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Are Indian pharmaceutical companies deliberately selling inferior medicines in African markets?

Tougher regulatory measures needed in order to improve drug safety and quality

A new study by MPRC faculty associate Ginger Zhe Jin and colleagues Roger Bate, Aparna Mathur, and Amir Attaran found that more than ten percent of samples of antibiotic and tuberculosis drugs made in India and sold in Africa failed basic assessment of active pharmaceutical ingredients (API). Most of the failed samples did contain some amount of the necessary active ingredient, but not at the appropriate dosage. These substandard pharmaceutical products, made in India, were more likely to be sold in Africa than in India or other non-African countries.

“Some Indian manufacturers as labeled in our drug samples do appear to differentially supply poor quality products to African markets where GDP per capita is low and local regulations are weak,” stated the researchers. Regulatory oversight of pharmaceutical products is weaker in many African countries compared to middle-income countries such as China or Brazil, making it possible for manufacturers to intentionally export lower quality products to those countries. The authors considered alternate explanations such as counterfeiting or the effects of poor storage, but found that neither of these possibilities was sufficient or likely to explain the prevalence of substandard pharmaceuticals in African markets.

“Regional, rather than simply national, regulatory action and boycotts of specific Indian manufacturers might drive better performance from all Indian exporters,” the authors stated. They also recommend tougher quality inspection practices, as well as releasing information to African doctors and pharmacists about which companies have repeatedly been found to sell substandard medicines.

Indian pharmaceutical manufacturers have taken issue with the results of the study, calling it “a deliberate campaign to malign the Indian pharma industry.”

In response to a threat from the Indian government to sue the research team over their findings, the researchers said, “None of our results are surprising. Anyone familiar with the pharmaceutical industry in India or Africa knows that a large number of Indian medicines are traded through poorly regulated channels where both compliance with the law and quality standards can be easily evaded.”

Read the full working paper

Read the news story in the Economic Times

Read a summary of the paper on the American Enterprise Institute website

Read a related news story in the Economic Times

Read about the Indian government's lawsuit in the Economic Times

Read a news story about the authors' response to the lawsuit in the Economic Times

Read the American Enterprise Institute's response to the government lawsuit