CDSCO grants approval for making RT-PCR testing kits to detect Mpox in India

• WHO seeks US$ 87.4 million over 6 months, to work with countries to contain the current outbreak of Mpox

Highlights:

• In a significant step towards bolstering India’s public health infrastructure, the Central Drugs Standard Control Organisation (CDSCO) has approved Siemens Healthineers for the manufacture of RT-PCR testing kits designed to detect Mpox.
• This development comes at a crucial time as the global community grapples with the rising threat of Mpox, which the World Health Organization (WHO) has recently classified as a global health emergency.

Key Features of the Mpox RT-PCR Kits:

• The Siemens Healthineers’ RT-PCR kits, to be manufactured at their molecular diagnostics unit in Vadodara, represent a significant advancement in the detection of Mpox.
• With a production capacity of one million tests per annum, these kits are poised to make a substantial impact on India's diagnostic capabilities.

1. Rapid Results: One of the standout features of these kits is the ability to deliver test results within 40 minutes, a significant improvement over traditional methods that require one to two hours.
2. Comprehensive Detection: The IMDX Monkeypox Detection RT-PCR Assay is designed to target two distinct regions in the viral genome, covering both clade I and clade II variants.
3. Platform-Agnostic: The assay is compatible with existing lab workflows and standard PCR setups, eliminating the need for new instruments. This allows laboratories to utilize their existing COVID-19 testing infrastructure, enhancing efficiency and reducing costs.
4. Clinical Validation and Standards: Clinically validated by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV) in Pune, the kits boast 100% sensitivity and specificity.

Implications for India’s Public Health System:

• The approval and subsequent production of these RT-PCR kits are pivotal in strengthening India’s public health response to Mpox.
• With the capacity to produce a million tests annually, India is better equipped to manage potential outbreaks, ensuring that testing capabilities are readily available across the country.

1. Enhanced Preparedness: The rapid availability of accurate testing kits is a critical component of India’s strategy to contain Mpox. With 32 laboratories already equipped for Mpox testing, the country is poised to respond swiftly to any potential outbreaks.
2. Leveraging Existing Infrastructure: By utilizing the existing COVID-19 testing infrastructure, these new kits allow for a seamless integration into current lab operations, minimizing the need for additional resources while maximizing the efficiency of the public health response.
3. Global Context and Collaboration: The WHO’s recent declaration of Mpox as a global health emergency underscores the urgency of such initiatives. The organization’s call for $87.4 million in funding to combat the outbreak highlights the global scale of the threat and the need for coordinated international efforts.

Prelims Takeaways:

• CDSCO