Just two days after Novo Nordisk launched Wegovy (semaglutide 2.4 mg) in India, Eli Lilly received regulatory approval for ...

However, according to official FDA records and publications, the FDA doesn’t independently collect and test >99.9% of drugs from overseas, including China and India.

After visiting Kilitch Healthcare India Limited’s Mumbai plant last month, FDA investigators found cracked floors, non-sterile conveyor belts and instances where staffers openly brushed their hair.

By opening its playbook to India's FDA—the Central Drugs Standard Control Organization (CDSCO)—the U.S. FDA may inadvertently make it easier for Indian companies to cheat, ...

An inspection blitz on Indian drug factories that supply to the U.S. helped push the broader index of Indian health-care stocks down by as much as 20 percent earlier this year from its all-time ...

FDA records show that 32 inspections were carried out last year in India, and most were for companies seeking approval to sell a drug or ingredients, not to check on the quality of manufacturing ...

FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of important documents from a facility being inspected.

WASHINGTON (AP) — The head of the Food and Drug Administration said Friday that her agency will add more inspectors in India to better monitor drugs from the country's burgeoning pharmaceutical ...

An interview with Dinesh Thakur and Prashant Reddy about India’s drug manufacturing industry and recent cases of India-made drugs leading to the deaths of children in Uzbekistan and Gambia.