China Revises Ganmaoling Instructions, Adds Driving Ban; Huaren Sanjiu 999 Sales Top RMB 2 Billion in 2025

China's National Medical Products Administration (NMPA) issued a notice in 2025, based on adverse drug reaction assessments, deciding to uniformly revise the instructions for Ganmaoling oral liquid preparations. The revision improves the warning statements, contraindications, adverse reactions, and precautions. The revised instructions emphasize that patients must not drive vehicles, operate boats, work at heights, perform mechanical work, or operate precision instruments while taking the medication. All marketing authorization holders of Ganmaoling oral liquid preparations must file the updated instructions with provincial drug regulatory authorities by October 15, 2026. Products manufactured after the filing date may no longer use the original instructions. Within nine months after filing, companies must replace the instructions and labels on already-marketed products or inform patients of the updated information through other appropriate means. Marketing authorization holders should conduct research on the mechanisms of newly added adverse reactions, carry out safety publicity and training, and guide rational drug use.

Huaren Sanjiu's 999 Ganmaoling brand, a leading product in the category, recorded retail sales exceeding RMB 2 billion in 2025.

The adverse reactions section has been significantly expanded, covering skin, nervous system, digestive system, liver, kidney, and urinary system reactions.

A manager of a chain pharmacy said that the new unified instructions clearly specify warnings such as the driving ban, allowing staff to provide risk reminders to purchasers based on official content, effectively reducing the likelihood of customer complaints and claims for counterfeit or defective products. In routine sales scenarios, general risk reminders are provided through in-store posters, electronic screens, and text on drug packaging.

Huang Xiuxiang, former secretary-general of the Hunan Pharmaceutical Circulation Industry Association, pointed out that the current Good Supply Practice for drugs does not require staff to verbally remind every customer individually, but pharmacies must provide compliant new instructions and are prohibited from selling products that have not updated their labels and instructions. Licensed pharmacists should proactively inquire about medical history and occupation when serving elderly patients, those with severe illnesses, and professional drivers, and provide medication guidance.

The People's Court of Renshou County in Sichuan Province once issued a judgment in a life rights dispute. Jin suffered a heavy craniocerebral injury from a traffic accident. His family purchased drugs from a pharmacy without mentioning his severe medical history. The pharmacy's licensed pharmacist did not proactively inquire and illegally split and repackaged four drugs into unlabeled bags without providing the original packaging and instructions.

Forensic examination showed that Jin's cause of death was consistent with heavy craniocerebral injury from the traffic accident complicated by pulmonary infection and chlorpheniramine poisoning. The court ruled that the pharmacy bore 40% liability due to multiple sales violations and ordered compensation of RMB 87,000. Huang Xiuxiang noted that in daily practice, consumers often 'do not know what drugs they have taken,' and liability is primarily determined based on the instructions. A pharmacy's fault mainly lies in failing to provide compliant products or causing harm due to material omissions, leading to corresponding liability. After the new regulations, pharmacies must ensure they provide the new instructions, and products in the distribution chain that have not updated their instructions as required may not be sold. Hospital pharmacies and retail pharmacies can strengthen training, but it is difficult to mandate verbal reminders for every transaction; auxiliary reminders such as labels, in-store displays, and electronic screens are more practical.