Bharat Biotech International Ltd in Hyderabad’s Genome Valley, failed the standard quality test conducted by the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh.

The Food and Drug Administration (FDA) of Goa had collected and sent the sample for testing.

CDL Kasauli: National Control Laboratory for Immunobiologicals:

CDL Kasauli holds the responsibility of being the National Control Laboratory for testing immunobiologicals, including vaccines and antisera intended for human use within the country.

It adheres to the national regulations for domestically produced vaccines, immunization programs implemented by the Government of India, as well as the import and export requirements.

Reason for Test Failure:

The sample of Typbar failed the quality test due to non-compliance with the O-acetyl content specification, as determined by the laboratory analysis.

Significance and Features of Typbar:

Typbar is recognized as the first vaccine in India to receive prequalification certification for Good Manufacturing Practices from the World Health Organization (WHO).

It consists of highly purified Vicapsular polysaccharide derived from Salmonella typhi Ty2. An interesting aspect of Typbar is that it is the world’s first vegetarian or non-bovine typhoid vaccine.

Bharat Biotech, the country’s leading typhoid vaccine manufacturer, dedicates this vaccine to Dr. John R. Robbins, an eminent figure in polysaccharide vaccines.

Administration Guidelines for Typbar:

Typbar should be administered intramuscularly, specifically in the deltoid muscle for adults and in the vastus lateralis (anterolateral thigh) for children up to 12 years of age.

The recommended dosage is 0.5 mL per injection. The primary series entails a single dose of 0.5 mL for children aged 2 years and above, as well as adults.

For individuals with repeated or continued exposure to Salmonella Typhi, a bacterium related to the bacteria that cause salmonella food poisoning, reimmunization is advised every 2 years with a single dose.

CDSCO’s Monthly Drug Alert:

The CDSCO’s alert regarding the Typbar vaccine follows its routine testing of samples collected nationwide in collaboration with its offices and state drug regulators.

In May, the CDSCO reported that nearly four percent of the drugs, cosmetics, and medical device samples tested in April 2023 were deemed not of standard quality (NSQ).

Out of the 895 drug samples tested during April, 35 were declared NSQ. Notably, samples from renowned pharmaceutical companies such as Glenmark Pharmaceuticals and Alkem Health Science, as well as public sector undertakings like Karnataka Antibiotics and Pharmaceuticals Ltd and Hindustan Antibiotics Ltd, were among those declared NSQ.

Failure of Urimax D Combination Drug:

Another notable case involved a batch of tamsulosin hydrochloride and dutasteride tablets, marketed as Urimax D and manufactured by Cipla Ltd at its Goa facility.

The Drug Control Department of Odisha collected the sample, which failed the identification and assay tests for tamsulosin hydrochloride and dutasteride at the Central Drugs Laboratory in Kolkata. The CDSCO classified the sample as spurious.

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