The telephone rang simply earlier than midnight.
It was early February in 2001 in Mumbai, and Yusuf Hamied, a seasoned chemist on the Indian multinational pharma firm Cipla, was at a cocktail party. He picked up the telephone anyway. A New York Occasions reporter was on the road, calling to examine a rumor: Was Hamied actually providing HIV meds for $1 a day?
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In 2001, AIDS — which develops when HIV goes untreated — killed round 3 million individuals, 70 p.c of whom had been in Africa. The primary therapy, antiretroviral remedy, was remarkably efficient however out of attain for many of the world, operating about $10,000 to $15,000 a yr per affected person. Hundreds of thousands of individuals had been dying as a result of they couldn’t afford these costs.
The Occasions reporter’s rumor turned out to be true. Hamied’s firm Cipla had simply publicly provided the most recent HIV therapy to the help group Docs With out Borders for under $350 a yr — a 97 p.c value minimize over prevailing medication. Virtually in a single day, a remedy as soon as priced for wealthy international locations was immediately inside attain for the international locations hit hardest by AIDS.
“Dr. Hamied, your life is not going to be the identical from tomorrow,” the reporter mentioned, and hung up.
The subsequent morning, the story of Hamied’s accomplishment was on the entrance web page of the Occasions. The information ricocheted via help companies, well being ministries, and the halls of Washington. The Cipla provide “adjustments every thing,” Toby Kaspar, an official of Docs With out Borders, mentioned on the time.
Indian generics would quickly develop into the spine of the worldwide HIV response. Inside two years, the US launched PEPFAR, the President’s Emergency Plan for AIDS Reduction, an enormous $15 billion program to ship HIV therapy to sub-Saharan Africa and past. Within the final 20 years, that single program has helped save greater than 25 million lives.
That victory was solely doable at that scale due to low-cost Indian generic medication, which helped PEPFAR save almost $1 billion early on, based on a US Authorities Accountability Workplace report. The competitors created by these generics additionally drove the price of HIV medication additional down.
That dollar-a-day provide in 2001 felt like a miracle, but it surely wasn’t. It was the payoff of a pharma revolution that had been quietly constructing for many years. India didn’t simply stumble into turning into the world’s pharmacy. It bought there via a sequence of intentional and defiant decisions.
Immediately, Indian generics dominate the world. By one estimate, roughly 60 p.c of prescription tablets and capsules for the US market are actually made in India. Throughout Africa and lots of Asian international locations, the share is even increased. Main help companies like UNICEF and International Fund supply most of their HIV medication and different necessities from Indian drugmakers. And generic competitors has pushed the popular HIV therapy in poor international locations to beneath $45 a yr.
However India’s dominance got here at a price.
Lately, contaminated cough syrups from India have been linked to the deaths of greater than 140 youngsters abroad. And dependence on the nation’s producers has develop into so nice that when a single Indian manufacturing unit making a vital most cancers drug shut down in 2023, US hospitals had been compelled to ration chemotherapy, even turning to China for emergency imports.
For many years, there was an implicit discount made with India. In trade for a flood of inexpensive, lifesaving medicines — the identical generics that turned HIV from a demise sentence right into a treatable illness — the world would tolerate a system constructed for the bottom doable value. Now, that discount is breaking, and the pharmacy of the world is turning into a choke level.
And that is all unfolding simply because the world is about to lean even tougher on India. Demand for medication that deal with power situations resembling diabetes and coronary heart illness is climbing. Patents on weight-loss blockbusters like Ozempic will begin to expire over the following decade, opening a market that analysts say may attain round $100 billion a yr, which might ship much more quantity to the most affordable, highest-capacity makers.
The query isn’t whether or not India could make the world’s medication. It’s whether or not it may possibly make them safely and reliably — and whether or not it may possibly adapt to the wants of the long run.
How India turned the pharmacy of the world
India received independence from the UK in 1947, however its patent system remained caught within the colonial period. Beneath outdated British guidelines, if a Western firm invented a drug, it successfully owned the drug itself — the basic molecule — and nobody else may make it.
