Serum Institute of India gets DCGI nod for skin test kit for latent TB diagnosis
Pune-based firm Mylab has partnered with the SII for this kit, an official source said.;
New Delhi: Drug regulator DCGI 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 (DCGI) 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 DCGI seeking market authorisation for the kit.
Read also: CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine
Pune-based firm Mylab has partnered with the SII for this kit, an official source said.
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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.
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