After Zhejiang Huahai Pharmaceutical’s tainted valsartan API and Changchun Changsheng Life Sciences’ fabricated vaccine production data exposé, China’s drug industry could be dealing with another major manufacturing scandal. This time, the protagonist is Fosun Pharma.
In an open letter (Chinese) to the drug regulator in Chongqing, China, self-claimed employees of Chongqing Pharma Research Institute, a unit of Fosun Pharma, depicted a “chaotic” production scene at the company. It alleged that the firm illegally changed production processes of almost all its APIs, while management pushed employees to fabricate data and manipulate testing readouts to achieve passing results.
The anonymous whistleblowers claimed that the company—which previously has been cited by U.S. regulators—conjured up fake sets of records to earn GMP certificates for a new production site, and that it bribed local drug officials to get go-aheads for proposed production changes to antipsychotic drug aripiprazole and chemotherapy pemetrexed disodium.
Refuting the whistleblower accusation, Fosun said in disclosures (PDF) published Friday that it made all existing products using approved production processes, and that any adjustments have been approved by or filed with authorities.
“The group places great emphasis on the quality and risk management throughout the life cycle of its products,” said Fosun. “The group has adopted and implemented quality and safety control mechanisms and adverse drug reaction monitoring mechanisms at each stage of the production chain.”
Chongqing FDA responded to the letter Friday, saying it has dispatched an inspection team to the firm, and an anti-corruption supervision team stationed at the agency found no evidence regarding the bribery accusation. Fosun also said the agency made an unannounced inspection a day before posting the open letter on its website but hasn’t made any conclusive opinion.
Because the whistleblowers didn’t provide real personal information, Chongqing’s drug regulator is calling for more detailed evidence to support their claims.
However, the Fosun unit is no stranger to such accusations. In a warning letter last February, the U.S. FDA identified “significant deviations” from cGMP standards at the firm, with data integrity notably mentioned as a problem, where the agency made a long list of recommendations for remediation.
Fosun itself revealed that the company’s new site in Chongqing was slapped with a Form 483 after an FDA pre-approval inspection last November. According to Fosun, the problem is related to API aripiprazole, “for its deficiency of invalidated OOS result in the testing (deviation investigation).” In addition, it said it “has dealt with and restructured the key leaders and the relevant responsible personnel … in a serious manner” as a result of the warning letter, and it’s taking steps to rectify the problems cited.
Last year, Chongqing Pharma Research Institute generated revenue of 77.8 million Chinese yuan ($11.4 million), of which 26% came from business abroad, said Fosun.
The snafu comes less than two months after valsartan API supplied by Zhejiang Huahai sparked a worldwide recall after the company reported a possible carcinogen called N-nitrosodimethylamine (NDMA) in the drug. It also follows a high-profile vaccine scandal in which Changsheng was found to have provided ineffective vaccines to children and systematically fabricated production data to cover up its violations. The case saw the resignation and dismissals of top government officials—including former China FDA chief Bi Jingquan—as the country’s top leaders worked to restore confidence in China’s drug industry and pacify public anger.
Editor's Note: This story has been updated to reflect that an anti-corruption team at Chongqing FDA found no evidence of bribery.