FDA roadblock to city start-up’s innovation

The quick-testing device for antibiotic resistance can be launched only after approval from the US agency

Published - January 23, 2017 01:59 am IST

Antibiotic resistance is a major global concern which researchers from BITS Pilani, Hyderabad, seek to address through a quick-testing device. However, a regulation seeking approval from a US agency for launching it in India seems to have become a hurdle for their innovation.

The device is a table-top urine analyser that can identify bacteria causing urine tract infections and also suggest antibiotics needed for treatment. Conventionally, the exercise called microbial culturing and antibiotic sensitivity, takes anywhere between 24 and 72 hours in a lab. The device invented by Suman Kapur and her team at BITS Pilani Hyderabad, can do it in four hours. “We have done blind studies in academic settings which have shown complete congruence with our device’s reports. Here, we say results are obtainable in three to four hours in sickest cases, except in cases of septicemia,” said Prof. Kapur, Senior Professor at Biological Sciences department of the institute.

In current clinical settings, a person who approaches a doctor with symptoms of a bacterial infection is started on a broad spectrum antibiotic, while a sample is sent for lab evaluation. By the time results arrive, a person is about halfway through the course.

“If the test indicates a wrong antibiotic has been prescribed, the course is stopped and a new course is started. So treatment that could have been finished in five days could take ten days,” Prof. Kapur explains. Stopping of antibiotics without completing a course is known to contribute to resistance building in microbes.

Resistance of bacteria to antibiotics is naturally occurring but abuse and irrational use has been shown to accelerate resistance in unpredictable ways and also facilitate transfer of resistance between different bacilli. In India, bacteria resistant to colistin, a class of antibiotics called polymyxins, has been detected.

These antibiotics are last resort options, following the exhaustion of which, no treatment options exist. Untreated bacterial infections can be fatal, killing through sepsis after prolonged hospital stays.

The device developed by Prof. Kapur’s team is owned by a start-up operating from her lab. Called xBITS, the company has had the product for more two years now, Prof. Kapur says. “But it has been patented only in India. The Indian patent does not protect it outside the country.”

The roadblock to launching it is a regulation of the country’s central drug regulator that requires an approval from US Food and Drug Administration (FDA) along with a CE approval which indicates conformity to European standards.

“We have a CE approval but to also obtain FDA approval is difficult for a start-up as it requires lot of money. We are also concerned that our innovation may go out of our hands,” she said adding that large medical device agencies have expressed interest in their product but they want to deploy it in the market to benefit the remotest of hospitals in public sector which do not have labs.

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