Mumbai-based healthcare enterprise Wockhardt has launched a new drug called 'nafithromycin' for community-acquired bacterial pneumonia (CABP). This is the latest drug, seen as a potential replacement to antibiotics like azithromycin that is facing growing resistance. The clinical cure rate of this new drug is 96.7 percent, which is much higher than traditional treatment. It provides eight times lung exposure and ten times the potency of azithromycin with fewer side effects and drug interactions, thus making it safer for patients. Developed over 14 years with an investment of Rs 500 crore, it received support from the Biotechnology Industry Research Assistance Council (BIRAC) and awaits final approval from the CDSCO (Central Drugs Standard Control Organisation), with a commercial launch expected by late 2025.
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India's First FDA-Approved Antimicrobial
Despite its huge success, nafithromycin is not the first drug developed in India that deals with antimicrobial resistance. In February this year, Chennai-based Orchid Pharma secured its first US Food and Drug Administration (FDA) nod for the approval of its antimicrobial enmetazobactam. Enmetazobactam is an injectable drug, which is indicated in complicated urinary tract infections (UTIs), pneumonia, or in the bloodstream. It works differently, however, by targeting the bacterial defenses and neutralizing them without causing any resistance. It also preserves the efficacy of carbapenems, crucially important antibiotics for most severe infections.
Pipeline Projects in Antimicrobial Research
India has several pharmaceutical companies which are actively fighting antimicrobial resistance. Pipeline projects include 'Zaynich', another antibiotic developed by Wockhardt for severe drug-resistant infections, which is in Phase-III trials and expected to be launched in 2025. Bugworks Research is also developing a new class of antibiotics for serious drug-resistant infections in collaboration with the Geneva-based Global Antibiotic Research and Development Partnership (GARDP), which is in early Phase-I trials. It shows a sustained effort to deal with the issue of antimicrobial resistance in India.
Challenge of Antimicrobial Resistance in India
Antimicrobial resistance poses a serious threat to public health in India. In 2019, antibiotic-resistant infections accounted for 300,000 deaths. Sadly, nearly 60,000 newborns die every year from these infections. According to a report by the Indian Council of Medical Research (ICMR) in 2023, resistance levels in some treatments have reached as high as 60 percent.
This alarming data calls for the focus on antimicrobial resistance drugs to take care of this growing health crisis. The inclusion of nafithromycin under the Ayushman Bharat scheme is aimed at making it affordable and accessible so that it can be a stride towards addressing the challenge in India.
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