[Reporter's View] BINEX & NDMA Phobia

It was said that it should never be done and it was malicious because it was deliberate.

 

This is a concern from the National Assembly, the government, and the pharmaceutical industry looking at the situation of BINEX, which violated the pharmaceutical affairs law due to suspicion of manufacturing method and dosage manipulation, which is also a bad thing for the global prestige of domestic drugs.

 

The confidence in the quality of domestic drugs, which only recovered after the detection of NDMA, a suspected carcinogen, has been broken again.

 

In this case, the violation of the Pharmaceutical Affairs Law, such as the intentional manipulation of the manufacturing method of a specific pharmaceutical company, rather than the incorporation of impurities (NDMA) caused by unknown external factors, sparked the incident.

 

Since the detection of NDMA such as Valsartan and Ranitidine is an overseas drug quality incident and is a common international issue, the impact on the quality and reliability of domestic drugs was not significant.

 

The impact was further mitigated as no fatal safety issues were identified in the NDMA detection survey by the MFDS.

 

This BINEX incident is very different from the NDMA incident.

 

As one pharmaceutical company was suspected of manipulating the manufacturing method and the dosage of the active ingredient, it had a negative impact on the reputation of domestic generics.

 

The MFDS, which is the main ministry, was also unable to escape responsibility.

 

The MFDS has introduced a GMP system and an item approval renewal system and is operating a management system after marketing approval.

 

BINEX violated the post-regulation system of the MFDS and the Pharmaceutical Affairs Act, ignored ethical management and pursued only profit.

 

On the 8th, the MFDS issued the same disposition to 32 items from 24 generic companies made in the same factory following the suspension of manufacturing and sales of 6 drugs that violated the Pharmaceutical Affairs Act manufactured at BINEX Busan Plant 1 and voluntary recovery.

 

Confidence in the consignment manufacturing generic system has collapsed.

 

"If a pharmaceutical company decides to cheat, it will be impossible for the MFDS to detect violations of the Pharmaceutical Affairs Act one by one," experts in the pharmaceutical industry say.

 

Medicines that treat sick patients should be perfect.

 

Drugs are sometimes poisonous in that they can have unexpected side effects.

 

The NDMA impurity crisis drove the public into drug phobia and stopped prescribing and dispensing in pharmacies at front-line medical institutions.

 

The BINEX crisis is highly likely to re-create the national turmoil caused by the NDMA crisis.

 

Some media reported the response to BINEX's case.

 

Among the numerous reports, BINEX's explanation of 'violation of the Pharmaceutical Affairs Act due to a change in manufacturing method rather than a major dose manipulation' is so much ridiculous.

 

The intention is to clear the company's position that it acknowledges the manipulation of the manufacturing method, but does not manipulate the dosage of the active ingredient, thereby removing some unfair accusations.

 

However, violation of the Pharmaceutical Affairs Act is another matter.

 

Since it is difficult for the general public to know the professional pharmacist law and drug information, it does not seem important that the manufacturing method was manipulated and the dose manipulated.

 

It is illegal to change the manufacturing method without permission from the MFDS, which can cause distrust in the pharmaceutical industry.

 

The National Assembly Health and Welfare Committee's attitude toward the BINEX situation is strict and serious.

 

This is because it is true that they deliberately tricked the people and the government into distributing and selling medicines, and negatively affecting the reliability of domestic and foreign medicines.

 

The BINEX incident made subsequent legislation in the National Assembly inevitable.

 

The illegality and deviation of a pharmaceutical company may increase the burden by strengthening the overall post-regulation of the pharmaceutical industry, including the good pharmaceutical companies who are properly complying with the law.

 

BINEX must repeatedly reflect on the violations it has committed.

 

The MFDS should prepare measures to prevent recurrence of BINEX as soon as possible.

 

The National Assembly, which is in charge of legislative responsibility on behalf of the people, must consider a reasonable legislation without unnecessary over regulation.

 

A reflection of illegal pharmaceutical companies, a transparent investigation by regulatory authorities, and smart and delicate legislation of the National Assembly are required.