The Malawian government has announced plans to implement regulations governing medicines and pharmacy practice by December 2026. This development comes almost seven years after Parliament enacted the Pharmacy and Medicines Regulatory Authority (PMRA) Act in February 2019. The regulations aim to provide a framework for enforcing the law and curbing the circulation of falsified and substandard medicines.
Minister of Health and Sanitation Madalitso Baloyi stated that the regulations will enable the effective implementation of the PMRA Act and strengthen the regulation of medicines, pharmacy practice, and pharmaceutical licensing. The PMRA Act was enacted to regulate medicines, allied substances, pharmacy practice, and related activities. However, no progress was made towards developing the regulations between 2020 and 2025.
The Ministry of Health is currently working with PMRA, the Parliamentary Committee on Health, and the Ministry of Justice and Constitutional Affairs to complete the regulations. Baloyi expressed optimism that the regulations will be in place by December 2026. The government's efforts to develop the regulations are part of a broader response to weaknesses identified in the country's medicines regulatory and supply-chain systems.
The absence of regulations has weakened PMRA's ability to enforce pharmaceutical standards, according to Pharmaceutical Society of Malawi president William Mpute. Mpute noted that the Act was reviewed in 2019, but seven years later, PMRA still lacks approved regulations, making it challenging to enforce standards. The lack of regulations has raised concerns about the safety and quality of medicines in the country.
Assessments conducted in 2023 by the European Union-funded Medsafe project and the World Health Organization (WHO) highlighted significant weaknesses in Malawi's medicines regulatory and supply-chain systems. The Medsafe project found that security in the formal medicines supply chain was only partially under control, while the WHO benchmarking assessment recommended improvements in managing threats posed by substandard and falsified medical products.
In response to these concerns, the Parliamentary Committee on Health called for a coordinated national response in September 2024. The Malawi Human Rights Commission also echoed this call in Machinga during a public inquiry into cases involving substandard and falsified medicines. The inquiry is examining the medicines chain from procurement and importation to regulation, storage, distribution, dispensing, and disposal.
Once implemented, the regulations are expected to strengthen controls over the registration, manufacture, importation, storage, distribution, and sale of medicines. They will also support enforcement action against individuals and institutions involved in dealing with falsified or substandard products. The regulations are a crucial step towards ensuring the quality and safety of medicines in Malawi.
Key points
- The regulations will provide a framework for enforcing the PMRA Act and curbing the circulation of falsified and substandard medicines.
- The absence of regulations has weakened PMRA's ability to enforce pharmaceutical standards.
- The regulations will strengthen controls over the registration, manufacture, importation, storage, distribution, and sale of medicines.
