Peru Tightens Scrutiny of Drug Imports from China and India
The Peruvian Ministry of Health (Minsa) has launched a critical mission to inspect 26 pharmaceutical plants in China and India, the primary sources of imported medications for the country. This move comes amid growing concerns about the quality and safety of pharmaceuticals entering the Peruvian market, particularly following reports of substandard and contaminated drugs.
A Response to Quality Concerns
Recent investigations, including reporting by Salud Con Lupa, revealed that between 2019 and 2025, the Minsa purchased 19 batches of essential cancer drugs – including cisplatin, ifosfamide, cyclophosphamide and doxorubicin – that were found to be defective. Issues ranged from bacterial contamination and visible particles like glass or lint to incorrect concentrations of active ingredients. Over 140,000 vials, valued at S/ 3.4 million, were ultimately destroyed, disrupting cancer treatment for numerous patients.
This situation prompted the Digemid (Peru’s General Directorate of Medicines, Supplies and Drugs) to suspend the registration of products from laboratories failing to meet Good Manufacturing Practice (GMP) standards. As of January 2026, 297 products, largely from India and China, were barred from sale within Peru.
The Scale of Imports and the Require for Oversight
Peru is heavily reliant on generic medications from India, which accounts for approximately 20% of global pharmaceutical production by volume and supplies over 200 countries. In 2024 alone, Peru’s pharmaceutical imports from India exceeded US$120 million. This dependence underscores the importance of robust quality control measures.
The current mission, comprised of 20 Digemid specialists, will focus on verifying strict adherence to GMP standards. Inspections will cover infrastructure, production processes, quality assurance systems, raw material controls, microbiological and physicochemical analyses, storage conditions, traceability, and compliance with international protocols.
Digemid’s Expanding Role and Future Strategies
Digemid Director General Lida Hildebrandt emphasized that this mission represents a proactive and technical approach to healthcare, strengthening transparency and formality within the national pharmaceutical market. The Minsa believes direct oversight at the source of production will minimize health risks and enhance the rigor applied to manufacturers.
The initiative also addresses past limitations in Digemid’s ability to conduct timely international inspections, which previously led to temporary waivers of GMP certification requirements. While these waivers remain in effect for some facilities, the Minsa aims to reduce reliance on such exceptions through increased on-site verification.
What’s Next for Pharmaceutical Regulation in Peru?
This inspection mission signals a broader trend toward stricter pharmaceutical regulation in Peru. The government is likely to continue prioritizing quality control and strengthening its oversight of imported medications. This could involve increased investment in Digemid’s inspection capabilities, closer collaboration with international regulatory bodies, and potentially stricter penalties for manufacturers found to be in violation of GMP standards.
The focus on GMP compliance is not unique to Peru. Globally, regulatory agencies are increasing scrutiny of pharmaceutical manufacturing processes to ensure patient safety and product efficacy.
Frequently Asked Questions
Q: Why is Peru focusing on China and India?
A: These two countries are the primary sources of imported pharmaceuticals for Peru, making them critical areas for quality control.
Q: What are Good Manufacturing Practices (GMP)?
A: GMP are a set of guidelines ensuring that pharmaceutical products are consistently produced and controlled according to quality standards.
Q: What happens if a pharmaceutical plant fails inspection?
A: Products from plants that fail inspection may be barred from sale in Peru, and the manufacturer may be subject to further regulatory action.
Q: How does this impact Peruvian patients?
A: The goal is to ensure that all medications available in Peru are safe, effective, and meet international quality standards, protecting patient health.
Did you know? Peru depends heavily on generic medications, making rigorous quality control even more crucial for affordable healthcare access.
Pro Tip: Always check the registration status of medications with Digemid before purchasing to ensure they are approved for use in Peru.
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