Biomed Vi-conjugate typhoid vaccine- 2 batches Not of Standard Quality, informs CDSCO
New Delhi: Through a recent notification, the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Directorate General of Health Services has informed that it has found two batches of Peda Typh, a Vi-conjugate vaccine for typhoid manufactured by Biomed, a Ghaziabad based firm as substandard in quality tests.
The notice states that it has been reported that the samples of Peda Typh (Vi Conjugate Typhoid Vaccine) (One dose), Batch No. TC010915 (CDL No. 453/2018) and Batch No. TC010417 (CDL No. 454/2018), manufactured by M/s Biomed Pvt. Ltd. Ghaziabad have been declared as Not of Standard Quality (NSQ) by CDL, Kasauli with respect to Vi Polysaccharide content vide test report no. CDL/2018/752,753 and CDL/2018/754,755 dated 09.02.2018.
The Drug Controller General of India (DCGI) on March 14 requested all States/UT Drugs Controllers, CDSCO Zonal/Sub-Zonal officers to direct the inspectorate staffs under their control to keep a strict vigil on the movement of said product (Batch Nos.TC010915 & TC010417) in the market.
Peda Typh, manufactured by Biomed, is the first commercially available Vi-antigen conjugated typhoid vaccine in India. It is used for active immunization against Salmonella Typhi in infants, children, and adults.
The Typhoid Vi Conjugate vaccine have been demonstrated to include ‘T’ Cell-dependent response with a much higher antibody. The conjugate Vi antigen vaccine also elicits booster response as is common to all conjugated vaccines.
A clear to slightly turbid solution containing purified Vi capsular polysaccharide of Salmonella typhi (Strain Ty2) conjugated with Tetanus toxoid protein for prevention of typhoid fever
Typhoid fever, also known simply as typhoid, is a bacterial infection due to Salmonella Typhi that causes symptoms.Symptoms may vary from mild to severe and usually begin six to thirty days after exposure. Often there is a gradual onset of a high fever over several days.
It is a communicable disease that affects 21 million people and causes 222,000 deaths annually worldwide. Typhoid is spread by eating or drinking food or water contaminated with the feces of an infected person. Risk factors include poor sanitation and poor hygiene.
Below is the attached notification.