Last month, an Indian pharmaceutical company accomplished something unprecedented. Wockhardt became the first Indian pharmaceutical company to win approval from the US Food and Drug Administration for a new chemical entity that it had discovered, developed, and commercialized itself. Its new intravenous antibiotic, Zaynich — a combination of cefepime and the novel agent zidebactam — marks a turning point for an industry that has typically worked on producing cheaper versions of medicines invented elsewhere. But this is changing and Indian companies are beginning to create new drugs that the world needs.

At a time when many antibiotics are failing because of bacterial resistance, Zaynich was approved for complicated urinary tract infections caused by Gram-negative bacteria, among the most difficult pathogens to treat because resistance has advanced furthest against them.

In its pivotal trial, the drug achieved an overall treatment success rate of 89% compared with 68% for meropenem, one of the antibiotics doctors currently reserve for the most resistant infections. Truly novel antibiotics against Gram-negative bacteria have been exceptionally rare for decades. Most of the world's large pharmaceutical companies have abandoned the field because antibiotic development is costly, commercially uncertain, and aimed primarily at high-income markets where the number of patients requiring these drugs is too small to sustain traditional business models.

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Meanwhile, in Bangalore, a smaller company, Bugworks has been developing an antibiotic of its own, BWC0977, built around a new mechanism designed to inhibit bacterial replication and overcome existing........

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