UPDATE : Thursday, July 19, 2018
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[Column] Carcinogen threat will continue unless Seoul overhauls generics approval system
  • By Howard Lee
  • Published 2018.07.12 13:44
  • Updated 2018.07.12 18:37
  • comments 0

The government’s recent ban on hypertension drugs containing a possible carcinogen is expected to create repercussions throughout this summer. A Chinese firm, which used to manufacture valsartan, discovered that its alteration of the manufacturing process generated N-Nitrosodimethylamine (NDMA) as an impurity. The company reported this to the European Medicines Agency.

The EMA immediately conducted a thorough review and requested client drugmakers of the Chinese firm to stop producing valsartan-using drugs and to recall their products. The regulatory authorities in Canada, Hong Kong, and Taiwan followed suit. Korea’s Ministry of Food and Drug Safety also took a similar measure quickly.

If the story ends here, we might think we’ve made a fuss out of this. Some criticized that the ministry’s announcement during the weekend stirred up panic unnecessarily, but such comments came from thoughtless dilettantes. If something threatens people’s safety, the government must wake up the public even in the early morning to let them know what is happening.

However, there is more to the story. The government’s list of banned drugs includes 115 medicines used to be produced by 54 companies, whereas the EMA’s recall list includes only several drugs. In the U.K., only eight drugs manufactured by two companies are on the prohibited list.

Why is there such a significant gap in the number of recalled products in Korea and those in other countries?

In the early 2000s, the government pushed to implement the separation of drug prescribing and dispensing. To allow pharmacists to dispense substitute drugs, the government had to increase the number of generic drugs significantly. However, the government could not do so in the standard way because the nation did not have a solid base for conducting bioequivalence tests.

So, the government introduced a very rare generic drugs approval system, which has been almost unseen in the world’s history of drug regulations. The system is called “the consigned bioequivalence test system” or “the joint bioequivalence test system,” which allows incapable drugmakers to “mooch off” another company to sell generic drugs. The system also enables several small firms to make a joint investment to conduct bioequivalence tests and sell generic drugs.

As a result, the number of generic drugs that passed bioequivalence tests surged to 2,555 in 2004 from 186 in 2001. Most of them received approval via the consigned bioequivalence test system or the joint bioequivalence test system.

In 2006, some generic drugmakers were found to have forged documents on equivalence test results. The government, all in a fluster, limited the scope of the consigned bioequivalence or joint bioequivalence test system, but the pharmaceutical industry dropped back into the old habit. In 2015, a total of 1,215 generic copies won a bioequivalence recognition but only 238, or less than 20 percent, went through direct bioequivalence tests.

If the generic drugs had undergone bioequivalence tests normally and won the nod, there is no problem in the increased number of generics. However, the government artificially lowered the market entry barrier for generic drugs and allowed incompetent pharmaceutical firms to obtain approval for generic copies easily. It is even embarrassing to call them “pharmaceutical” companies.

The mass production of generic copies via dubious methods has brought down the market order. The domestic system, which helps generic drugs maintain their prices relatively high, accelerated the market distortion. This is like paying illegal rebates to drugmakers so that they can make profits.

The exponential growth in the number of generic drugs made the regulator unable to manage drug quality properly. Many companies initially purchased ingredients in sound quality but later changed them to cheap and suspicious ones. The government’s incentives to pharmacists who dispense low-priced substitute medicines also played a part to worsen the overall quality of generic drugs.

If a pharmaceutical company makes original drugs or generic drugs under the name of its own, the company tends to manage their product quality strictly even after the market release. However, an incompetent one depends on a single manufacturer via a consigned or joint bioequivalence test system to sell a generic drug, and the company is likely to turn a blind eye to the product quality. When everyone is responsible for something, no one is responsible.

This is why the latest valsartan issue is so serious. The failure of filtering out a dangerous substance in a generic drug could keep occurring with different medicines. The problem remains to be unsolved because the government puts products, not humans, first in the drug approval system. If the authorities do not correct the wrong principle, the government’s emphasis on promoting safe drug use will ring hollow.

Novartis, the seller of valsartan original, is performing well amid the failure of possibly hazardous generic drugs. The company is enjoying valsartan sales growth because it did not use the Chinese-made ingredient. People started to question the quality of generic copies sold in the local market. It is ironic that the generics approval system, initially made to help generic drugmakers, is now threatening their existence.

howardlee@snu.ac.kr

<© Korea Biomedical Review, All rights reserved.>

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