India’s personal governmental reviews warned that these guidelines had been choking off native manufacturing, but they remained in place for many years. In consequence, the nation needed to rely closely on Western drugmakers for nearly each important drugs.
By 1966, newly elected Prime Minister Indira Gandhi noticed a possibility to alter that. Her socialist authorities was constructing momentum, nationalizing banks and pushing a robust marketing campaign for “self-reliance.” India was creating its personal public-sector drug corporations. However patent hurdles stood in the way in which of innovation and self-sufficiency.
So in 1970, India rewrote the foundations. The new Patents Act made a surprisingly easy however transformative change: it eradicated product patents for medication and meals, permitting solely course of patents. An organization may now not personal a drug outright — solely its explicit approach of constructing it. If an Indian agency like Cipla may work out a distinct strategy to make the identical drug, it may legally promote it.
That meant that if an Indian drug firm modified the manufacturing steps even barely, it may declare a brand new course of and legally promote the identical drug. As Achal Prabhala, a public well being activist who campaigns for entry to medicines, places it, “having no product patents was equal to having no patents.”
A brand new wave of companies, together with Cipla, turned reverse-engineering right into a craft after which an business. India’s generics business blossomed, although exterior the nation, nearly no one was paying consideration. In greenback phrases, the nation was mainly a rounding error within the international medication market.
However then coverage selections made removed from New Delhi supercharged India’s generic business.
In 1984, america handed the Hatch-Waxman Act, which basically created a quick lane for generic drug candidates. As an alternative of repeating years-long, wildly costly scientific trials, generic makers may win approval by displaying their model behaved the identical approach within the physique because the brand-name drug. All of the sudden, it turned a lot simpler and cheaper for generic medication to enter the US market.
The second vital transfer got here from Geneva. In 2001, The World Well being Group launched its medicines prequalification program to vet medication for UN companies and large funders. Indian producers rapidly met this system’s high quality requirements and, inside a number of years, made up a big share of HIV, TB, and malaria medicines on its permitted lists.
By the early 2000s, Indian drug makers had develop into main exporters of low-cost generics to different creating international locations and had been beginning to carve out a foothold within the US market.
India’s combat to maintain its quirky patent system
Western pharmaceutical corporations, media conglomerates, and tech giants noticed India’s patent mannequin as a direct risk. Starting within the late Seventies, a small group of executives from Pfizer, IBM, and different US giants — together with Warner Communications — lobbied Washington to rewrite the worldwide commerce guidelines on mental property. They pushed to shift the locus of enforcement out of a sleepy discussion board with nearly no actual energy into the brand new World Commerce Group (WTO), the place breaking the foundations may set off commerce sanctions. And it labored.
The outcome was TRIPS — Commerce-Associated Facets of Mental Property Rights — a worldwide treaty that inextricably tied patents with commerce, and basically required member international locations to just accept the entire bundle of guidelines, together with the patent ones. In observe, it was an all-or-nothing alternative: be a part of the system that governs almost all world commerce on TRIPS phrases, or stand exterior it. Critics accused wealthy international locations like america and Japan of “pulling up the ladder” as a result of they themselves had constructed key industries by copying international know-how, solely to now shut that path off for everybody else.
Earlier than I turned a journalist, I labored inside India’s pharmaceutical business. Again then, I considered the nation as “the place that made lifesaving medication out there for individuals who’d by no means afford them in any other case,” and I used to be pleased with that. It felt like one of many uncommon methods India was clearly making the world higher off.
However reporting this piece has compelled me to revisit that feeling. It was fascinating to dig into the early ethical arguments and the political maneuvering that made India’s “pharmacy of the world” doable within the first place. However the extra I learn, and the extra I talked to individuals who’d investigated the business, the clearer it turned that India’s dominance over the event of generic medication had a darkish facet.
Most of us have most likely swallowed Indian-made drugs with out ever excited about it, and I needed to know how they’re made, how the system we’ve relied on is beginning to fail us, and what India’s function is in maintaining — or shedding — the world’s entry to drugs.
