Notice Regarding the Stop Production and Distribution of Medicines DDA

Department of Drug Administration has published a notice on its website, dated 2080/08/11, based on the recommendations of the Drug Advisory Committee from meetings held on 2080/06/04 and 2080/06/18. The notice states that no new production of the following medicines, which are not registered with stringent regulatory authorities, should be undertaken, and the existing brands in the market should not be further produced or distributed until recommendations are received from the Drug Advisory Committee regarding their strengths.

Based on the decision of the 56th meeting of the Drug Advisory Committee held on 2080/12/21, it has been recommended to this department to implement the actions mentioned below for the eight types of medicines listed in Table 1. Accordingly, this notice is being published for the information of all concerned stakeholders as per the departmental decision dated 2081/03/09.

Table 1:

Linagliptin 2.5 mg
Linagliptin 10 mg
Linagliptin + Metformin SR (2.5/500)
Linagliptin + Metformin SR (2.5/850)
Linagliptin + Metformin IR (5/500)
Rivaroxaban tab 5 mg
Aceclofenac 200 mg immediate release tablet
Aceclofenac 300 mg IR

Decisions:

For the mentioned medicines/combinations that are currently available in the market, they must be withdrawn within a maximum of three months from the date of the decision.
An official report of the stock of these combination medicines present in the market must be submitted to the department, and the related certificates, licenses, and recommendation letters should be returned and canceled according to regulations.