Nepal Launches First Ever Guidelines to Improve Quality of Pharmaceutical Products and Practices

Nepal’s National Regulatory Authority, the Department of Drug Administration (DDA) has revised the Codes on Sale and Distribution of Drugs (CSD) and prepared Nepal’s first Good Pharmacy Practices (GPP) and Good Storage and Distribution Practices (GSDP) guidelines. Nepal has more than 27,000 pharmacies and 5,000 wholesalers which fall under the CSD’s legal purview. The first CSD was approved in 2014 but was inadequate to ensure the quality of services and products that pharmacies and wholesalers provide. This CSD revision and the development of the GPP guidelines for pharmacies and GSDP guidelines for wholesalers legally addresses this inadequacy and will improve service and product quality in the pharmaceutical sector.

DDA Director General Narayan Prasad Dhakal signs the revised Codes on Sale and Distribution and the good practices guidelines to present to the Drug Advisory Committee

Creating Nepal’s First GPP and GSDP Guidelines and Updating CSD

Using the World Health Organization’s globally accepted GPP and GSDP guidelines, DDA and stakeholders measured the level of guideline adherence in 39 pharmacies and 30 wholesalers, with support from MTaPS. The findings showed that public-sector pharmacies implemented GPP relatively well compared to private-sector pharmacies and wholesalers’ GSDP implementation. Wholesalers complied poorly with the GSDP critical areas of Quality Management System, Qualified Pharmacy Manpower, Proper Transportation, and Product Safety during Transport.

Having already recognized the need to improve pharmaceutical practices in Nepal, these findings spurred DDA to prioritize the update of the CSD and development of national GPP and GSDP guidelines and begin working with MTaPS on this process in November 2021. The DDA and MTaPS involved stakeholders extensively from the conceptual to the final drafts and specifically included representatives from pharmacy and wholesaler associations, who stood as potential roadblocks. Other stakeholders included representatives from Nepali pharmaceutical and professional associations and organizations. In July 2022, the DDA sent the revised CSD and the finalized good practices guidelines to the Drug Advisory Committee (DAC) formed by representatives from several government entities, such as MOHP, DDA, Department of Health Services, Ministry of Law, Nepal Medical Association, Nepal Pharmaceutical Association, etc.; however, the approval process was delayed for months.

When the current DDA Director General, Mr. Naryan Prasad Dhakal took office in June 2023, he immediately understood the importance of the revised CSD and best practices guidelines and realized that the approval process could be done at the DDA level. Subsequently, the Director General assigned DDA officers to update the drafts of the CSD revision and guidelines and even provided feedback himself. After weeks of coordination between the DDA and MTaPS, the final revised CSD and the annexed guidelines were presented to the Director General, who published them on the DDA website on July 13, 2023, for a 15-day notice period. The codes and guidelines were revised further after feedback from the public and stakeholders and were re-submitted to the DAC on August 9, 2023. The committee decided to revise and discuss the codes and guidelines for a further three months before implementing them.

Putting the Guidelines to Work as Part of CSD

The CSD and the guidelines are expected to come into full effect after being mandated by the DAC. The DDA will work with pharmacies and wholesalers to phase in the guidelines as part of CSD using a multipronged approach that will build the capacity of both the DDA and stakeholders and will allow the good practices to be carried out seamlessly. The GPP certification of retail pharmacies is planned to be voluntary while the GSDP certification of wholesalers will be mandatory.

Deriving from the initial assessment’s evidence of inadequate pharmacy and wholesale practices, the endorsement of these critical regulatory documents resulted from the DDA leadership’s commitment and inclusive and comprehensive stakeholder involvement. The effective implementation of the revised CSD and introduction of the GPP and GSDP guidelines will contribute to good-quality pharmaceutical products and services that protect public health in Nepal.

“The revised Codes on Sale and Distribution of Drugs and the good practices guidelines will improve the standards of pharmacy and wholesaler practices and ensure safe and effective medicines and health technology products for the Nepali people.”

—Mr. Narayan Prasad Dhakal, Director General, Department of Drug Administration