India begrudgingly accepted the cut price, selecting to take successful to its pharmaceutical sector so as to preserve promoting textiles and farm items overseas and achieve entry to richer markets. As soon as India signed on, the WTO gave it a decade of grace interval — till 2005 — to dismantle its outdated patent legislation and restore product patents.
However for India, it was, in Prabhala’s phrases, “shedding a pawn to achieve a knight.”
Because the deadline approached, lawmakers started drafting a brand new patent legislation. Then, a political earthquake hit. India’s BJP-led ruling alliance get together was unexpectedly voted out in 2004. The brand new authorities, led by the Congress get together, trusted the help of a small bloc of communist events that had spent many years railing in opposition to monopolies. “We informed the federal government that we will help the laws provided that you settle for our strategies in nationwide curiosity,” one communist chief mentioned on the time.
The brand new authorities hammered out an improvised compromise: it will restore product patents as TRIPS required, however attempt to curb drug monopolies. In March 2005, with nearly no debate, the federal government slipped in a last-minute change that set a better bar than the US or Europe for what counted as significant innovation.
“Right here’s the ground TRIPS units — what if we dig it 5 ft deeper?” mentioned Prabhala, who campaigned alongside activists for India’s 2005 patent legislation. “It’s nonetheless the ground, proper?”
The brand new clause aimed squarely at one in all pharma’s favourite methods: evergreening, which is when corporations stretch a monopoly by making minor tweaks to an outdated drug — a brand new coating, a distinct salt, a slow-release model. Beneath the brand new rule, you couldn’t get a recent patent only for repackaging an outdated drugs. You needed to present the brand new model truly labored higher for sufferers.
The worldwide pharma business instantly fired again.
The primary massive take a look at got here in 2006 from Novartis, the Swiss drug maker behind the most cancers drug Glivec. It needed a brand new Indian patent not on the unique molecule, however on a brand new type of the identical drug. India’s patent workplace rejected it, citing the brand new legislation.
Novartis, in response, went to a state excessive court docket in southern India to dismantle the legislation itself, arguing that the Indian clause was unconstitutional and violated WTO guidelines. A win for Novartis would make it simpler for minor patent tweaks to outdated medication to delay generics — an actual danger not solely to Indian corporations, however to the hundreds of thousands of people that trusted Indian-made medication.
Then got here a twist. Earlier than a pivotal 2007 listening to, a authorities skilled panel launched a report hinting that India’s more durable patent guidelines may conflict with TRIPS. For Novartis, it appeared like helpful ammunition, till activists combed via the textual content and seen acquainted language. Passages seemed to be lifted nearly verbatim from a research funded by a pharma business group that included Novartis.
The report was withdrawn, and Novartis misplaced its greatest speaking level. The excessive court docket rejected the corporate’s problem, and in 2013, India’s Supreme Court docket put an finish to the case. India’s new legislation stood; Novartis’ patent didn’t.
David had crushed Goliath in court docket. However may he preserve profitable within the factories that now equipped the world?
India bent the foundations with out breaking them, and the world bought low-cost medication due to it. However that discount rested on an unwritten promise: that generic medicines could be low-cost, sure, however that they’d additionally work. Immediately, that basis is cracking.
For years, reporters and whistleblowers flagged Indian-made medicines in poorer international locations as substandard or contaminated, however exterior public-health circles, these warnings barely registered. When outsiders have raised the alarm, the federal government’s intuition has usually been to suppress. When lecturers printed research discovering substandard Indian medication in Africa in 2014, for instance, the federal government threatened to sue the researchers moderately than act on their findings.
In 2022, two deadly outbreaks confirmed how contaminated medication can slip via India’s safeguards. Within the Gambia, pediatric acute kidney an infection circumstances had been tied to 4 Indian-made cough syrups; the WHO issued a worldwide alert after labs discovered diethylene and ethylene glycol within the merchandise, resulting in the deaths of 141 youngsters. A couple of months later, Uzbekistan reported little one deaths linked to syrups from one other Indian agency; a court docket later convicted 23 individuals over the episode. That very same yr, the WHO issued a worldwide alert highlighting how shaky India’s drug oversight will be.
