HiMedia Laboratories Pvt. Ltd., a global leader in diagnostics and life sciences, has received manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) for two advanced molecular diagnostic kits:

Hi-PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit

Hi-PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit

These regulatory approvals empower HiGenoMB - HiMedia to manufacture these highly sensitive and specific diagnostic tools on a large scale, developed indigenously as part of the Make in India initiative to tackle two of the most significant viral infections impacting both the global and Indian populations. This achievement aligns strongly with HiGenoMB's vision to help make India hepatitis free by enabling early, accurate diagnosis and effective management of hepatitis B and C.

Tackling Hepatitis with Accuracy & Speed

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

Hi-PCR® HBV Kit (MBPCR181)

• Detects HBV DNA across all genotypes (A–J) with 100 per cent 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% 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.