This situation of mixing Lyrica with other doses is absurd

Multinational companies must fulfill their responsibility for quality control and follow-up measures

When it was confirmed that Pfizer Korea's Lyrica had mixed drugs with different doses, The Korean Pharmaceutical Association urged a countermeasure to prevent recurrence.

 

The KPA(Chairman Dae-eop Kim) made a statement on the 17th, saying, "The case where different doses of pharmaceuticals are mixed & packaging in the bottle is a serious problem that should not exist in the GMP process." "The basics of quality control have not been observed," he pointed out.

 

The KPA said, "The government has achieved success in joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to enhance the international reliability of the quality of domestic drugs, but paradoxically, the management of overseas manufacturing facilities of multinational pharmaceuticals has been neglected.

 

In the year, the quality problems of imported medicines have been constantly being raised.” The KPA said, "As the manufacturing facilities for imported drugs are overseas, it is limited to check the problems of the manufacturing process.

 

It is necessary to prepare intensive measures related to imported drugs, such as expanding due diligence at overseas manufacturing facilities and strengthening customs clearance procedures.

 

As the 20th National Assembly has implemented a registration system for overseas manufacturing companies to strengthen safety management of imported drugs, and amendments to the Pharmaceutical Affairs Act, which established the grounds for taking measures to suspend imports according to the results of local due diligence, thorough supervision and expansion of specialized overseas investigators." In addition, The KPA said that it was necessary to improve the quality of imported drugs and to cooperate in prompt handling of complaints with the suspension of the sale and collection of imported drugs.

 

The MFDS confirmed that Pfizer imported and distributed Lyrica bottles with different doses mixed with medicines, and issued an urgent sales suspension and recall order.