Cancer drugs found to violate quality

The Drug Administration of Vietnam ( Ministry of Health ) has just issued Decision No. 483/QD-XPHC to administratively sanction Binh Dinh Pharmaceutical and Medical Equipment Joint Stock Company (Bidiphar) with its head office at 498 Nguyen Thai Hoc Street, Quang Trung Ward, Quy Nhon City, Binh Dinh Province.

The company was fined for administrative violations: manufacturing drugs that violate level 1 quality standards according to the law for the drug Methotrexat Bidiphar 50mg/2ml, circulation registration number QLDB-638-17, batch number 21003, production date August 30, 2021, expiration date August 30, 2023.

Bidiphar was fined for producing Methotrexat Bidiphar 50mg/2ml, violating quality level 1.

Bidiphar was administratively fined 100 million VND and additionally fined: suspension of the production line related to the violation, which is Bidiphar's cytotoxic injection production line at the above address.

At the same time, all drugs violating quality must be destroyed (Methotrexat Bidiphar 50mg/2ml batch, circulation registration number QLDB-638-17, batch number 21003, production date August 30, 2021, expiration date August 30, 2023).

The Drug Administration requires Bidiphar to submit a report on the recall and take remedial measures to the Drug Administration within 30 days from the date of issuance of this decision (July 7, 2023). If Bidiphar fails to voluntarily comply within the deadline, it will be forced to comply in accordance with the provisions of law.

According to the National Pharmacopoeia, Mathethotrexa is an anti-cancer drug (high dose) and immunosuppressant (low dose), indicated for the following cases: trophoblastic cancer, breast cancer, lung cancer, bladder cancer, head and neck cancer...

According to the classification regulations of the Ministry of Health , level 1 violating drugs are drugs that pose a risk of causing serious harm to the health or life of users, falling into one of the following cases: counterfeit drugs, smuggled drugs, drugs of unknown origin; drugs with an urgent recall notice from a competent foreign state agency; drugs with a conclusion that do not ensure safety requirements from a competent state agency; intravenous drugs that do not meet sterility standards or do not meet pyrogen standards or endotoxin standards...

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