According to an official source, the Centre has waived the requirement for testing of Cy-Tb injection, manufactured by the Serum Institute, at government laboratories due to a lack of testing facilities.

The step was taken after Mr. Prakash Kumar Singh, Director of Serum Institute of India, wrote a letter addressing the Union health ministry on April 24, followed by another letter on May 30.

Additionally, Mr. Singh wrote a letter to the Drugs Controller General of India (DCGI) seeking a waiver of testing of Cy-Tb injection in government institutions, citing the lack of testing facilities in state-run setups.

In his letter, he emphasized the significance of Cy-Tb in identifying latent tuberculosis (TB). He urged the government to permit in-house testing to enable the injections availability in India and worldwide.

The DCGI had approved market authorization of Cy-Tb injection on May 9, 2022, for those aged 18 and above. But even after a year of approval, Cy-Tb is unavailable in the market due to the non-availability of testing facilities in any government lab in India.

(Source:https://theprint.in/india/centre-waives-testing-requirement-for-siis-cy-tb-injection-at-govt-labs-sources/1631472/ )