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|Many popular drugs in Vietnam are produced by companies that sometimes skirt the rules for profit, photo: Dung Minh|
The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) on November 26 asked departments of health to carry out a nationwide retrieval of Sedtyl (Desloratadin 5mg), circulation No.VD-25077-16, batches 02L19, for failing to meet quality requirements.
In Document No.17570/QLD-CL dated the same day, the DAV required BRV Healthcare to submit a report on the recall, including volumes of production, distribution, and retrieval, and evidence of the recall at wholesale and retail units within 18 days.
The DAV also asked the group to check the quality of all batches of Desloratadin and then analyse and test related contaminants, as well as possible risks. The results must be sent to the DAV by December 31.
The recall is a blow to BRV Healthcare, which has gained a positive reputation since the turn of the century thanks to strong development, rich experience, and professionalism of staff, many of whom previously worked at various multinational corporations.
Despite a request from VIR, BRV Healthcare has so far declined to comment.
The recall has triggered concern over the code of ethics of such a prestigious company, which vowed often to carry out research, apply advanced technology, and produce safe and high-quality pharmaceuticals.
“I am concerned because I often use Sedtyl to treat allergy symptoms in my family,” said a 54-year-old woman in Hanoi who declined to be named. “The medicine is popular in families of my relatives and friends. They are also worried about whether it causes any side effects.”
BRV Healthcare owns a number of prescription drug medicines such as Zacutas for hepatitis C, Ausvair for nerve pain, and Vimethy for arthritis.
Violations of drug quality and related matters are not a rare issue in Vietnam’s lucrative pharmaceutical industry, with the number increasing on an annual basis – and humble punishments mean companies are often willing to violate some rules in order to gain higher profits.
A few weeks ago, after Young Il Pharm, USV Private and Armepharco were named as prominent drug quality violators, industry insiders expected that future incidences could be deterred thanks to Decree No.117/2020/ND-CP governing fines in the healthcare sector, which took effect from November 15.
The new decree features toughest-ever rules including suspension of violation-related business activities for 1-3 months if mobile drug retailing establishments fail to satisfy conditions as ruled, and suspension of violation-related business activities for 6-12 months for forging papers in dossiers announcing business establishment, among others.
However despite this, an increasing number of violations in the pharmaceutical industry are still continuing, with Modern Cass International Cosmetics, Pacific Pharmacy JSC, and many others also named as quality violators.