India pharma quality lapses force U.S. to look to China for vital drugs

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India's lax regulatory oversight, analog practices where things should be digitized, and data integrity issues have far-reaching consequences that include hundreds of children dying from contaminated cough syrups across the world, and the potential to reshape geopolitical dynamics in the global drug trade.

"India can maintain its lead if it undertakes reforms to bring regulations closer to international standards, invests in state-of-the-art facilities and technology, and focuses on training," Yanzhong Huang, senior fellow in global health at American think tank Council on Foreign Relations (CFR), told Nikkei.

Taking advantage of cheaper infrastructure and inexpensive labor in countries like India and China, the U.S. relies on foreign manufacturers for more than half its active pharmaceutical ingredients (APIs) - the components responsible for the remedial effect in medicine - for its essential drugs.

The attitude is illustrative of a results-oriented culture where breaching guardrails stems from a place of getting things done amid resource constraints, Saswati Barat, an industrial psychologist and CEO of AIOU, a boutique behavioral consultancy, told Nikkei.

The concept of "manage," a colloquial Indian English term for quick-fix workarounds that often bend the rules to get things done, worries Ajaz Hussain, a former deputy director in the office of pharmaceutical science at the Center for Drug Evaluation and Research at the U.S. FDA.

Dinesh Thakur, a Ranbaxy whistleblower who exposed the drugmaker's violations, told Nikkei that senior leaders at Indian pharma companies are often reluctant to invest in digitalization, which would eliminate nearly all human intervention and minimize the possibility of fudged data.

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