A pharmaceutical company in Rugao, Nantong was fined 100,000 yuan for incinerating and landfilling substandard drugs without authorization
2024-08-21
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In May this year, the Rugao Ecological Environment Bureau of Nantong City received a report from the public that a pharmaceutical company had handled substandard drugs without authorization and hoped that the environmental protection department would investigate and deal with it. The law enforcement officers of the Rugao Ecological Environment Bureau carefully reviewed the video materials provided by the reporter and initially determined that there might be environmental violations.
On May 30, law enforcement officers from the Rugao Ecological Environment Bureau conducted an on-site inspection of a pharmaceutical company involved in the case. However, to the surprise of the law enforcement officers, the company's legal representative, Jiang, brought a thick ledger and said that all the destruction of the company's substandard drugs was recorded in this ledger, and expressed his willingness to cooperate with the Rugao Bureau's investigation. It turned out that the drug supervision department has strict regulations on the wholesale and sales of drugs, and the disposal of substandard drugs must be recorded in the ledger.
The records are complete, and law enforcement officers are somewhat puzzled. This record has records of destruction from 2013 to May 2024. The disposal methods include direct incineration and return to upstream manufacturers. The types of drugs are also varied. How to characterize? According to relevant laws and regulations on the ecological environment, the company's near-expiry, expired, and substandard drugs generated during its operations, including "vitamins and mineral drugs" and "water, electrolyte and acid-base balance drugs" that are chemical drugs and are not included in the "National Essential Medicines Catalog", belong to HW03 900-002-03 "ineffective, deteriorated, substandard, obsolete, and counterfeit chemical drugs generated during sales and use", which are hazardous wastes. However, companies that sell wholesale drugs have never been exposed before. Will there be any special regulations or exemptions?
Under this circumstance, the environmental law enforcement personnel negotiated with Jiang Mou, retrieved the records of the drug supervision department's inspection of the unit in 2023, and consulted the "Pharmaceutical Administration Law of the People's Republic of China", "Pharmaceutical Business Quality Management Standards" and other laws and regulations. It was finally determined that the unit disposed of unqualified drugs by incineration, landfill and other methods without the qualification for hazardous waste treatment, which was a failure to dispose of hazardous waste in accordance with national environmental protection standards. Subsequently, the environmental law enforcement personnel confirmed through investigation and questioning, on-site identification, and ledger comparison that the unit disposed of unqualified drugs 8 times (including 2 times involved in the petitioner's report materials) from 2023 to 2024, disposed of unqualified drugs 2 times in 2020, and disposed of unqualified drugs once in 2015, 2014, and 2013, and dug out a total of 16.60 kilograms of burned aluminum foil packaging boards and packaging residues.
The illegal facts have been determined, and the next question is how to deal with them. In the case discretion process, law enforcement officers strictly followed the spirit of the "Rules for Discretion of Administrative Penalties for Ecological Environment in the Yangtze River Delta Region" (Shanghai Environmental Regulation [2024] No. 6), and comprehensively considered the time of violation, environmental impact consequences, overall industry supervision, the unit's rectification performance, cooperation with the investigation, subjective motivation and other factors, and finally decided to order the unit to immediately correct the illegal behavior; and impose a fine of RMB 100,000 on the unit.
At the same time, according to the principle of "combining law enforcement with popularization of law", the law enforcement officers of Rugao Bureau popularized the knowledge of relevant laws and regulations to Jiang and the employees involved in the case during on-site law enforcement and case handling, and guided them to further standardize the disposal process of unqualified drugs. At present, the unit has re-drafted the unqualified drug management system, signed a hazardous waste disposal agreement with a qualified company, opened an account and declared in the hazardous waste life cycle management system, and signed an ecological damage compensation agreement.
Since the industries involved in such cases have not been included in the scope of ecological environment supervision before, they are rarely paid attention to in daily law enforcement. In the next step, Rugao Ecological Environment Bureau will refer to the handling of this case, rely on "double random, one public" and "hazardous waste life cycle management system" and other supervision methods, strengthen communication and coordination with the Market Supervision Bureau and other relevant departments, and further promote the standardization of the pharmaceutical wholesale and retail industry in the disposal of unqualified drugs, and promote the improvement of the ecological environment management level of the entire industry from point to surface.
Correspondent Su Xiaohuan Yangtze Evening News/Ziniu News reporter Cao Lujie
Proofread by Tao Shangong
