Harsher penalties sought as pharma violations continue

On August 3, the Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) imposed a fine of VND50 million ($2,175) on Incepta Pharmaceuticals Ltd., a group from Bangladesh and established in 1999, for violating level 3 quality regulations. Nam Phuong Cosmetics and Pharmacy Trading Company Limited is the representative of the Bangladeshi firm to execute the fine.

Harsher penalties sought as pharma violations continue, illustration photo

The week previously, the DAV also fined Italian group Industria Farmaceutica Nova Argentia S.p.A for quality violation. It makes Navacarzol, with various lots of the drug violating level 2 quality regulations. The fine was set at VND150 million ($6,500) and a recall has taken place.

Also last month, a similar fine was imposed on PT. Merck Tbk from Indonesia, which produced two lots of Neurobion 200mg, Thiamin mononitrate 100mg; and Cyanocobanlamin 200mcg.

More seriously, the DAV in July revoked marketing authorisation for Zinnat Suspension for violating level 2 quality regulations. Zinnat Suspension is a broad-spectrum antibiotic registered by GlaxoSmithKline (GSK) in Singapore. The producer is Glaxo Operations UK, while Zuellig Pharma Vietnam is the importer. The DAV asked the registering company to work with the importer and distributors to recall the violators and then report the result to the agency.

According to GSK, in April 2022, GSK communicated with local regulatory agencies in five markets after identifying an issue during routine stability testing which resulted in a Cefuroxime axetil sachet Oral Suspension 125mg/5ml failing to meet the specification for appearance, moisture and impurities.

A GKS representative told VIR that in Vietnam, GSK proposed to local regulatory authorities to implement voluntary recall of Cefuroxime axetil sachet Oral Suspension 125mg/5ml as a precautionary measure and to ensure the interests of patients are fully protected. GSK worked with the importer to implement this voluntary recall in accordance with local regulations and it was completed accordingly.

“GSK is committed to supplying high-quality medicines to our patients and is conducting a thorough investigation to identify and correct the root cause of the issue. Patient safety remains our utmost priority and we are taking this issue very seriously. We sincerely regret any inconvenience caused to patients and healthcare professionals,” the representative noted.

Domestic enterprises were also hammered with fines. They included Nghe An Pharmaceutical Medical Material and Equipment JSC, BRV Healthcare, and Mebiphar JSC among others. For BRV Healthcare, this is not the first time. On two separate occasions last year it was fined for Desloratadine 5mg failing to meet quality standards. The MoH earlier announced stricter rules to deter any new violators. They include toughest-ever rules including suspension of violation-related business activities for 1-3 months if mobile drug retailing establishments fail to satisfy the conditions as ruled, and suspension of violation-related business activities for 6-12 months for forging papers in dossiers announcing business establishment.

In addition, some guilty parties may even have their certificates of eligibility for pharmacy temporarily revoked for up to two years.

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