HiMedia Laboratories receives CDSCO approval for Hepatitis B and C Molecular Diagnostic Kits

HiMedia Laboratories Pvt. Ltd. has received manufacturing licences from the Central Drugs Standard Control Organisation (CDSCO) for two molecular diagnostic kits – the Hi-PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit and the Hi-PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit. The company stated that the approvals enable HiGenoMB – HiMedia to manufacture the kits on a large scale as part of the Make in India initiative, aimed at addressing hepatitis B and C through early and accurate detection.

Hepatitis B and C are among the leading causes of chronic liver disease, cirrhosis, and liver cancer. Early diagnosis is vital for timely treatment and prevention of transmission.

Hi-PCR® HBV Kit (MBPCR181)

• Detects HBV DNA across all genotypes (A–J) with 100% specificity.
• Analytical Sensitivity ≈15 IU/mL
• Includes quantitative standards for precise viral load measurement
• Includes endogenous internal control
• Compatible with various RT-PCR instruments
• Based on TaqMan chemistry
• Quantitative standards calibrated against 5th WHO International Standard (NIBSC Code:    22/120)

Hi-PCR® HCV Kit (MBPCR182)

• Detects HCV RNA across all genotypes (1–7) with 100 per cent specificity.
• Analytical Sensitivity ≈43 IU/mL
• Includes quantitative standards for precise viral load measurement
• Includes endogenous internal control 
• Compatible with various RT-PCR instruments
• Based on TaqMan chemistry
• Quantitative standards calibrated against 6th WHO International Standard (NIBSC Code:    18/184)

Both kits are validated for EDTA plasma samples and intended for In vitro diagnostic use by trained clinical laboratory personnel.

“This achievement underscores our commitment to delivering world-class affordable diagnostics from India to the world. These kits offer accuracy, speed, and accessibility, helping healthcare providers diagnose and manage hepatitis more effectively, even in resource-limited settings,” said Dr. Rajas V. Warke, Director, Molecular Biology & Virology, HiMedia Laboratories.

With CDSCO approval, HiMedia will supply these kits to hospitals, diagnostic labs, and public health programs across India, ensuring improved testing availability in both urban and rural regions.