Why Pharma Companies Get Stuck in Africa: From Cough Syrup Controversies to Regulatory Roadblocks

Africa is one of the most important growth markets for global pharmaceutical companies. The continent has a large unmet need for affordable medicines, vaccines and healthcare products, while many countries continue to depend heavily on imported drugs.

Yet entering Africa is far from straightforward. Pharmaceutical companies can face a maze of product registrations, different national regulations, quality inspections, supply-chain challenges and market-access barriers. In some cases, controversies involving contaminated or substandard medicines have also brought the quality of pharmaceutical exports into sharp focus.

The result is a paradox: Africa needs more affordable medicines, but companies can spend years navigating the regulatory and commercial environment before a product reaches patients.

The Cough Syrup Controversy Showed the Risk

One of the most serious examples came to light in The Gambia in 2022.

The World Health Organization (WHO) identified four paediatric liquid medicines manufactured by India's Maiden Pharmaceuticals as substandard. Laboratory testing found unacceptable levels of diethylene glycol and ethylene glycol in four products, including cough syrups. These substances are toxic and should not be present in medicines.

The incident became a major international pharmaceutical-quality story and triggered recalls and investigations. WHO later confirmed that the contaminated products had been manufactured by Maiden Pharmaceuticals in Haryana, India.

Importantly, this should not be interpreted as evidence that Indian pharmaceutical products generally are unsafe. India remains one of the world's major suppliers of affordable medicines, and African countries rely heavily on Indian pharmaceutical exports.

But the episode demonstrated how quickly a quality-control failure can become a regulatory, commercial and reputational problem across borders.

Why Africa Is a Difficult Pharmaceutical Market

The fundamental problem is that Africa is not one pharmaceutical market.

A company seeking to sell a medicine across several African countries can encounter different registration requirements, regulatory authorities, documentation procedures and approval timelines.

A pharmaceutical product approved in one country may still require a separate registration process elsewhere.

Research published in 2026 notes that companies can face multiple approval systems across African countries, creating additional costs and delays.

This fragmentation matters because pharmaceutical economics depend heavily on scale.

If a company has to prepare separate regulatory submissions, maintain local compliance arrangements and manage different distribution systems for multiple countries, the cost of entering smaller markets can become difficult to justify.

For Indian pharmaceutical companies, which compete partly on affordable pricing, those additional costs can be particularly important.

Regulatory Capacity Is Uneven

Another challenge is the difference in regulatory capacity between countries.

WHO's framework evaluates national medicines regulators according to their regulatory maturity. As of October 2025, only nine African countries were classified at Maturity Level 3, according to recent research reviewing the continent's regulatory landscape. No African regulator had reached Level 4 at that point.

This does not mean medicines in countries with lower regulatory maturity are automatically unsafe. Instead, it highlights differences in the ability to consistently perform activities such as product assessment, inspections, laboratory testing, pharmacovigilance and market surveillance.

For pharmaceutical companies, inconsistent regulatory capacity creates uncertainty.

A company may have a product that meets stringent manufacturing standards but still encounter lengthy or unpredictable procedures in a particular market.

The Bigger Problem: Fragmented Rules and Slow Approvals

The approval process can become a major commercial bottleneck.

A 2025 report on Indian pharmaceutical exports noted that fragmented approval systems in Africa can significantly delay the arrival of medicines and vaccines from India.

Research also highlights large differences in approval timelines between African countries. For example, one analysis cited an average approval time for new generics of 1,035 days in Rwanda in 2022, compared with 61 days in Tanzania.

For a pharmaceutical company, such delays affect more than paperwork.

They can influence:

• Product launch schedules
• Inventory planning
• Working capital
• Pricing
• Distributor relationships
• Patent and exclusivity strategies
• Investment decisions

In other words, regulation becomes a direct business issue.

Why Quality Problems Become Especially Serious

Africa's pharmaceutical challenge is not simply about foreign companies making mistakes.

WHO estimates that at least one in 10 medicines in low- and middle-income countries is substandard or falsified. Its earlier global surveillance work found that 42% of reported cases of substandard or falsified medical products came from the WHO African Region.

The problem can involve genuine products that fail quality specifications, deliberately falsified medicines, illegal distribution channels and poor storage or supply-chain practices.

Limited testing capacity and weak post-market surveillance can make these problems harder to detect.

A 2025 review of the African pharmaceutical sector identified shortages of skilled personnel, limited laboratory capacity, inadequate funding and weaknesses in medicine surveillance among the major regulatory challenges.

For legitimate pharmaceutical manufacturers, that creates another problem: counterfeit or poor-quality medicines can damage consumer trust in an entire therapeutic category.

India Still Has a Major Opportunity

Despite these challenges, Africa remains strategically important for India's pharmaceutical industry.

India supplies a substantial share of Africa's imported medicines and has built a strong position in affordable generics.

The opportunity is particularly significant because many African countries face large healthcare needs while attempting to expand access to affordable treatment.

Indian companies can therefore benefit from demand for generic medicines, chronic-disease treatments, anti-infectives, vaccines and other healthcare products.

But the future opportunity is likely to depend increasingly on quality, regulatory credibility and local partnerships, rather than simply offering lower prices.

African Medicines Agency Could Change the Equation

One of the most important developments is the effort to harmonise pharmaceutical regulation across the continent.

The African Medicines Agency (AMA) is intended to improve cooperation between national regulators and strengthen the regulatory framework for medicines.

The objective is not necessarily to eliminate national regulators, but to make the system more coordinated and predictable.

That could eventually reduce duplication for pharmaceutical companies and make it easier for high-quality manufacturers to launch products across multiple African markets.

However, the transition will take time. Political commitment, funding and participation by major African economies remain important factors.

What This Means for Indian Pharma Investors

For investors tracking Indian pharmaceutical companies, Africa should not be viewed simply as an export-growth story.

The key questions are more specific.

Investors should monitor a company's exposure to African markets, regulatory track record, product concentration, manufacturing quality systems and dependence on individual distributors or countries.

A company with strong compliance systems and diversified markets may be better positioned to handle regulatory shocks than one heavily dependent on a small number of markets.

Quality-related controversies can also have consequences beyond the affected product. Regulators in importing countries may increase scrutiny, while customers and distributors can become more cautious.

At the same time, regulatory tightening can ultimately benefit established manufacturers that already operate with strong quality systems because it raises the barriers for weaker competitors.

The Road Ahead

Africa's pharmaceutical market presents both a major opportunity and a complicated operating environment.

The continent needs affordable medicines, while pharmaceutical companies need predictable rules, efficient approvals and reliable supply chains. The challenge is bringing these interests together without compromising medicine quality.

The cough syrup controversy demonstrated the potential human and reputational cost when quality controls fail. But the broader story is much bigger: fragmented regulation, limited testing capacity, supply-chain weaknesses and slow approvals can all determine how successfully pharmaceutical companies operate in Africa.

For Indian pharma companies, the opportunity remains significant. The companies most likely to benefit over the long term will be those that combine competitive pricing with strong manufacturing standards, regulatory discipline and deeper engagement with African markets.

For investors, the key takeaway is simple: Africa's pharma opportunity is real, but regulatory execution and quality compliance will be just as important as sales growth.

This article is for informational and educational purposes only and should not be considered investment advice.

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