[Reporter's View] It's up to pharmaceutical companies

Drug quality management is at stake.

 

Over the past two months, four companies, including Binex, Vivozon, Chong Kun Dang and Hanall Biopharma, have been caught violating drug quality control.

 

A total of 62 products are under administrative disposition due to violations of quality control by four companies.

 

Including pharmaceutical companies in consignment contracts, the impact is even greater.

 

Thirty-four pharmaceutical companies that have entrusted production to four companies are also focusing to whether the MFDS will dispose of them further.

 

A total of 38 companies are on the verge of being kicked out of the market because of the trustee's deviant behavior.

 

The pharmaceutical industry fears it will spread to distrust of consignment generics.

 

It is only a matter for some companies, and the consignment act itself should not be a problem.

 

In July 2018, the Valsartan crisis, which shook the global pharmaceutical market, was unprecedented in overseas countries as carcinogenic substance N-Nitrosodimethylamine (NDMA) was detected in Valsartan manufactured by China's Zhejiang Huahai.

 

NDMA was not originally subject to standard checks on Valsartan.

 

Until Zhejiang Huahai reported that more NDMA was detected than the standard, no pharmaceutical company in the world cared about NDMA detection.

 

The FDA and the EMA were not aware of the need for inspections, but rushed to investigate and come up with measures to determine the cause.

 

It was just an unexpected accident.

 

Chinese raw medicine and generic are starting to be blamed as if they were the causes of "low quality." It is also from this time that regulations on consignment generic have been tightened in Korea.

 

Health authorities set up a "Generic Drug System Improvement Council" and began to come up with measures to curb generic disorder.

 

The MFDS has removed all deregulation granted to Entrusted generic.

 

From next year, mandatory production of licensed products, which had been exempted from consignment generics, will be implemented again.

 

It is also pushing to exclude consignment generics from generic exclusivity.

 

Following the reorganization of the drug price system, which took effect in July last year, the standard for calculating the drug price of consigned generic has also been lowered.

 

The 53.55% upper limit price can be maintained compared to the original drug before the patent expires only when all requirements are met to conduct biological equivalence tests directly and use registered raw material drugs.

 

The regulation on joint development of drugs under discussion at the National Assembly is also key to restricting the permission of consignment generic.

 

Some amendments to the Pharmaceutical Affairs Law, which limits the number of drugs licensed in one clinical trial, passed the Health and Welfare Committee, leaving procedures for future plenary sessions, the Legislation and Judiciary Committee, and the plenary session.

 

The government's justification for tightening regulations on generic seems to be somewhat out of standard.

 

The MFDS defines "generic" as a officially licensed drug based on the same quality as the original developed drug.

 

It is not appropriate that the large number of generic drugs authorised by the Government is of low quality.

 

Nevertheless, pharmaceutical companies are largely to blame.

 

If unreasonable regulations and misunderstandings are unfair, they should prevent repeated violations and come up with self-rescue measures to improve competitiveness in drug quality.

 

The drug quality control agenda has already been controversial, although it was not originally due to generic.

 

It is up to pharmaceutical companies to restore generic drug reputation.