Saturday, April 19, 2014
Fake Gelatin Capsules Minimize

Contaminated Capsules Updated: 01-June-2012

China Daily has reported that SFDA on Wednesday invited public consultation on a proposal to blacklist illegal drug producers and sellers.   

Companies and individuals severely violating drug and medical instrument-related laws and rules would be documented on a blacklist established by drug administrations, according to the draft regulation published on the website of the State Food and Drug Administration (SFDA).

Chinese flag with capsules

Image from SecuringPharma and to read their article go to http://goo.gl/wfhUZ

If the draft is approved, their names and pertinent details will be publicized through government websites or media for better public supervision, as well as be provided to departments concerning finance, the environment and commerce as a reference in their planning, bid inviting and procurement of supplies.

The move, cited by the SFDA as an effort to further ensure drug safety, comes after a scandal in April in which it was revealed that poisonous drug capsules made with industrial gelatin were arriving on the market.

Eight categories of individuals and companies would be blacklisted, including those who produce or sell fake drugs, produce medical instruments without business credentials and cause major security incidents with their unlicensed products, under the proposal.

People banned from the drug business for 10 years by law would also be recorded in the blacklist, it added.

Drug administrations would pay special attention to those included on the list and require them to report their quality management periodically, said SFDA spokesperson Wang Lianglan. 

Contaminated Capsules Updated: 25-May-2012

China's SFDA announced that 254 pharmaceutical enterprises, or 12.7 percent of all capsule makers in the country, were found to be producing unsafe drug capsules during a month-long inspection program.

Of the 11,561 batches of drugs tested, 5.8 percent were found to contain excessive levels of chromium, according to the SFDA, which began the checks after a media expose of companies producing such capsules.

e SFDA ordered substandard drugs to be immediately taken off shelves, sealed, recalled and destroyed.

Meanwhile, every batch of capsules produced by problematic companies was checked one after another, the SFDA said in a statement.
 
The SFDA has urged local authorities to investigate and "severely punish" problematic pharmaceutical makers them in line with laws and regulations. Those suspected of crimes should be referred to the police, it said.

Fake Gelatin Capsules found in China

As reported in China Daily and on the The State Food and Drug Administration's (SFDA's) website, contaminated gelatin capsules were produced and contain excessive levels of a toxic material (chromium).

Local police will investigate 43 capsule manufacturing companies in Xinchang and suspend operations for those found to be operating outside the law, the spokesman said.   As of today, 53 individuals have been arrested for allegedly producing and selling pharmaceutical capsules containing excessive levels of chromium.

To read the full story in the China Daily go to: http://goo.gl/8KjKg

The State Food and Drug Administration (SFDA) says it has ordered a recall of 13 products produced at 9 plants known to have used the contaminated gelatin-based capsules, including two antibiotics, according to the state-run Xinhua news agency.


Products

The fake edible gelatin raw materials were made from waste leather leftovers supposed to be used in leather clothing.  The leftovers were treated industrial chemicals that lead to the excessive levels of chromium.  Once the gelatin is extracted from the leather it is then sold to capsule manufacturers that then sold the capsules to pharmaceutical companies to use to make medicines.

shoe leater
As this case and others demonstrate, it is not just expensive Active Pharmaceutical Ingredients or Drug Products that are faked.   Inexpensive raw materials like sodium chloride and glycerin have caused many deaths around the world once contaminated, adulterated or counterfeited. 

 

  

 

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