Abstract
The U.S. Food and Drug Administration (FDA) evolved from a weak bureau into a globally respected regulator only after major preventable disasters forced legal and cultural change. The Central Drugs Standard Control Organisation (CDCSO) of India now faces a similar inflection point following the deaths of more than 300 children linked to contaminated cough syrups exported from India. This article analyzes the FDA’s historical transformation—focusing on the Elixir Sulfanilamide (1937) and thalidomide (early 1960s) crises—and extracts actionable lessons for the CDCSO. It argues that without structural centralization, mandatory raw‑material testing, transparent recall systems, and a cultural shift toward patient‑first enforcement, India’s “pharmacy of the world” status will remain fragile.
1. Introduction
The transition of the U.S. Food and Drug Administration from a small chemistry laboratory into a globally influential regulator did not happen by design. It happened through catastrophe. Today, the Central Drugs Standard Control Organisation (CDCSO) stands at a similar crossroads. Following international outrage over contaminated paediatric cough syrups that caused child deaths in The Gambia, Uzbekistan, and Cameroon (2022–2023), India’s reputation as the “pharmacy of the world” now depends on whether the CDCSO can pivot from a volume‑driven facilitator to a quality‑obsessed enforcer.
Free Membership Required
You must be a Free member to access this content.
