DGCI grants market authorisation to SII kit for TB diagnosis

Drug regulator DGCI has granted market authorisation to the Serum Institute of India’s Cy-Tb kit for 18 years and above which can be used for skin test for diagnosis of latent Tuberculosis, official sources said on Tuesday.

The approval comes following recommendations by the Subject Expert Committee (SEC) which had reviewed the findings of the study, conducted by the Indian Council of Medical Research (ICMR), for using the kit for diagnosis of latent TB infection in the country.

The Drugs Controller General of India (DGCI) gave its approval on Monday.

Director, government and regulatory affairs at Serum Institute of India (SII), Prakash Kumar Singh, had submitted an application to the DGCI seeking market authorisation for the kit.

Pune-based firm Mylab has partnered with the SII for this kit, an official source said.

“Under the leadership of our CEO Adar Poonawalla our firm (SII) is committed to make available a made in India, next generation, highly cost effective skin test for diagnosis of Tuberculosis infection (Cy-Tb). The availability of Cy-Tb will play a crucial role in making India TB free and will also be in line with our Prime Minister’s vision of Making in India for the world,” an official source quoted Singh as having said in the application.

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