SEC asks SII and ICMR combined view for TB testing product C-Tb

A Subject Expert Committee (SEC) meant for advising the drug regulator on different approval related technical matters has sought the Serum Institute of India (SII) and India’s apex medical research body Indian Council of Medical Research (ICMR), to present a combined view on the subject of the approval of the former’s tuberculosis (TB) testing product C-Tb and on the latter’s request to extend the trial for an additional clinical trial in population less than 18 years of age.

In a recent meeting of the  Subject Expert Committee (SEC) for antimicrobial and antiviral segments, the Indian Council of Medical Research (ICMR)  has recommended the use of the new test in the adult population under the National tuberculosis Elimination Programme (NTEP). The test is presently claimed to have the ability to identify those infected with tuberculosis (TB) and at risk of developing active disease.

Indian Council of Medical Research (ICMR) has presented its own clinical study data on C-Tb, along with the recommendations of the Indian Council of Medical Research (ICMR)  expert group on the study previously conducted with the product, which was manufactured by the Danish firm Statens Serum Institut (SSI). Serum Institute of India (SII) entered into a partnership with Statens Serum Institut (SSI) in October 2019, under which the former will be producing and distributing the test.

It claimed that the C-Tb shows a similar safety profile to that of the Purified Protein Derivative (PPD) test and is safe in the Indian population at 48 to 72 hours and at 28 days. It has also shown overall better sensitivity in the general population and household contacts of the high-risk population of tuberculosis (TB) patients compared to Purified Protein Derivative (PPD). At the same time, specificity was also comparable in both groups in detecting latent tuberculosis (TB), taking Interferon-Gamma Release Assays (IGRAs) as the reference standard.

“C-Tb can be used for detection of latent-TB under the NTEP for population 18 years and above. It asserted that more data needs to be generated in less than 18 years of age,” it asserted.

“Lack of availability of PPD necessitates the use of C-Tb, which is more sensitive than PPD from a programmatic point of view,” it claimed.

Indian Council of Medical Research (ICMR) has also requested for extension of the trial on additional 400 subjects who are less than 18 years of age as per the approved protocol.

Meanwhile, SII has also submitted its proposal for the manufacturing and marketing of the C-Tb along with all the published clinical study data conducted in several other countries and comparability data regarding various manufacturing details and analytical and release profiles.

The company has informed the Committee that the product will be manufactured by the Serum Institute of India (SII), using the same technology as Statens Serum Institut, Denmark.

Considering both those requests, the Committee concluded, “After detailed deliberation and varying requests from ICMR & SII, the committee recommended that SII and ICMR should deliberate the matter amongst themselves and present the combined view with regards to the application for approval of the product of SII in adult population and proposal to conduct a clinical trial in additional subjects including the population less than 18 years for further consideration by the Committee”.

“The new test makes it possible for the very first time to determine with certainty, in a very simple way, whether a person is infected with TB or not, and in this way target preventive treatment,” said Peter Lawaetz Andersen. He is the research director for vaccines at SSI. Production of this test is expected to take place in Serum Institute of India (SII)’s high-tech facilities in Pune, India.