The world’s pharmacy is leaking its antibiotics

In 2007, a Swedish team led by Joakim Larsson sampled treated effluent from a common treatment plant at Patancheru, near Hyderabad, that served about 90 bulk drug manufacturers. Ciprofloxacin, a workhorse antibiotic, showed up at concentrations as high as 31,000 micrograms per litre.

The team estimated the plant released around 45 kg of the drug a day, roughly what all of Sweden consumed in 5 days. A decade later, German researchers sampling sewers in the same Patancheru-Bollaram belt found moxifloxacin at up to 694 micrograms per litre, and carbapenemase-producing bacteria in more than 95% of samples.

As a biotechnologist, I find this the most fixable part of the resistance story. The pollution leaves a factory through pipes you can sample, and the science now tells us what number to hold those pipes to.

Why a pipe near Hyderabad matters in London and Lagos

India is the largest supplier of generic drugs, with about 20% of global supply. It meets over half of Africa’s generic needs and about a quarter of all medicine used in the UK. That makes India’s manufacturing standards a global health standard, whether anyone planned it or not.

The stakes keep rising. The GRAM study in The Lancet estimates that bacterial antimicrobial resistance (AMR) directly caused 1.14 million deaths in 2021, and projects 1.91 million a year by 2050 and 39 million deaths between 2025 and 2050. South and Southeast Asia and sub-Saharan Africa are forecast to carry the heaviest toll.

WHO states the link plainly: resistance bred by antibiotic pollution can undermine antibiotics worldwide, including the medicines made at the very sites responsible. A factory that pollutes is slowly devaluing its own product.

India wrote the rule first, then shelved it

India saw this early. On 23 January 2020, the environment ministry published draft limits for residues of 121 antibiotics in treated effluent, covering pharmaceutical units and the common treatment plants that serve them. Had the rule been notified, India would have been the first country with legally enforceable antibiotic discharge limits.

The proposed limits were strict. Moxifloxacin was capped at 0.05 micrograms per litre, and samples collected outside factories had shown concentrations more than 10,000 times higher.

Then the draft disappeared. The Environment (Protection) Second Amendment Rules, notified on 6 August 2021, left out antibiotic residue limits entirely. In a 2024 reply before the National Green Tribunal, the Central Pollution Control Board said it had validated test methods for 21 of the 121 antibiotics.

So India can now test for 21 of the antibiotics it once proposed to regulate. It holds factories to a discharge limit on none of them.

The science has settled on the numbers

The technical debate has largely closed. In September 2024, WHO and UNEP published the first global guidance on wastewater and solid waste from antibiotic manufacturing. It sets health-based targets against resistance and separate targets for aquatic life, and it covers every step from making the active ingredient to primary packaging.

WHO’s environment director said the guidance gives regulators, procurers, inspectors and industry an impartial scientific basis to build pollution control into their standards. Industry has published its own numbers too. The AMR Industry Alliance’s 2026 table sets a target of 0.06 micrograms per litre for ciprofloxacin and 0.125 for moxifloxacin, with a default of 0.05 where data are missing.

Those targets apply to the receiving river after dilution, so raw effluent can’t be compared with them one-to-one. Even so, the distance in Exhibit 1 runs to several orders of magnitude.

Buyers have started to price clean production

The market is moving ahead of the regulator. The AMR Industry Alliance released its Antibiotic Manufacturing Standard in May 2025, with the new version in force from 1 January 2026.¹⁴ BSI certifies sites against it, and its Kitemark is built into the NHS antibiotic subscription model and the audit requirements of the Pharmaceutical Supply Chain Initiative.

Early certificates include GSK’s Worthing site in the UK, which certified 7 antibiotic products in 2024, and Shionogi’s Kanegasaki plant in Japan in 2025. Each certificate tells a hospital buyer how the medicine was made, alongside what it costs.

Europe’s rules will reach Indian factories

On 11 December 2025, the European Parliament and Council reached political agreement on the EU pharmaceutical package. Under it, environmental risk assessment becomes a gatekeeper, and applications can be refused if they lack adequate environmental data or mitigation measures.

The Commission’s original proposal extended that assessment to the risk of resistance selection across the entire manufacturing supply chain, inside and outside the EU. With a transition period expected to run until 2028, an Indian API maker supplying European generics will probably need to show its effluent numbers within 2 years.

India is building new antibiotic plants right now

The timing matters because India is adding capacity. The production-linked incentive (PLI) scheme for bulk drugs, with an outlay of ₹6,940 crore to 2029-30, prioritised 4 fermentation products that India fully imported, including penicillin G and clavulanic acid.

Aurobindo’s subsidiary Lyfius Pharma opened a 15,000-tonne-a-year penicillin G plant at Kakinada in October 2024, a ₹2,500 crore investment. In FY24, China supplied 77% of India’s penicillin G imports, 94.1% of its 6-APA and 85.3% of its clavulanic acid.

Fermentation plants generate large volumes of wastewater and spent fermentation residue, and the WHO guidance sets targets for both streams. Every fermenter India commissions this decade will run for 20 years or more. Building controls in at the design stage almost always costs less than bolting them on after a closure notice.

The gap sits with smaller manufacturers

A 2023 study interviewed 29 people across regulators and industry in Telangana and Haryana. It found that multinational companies ran advanced effluent technology, while small and medium firms had treatment plants that met the rules on paper but were often under-used.

The same study found that state pollution boards and smaller firms often treated antibiotic residues as inconsequential. That points to a capacity problem, and capacity can be built.

A five-part plan to bring the limits back

The Centre for Science and Environment, which sat on the expert panel behind the 2020 draft, argued that the limits were technically and economically feasible. Here’s how India could notify them while keeping medicines flowing:

1. Notify in phases. Start with the antibiotics CPCB can already measure, and use the staged levels in the WHO guidance, which are designed to protect access to antibiotics.
2. Tie incentives to effluent performance. The PLI scheme for these products can pay out up to ₹3,600 crore over 6 years. Linking the remaining payouts to verified discharge data would make clean production the profitable path.
3. Publish the numbers. WHO’s consultation draft asked manufacturers to disclose measured concentrations publicly. India could start with the common treatment plants in bulk drug clusters.
4. Upgrade shared treatment for small firms. Co-financing advanced treatment at common plants in clusters such as Patancheru would reach the units least able to invest alone.
5. Buy clean. Central and state medicine procurement agencies could give preference to certified antibiotics, as the NHS already does.

Conclusion: clean antibiotics can be India’s next export edge

India makes a fifth of the world’s generic medicines. Its drug clusters have released antibiotics at concentrations far above what science now treats as safe, and the discharge limits it drafted in 2020 were dropped a year later.

Since then, WHO has set scientific targets and Europe has begun writing manufacturing emissions into market access. Buyers such as the NHS already reward certified production.

India’s new fermentation plants give it a rare chance to build the controls in from day one. Phased limits, incentives tied to verified data, public disclosure, shared treatment for small firms and clean procurement would get it there.

India wrote this rule first, in 2020. Notifying it now would let the world’s pharmacy set the standard everyone else follows.

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