"During the environmental inspection, most of the companies in the industrial park suspended production for rectification. The various environmental protection measures implemented by the industrial park management office take into account both ecological and environmental protection and the economic benefits of enterprises. Currently, the companies that suspended production in the industrial park have gradually resumed production," said the head of the publicity department of the industrial park where a raw material pharmaceutical company is located.

This year, the pharmaceutical industry, including the active pharmaceutical ingredient (API) sector, has been embroiled in turmoil due to increased environmental inspections and restrictions on approvals. Many pharmaceutical companies have been ordered to suspend production for rectification due to environmental issues, and some even face bankruptcy. However, many pharmaceutical companies have a lot of grievances to share regarding these rectification efforts.

"Since 2018, many API companies have been fined multiple times for environmental issues. Some companies that were temporarily shut down for rectification may have submitted applications to resume production, been granted permission, and then received fines again shortly afterward. It's quite a hassle," said a manager at a pharmaceutical company. He added that with increasingly stringent environmental regulations and more frequent unannounced inspections, API companies are facing a survival crisis, and their performance has been affected.

It is reported that a technical upgrade project for an API production line in Jiangsu Province, after its trial production expired on September 1, 2017, still failed to pass the environmental protection "three simultaneous" acceptance inspection by the environmental protection bureau on June 8, 2018, and received a large fine. Its performance also fluctuated significantly.

In fact, API pollution problems have existed for a long time and are extremely difficult to resolve. In the past, my country's environmental inspections covered a wide range of areas. However, in recent years, under sustained high environmental pressure, pollution problems from raw material pharmaceutical companies have been frequently exposed. For example, some pharmaceutical companies' emissions, while "not exceeding standards in test results, were noticeable to the smell," and issues such as "illegally dumping hazardous waste" and "seriously impacting the surrounding environment" have received high attention from relevant regulatory departments and have been punished accordingly.

Industry insiders say that since the implementation of the new Environmental Protection Law, the pharmaceutical industry, a heavily polluting sector, has inevitably faced environmental pressure. It is understood that the newly revised Environmental Protection Law of the People's Republic of China is considered the "strictest" environmental protection law in history because it increases the liability for illegal discharge. Firstly, it stipulates a daily penalty system. This means that companies that illegally discharge pollutants will be fined based on the number of days of violation, rather than a one-time fine, with no upper limit on the total amount of fines, and a "blacklist" system has been established. Secondly, it orders companies to suspend operations or close down. Thirdly, it stipulates administrative detention.

It is evident that with increasing environmental pressure, China's raw material pharmaceutical industry is facing an unprecedented struggle for survival. An overall price increase for domestic raw material pharmaceutical companies is also an inevitable trend. As for when raw material drug prices will decrease, it depends on when the supply shortage subsides. Regarding the deliberate "monopoly" of raw materials by some companies to raise prices, my country has also introduced a series of policies.

For example, to strengthen control over the recent surge in raw material drug prices, the General Office of the State Council issued the "Opinions on Improving the National Essential Medicines System," which states that "for those who monopolize the raw material market and drive up drug prices leading to drug shortages, and are suspected of constituting monopoly agreements and abusing their market dominance, anti-monopoly investigations will be carried out in accordance with the law, and penalties will be increased." However, judging from the current situation, the raw material drug industry is affected by the overall environmental protection crackdown, and the "receding tide" may not be short-lived.