[FOCUS] There is no reliability of cluless government policy

The impurity issues that started in Valsartan last summer led to Ranitidine and Nizatidine, and many drug products were discontinued.

 

This year, the domestic pharmaceutical industry suffered greatly due to impurity risk all year round.

 

Using a stigma called "carcinogen", a huge amount of medicines were recovered, and pharmaceutical companies suffered huge losses.

 

So far, the government's follow-up on impurity drugs has been a fear to pharmaceutical companies.

 

From the Valsartan to Nizatidine, the pharmaceutical industry continued to report that the domestic measures were strong.

 

Valsartan immediately suspended the sale of products using the company's drug substance when recalls were received in Europe.

 

Since January 2015, the Ministry of Food and Drug Safety has stopped selling all drug products that used the ingredients in question.

 

It has been criticized that losses have increased and confusion has increased as the problem-free products have been recovered.

 

It has been concluded that impurity-containing Valsartan medicines are not harmful to humans in both Korea and the United States.

 

In Korea, Ranitidine has been inspected for the collection of finished drugs and drug substances, and all products of Ranitidine have been suspended.

 

Not all Ranitidine has been removed from abroad.

 

In the United States and Europe, companies made their own recovery.

 

The US Food and Drug Administration (FDA) issued an official statement last month stating that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat".

 

13 products of Nizatidine was discontinued.

 

No products have been issued a recall order in the US and Europe.

 

Mainly older products were classified as subjects of recovery, and pharmaceutical companies complained that they were forced to sacrifice while stopping the sale of trouble-free products.

 

The MFDS is currently investigating the presence of impurities in Metformin.

 

Singapore's Ministry of Health (HSA) recently retrieved 46 items of Metformin sold locally and recovered three.

 

N-nitrosodimethylamine (NDMA) was detected above the daily allowance.

 

Unlike Valsartan, Ranitidine, and Nizatidine, Metformin investigations are cautious.

 

The MFDS said they are investigating an Metformin, but has not yet conducted a collection test.

 

The MFDS set out to conduct collection tests after Metformin's NDMA test was established this year.

 

In this situation, the MFDS ordered pharmaceutical companies to submit data on the production of pharmaceuticals containing Metformin hydrochloride and the system of active drug substance investigation.

 

Pharmaceutical companies are questioning whether “products using raw materials recovered from Singapore have been brought into the country”.

 

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

 

However, the MFDS has not yet made an official position on whether the drug substance used in the product is imported into Korea.

 

In the case of Valsartan, products that use the same raw material pharmaceuticals as those recovered as impurities from overseas must be discontinued in Korea.

 

If it is confirmed that the same drug substance as Metformin recovered in Singapore is imported into Korea, it may be decided whether to discontinue the sale.

 

In fact, it is reasonable to take follow-up measures through collection inspection even if the drug substance and the same manufactory that were recovered overseas are imported into Korea.

 

It is reasonable to recover only the serial number in question even for the same product.

 

This is a lesson already learned from the Valsartan issue.

 

Rather, the bold policy to relieve the anxiety of the people encouraged anxiety.

 

It caused a lot of social cost waste.

 

It would be even more frustrating if they were reluctant to disclose transparent information because they were afraid of criticism that the MFDS would be in conflict with public insecurity or past policies.

 

If they have experienced trial and error in the past, it is the government's role to honestly admit and implement an evolved policy.

 

Then they should ask for understanding why it should have been.

 

Only then they can gain trust.

 

We want a "cool" government that can reflect on their mistakes.