Indian drugs banned after quality failures
Indian drugs banned after quality failures
India-based pharmaceutical firm XL Laboratories Pvt., Ltd has had all of its products permanently banned from being marketed in Vietnam for consistently trading sub-standard products.
The Ministry of Health’s Drug Administration sent word of the ruling to XL Laboratories’ India headquarters, explaining that it had revoked the registration numbers of drugs produced by the company which fail to meet Vietnam’s drug quality standards.
In addition, no new registrations will be granted to the company and authorities have stopped receiving registration applications for new products made by XL Laboratories Pvt., Ltd.
The punishments came following reports from the National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control and the Hanoi equivalent found XL Laboratories to have been producing sub-standard medicines as far back as 2010.
“XL Laboratories’ medicine quality violations are very serious, frequent and consecutive over the past few years,” said Drug Administration head Truong Quoc Cuong.
XL Laboratories’ drug standards infringements in Vietnam came to light in January 2013, prompting the Drug Administration to stop granting certificates for drug and drug material operations to the company. The administration then suspended the nationwide use of anti-arthritis Diclofocal, a XL Laboratories product imported by Vimedimex in Ho Chi Minh City.
As a result of the findings, the Drug Administration launched a crackdown on the producers of poor quality drugs in September 2013, asking departments of health nationwide, the Vietnam’s National Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, and all drug importers to examine imported pharmaceutical products from 37 foreign drug firms.
The companies, hailing from Canada, Cyprus, France, Germany, India, South Korea, Pakistan, the Philippines, Russia and the US, have been highlighted for inspection having been discovered previously marketing low quality products.
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