Supervisory step forward
In a recent unannounced inspection of medical apparatus suppliers nationwide, several were ordered to close or conduct rectification measures as their products failed to meet the required quality standards. The low-quality medical apparatus and instruments, as well as the chaotic management revealed by the inspection, are further cause for concern, as they come on top of the frequent exposures of problematic pharmaceutical products in recent years — from poisonous capsules to problematic vaccines.
Many of the past quality scandals have revealed problems and loopholes in the sector’s supervision and management. Under these circumstances, more frequent and stricter quality checkups of pharmaceutical products and medical equipment are necessary.
The recent unannounced quality inspections conducted by the drug regulators nationwide mark a step toward improving their previous supervision and examination model. For a long time, the authorities have notified companies before conducting quality inspections. Such a model has resulted in the bizarre phenomenon of pharmaceutical drug manufacturers being involved in quality scandals after they have previously been given the all clear by the authorities.
Quality checks carried out in this way will help regulators gain an accurate picture of the sector and help them more effectively carry out their supervision and law enforcement duties.
Unannounced quality inspections will also help the regulatory authorities regain their credibility and the public’s trust, which have been severely damaged as a result of the many quality scandals that have occurred in the country’s food and drug sector in recent years.
Such inspections require that companies not be forewarned, so anyone found responsible for leaking information about a planned inspection should be severely punished. A supervisory mechanism should be also introduced, in which relevant experts and the media can better act as a deterrent against malpractices.