Drugs regulator approves first indigenous TB testing kit

TB is an infectious disease, and according to the government data, India reported 1.93 million new TB cases in 2021

India’s national drugs regulator has approved Pune based Mylab’s test kit to detect tuberculosis (TB) , making it the first made in India test kit to be approved for TB diagnosis, the company announced on Tuesday.

India currently uses imported test kits; most of them come from US and Europe. (PTI)

The kit simultaneously detects drug resistance to the two most commonly used drugs in TB treatment— Rifampicin and Isoniazid, the company added.

TB is an infectious disease, and according to the government data, India reported 1.93 million new TB cases in 2021, making it one of the major public health concerns in the country. India currently uses imported test kits; most of them come from US and Europe.

Apart from the central drugs standard control organization (CDSCO), the kit has also received approval from the national TB expert committee and the Indian Council of Medical Research (ICMR).

“We are addressing several problems simultaneously here. First being able to speed up testing by automated systems that can do multiple tests at one time. Secondly, there is scarce trained manpower for RT-PCR testing, which India can now overcome with fully automated system which does not need highly technical person to handle samples and reagents,” said Hasmukh Rawal, managing director, Mylab.

According to people familiar with the matter, this kit is more automated that others in the market and reduces the need for high expertise to run the test. Also, the kit can be stored at Indian room temperature; thus catering to look temperature requirements.

The kit is priced around ₹650 per unit, which is almost comparable to the prices of others in the market.

“We have technology to detect TB and drug resistance in the form of genexpert that’s a cartridge based nucleic acid amplification test. But this is an expensive test in the private sector and the advantage of made-in-India kit will be its low cost. We will still have to be sure how reliable the technology is,” said Dr Vikas Maurya, director, department of Pulmonology, Fortis Healthcare.

According to the company, the kit has been approved after rigorous and large scale field trials and recommended by TB Expert Committee under the aegis of ICMR. Multicentre centre evaluation study and field feasibility testing studies were also carried out for the test kit.

Emphasizing on the important point of drug resistance, Rawal said, “There is a huge problem of resistance to drugs when it comes to TB. Until now, India had to conduct 2 tests: one to detect TB first and to check drug resistance – that against only one drug (Rifampicin). With Mylab’s PathoDetect™ kit, in a single test – patients can know their active TB infection as well as drug resistance to 2 most common drugs - Isoniazid and Rifampacin - so that they take treatment that will actually work. This is a milestone moment in India’s TB Testing.”

The test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage. Mylab Compact device systems do not require special infrastructure for operations and feasibility studies done on mobile van in rural areas indicate them to be very robust, said the company.