The title of the Sahitya Akademi Award-winning novel Deewar Mein Ek Khirki Rehti Thi (A Window Lived in the Wall) describes India’s pharmaceutical industry. It makes 60 per cent of the world’s medicines, saved patients over $2 trillion just in the last decade, operates more than a third of USFDA-authorised factories, and sells in 200-plus countries. Global mortality in AIDS and TB wouldn’t have crashed by 85 per cent without Cipla’s antiretrovirals and Lupin’s Rifampicin. This is not trade, it’s life support. But this success, impossible without policymaking — India’s Patents Act and America’s Hatch-Waxman Act — demonstrates the possibilities when entrepreneurial policy partners with entrepreneurs.

Dexterity by governments on opposite sides of the planet had the same motivations 14 years apart: Affordability and availability. In India in the 1960s, medicines cost more than in Europe, and Western pharma was neglecting infectious diseases. In America in the 1980s, prices for off-patent drugs did not decline without a clear path for generic competition. The Indian Patents Act of 1970 replaced product patents with process patents for 35 years. The Hatch-Waxman Act of 1984 formalised an abbreviated approval process and six-month exclusivity for the first successful applicant of a generic molecule.

The result was remarkable. America’s generic share of dispensed prescriptions rose from 1 per cent to 90 per cent today; the launch price of $2.62 per pill of the heart medication Crestor 20 years ago is now down by 90 per cent. The forthcoming generic versions of the breakthrough drug semaglutide (a weight-loss medication) will soon reduce current prices by a........

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