New Delhi: India has long been the world’s pharmacy, supplying cheap generic versions of drugs invented elsewhere. Original drug discovery has remained almost entirely the preserve of American and European companies.
That changed this week when Indian drugmaker Wockhardt’s Zaynich, an antibiotic developed entirely in India, became the first New Chemical Entity (NCE) to be fully invented, developed and commercialised by an Indian pharmaceutical company and cleared by the US Food and Drug Administration (FDA), the world’s most stringent drug regulator.
NCE is a molecule that did not previously exist and has never before been approved as a medicine.
Mumbai-based Wockhardt received FDA approval early this week for Zaynich, a new injectable antibiotic for complicated urinary tract infections (UTIs) caused by drug-resistant bacteria. With this, Zaynich has entered a global antibiotic market valued at roughly $9 billion, according to India Brand Equity Foundation (IBEF), a trust under the Ministry of Commerce and Industry.
“The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations,” said Dennis Deruelle, MD, FHM, and Chief Medical Officer at Wockhardt, in a press statement.
Antimicrobial resistance, or AMR, occurs when bacteria, viruses and fungi evolve to defeat the drugs designed to kill them. It is now one of the leading public health emergencies in the world.
Globally, AMR directly causes an estimated 1.27 million deaths every year and contributes to nearly 5 million more. In India, the burden is among the heaviest in the world, with studies estimating that over 300,000 people died from AMR-related causes in 2019 alone, driven by high rates of infection, widespread antibiotic overuse, and limited access to newer treatments.
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How makes Zaynich different
Most antibiotics used against drug-resistant bacteria work by pairing an antibiotic with a compound that blocks the enzymes bacteria produce to destroy the drug. Popular examples include ceftazidime-avibactam and meropenem-vaborbactam.
However, Zaynich takes a different route. It combines cefepime, an existing antibiotic, with zidebactam, a new molecule discovered by Wockhardt.
According to Dr Kamini Walia, senior scientist at the Indian Council of Medical Research (ICMR) and head of India’s antimicrobial resistance surveillance network, the two components attack bacteria at different points in the process of building their protective cell wall.
Cefepime targets Penicillin-Binding Protein 3 (PBP3), while zidebactam binds strongly to Penicillin-Binding Protein 2 (PBP2).
Both proteins are essential for bacteria to grow and survive.
By blocking both proteins at the same time, the drug disrupts two critical steps in cell-wall construction. This makes it much harder for bacteria to survive, even when they have developed resistance to many existing antibiotics.
Scientists call this the “beta-lactam enhancer” approach. Unlike older combinations that mainly protect an antibiotic from bacterial enzymes, zidebactam actively helps kill the bacteria by targeting a second weak point. That is what makes Zaynich different from most antibiotics currently available.
“ICMR data from its AMR surveillance network identified the needs for Indian patients and the data on the mechanisms of resistance in Indian bugs generated through this network led the company to strategise the beta-lactam enhancer,” Dr Walia told ThePrint.
The strategy appears to have paid off in clinical trials.
In the Phase 3 ENHANCE-1 study, which enrolled 530 patients across 64 hospitals in the United States, Europe, Latin America, China and India, 89 percent of patients treated with Zaynich achieved both a clinical cure and complete clearance of the infection-causing bacteria.
By comparison, 68.4 percent of patients who received meropenem, one of the most widely used last-resort antibiotics for severe drug-resistant infections, achieved the same outcome. In a field where new antibiotics often offer only modest improvements over existing treatments, the difference was notable.
India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), approved Zaynich on 27 May, ahead of the US FDA decision.
Wockhardt has also sought approval from the European Medicines Agency (EMA), as it looks to bring the drug to more markets worldwide.
Why making a new antibiotic is so hard
The science behind Zaynich is not just medically significant but also unusually innovative for a field that has been largely running dry.
The global pipeline for new antibiotics has been steadily shrinking. According to a WHO analysis published in October 2025, the number of antibacterials in the global clinical pipeline has shrunk, from 97 candidates in 2023 to 90 in 2025. Of those 90, only 15 qualify as innovative.
Since the previous analysis in 2023, four agents have secured regulatory approval, one is currently under review, and ten have been discontinued during clinical development. Over the past decade, most major pharmaceutical companies have scaled back or exited antibiotic research and development.
