Lack of testing facilities: Centre waives testing requirement for SII Cy-Tb injection at Govt labs

Written by Ruchika Sharma Published On 2023-06-19T12:30:15+05:30 | Updated On 19 Jun 2023 12:30 PM IST

Lack of testing facilities: Centre waives testing requirement for SII Cy-Tb injection at Govt labs

New Delhi: 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.

India is committed to eliminate Tuberculosis by 2025, five years ahead of the target for TB set by Sustainable Development Goals 2030.

Serum Institute of India is an Indian biotechnology and biopharmaceuticals company headquartered in Pune, India. The company was founded by Dr. Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.

Read also: Serum Institute of India gets DCGI nod for skin test kit for latent TB diagnosis

Cy Tb injectiontuberculosisserum institute of indiaserum institute of India newsDrugs Controller General of IndiaDCGI

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751