Serum Institute writes to govt, seeks in-house testing of its injection for detection of latent TB

The Serum Institute of India (SII) has urged the Union health ministry to allow in-house testing of its Cy-Tb injection for the detection of latent tuberculosis, saying the testing facility for this product is not available in any government lab in the country, official sources said on Wednesday.

A letter in this regard was written by Prakash Kumar Singh, Director at SII, they said.

The Drugs Controller General of India (DCGI) approved market authorisation of Cy-Tb injection on May 9, 2022, but even after a year of approval, Cy-Tb is not available in the market due to the non-availability of testing facility in any government lab in India, Singh said in the letter.

According to the sources, Singh is also learnt to have mentioned that Cy-Tb is important for the detection of latent TB and the government should allow its in-house testing so that the injection can be made available in India and the world at large.

The DGCA had granted market authorisation to the SII's Cy-Tb injection, which can be used for skin test for diagnosis of latent TB, for those aged 18 and above.

The government has said India is committed to eliminating TB by 2025, five years ahead of the target set by Sustainable Development Goals (SDG) 2030.