China gets tough on manufacturers

By Katrina Megget

- Last updated on GMT

Related tags: Pharmacology, Pharmaceutical drug

China is cracking down on its pharmaceutical manufacturers with the
State Food and Drug Administration (SFDA) revoking the production
licenses of five drug makers since July, according to reports in
the local media.

The country's food and drug watchdog has also withdrawn the Good Manufacturing Practice (GMP) certificates from 128 drug makers, the China Daily website reported. The moves follow a spate of scandals that have recently rocked the Chinese food and drug economy, from poisoned toothpaste and pet food, to the recent death sentence handed to former SFDA director Zheng Xiaoyu for taking bribes to approve hundreds of drugs. The hard-line approach is part of an attempt to rev up the quality of products and counteract the growing international criticism of the country's pharmaceutical industry, which is described as poorly regulated. In the recent overhaul, the SFDA shut the door on five manufacturers, including the Qiqihar No. 2 Pharmaceutical Co., which was in the centre of fake Armillarisni A injection incident last year where 11 people died. The drug, used for treating inflammation of the gall bladder wall, contained diglycol instead of propylene glycol, and caused kidney failure. Five other drugs by the company were also been found to be fake. A second company, Guangdong Baiyi Pharmaceuticals, also had its license revoked after it was found to have made haemoglobin infected with a virus from a donor, the China Daily reported. Three other unnamed manufacturing facilities where shutdown, while the GMP certificates of 128 drug makers were also withdrawn as the SFDA upped the number of GMP inspectors at the start of the year. Meanwhile, the China Daily reported that a further crackdown over the weekend occurred with the banning of Shanghai-based Hualian Pharmaceutical's drug methotrexate to treat leukaemia and rheumatoid arthritis. Several child leukaemia patients described pain in their legs and difficulty walking after being administered with the drug, which would now be re-evaluated. Plans for the nationwide cleanup of the food and drug industry will also include a review of the production licenses of nearly 170,000 medicines.

Related news

Show more

Related products

show more

Strategies to Achieve Successful Approval & Launch

Strategies to Achieve Successful Approval & Launch

Catalent Pharma Solutions | 03-Sep-2020 | Data Sheet

There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch...

Single-Pass Tangential Flow Filtration

Single-Pass Tangential Flow Filtration

BioContinuum™ Platform - MilliporeSigma | 01-Aug-2020 | Application Note

Tangential flow filtration (TFF) is widely used in the biopharmaceutical industry for downstream processing applications. Typical TFF steps concentrate...

Follow us


View more