In response to Dinesh Thakur, a public well being activist and pharma whistleblower, and Prabhala, India’s drug business covertly operates a two-track system: one set of factories constructed to impress international inspectors, and one other for India and poorer markets. States accumulate licensing charges from producers, so that they have little urge for food for shutting crops down. Even when unhealthy actors are caught, the penalties are largely administrative — a 60-day suspension after which again to enterprise. In consequence, many producers do exactly sufficient to scrape via inspections.
After the Gambia scandals, regulators ran nationwide inspections and informed producers to improve crops to WHO-level requirements or shut them down. Some licenses have been cancelled, and some house owners arrested. However even the WHO says India nonetheless has “a protracted strategy to go,” mentioning that exports now face more durable checks than many medication bought at dwelling.
The response has to this point been “piecemeal reforms, opaque and badly worded laws, and the absence of each assets and the need to implement high quality requirements,” Thakur mentioned. India nonetheless has no actual nationwide system for recalling unhealthy medication as soon as they’ve gone out the door.
However even when India reforms its pharmaceutical system, extra challenges are on the way in which.
The world’s illness map is altering. Local weather change and new pandemics will demand vaccines and therapies that don’t exist but. As extra international locations get richer and older, power situations might be answerable for extra deaths. And India has been largely lacking from the worldwide race to create new first-in-class medicines.
India’s generic increase was constructed on old-school chemistry: “small-molecule” drugs. Suppose statins for ldl cholesterol, HIV medication, blood stress tablets — medicines that, as soon as you recognize the method, a talented chemist can copy and switch into an affordable capsule. That’s the world India mastered. However the brand new frontier isn’t like that. It runs from weight-loss injections like Ozempic and Wegovy to cancer-treating antibodies and experimental gene and cell therapies — advanced biologic medication grown from dwelling cells, not simply chemical substances blended and pressed right into a pill.
It’s considerably more difficult to reverse-engineer these the way in which you’ll for a ldl cholesterol capsule. China has managed it, making biotech an express nationwide precedence and pouring public cash into labs, analysis parks, and startups. Immediately, Chinese language companies account for roughly 30 p.c of the drug molecules that Large Pharma is now licensing from exterior corporations, together with new most cancers and autoimmune therapies.
A handful of Indian companies are making cheaper variations of insulin and most cancers antibodies or signing licensing offers, however a majority of the business continues to be geared to make low-cost generics as soon as a patent lifts. And India nearly by no means invents the underlying medication.
If the following breakthroughs are invented in Boston and Beijing, and India isn’t in that room, poorer international locations might by no means see an affordable model in any respect. That’s as a result of there’s nothing Indian factories can legally copy till another person has accomplished the laborious, costly science first.
Large Western drug makers usually spend round 20 p.c of their gross sales on analysis and growth, whereas Indian pharma corporations are nearer to 7 p.c. India as a complete places little over half a p.c of its GDP into R&D, whereas China allocates greater than 4 instances that share. In 2024, Cosentyx, a drug from Novartis that treats psoriasis and arthritis, introduced in additional income than Solar Pharma, India’s greatest drug firm, made throughout its total international enterprise.
Except India finds a approach, its “pharmacy of the world” mannequin dangers turning into a pharmacy of yesterday’s medication, with the most recent medicines reserved for many who will pay full value. On paper, India nonetheless has probably the most radical patent legal guidelines on the earth — and it nonetheless has the potential to do the world a variety of good.
If India can repair its high quality disaster and begin investing in new science, the legislation it fought for may as soon as once more be used to push down costs on the following era of medicine, the way in which it as soon as did for HIV therapy. If it doesn’t, that hard-won legislation will keep largely symbolic — and India might be remembered extra for what it may have accomplished for international well being than for what it selected to do.
