Serum - Protection from birth onwards
Pune (India) – London (UK), November 18, 2025 - Serum Institute of India (SIIPL) Pvt. Ltd., part of Cyrus Poonawalla Group, in collaboration with its UK subsidiary Serum Life Sciences Ltd (SLS-UK), is pleased to announce that the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom, has granted Marketing Authorisation for SIILTIBCY®, a novel tuberculosis (TB) skin test. This UK authorisation follows the earlier approval of SIILTIBCY® by the European Commission in January 2025 and further expands SIILTIBCY®’s availability across regulated markets in Europe.
SIILTIBCY® is indicated as a diagnostic aid for detecting Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days and older. It contains recombinant TB-specific antigens rdESAT-6 and rCFP-10, which, when administered intradermally, elicit a delayed-type hypersensitivity reaction in infected individuals. The test offers demonstrated sensitivity and specificity, regardless of BCG vaccination status, and is intended for diagnostic use by healthcare professionals.
The MHRA approval marks the first UK Marketing Authorisation granted under the "Serum" name, underscoring SIIPL’s growing presence in highly regulated markets. Serum Life Sciences Ltd (SLS-UK) is the Marketing Authorisation Holder in the United Kingdom, supporting product registration, market readiness, and future stakeholder engagement.
This UK approval builds on the EC authorisation for SIILTIBCY® across EU and EEA member states, and underscores SIIPL’s commitment to accessible, high-quality diagnostic tools to support targeted testing strategies and global TB elimination efforts.
About SIILTIBCY®
Active substances: 0.05 µg rdESAT-6 and 0.05 µg rCFP-10 in one dose (0.1 mL)
Indication: Diagnostic aid for the detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. For diagnostic use only.
Contraindications: Hypersensitivity to the active substances or any of the excipients. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis-derived products.
Side effects: The most common side effects include pruritus, pain, and hematoma at the injection site.
SIILTIBCY® is a skin test, indicated in the UK, EU and EEA countries for diagnosing TB infection, in adults and children aged 28 days or older.
Prescription-only. For further information, please refer to the Summary of Product Characteristics (SmPC).
About TB
An estimated 2 billion people worldwide are infected with TB, and each year 9 million people fall ill with the disease. While the United Kingdom remains a low incidence country, the latest UK TB Surveillance Report (2024) shows that notifications have increased for a second consecutive year, particularly in urban centres, underserved communities, and those born outside the UK. These trends highlight the need for improved targeted testing and early diagnosis; key pillars of WHO’s End TB Strategy.
About Serum Life Sciences Ltd. - UK
Serum Life Sciences Ltd (SLS-UK), based in the United Kingdom is a wholly owned subsidiary of Serum Institute of India Pvt. Ltd (SIIPL), part of Cyrus Poonawalla Group, a global leader in vaccine manufacturing. SLS-UK is the Marketing Authorisation Holder for SIILTIBCY® in the UK, supporting regulatory engagement, product rollout, and market development. Together, SIIPL and SLS-UK aim to accelerate access to critical diagnostics and biologics in service of global public health.
About Serum Institute of India
Serum Institute of India Pvt. Ltd., part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SIIPL's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosiil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric and adult population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.
www.seruminstitute.com
For more information, please contact:
Mayank Sen
+91 9867974055
media.enquiries@seruminstitute.com