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Indian pharma develops more effective drug to combat antibiotic-resistance

Wockhardt's nafithromycin is India's first FDA-approved antimicrobial that is seen as an alternative to existing antibiotics like azithromycin, which is facing increasing resistance in humans

medicine, drugs, antibiotics

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Vasudha Mukherjee New Delhi

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Mumbai-based healthcare enterprise Wockhardt has developed a new drug called ‘nafithromycin’, aimed at treating community-acquired bacterial pneumonia (CABP). This drug is seen as a potent alternative to existing antibiotics like azithromycin, which is facing resistance levels, according to a report by The Times of India.
 
Nafithromycin is the product of significant effort by pharmaceutical firms in India trying to combat antibiotics and antimicrobial resistance (AMR).
 
So far, testing of nafithromycin (Miqnaf) has found a 96.7 per cent clinical cure rate, one that is significantly higher than traditional treatments. It also offers eight times the lung exposure and ten times the potency of azithromycin. Moreover, this new drug is expected to have fewer side effects and drug interactions, making it a safer option for patients.
 
 
Developed over 14 years with a total investment of Rs 500 crore, nafithromycin received technical and financial support from the Biotechnology Industry Research Assistance Council (BIRAC). The drug is currently awaiting final manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO) and is expected to launch commercially by late 2025.
 
To ensure affordability and accessibility, the government plans to include nafithromycin under the Ayushman Bharat scheme, the report said.
 

India’s first FDA-approved antimicrobial

Although a significant breakthrough, this is not the first AMR to be developed in India. Chennai-based Orchid Pharma was the first to receive approval from the US Food and Drug Administration (FDA) for its antimicrobial enmetazobactam in February of this year to treat complicated urinary tract infections (UTIs). This injectable drug is designed to treat severe infections, including UTIs, pneumonia, and bloodstream infections.
 
Unlike traditional antibiotics, enmetazobactam targets bacteria’s defence mechanisms, immobilising their ‘weapon’ without triggering resistance.  The drug also helps preserve the effectiveness of carbapenems, the last-resort antibiotics for many severe infections.
 
There are many more pharmaceuticals in India that are working to fight this. Pipeline projects include:
Zaynich: Also developed by Wockhardt, this antibiotic for severe drug-resistant infections is in Phase-III trials and expected to launch in 2025.
 
Bugworks Research: In collaboration with the Geneva-based Global Antibiotic Research and Development Partnership (GARDP), the Bengaluru-based company is working on a new class of antibiotics for serious drug-resistant infections, currently in early Phase-I trials.
 

Fight antimicrobial resistance in India

Antimicrobial resistance poses a severe threat to public health in India, which reported 300,000 deaths from antibiotic-resistant infections in 2019 alone, according to a study quoted by BBC news report.
 
Alarmingly, nearly 60,000 newborns succumb to these infections each year, the report added.  A 2023 report by the Indian Council of Medical Research (ICMR) also found levels of resistance, with some treatments showing resistance as high as 60 per cent. Making MR drugs a priority for the country. 

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First Published: Dec 05 2024 | 1:35 PM IST

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