Centre waives testing requirement for SII's Cy-Tb injection at govt labs

The Centre has waived the requirement for testing of Cy-Tb injection, meant for detection of latent tuberculosis and manufactured by the Serum Institute, at government laboratories due to lack of testing facilities in state-run set ups, official sources said.

The move comes after Prakash Kumar Singh, Director, Serum Institute of India wrote to the Union health ministry on April 24 and subsequently on May 30 in this regard, they said.

According to the sources, Singh had written a letter to the Drugs Controller General of India (DCGI) seeking waiver of testing of Cy-Tb injection in government institutions due to lack of testing facilities there.

He then requested for the intervention and approval of the health ministry in the matter, an official source said.

The DCGI had 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 facilities in any government lab in India, Singh is leant to have said in the letter.

Singh also mentioned that Cy-Tb is important for the detection of latent tuberculosis (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 DCGI 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.