The Central Drugs Standard Control Organisation (CDSCO) has found two batches 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 showed that Peda Typh’s certain batches were not meeting the regulatory requirement. The Vi-polysacchride content in the product was not up to the mark. The inspection was conducted by the CDSCO team and the samples were tested at our facility,” Director of Central Drugs Laboratory at Kasauli Dr Arun Bharadwaj told Pharmabiz.
“We have sent our test report to the national drug regulator. Now it is up to the manufacturer to clear the air and adopt necessary corrective measures,” Dr Bharadwaj added.
The Drug Controller General of India (DCGI) on March 14 sent notifications to drug controllers of all states and Union Territories and CDSCO zonal offices to keep strict vigil on the movement of the product. The batches that failed the quality test are TC010915 and TC010417.
Regional drugs inspectors are keeping an eye on warehouses and supply chain to make sure that vaccines belonging to the batches in question are not reaching the market. According to industry sources, the manufacturer is contesting the test result over the method and parameters used for determining vaccine quality.
An email sent on March 15 to the spokesperson of the Ghaziabad-based company remained unanswered.
Peda Typh, introduced by Bio-Med, is the first commercially available Vi-antigen conjugated typhoid vaccine in India. It is used for active immunisation against Salmonella Typhi -- the bacterium causing the disease -- in infants, children and adults.
Two types of typhoid vaccines are widely available across the globe and recommended by the World Health Organization (WHO). But both of them are either not immunogenic in early childhood or are unsuitable for administration in children younger than 5 years. For instance, the oral live attenuated typhoid vaccine, Ty21a, is unsuitable for use in children younger than 5 years because of its formulation in capsules, which are difficult for toddlers to swallow. Vi capsular polysaccharide vaccine, or ViCPS, is a subunit vaccine but is not effective in infants.
By contrast, typhoid conjugate vaccines, which combine the Vi-polysaccharide capsule with a protein carrier, have improved immunological properties and can be used from early infancy.
Typhoid fever is a communicable disease that affects 21 million people and causes 222,000 deaths annually worldwide. It is endemic in almost all parts of India with periodic outbreaks of water borne or food borne diseases.
It may be noted that last month, the CDSCO had declared 39 medicines as substandard, spurious or adulterated. The drugs that failed different quality tests include Glenmark Pharmaceuticals’ Coly-Monas injection, used primarily for bowl sterilisation before surgeries, and Lupin’s Pyrazinamide tablets, a tuberculosis drug. Coly-Monas flunked over clarity of solution and particulate matter while Pyrazinamide failed the disintegration test.