Nepal’s Department of Drug Administration (DDA) has banned the import and new production of 47 types of medicines after determining that they do not meet the World Health Organization’s international TRS criteria. The decision was taken at director-general level on Asoj 20, according to Director General Bharat Bhattarai, and the department has issued a public notice announcing the action.
Licences and registrations cancelled
The DDA’s decision covers the permissions that allow the affected medicines to be produced, sold, distributed and imported. It cancelled their production licences and sales and distribution registration certificates, as well as import registration certificates and import recommendation letters. The measures therefore block new production and imports of the listed medicines and remove the specified regulatory approvals associated with their sale and distribution.
The department said the medicines failed to meet the World Health Organization’s international TRS criteria. Its action applies to 47 types of medicines, but the information provided by the department in the announcement, as reported, does not identify the products individually. The public notice is the formal communication of the decision; the department has not provided further details here about the medicines or the assessments behind each cancellation.
What the decision covers
The cancellation of multiple kinds of approvals distinguishes the move from an import restriction alone. Production licences relate to making the medicines, while the sales and distribution certificates and import registrations concern their authorisation in Nepal. Import recommendation letters, which were also cancelled, are among the documents covered by the department’s action.
The notice establishes the restrictions on import and new production and identifies the affected approvals. It does not, in the information available, explain whether medicines already in circulation are subject to separate measures, set out any transition arrangements, or provide details about enforcement. Those points should not be assumed from the cancellation announcement alone.
Department’s public notice
Bhattarai said the decision was taken at the director-general level on Asoj 20. The DDA has issued a public notice to inform the public about the ban and the cancellation of licences, certificates and import recommendations. The department’s announcement places the decision on record, while the stated basis for it is that the 47 medicine types do not satisfy the WHO’s international TRS criteria.
The action makes the DDA’s position clear: the affected products cannot be newly produced or imported under the approvals that have been cancelled. The notice does not provide a product-by-product explanation or additional information about the review process. Further details about the individual medicines, any related action concerning existing supplies, and implementation arrangements would need to come from the department or a fuller notice.
