Overseas inspection of imported drugs in India | National suspended sales, use

Medicine Network May 15th, an imported drug is banned nationwide.

On May 14, the State Food and Drug Administration issued the "Announcement on the Suspension of Sale of Imipenem Cilastatin Sodium for Injection by Indian Sun Pharmaceutical Co., Ltd. (No. 21 of 2018)".

Announcement shows: The original national food drug The General Administration of Supervision and Administration of India Sun Pharmaceutical Co., Ltd. organizes and conducts on-site inspections of imported pharmaceuticals for overseas production. The type of inspection is imipenem cilastatin sodium for injection.

Examination revealed enterprise There is a failure to effectively control the bacterial endotoxins of the above species, fail to prove the effectiveness of aseptic safeguards in the production process, and the cleaning methods of the raw material drug reaction tanks have not been effectively verified such as production management and quality management problems. Does not meet China's "drug production quality management practices (2010 revision)" requirements.

The product has quality risks. In order to ensure the safety of public drug use, it is decided to suspend the sale and use of the product in China from now on. The food and drug supervision authorities at all ports will suspend the issuance of the import customs clearance certificate for the product, and organize the processing according to law.

▍ 2.6 billion market, Merck

The database of the Directorate-General shows that the 10 domestic approvals for the injection of imipenem cilastatin sodium were approved by Pyongei of Haizheng, Shandong New Era, Sinopharm Group of Sinopharm Group, Zhuhai Federation, and Shenzhen Waterfront.

The eight approvals for imports were taken up by four drug companies, namely Xindong Biotech and Merck East. In the import drug database of the General Administration of Customs, there was no information about the Indian Sun Pharmaceuticals drug.

According to the author's research, the injection of imipenem cilastatin sodium by Indian Sun Pharmaceuticals actually belonged to the Indian Lambert Laboratories before their acquisition.

According to the authoritative database, the use of imipenem cilastatin sodium for injection has a total market share of 2.66 billion yuan in 2016, but Merck's 'Taineng' accounted for nearly 2 billion. This is Lan Boxi’s. The market share is about 5, 60 million yuan.