India has restricted imports of a key pharmaceutical chemical, ATS-8, with a price cap set until September 2026 to regulate low-cost imports, primarily from China.
In a move to regulate imports and support domestic manufacturers, India has imposed import restrictions on a crucial pharmaceutical chemical, ATS-8, until September 30, 2026. The Directorate General of Foreign Trade (DGFT) issued a notification stating that imports of the chemical, officially known as (4r-cis)-1 1-dimethylethyl-6-cyanomethyl-2 2-dimethyl-1 3-dioxane-4-acetate, are restricted if their CIF (cost, insurance, freight) value is below $111 per kilogram.
The new regulation, which takes immediate effect, aims to curb the influx of cheap imports, which have historically impacted the domestic market.
ATS-8 is a key intermediate used in the synthesis of Atorvastatin Calcium, a widely-prescribed statin medication for lowering cholesterol. It helps in prevention of cardiovascular events such as heart attacks, strokes, and angina (chest pain).
In essence, ATS-8 is a vital component in the production chain of a drug that is imperative for managing and preventing a wide range of heart and blood vessel-related diseases. The majority of this chemical is imported from countries like China.
In addition to China, India imports atorvastatin calcium from several countries, including Mexico, United States, France, and Belgium. To reduce dependency on imports, India is investing in domestic production capabilities for atorvastatin intermediates. For instance, Cocreate Global Technologies manufactures ATS-8 in Bengaluru, Karnataka.
However, the DGFT's notification includes specific exemptions to ensure that the export-oriented sector remains unaffected. The minimum import price (MIP) condition will not apply to inputs imported by advanced authorisation holders, export-oriented units (EOUs), and businesses located in special economic zones (SEZs). This allows these entities to continue importing the chemical without the price restriction, which is crucial for manufacturing products for the global market.
