The Central Drugs Standard Control Organization (CDSCO) has discovered two groups of Peda Typh, a Vi-conjugate vaccine for typhoid prevention manufactured by Bio-Med, to be substandard in quality tests done this month.
“The tests demonstrated that Peda Typh’s certain batches were not meeting the regulatory requirement. The Vi-polysaccharide content in the product was not up to the mark. The inspection was led by the CDSCO group and the samples were tested at our office,” Director of Central Drugs Laboratory at Kasauli Dr. Arun Bharadwaj told.
“We have sent our test details to the national drug controller. Currently, it is up to the manufacturer to clear the air and adopt necessary corrective measures,” Dr. Bharadwaj included.
The Drug Controller General of India (DCGI) on March 14 sent notices to drug controllers of all states and Union Territories and CDSCO zonal offices to keep a strict vigil on the movement of the product. The batches that failed the CDSCO quality test are TC010417 and TC010915.
Regional drugs inspectors are observing on warehouses and supply chain to make that vaccines having a place with the batches being referred to are not reaching the market. As indicated by industry sources, the manufacturer is contesting the test result over the method and parameters used for determining vaccine quality.
Peda Typh is the first commercially available Vi-antigen conjugated typhoid vaccine introduced by Bio-Med in India. It is used for active immunization against Salmonella Typhi – the bacterium causing the disease in infants, children and adults. Two types of typhoid vaccines are broadly available over the globe and recommended by the World Health Organization (WHO).
But both of the two are either not immunogenic in early childhood or are unsuitable for administration in children younger than 5 years. For example, the oral live attenuated typhoid vaccine, Ty21a, is unsuitable for use in children younger than 5 years due to its formulation in capsules, which are difficult for kids to swallow.
Vi capsular polysaccharide vaccine, or ViCPS, is a subunit vaccine but isn’t viable in infants. By contrast, typhoid conjugate vaccines, which combine the Vi-polysaccharide capsule with a protein carrier, have enhanced immunological properties and can be utilized from the early outset.
Typhoid fever is a communicable disease that influences 21 million individuals and causes 222,000 deaths yearly around the world. It is endemic in all parts of India with intermittent outbreaks of waterborne or foodborne diseases. It might be noticed that last month, the CDSCO had announced 39 medicines as substandard, spurious or adulterated.
The drugs that failed different quality tests include Glenmark Pharmaceuticals’ Coly-Monas injection, utilized primarily for bowl sterilization before surgeries, and Lupin’s Pyrazinamide tablets, tuberculosis sedate.
Coly-Monas failed over clarity of solution and particulate matter while Pyrazinamide failed the disintegration test.
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