After the government banned the import and sale of all drugs containing Chinese-made valsartan due to a possible carcinogen in the ingredient, the medical community called for a sharp reprimand on regulators and a full review of the verification system for generic drugs. Valsartan is a key ingredient in drugs to treat hypertension.
“About 6 million patients with high blood pressure will suffer the damage the most. Their health is in danger now,” the Korean Medical Association said in a statement on Monday. “Physicians, who prescribed those drugs out of trust in the Ministry of Food and Drug Safety, are now full of anger.”
KMA said the valsartan debacle partly stemmed from the ministry’s neglect of duty to manage the safety of all medicines and their side effects. “Related officials, including food and drug safety minister, should face a serious reprimand,” it said.
The doctors’ group also emphasized that an abnormal drug pricing policy was the primary cause of the valsartan fiasco.
“Drugmakers try to maximize profits by using cheap Chinese ingredients and the government sets absurdly high prices for generic copy drugs. So, pharmaceutical firms were able to survive in the market without much effort such as R&D,” the KMA said. “Unless we change the wrong drug pricing system, this kind of incident will keep occurring.”
The KMA asserted that the government should scrap the policy of giving incentives to low-priced drugs that help reduce the state spending on national health insurance.
“The regulators should break free from old practices that set generic drug prices too high, compared to those in other countries. They should set the right drug prices so that they can protect public health,” the KMA said.
The KMA also called for an overhaul of the generic drug verification system.
“The food and drug safety ministry should assure the public in a panic. To protect the people’s rights to life, the ministry should investigate the safety of all the ingredients of generic drugs available in the market,” the KMA said. “Also, the government should apply stricter criteria to the bioequivalence test, which is unreliable now.”
The group went on to say that the government should sternly prohibit the prescription by ingredient names and a pharmacist’s arbitrary dispensing of drugs.
“Even when a medicine passed a bioequivalence test, its efficacy is not 100 percent reliable. The government should randomly pick a generic copy and investigate its safety,” the KMA said. “To allow pharmacists to dispense medicines out of the prescriptions made via ingredient names is to threaten people’s rights to health seriously.”
The KMA advised patients to check with a physician about their medications.
“Pharmacists may dispense drugs that are different from a doctor’s prescription. Even when a prescribed drug is not in the list of the banned valsartan-containing medicines, patients should not be complacent,” the KMA said. “Hypertension patients should take their medications to their doctors and make sure they can keep taking them safely.”