Green Development: Not Merely Conceptual, But Compulsory for Pharma Manufacturing in China

by Grace Wang Apr 19, 2023

On April 12, the 2023 China Pharmaceutical Industry Green Development Conference, a sub-event of API China, took place in Qingdao, China. At the conference, experts shared their insights into the green development of pharmaceutical manufacturing industry. One of the focuses was improving the technologies and regulations for tackling pollution emissions. 

Hou Li’an, member of the Chinese Academy of Engineering, shared the data of chemical drugs’ active pharmaceutical ingredients (APIs) produced by China in 2022: a total of 3.626 million tons, with an increase of 16% from 2021. He said the API production generated an enormous amount of wastewater with complex pollutants, which was costly to decontaminate.

Mr. Hou proposed membrane technology as an effective method to separate pollutions such as inorganic salt, antibiotics, and organics from the wastewater. In addition, he pointed out the shortcomings of the membrane technology, e.g., general membranes may not be capable to separate pollutants from the wastewater with extremely complex quality attributes. Thus, he recommended the use of nanomaterials which can help efficiently separate pollutants from wastewater, with the consideration of improving the biosafety level of nanomaterials.

Besides technologies, green development in the pharmaceutical sector is also supported by regulations. With “pursue green development” written in the Outline of the 14th Five-Year Plan for Economic and Social Development (2021–2025), China has rolled out more detailed regulations.

For example, China’s State Council issued the Action Plan for New Contaminants Treatment (hereafter referred to as the Action Plan) on May 24, 2022 with immediate effect. According to the Action Plan, persistent organic pollutants, endocrine disruptors, and antibiotics are new contaminants.

Item 12 in the Action Plan requires local governments to study the system for evaluating the environmental hazard of antibiotic drugs and enhance the administration of their clinical uses. Item 14 asks companies to apply for pollution emission licenses or fill in the registration forms, and publicize the new contaminants emitted by themselves.

In conclusion, China is not advanced enough in regulations and technologies for green development, but the good news is that China has been making progress. China tends to turn guidelines into compulsory regulations, including setting up clearer standards for regulating pollution emission.

Grace Wang
ChemLinked Regulatory Analyst / Editor
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