India’s Crisis of Substandard Drugs, at Home and Abroad

In the past months, sub-standard Indian-made cough syrups and eye drops have led to deaths and infections across the world, most notably of over 70 children in The Gambia, in West Africa. While the WHO, the U.S., CDC, and other independent bodies have held Indian companies responsible, the Indian regulator shielded the manufacturer of cough syrups that caused deaths in The Gambia. The deaths reveal a medical crisis with a global footprint, originating in India, the pharmacy of the world. Nearly all developing countries, especially in South Asia, rely heavily, if not exclusively, on Indian pharmaceuticals.

The Indian pharmaceutical industry, worth around $50 billion, is underpinned by lax regulations, domestic pharmaceutical companies that exploit these systems, and a political environment that allows unsafe drugs into both domestic and export markets. In particular, Indian manufacturers have been following (and getting away with) different quality safety standards for different markets, with the poorest countries often treated the worst.

In a series of reports for Himal Southasian, Vidya Krishnan and Arshu John will scrutinize pharmaceutical regulation in India, the processes through which manufacturers obtain licenses and export drugs, and the risks it imposes on developing nations. The investigation will examine the vulnerability of South Asian markets to the Indian pharmaceutical industry—with a focus on Bangladesh and Nepal—and study parallels with the case in The Gambia.