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

One imported drug is banned nationwide.

Overseas inspection of Indian imports

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 former State Food and Drug Administration organized the Indian Sun Pharmaceutical Co., Ltd. to conduct an on-site examination of imported pharmaceuticals for overseas production. The inspection was performed on imipenem cilastatin sodium for injection.

Suspended sales nationwide, use

The inspection found that the company had failed to effectively control the bacterial endotoxins of the above varieties, failed to prove the effectiveness of aseptic safeguards in the production process, and the cleaning method of the raw material drug reaction tanks had not been effectively verified such as production management and quality management. The problem does not comply with the requirements of China's "Standards for Quality Control of Pharmaceutical Production (2010 Revision)".

The product has quality risks. In order to ensure the safety of public drug use, it has decided to suspend the sale and use of the product within China since that day. The food and drug supervision authorities of the 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 'Tai Neng' accounted for nearly 2 billion. This is Lan Boxi’s. The market share is about 5, 60 million yuan.

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