On May 30, 2026, the US Food and Drug Administration (USFDA) approved Zaynich, an injectable antibiotic for drug-resistant urinary tract infections developed by Mumbai-based Wockhardt.
“Zaynich is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.” said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group.
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It is a small, technical-sounding milestone. But set against the arc of India’s pharmaceutical history, it serves as a symbolic bookend: a country that once could not manufacture its own smallpox vaccine now inventing a drug that America’s toughest regulator has signed off on.
“India’s pharmaceutical journey has always been driven by one objective: improving patient access to medicines,” said Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA). “Its leadership in manufacturing affordable generic medicines is not only India’s but also the world’s greatest public health contribution.” Those same capabilities, he said, are now powering the industry’s innovation journey.
A country that used to import even its vaccines
Long before “Made in India” pharma meant generics or vaccines, it meant nothing at all. The Indian Council of Medical Research’s (ICMR) own published history of vaccination in the country notes that until 1850, India imported all of its smallpox vaccine from Great Britain, with no domestic production of its own. It would take the setting up of institutions like the Haffkine Institute in Bombay, in 1899, for India to begin producing vaccines domestically at any real scale, decades before independence, but under colonial administration, not Indian ownership.
ET OnlineBy the time India became Independent in 1947, the country was still not self-sufficient in medicine production. It remained a net importer of pharmaceuticals well into the 1970s, with foreign firms such as Glaxo and Pfizer together controlling nearly 70% of the domestic market, according to The Alchemy of Cure, a history of the industry published this year by the IPA.
The law that changed everything
What eventually broke that dependency wasn’t a scientific breakthrough, it was a change in the law. In 1970, Indira Gandhi’s government passed the Patents Act, which did away with product patents for food and drugs and allowed only process patents, with a sharply reduced term, according to an analysis of the law’s history published by Springer Nature in the Journal of the Knowledge Economy. In practice, this meant an Indian company could legally manufacture and sell any drug already patented abroad, as long as it used a different chemical process to make it, without paying the original patent holder a rupee.
Cipla‘s Yusuf Hamied made the industry’s case plainly in a 2005 speech titled “Indian Pharma Industry: Decades of Struggle and Achievements”: It never opposed patents, he said, only the monopoly rights that came with them, according to The Alchemy of Cure, which cites the speech.
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The effect was immediate and lasting. Companies such as Cipla, Dr Reddy’s, Ranbaxy and Sun Pharma built entire businesses reverse-engineering patented Western drugs through the 1970s and 80s. By the 1980s, the value of India’s pharmaceutical exports had overtaken its imports for the first time, according to a review of India’s drug pricing and trade history published by the Gujarat Institute of Development Research. When India rejoined the global product-patent regime under its WTO commitments in 2005, the domestic generics industry was already too large, too export-oriented and too deeply rooted to be displaced.
The scale of that legacy is visible in government data today: India supplies close to 20% of the world’s generic medicines by volume and meets around 55-60% of global vaccine demand, according to figures released by the Ministry of Commerce and cited by India’s official trade promotion body, Indian Brand Equity Foundation. Pharmaceutical exports touched $30.47 billion in 2024-25, the Commerce Ministry said in a release earlier this year.
“India’s focus on generic medicines reflected the healthcare priorities of the time,” Jain said. “It built a globally competitive generics industry because of its entrepreneurship, a supportive policy framework, and a market environment that rewarded speed, affordability and manufacturing excellence.”
Covid: The industry’s first real stress test
If the 1970 law built India’s manufacturing muscle, the Covid-19 pandemic was the moment that muscle was tested on a genuinely global stage. Serum Institute of India, partnering with Oxford-AstraZeneca, mass-produced Covishield; Bharat Biotech, working with the ICMR, developed Covaxin as a wholly indigenous vaccine.
Under the government’s Vaccine Maitri programme, launched in January 2021, India sent just over 301 million vaccine doses to 99 countries and two UN organisations. The doses went out as grants, commercial exports, and supplies routed through the global COVAX facility, according to a written reply given by Union Minister of State for Health Prataprao Jadhav in the Lok Sabha.
Both of India’s own vaccines were part of the mix, Covishield, made under licence from Oxford-AstraZeneca, and Covaxin, developed entirely in India by Bharat Biotech with the ICMR.
Exports were briefly suspended in mid-2021 during India’s own devastating second wave, before then Health Minister Mansukh Mandaviya announced their resumption from October that year.
It was the first time in decades that Indian-made medicine reached people in dozens of countries during an acute global emergency, and it briefly turned “Made in India” pharma into something the wider world actually noticed, rather than a quiet fact buried in export data.
Not just Wockhardt
Zaynich is the first of its kind to reach the USFDA, but it isn’t the only bet India’s pharma industry has placed on discovery. “Companies such as Glenmark, Zydus Lifesciences, Sun Pharma, Dr Reddy’s, Biocon and Wockhardt have been investing in innovation, biologics and new drug research for many years,” said Jain.
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Zydus got there first, in a sense: its fatty-liver-disease drug Lipaglyn, cleared by India’s Drugs Controller General in 2013, has treated over 1.5 million patients, though it never went to the US FDA.
Glenmark took a different route, licensing its discovery-stage drugs to global partners since 2004, most recently ISB 2001, a cancer and autoimmune-disease drug that AbbVie licensed from Glenmark’s biotech venture, Ichnos Glenmark Innovation, in July 2025.
“Developing a new medicine requires patient capital, regulatory simplification, advanced clinical research infrastructure, and the ability to absorb a high risk of failure,” Jain said. “The good news is that this is changing.”
What the government is betting on next
The clearest official signal that New Delhi wants more stories like Zaynich’s came in this year’s Union Budget. Finance Minister Nirmala Sitharaman announced Biopharma SHAKTI, a ₹10,000-crore, five-year programme aimed at pushing India beyond its traditional strength in small-molecule generics and toward high-value biologics and biosimilars, according to the Budget documents and a subsequent government release. The government’s own stated target is a 5% share of the global biopharmaceutical market.
Jain pointed to this shift too, citing government initiatives such as PRIP (the Promotion of Research and Innovation in Pharma-MedTech sector scheme), the expansion of clinical research infrastructure, and regulatory reforms as evidence the ecosystem is “moving in the right direction.” The next phase, he said, would mean strengthening regulation, clinical research, academia-industry collaboration and financing together, “building innovation on top of that strong generic manufacturing foundation.”
Affordable innovation
Seventy-nine years of Independence have given India’s pharmaceutical industry a word to define itself by: affordable. Whether innovation can stand alongside affordability, is a question even the industry’s leadership answers carefully.
“India will continue to be the Pharmacy of the World, while increasingly becoming a hub for affordable innovation,” Jain said, when asked if “drug discovery hub” would be the more accurate description five years from now.
Getting there, he added, will take sustained research and development (R&D) investment, deeper industry-academia collaboration, simplified regulation, and greater use of AI in research, “India has already shown the world what it can achieve through quality, scale and affordability. There is every reason to believe it can do the same in drug discovery.”
Whether that becomes a pattern, or stays a headline the industry cites for another decade, is likely to take five more years to answer.