The move comes after Prakash Kumar Singh, Director of SII wrote to the Union Health Ministry in this regard, they said.
Published Jun 18, 2023 | 5:59 PM ⚊ Updated Jun 18, 2023 | 6:01 PM
Vaccination. Representational Image. (Creative Commons)
The Centre has waived the requirement for testing of Cy-Tb injection, meant for detection of latent tuberculosis and manufactured by the Serum Institute of India (SII), at government laboratories due to the lack of testing facilities in state-run setups, official sources said.
The move comes after Prakash Kumar Singh, Director of SII wrote to the Union Health Ministry on 24 April and subsequently on 30 May in this regard, they said.
According to the sources, Singh had written a letter to the Drugs Controller General of India (DCGI) seeking a waiver of testing of Cy-Tb injection in government institutions due to the lack of testing facilities there.
He then requested the health ministry’s intervention and approval 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 tests for diagnosis of latent TB, for those aged 18 and above.
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