Pharmaceutical violators under fire

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Minister of Health Nguyen Thi Kim Tien told the National Assembly Standing Committee that “all drugs failing to meet the standards outlined in their distribution agreements will be revoked and firms will have new registration numbers for their products ended.”

“In the coming time, we will continue to boost inspections of pharmaceutical firms. Any violations will face severe punishment. Abuses that have already been uncovered involving the distribution and sale of poor quality pharmaceuticals have been strictly dealt with,” Tien said.

The issue of poor quality pharmaceuticals has plagued Vietnam’s health sector. Last year VIR reported that a slew of domestically-based firms include German-Vietnamese joint venture Stada-Vietnam, and locally-owned Imexpharm, Tipharco, Ho Chi Minh City Medical Export Import, Minh Hai Pharmaceuticals and Ha Tay Pharmaceuticals had all flouted pharmaceutical quality control measures.

Several international firms including Hong Kong’s Amoli Enterprises Ltd., and India’s Umedica Laboratories Pvt., Ltd have had products banned from Vietnam until late January 2016.

The Ministry of Health (MoH)’s Drug Administration recently announced that the firms had their registration dossiers suspended and also faced a pause in the granting of pharmaceutical distribution registration until January 24, 2016.

Recently banned pharmaceutical products

The administration also stopped receiving registration dossiers for drug products made by XL Laboratories Pvt., Ltd. The administration also announced that this company had violated medicine regulations in Vietnam on four ocassions.

Also in December 2013, the administration required the departments of health nationwide, Vietnam’s National Institute of Drug Quality Control, Ho Chi Minh City Institute of Drug Quality Control, and all drug importers to examine all imported drug products of 37 foreign pharmaceutical firms from Canada, Cyprus, France, Germany, India, South Korea, Pakistan, the Philippines, Russia and the US.

These 37 firms, including XL Laboratories, were at that time found to have marketed bad quality products in Vietnam.

Last October, the administration also halted receiving India’s Axon Drugs Private Ltd’s new drug registration dossiers and also paused granting drug distribution registration to the firm until late October 2015, after the firm was found to have distributed two sub-par pharmaceuticals.