**Summary:**
The Drugs Controller General of India (DCGI), under the Directorate General of Health Services, Ministry of Health and Family Welfare, has issued a directive to all State/Union Territory Drugs Controllers and CDSCO Zonal/Sub-Zonal offices regarding two batches of Peda Typh Vi-Conjugate Typhoid Vaccine One dose, manufactured by Ms. Bio Med Pvt. Ltd, Ghaziabad. The affected batches are Batch No. TC010915 (CDL No. 4532018) and Batch No. TC010417 (CDL No. 4542018). These batches have been declared Not of Standard Quality (NSQ) by the Central Drugs Laboratory (CDL), Kasauli, due to issues with Vi Polysaccharide content, as per test report numbers CDL2018752, 753 and CDL2018754,755 dated 09.02.2018. The directive requests all relevant authorities to maintain strict vigilance on the movement of these specific vaccine batches within the market. The communication was issued by Dr. S. Eswara Reddy, Drugs Controller General India.
Key Entities Referenced
Directorate General of Health Services: An agency of the Ministry of Health and Family Welfare, Government of India.
Ministry of Health and Family Welfare: A government ministry of India.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization in India.
FDA Bhawan, Kotla Road, New Delhi: Location of the Central Drugs Standard Control Organization office in Delhi, India.
Peda Typh ViConjugate Typhoid Vaccine One dose: A typhoid vaccine manufactured by Bio Med Pvt. Ltd.
Bio Med Pvt. Ltd, Ghaziabad: A pharmaceutical company based in Ghaziabad, Uttar Pradesh, India, that manufactures the vaccine in question.
CDL, Kasauli: Central Drugs Laboratory, Kasauli, a government drug testing laboratory in Himachal Pradesh, India.
Directorate General of Health Services
Ministry of Health and Family Welfare
Central Drugs Standard Control Organization
Office of Drugs Controller General (India)
(Biological Division)
FDA Bhawan, Kotla Road,
New Delhi- 110 002, India
Dated: ee
1. All States/UT Drugs Controllers
2. AllCDSCO Zonal/Sub-Zonal offices
Subject: 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 Bio Med Pvt. Ltd, Ghaziabad - regarding.
Sir/Madam,
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.
In this regard, all States/UT Drugs Controllers, CDSCO Zonal/Sub-Zonal officers
are requested to direct the inspectorate staffs under their control to keep strict vigil on
the movement of said product (Batch Nos. TC010915 & TC010417) in the market.
Yours faithfully,
“ear
(Dr. S. EsWara Reddy)
Drugs Controller General (India)