India has emerged as one of the leading suppliers of generic medicines globally. Its pharmaceutical industry supplies more than 50% of vaccines worldwide and roughly 40% of generic drugs used in the United States.

Strength of India’s Pharma Sector

Known as the “pharmacy of the world,” India is home to thousands of drug manufacturing units, many of which are approved by global regulators like the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).

• Low production costs and skilled labor contribute to competitive pricing.
• Major Indian companies like Sun Pharma, Dr. Reddy’s, and Cipla have a strong international presence.
• India is a critical supplier in global health emergencies, including COVID-19.

Concerns About Quality and Safety

Despite India’s pharmaceutical achievements, concerns persist over drug quality and regulatory enforcement. Several high-profile recalls and investigations have highlighted gaps in oversight.

According to a ProPublica investigation^*, some Indian drug manufacturers have faced allegations of data manipulation, inadequate safety testing, and non-compliance with international standards.

“The global dependence on cheap generics has outpaced regulatory capacity,” is a concern raised by many public health experts.

Recent Drug Recalls and Investigations

Over the past few years, multiple generic drugs manufactured in India have been recalled in the U.S. and Europe due to contamination or quality failures. These include blood pressure medications and eye drops.

In 2023 and 2024, the WHO also issued alerts about contaminated pediatric cough syrups exported from India, linking them to child deaths in several countries.

The Road Ahead

The Indian government has initiated steps to improve transparency, upgrade manufacturing standards, and strengthen regulatory agencies. Greater collaboration with international bodies is expected to boost trust and accountability.