DCGI Approves First Made-in-India Tuberculosis Testing Kit: What We Know

The Drugs Controller General of India has approved the country’s first indigenous testing kit for tuberculosis.

The US Food and Drug Administration (FDA) approved a new drug for the treatment of a deadly type of treatment-resistant tuberculosis.

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The Drugs Controller General of India, the Indian Council of Medical Research, and the national TB expert committee have approved the country’s first indigenous testing kit for tuberculosis. The kit, called PathoDetect™, is manufactured by Pune-based Mylab.

What should you know? FIT tells you.

Literally, Make in India: So far, India has been using imported test kits from the United States and Europe. However, the new RT-PCR-based testing kit developed by Mylab also “detects drug resistance” to Rifampicin and Isoniazid, which are the two most commonly used drugs for TB treatment. 

Why does it matter? TB is a public health concern in our country. 19.3 lakh TB cases were reported in India last year. In 2020, 4.93 lakh people died due to TB.

USP: The kit, priced at Rs 650 per unit, can be stored at room temperature in India, and does not require the consultancy or need of an expert, thus making itself more accessible to the general population. 

The company stated that since the testing kit does not require any special infrastructure for operations and feasibility, the tests can be conducted even in mobile vans in rural areas.

What they said: Hasmukh Rawal, the managing director of Mylab, stated:

“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.”