Tension on impurity diabetic drugs is for a month

The MFDS, presents Metformin test this week

No action at home or abroad after Singapore recovery

Expect conclusion after test method presentation

The whole view of the MFDS

It's been a month since concerns of impurity Metformin were triggered overseas, but there are still no clear conclusions.

 

Expectations are raised in the pharmaceutical industry that there is no recovery country other than Singapore and that it can only be a surprise.

 

However, there is still a lot of tension that if there is a recovery from the excess of impurities from overseas, there will be an instant spark in Korea.

 

According to the industry on the 5th, no further follow-up measures have been taken at home and abroad for a month after some Metformin recovery measures have been taken in Singapore.

 

Molecular structure of Metformin

On December 4, last year, the Singapore Health Sciences (HSA) surveyed 46 Metformin products sold locally and recovered three products.

 

This is because NDMA above the daily allowance was detected.

 

Shortly after Singapore's recovery, Metformin impurities were investigated in the US and Europe.

 

The US Food and Drug Administration (FDA) has begun investigating the detection of NDMA in Metformin products in the United States.

 

The European Medicines Agency (EMA) has also ordered companies to investigate Metformin's NDMA detection.

 

Japan's Ministry of Health, Labor and Welfare also instructed manufacturers and distributors of Metformin-containing preparations to conduct risk analysis on NDMA incorporation of ingredients and drug products and report the results.

 

A month has passed since then, but no conclusions have been made regarding the recovery of Metformin in countries other than Singapore.

 

No follow-up has been made in Korea yet.

 

This is not the same as the case of Valsartan and Ranitidine.

 

The biggest difference is that both Valsartan and Ranitidine have been preempted in Europe and the United States.

 

Valsartan immediately suspended the sale of products using the drug substance when recovery news came from Europe.

 

Ranitidine began collecting inspections in the country after cases of discontinuation in the United States, and secondly suspended all products after announcing "no problem." In Korea, the MFDS has already submitted the usage data of Metformin preparations from pharmaceutical companies.

 

Last month, the MFDS instructed pharmaceutical companies to submit the production history of the drug containing 'Methformin HCl' and the system for investigation of the active drug substance by the 17th.

 

Pharmaceutical companies submitted the total number of drugs containing Metformin-containing products, items and number of production records, and items and number without production record to the MFDS.

 

The Metformin lineage survey at the MFDS is a preliminary motion in preparation for the detection of impurities.

 

If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company.

 

In the pharmaceutical industry, anxiety continues: "Is there a problem with the drug substance used in products recovered from Singapore?" The MFDS formalized its stance on the 16th to conduct an investigation into Metformin impurities.

 

It is known to look into the NDMA detection potential in the Metformin’s chemical structure and manufacturing environment.

 

The industry points out that there is no standardized Metformin NDMA test, which limits the self-inspection.

 

As soon as possible this week, the MFDS will draw up a test method for detecting N-nitrosodimethylamine (NDMA) in Metformin and present it to pharmaceutical companies.

 

Initially, the plan was planned to be completed by the end of last year, but the schedule was delayed.

 

Given the NDMA test method of Metformin preparation, it is expected to be actively checked in Korea.

 

The pharmaceutical industry is expecting a final conclusion on whether or not to detect NDMA after the preparation of the test method.

 

The possibility of preferentially conducting a collection inspection on the drug substance used in products recovered in Singapore is raised.

 

Metformin's drug product recovered from Singapore has never been imported into Korea.

 

In Singapore, however, it was determined that the recovery of the test results for the drug product, not the drug substance.

 

If Metformin preparations are collected in the US or Europe, the same raw materials or finished drugs can be promptly inspected in Korea.

 

In reality, it is impossible to conduct a full survey on Metformin preparations in Korea.

 

Metformin is the most widely prescribed diabetic drug used as a primary treatment for glycemic control in patients with type II diabetes.

 

There are 642 Metformin-containing products in Korea.

 

Virtually all pharmaceutical companies have Metformin.

 

Metformin is overwhelmingly larger than Valsartan and Ranitidine.

 

According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion.

 

Ranitidine, which had been suspended from selling all its products, formed a prescription scale of about ₩200 billion, which is more than double the market.

 

The unit price of Metformin is less than ₩100.

 

In terms of usage, it is overwhelmingly higher than Ranitidine.

 

Pharmaceutical companies are already paying attention to domestic and international measures.

 

In the face of massive losses in Valsartan and Ranitidine, there is a strong concern that Metformin can cause irreversible loss if fire breaks out.

 

Some pharmaceuticals are struggling to minimize the damage, saying “NDMA has not been detected by our own tests,” even though the FDA's test method was not proposed.

 

An official of the pharmaceutical company said, “There are no test methods yet, and there are not enough organizations to check, so we did not proceed with NDMA inspection of metformin, and plan to check quickly after the preparation of test method”.