Anglophone markets are those formerly colonized by the United Kingdom, and Francophone markets are those formerly colonized by France and Belgium.
Anglophone markets are primarily English-speaking countries, whereas Francophone markets are primarily French speaking. (Portuguese-speaking countries like Angola and Brazil are Lusophone but often grouped similarly for strategic analysis.)
The Indian generic pharma business (branded/unbranded) is designed and skilled to serve Anglophone markets—because regulatory filings and communication happen in English, which Indian pharma companies are well-versed in. This makes the Anglophone market crowded—too many Indian generic players competing for the same piece of the pie, with limited differentiated skill or competency in this space.
As per my understanding, Francophone Africa and parts of Latin America, like Guatemala, El Salvador, Honduras, Angola, Guinea, Chad, etc., present more difficult operating environments. In addition to the language barrier, the challenges described below are particularly hard to mitigate. (Look at the comments section for further read)
Difficulty #1: Regulatory Framework
Each country has its own regulatory agency:
=> In Peru, it’s DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
=> In Chile, it’s ISP (Instituto de Salud Pública)
=> In Honduras, El Salvador, and Nicaragua, regulatory oversight generally falls under the Ministry of Health, though they may have specialized departments under it.
In Latin America, all documentation must be submitted in Spanish, except in Brazil, where it must be in Portuguese.
Regulatory processes in Francophone Africa—in countries like Senegal, Ivory Coast, and Congo—are even more fragmented, slow, and opaque. Documentation is required in French.
In Central America, a regional framework known as RTCA (Technical Regulation of Central America) exists to harmonize pharmaceutical regulation.
However, in practice, individual countries often override regional guidelines and apply their own national regulations.
Approvals frequently depend on the discretion of local regulators, who may not accept Reliance mechanisms (e.g., fast-tracking drugs approved by the USFDA or EMA), even when regional policy allows it.
This kind of non-harmonized, discretionary, and bureaucratic framework poses significant difficulties for Indian generic pharma companies, which are trained to follow structured and standardized frameworks like USFDA processes and ANDA filings.
Difficulty #2: Distribution Challenges
In Francophone Africa and parts of Latin America, weak infrastructure, low margins, and fragmented retail structures result in multi-tiered distribution chains—from importer to national distributor to regional or local wholesalers to pharmacies. This increases the cost of delivery, reduces margins, and creates efficiency losses at every level.
In developed economies such as the United States or urban India, companies like CVS and Apollo Pharmacy can handle last-mile distribution directly and efficiently due to well-developed infrastructure (e.g., interconnected roads, reliable cold chain, consistent regulations).
In contrast, countries like Guatemala, El Salvador, and Honduras have thousands of small, independent pharmacies scattered across rural and urban areas. These markets lack centralized distribution hubs, and poor road conditions, limited cold-chain infrastructure, and long distances between cities and villages necessitate involvement from multiple distributors.
Pharmacies often operate on low margins and maintain limited inventory. Combined with the scarcity of temperature-controlled storage across the chain, this creates significant logistical challenges and risk of spoilage—especially for temperature-sensitive products.
Difficulty #3: Inventory Management Risks
Stable demand for branded or generic medicine is usually an outcome of consistent economic development. Without economic stability, there is no consistent culture of preventive health or chronic disease management.
In West Africa and parts of Latin America, such stability is often lacking. This makes demand forecasting extremely difficult. Demand can surge unexpectedly due to:
=> Disease outbreaks (e.g., malaria or dengue)
=> Temporary WHO- or NGO-funded campaigns
=> Sudden public health emergencies
These bursts are often followed by long periods of minimal activity, leading to challenges in inventory planning, warehousing, and expiry management.
Difficulty #4: Opaque and Informal Systems, Limited Central Databases
Unlike developed countries, where centralized drug usage and sales data are widely available, most countries in Francophone Africa and Latin America lack reliable national databases.
Pharma exporters must rely on:
=> Fragmented distributor sales data
=> Local informal feedback
=> On-ground field staff knowledge
In the absence of structured demand data, inventory planning and market strategy become a matter of trial and error. Smaller Indian exporters, in particular, risk rapid market exit if they fail to adapt to local uncertainties quickly.
Opportunity Within Difficulty
Now, such difficulties also present an opportunity. It is a chance to establish yourself in a market where others would not dare to enter or simply reject outright due to the perceived investment risk.
If any pharma exporter can deeply entrench a profitable business operation in such a testing market, it would represent what I consider to be a formidable competitive moat.