Industry policy environment

API industry is obviously disturbed by policies, among which environmental protection and supply side reform are important policy factors affecting the trend of the industry. The 13th five year plan for ecological and environmental protection issued by the State Council in 2016 clearly requires the API manufacturing industry to promote the transformation of the industry to meet the emission standards; According to the regulations on the management of the list of key pollutant discharge units (Trial), API manufacturing and pharmaceutical have been included in the list of key pollutant discharge units of water environment and the list of key pollutant discharge units of atmospheric environment respectively. Under the pressure of increasingly stringent environmental protection policies, small and medium-sized pharmaceutical enterprises face the risk of production restriction or shutdown because they can not bear the high pollution control cost.

In addition, there is a structural contradiction between the supply side and the demand side in China’s API industry. On the one hand, the blind expansion of traditional bulk APIs leads to serious overcapacity. On the other hand, due to the high technical requirements and large R & D investment of characteristic APIs, it is still difficult to meet the demand for some clinically urgently needed or characteristic APIs. In this context, the national development and Reform Commission and other relevant departments have made it clear that they should strengthen guidance on the R & D and production information of API, strongly encourage the characteristic API in urgent need and shortage in clinic, support the new technological innovation of API, strengthen the investigation and punishment of the abuse of market dominance and monopoly, and guide the healthy development of the industry.