Dr Sarman Singh, founder and director of the Advanced Centre for Chronic and Rare Diseases (ACCORD-Asha) in New Delhi and former director and CEO of AIIMS Bhopal, explained that the reasons are largely economic. Unlike medicines for chronic conditions such as diabetes or hypertension, which patients may take daily for years, antibiotics are intended to be used sparingly and for short durations. The more effective an antibiotic is, the more carefully it must be prescribed to slow the emergence of resistance.
That makes antibiotics far less lucrative than long-term therapies. Adding to the challenge is the sheer length of the development process.
Bringing a new antibiotic from the laboratory to the market typically takes 10 to 15 years and can cost hundreds of millions of dollars. “By the time a company recovers its investment, bacteria may already be evolving ways to resist the drug,” Dr Singh told ThePrint.
In India, the problem is compounded by the widespread misuse of antibiotics.
Despite regulations, antibiotics are often sold without prescriptions, while self-medication, incomplete treatment courses and their excessive use in healthcare and agriculture have contributed to rising antimicrobial resistance. As a result, bacteria are exposed to these drugs more frequently, accelerating their ability to evolve defences against them.
Besides, new antibiotics are often held in reserve and prescribed only for the most severe or drug-resistant infections to preserve their effectiveness. While medically necessary, this stewardship approach further limits sales. The result is a market in which the need for innovation is immense but the financial incentives to invest in it remain weak.
Singh explained that the process of discovering a new drug is also a high-risk endeavour with extraordinarily low odds of success.
“Millions of molecules are screened,” he said. “Today, scientists use in silico or computer-based methods to identify molecules that may show activity against bacteria or cancer cells. But, when those candidates are tested in the laboratory, only five to 10 out of a million show any meaningful effect. Of those, perhaps one or two advance to animal studies.”
Even promising results in animals offer no assurance that a drug will work in humans. Differences in physiology, diet, drug interactions, side-effect profiles and dosage requirements can derail a candidate that initially appeared successful. The attrition continues through multiple phases of human trials, each requiring years of work and substantial investment.
“In many cases, despite screening millions of molecules and spending hundreds of millions of dollars, companies may still fail to produce an approved medicine,” Dr Singh said. “It is a very risky business,” he added.
Dr N.K. Ganguly said that bacteria develop resistance very quickly. He noted that resistance to penicillin emerged within two years of its discovery by Scottish scientist Alexander Fleming in the late 1920s, and the same pattern has been seen with many other antibiotics.
According to him, whenever scientists develop a new chemical structure to overcome resistance, bacteria eventually evolve new ways to defeat it. As a result, newer versions of existing antibiotics also become less effective over time.
This rapid emergence of resistance makes antibiotic development financially challenging, as companies often struggle to recover the large investments required to develop new drugs.
“There has been only one recent antibiotic that has gained both fame and financial success. It was developed by Johnson & Johnson to target beta-lactamase-producing drug-resistant bacteria,” Dr N.K. Ganguly told ThePrint.
Beta-lactamase-producing bacteria make enzymes that can break down many commonly used antibiotics, rendering them ineffective and making infections harder to treat.
The harder question of access
The discovery is only part of the challenge. Antibiotic resistance falls hardest on patients least able to afford new treatments, and India’s drug supply system has a long history of failing exactly those people. Bhakti Chavan, an Extensively Drug-Resistant Tuberculosis (XDR-TB) survivor and member of the WHO Task Force of AMR Survivors, knows this from personal experience.
“As an XDR-TB survivor, I witnessed firsthand how life-saving novel antibiotics had to be imported into India on compassionate grounds,” she said.
“Today, when an Indian-developed, US FDA-approved breakthrough antibiotic for drug-resistant UTI exists, making it accessible in India is not just important, it is the need of the hour for a country carrying a high burden of resistant infections,” she told ThePrint.
XDR-TB is a severe, hard-to-treat form of tuberculosis caused by bacteria that are resistant to the most powerful, standard anti-TB drugs.
Shobha Shukla, chairperson of the Global AMR Media Alliance, said, “We need to make sure that scientific breakthroughs like the indigenous development of new medicines like Zaynich are converted into public health outcomes without any delay.”
“We must address access barriers which people and communities face, especially in the Global South, so that new medicines like Zaynich can reach those in need equitably and without any delay,” she added.
(Edited by Amrtansh Arora)
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