Why did MFDS release its Metformin self-investigation plan?

Raw materials from the same manufactory as Singapore recovered products were confirmed

The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore.

 

It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the recovery of three Metformin items.

 

The MFDS has said through media coverage that it is investigating the domestic inflow of raw materials used in Singapore's products in question, but the MFDS kept silent about collection and inspection plans for domestic distribution items.

 

Let’s learn about the background of MFDS' silence and the release of Metformin's own investigation through a press release.

 

Public opinion has changed, ordered from the Diabetes Association The MFDS released a press release on the 16th, is currently preparing a test method for Metformin formulations, and is conducting a systematic survey on domestic distribution items to identify the source of raw materials.

 

In addition, as soon as the test method was prepared, the MFDS added that they plans to collect and inspect domestic distribution items.

 

In fact, the MFDS has not said that they will not directly conduct an investigation into Metformin's impurities.

 

Nor did they instruct the vendor to do the test autonomously.

 

However, as part of the follow-up measures of Ranitidine and Nizatidine, the press release and public hearings revealed that companies should directly investigate raw materials and finished products that are likely to cause impurities.

 

Some companies have conducted their own tests.

 

Some expressed suspicion that the MFDS was not actively involved in collection and inspection, as opposed to when NDMA problems were raised in Valsartan or Ranitidine.

 

Indeed, the Korean Diabetes Association, which consists of domestic diabetic doctors on the 13th, said, "There is no official announcement whether the raw materials of the company in question were imported to Korea".

 

The Society stressed that the MFDS should address the public's concerns through direct investigations.

 

The Diabetes Society's point was enough to raise suspicion that the MFDS remained a mere spectator.

 

An official from the industry said, “If the MFDS conducted a survey of domestic distribution items based on Singapore collection only when the impurity risks of Metformin preparations were not verified, it would have increased public anxiety, however, on the contrary, it seems to have disclosed its own research plan immediately after pointing out that it should actively take the measures to resolve the public unrest”.

 

Raw material check… increased need for recovery investigation Although it did not appear in the press release distributed on the 16th, it is confirmed that the drug substance imported from Singapore is met with the same drug substance as the Metformin preparation recovered in Singapore.

 

Earlier, the MFDS said that there was no inflow of finished products in Korea, and that it was checking whether the drug substance was imported.

 

The fact that the MFDS conducted a systematic investigation to identify drug substance manufacturers for Metformin ingredients and finished drugs in Korea was influenced by the inflow of ingredients from the same factories as those of Singapore.

 

Therefore, the necessity of checking the raw materials through the systematic investigation, collecting them directly, and increasing the need for self-investigation was increased.

 

However, an official of the MFDS said, “Even if the raw materials are the same, there is no risk because the production lot (process) may be different”.

 

also added “there is no intention to select the raw materials in question because the systematic survey is to investigate the source of all distribution items”.

 

However, it is highly likely that the target of the first collection, inspection planned by MFDS will be the same raw material manufacturer as the recalled product in Singapore.

 

If the risk is identified, the collection and inspection can be extended, otherwise the case can be closed.

 

The MFDS also recognizes the limitation of recovery and investigation of all items.

 

Metformin is a multi-frequency prescription drug that is used as the first-line drug for type 2 diabetes treatment, and this is because 640 domestic licensed items are available.

 

The MFDS expects to investigate domestic distribution items as early as January next year.

 

As such, collection of some distribution items is highly likely to begin this month.

 

The MFDS' full-fledged investigation does not increase the risk of Metformin.

 

The MFDS said in a press release on the 16th.

 

that, among other things, patients taking Metformin-containing medicines should not stop taking it without consulting their MDs or pharmacists.