Listed pharmaceutical companies are fined for operating without a license! Genetic testing has become a frequent area for enterprise violations

Genetic testing has become a frequent area for enterprise violations

On December 13, two pharmaceutical companies received administrative penalty notices on the same day.

According to the official website of the Jiangsu Provincial Food and Drug Administration, a "gastric lavage machine" owned by Yuyue Medical was fined 147,300 yuan for not meeting the regulations.

This is the second time that Yuyue Medical has been fined this year. On September 10 this year, the Shanghai Municipal Food and Drug Administration issued an administrative penalty decision, from January 2020 to July 2021, Yuyue Medical set up a medical device warehouse without going through the filing and change procedures, and did not make a purchase acceptance record, violating relevant regulations, was fined 21,000 yuan, and given a warning sanction.

Yuyue Medical also received a warning this year because it did not display the medical device registration certificate on the Taobao store page.

Another listed company that was exposed was Enhua Pharmaceutical. On November 30, the Dalian Market Supervision Bureau released the news that Enyuan Biologics, a subsidiary of Enhua Pharmaceutical, carried out genetic testing services in the name of Dalian Seventh People's Hospital without medical institution qualifications.

In February this year, the patient complained about Enyuan Biotech, and after investigation by the Market Supervision Bureau, Enyuan Bio was involved in false publicity and was fined 200,000 yuan. Enyuan Bio is a subsidiary of Enhua Pharmaceutical in charge of genetic testing, and its main product is "Bei An Zhen", which is used for epilepsy diagnosis and treatment.

Interestingly, the announcement of Enhua Pharmaceutical said that the laboratory qualification of Enyuan Biology was only issued in August this year. That is to say, Enyuan Bio has carried out genetic testing services in violation of the law for at least half a year without obtaining a certificate.

According to the penalty decision, Enyuan Bio collected money from patients through the WeChat QR code, and the sales staff of a genetic testing company once told the Health Bureau that some genetic testing services could not enter the hospital from formal channels, so the sales staff would carry a QR code with them, and after successful recommendation by the doctor, settle with the patient through personal transfer.

According to the relevant regulations of the state, it is illegal for enterprises to use this collection method, and sales personnel also take great risks.

Genetic testing has always been a vague area of regulation, and it is easy for companies to rub the edge. In early December this year, the Shanghai Municipal Bureau of Market Supervision released a typical case, Meinian Health sold a intestinal early screening genetic testing product, because the words "need to be used under the guidance of a doctor" in the advertisement did not significantly explain, which may mislead consumers and was fined 100,000 yuan.

Text | David

Operational | Twenty-thirteen

Two in-depth manuscripts per day to decode medicine and health

#Fish Leap Medical ##上市药企 #