The Government of Nepal seeks to sustainably expand the coverage of essential health services for its citizens, including access to quality-assured medicines. In support of this goal, the Department of Drug Administration (DDA), the country’s medicines regulatory authority, revised Nepal’s good manufacturing practices (GMP) code to align with international standards. The updated code applies to both locally produced and imported medicines, enabling the government to better control the quality of medical products circulating in Nepal.

Nepal’s updated Codes on Good Manufacturing Practices (First Amendment 2079) includes requirements for manufacturing quality assurance systems and clearly defined provisions for manufacturing. PQM+ worked with DDA's inspection technical working group (TWG) to conduct a gap assessment and make recommendations for aligning Nepal’s GMP requirements with international standards. PQM+ supported the TWG to draft the new code, which the Ministry of Health and Population approved in October. The DDA provides a certificate for compliance with GMP to pharmaceutical manufacturers after successful inspection, which is now valid for three years instead of two. By updating the standards for pharmaceutical manufacturing and ensuring manufacturers' compliance, the government has helped improve the quality of medicines for the people of Nepal.

In a country with a high burden of multi-drug resistant tuberculosis (MDR-TB), the Government of Uzbekistan is keenly aware of the need for continuous access to quality-assured medicines to treat TB. To speed access to those medicines, PQM+ supported the operationalization of WHO’s collaborative procedure for accelerated registration of WHO-prequalified medicines. Read the story.

Privately owned pharmaceutical retail outlets, such as community pharmacies and patent medicine vendors, are a vital component of Nigeria’s health care system because they provide medicines, consumables, and services in local communities. The vendors are not pharmacists, but they are licensed to disburse some medicines. In partnership with the Pharmacy Council of Nigeria (PCN), PQM+ has trained more than 2,300 community providers on good practices in stocking and selling quality-assured medicines, detecting poor-quality medicines and medical products, and storing medicines to maintain product integrity.

“If I want to buy meds, I check the company, I check the marketer, I check the batch number, expiry date,” said Eze Kenneth Ikechukwu, a patent medicine vendor in Abuja. “I always check because it is something someone will consume and the person can go and say, ‘This is where I got this.’ Our names are involved. I grew up with my uncle who is a pharmacist and I take interest in the whole system.”

PCN, also with PQM+ support, trained members of the PCN pharmaceutical inspection committees in six Nigerian states (Bauchi, Benue, Ebonyi, Federal Capital Territory, Kebbi, and Sokoto). Inspectors received training on effective communication and people management skills. This type of capacity and skills building is essential to ensuring the quality of medicines in the locations where many Nigerians buy their medicines. It also helps improve the relationship between regulators and community health providers.

Mali’s NQCL earns global recognition

Mali’s National Quality Control Laboratory (NQCL) recently achieved ISO/IEC 17025:2017 accreditation. As a result, the lab is better positioned to ensure the quality of antimalarials, maternal and child health medicines and products, and other medical goods circulating in country and the region. 

“This could not have been done without the constant and quality support of the PQM+ program funded by USAID,” said Benoît Yaranga Koumare, President of Laboratoire National De La Santé (LNS), Mali’s NQCL. USAID’s PQM+ and PQM (2009-2020) programs have helped strengthen labs across West Africa. Mali’s NQCL is the first in francophone West Africa to achieve global accreditation with support from these programs.

Tajikistan registers WHO-prequalified TB medicines

To expand access to life-saving TB medicines, PQM+ is supporting the registration of quality-assured medical products through Tajikistan’s existing national registration procedure. PQM+ coordinated closely with the Global Drug Facility and the National TB Program to successfully facilitate the registration of nine first-line quality-assured TB medicines from two manufacturers. This is the first time WHO-prequalified TB medicines have been registered in Tajikistan. PQM+, NTP, and GDF are in the process of registering other WHO-prequalified TB medicines as well. National registration of these medicines will enable the government to swiftly procure and deliver TB medicines, saving precious time and resources, and ensuring patients' access to effective treatments.

Recently, PQM+ facilitated a lot release training with Ghana’s Food and Drug Authority and two local manufacturers. Participants learned about independent lot release and evaluating lot summary protocol. This training helped strengthen manufacturing and regulatory capacity in Ghana to produce and oversee quality-assured vaccines for distribution across the region.

"I have an improved understanding of the vaccine manufacturing process, especially for COVID-19 vaccines. I now have a better appreciation of the lot release process. Coming from a safety background, the training has been very beneficial as we can better speak to clients to address any vaccine hesitancy they may have, based on myths [around] vaccine production and vaccination." - Adela Ashie, Ghana FDA