Govt Waives BIS for Syringe-Use Plastic

The exemption follows industry concerns and a 42% drop in HDPE imports in FY25 amid regulatory bottlenecks

- Dhirendra Kumar

The Centre has exempted pharmaceutical-grade high-density polyethylene (HDPE), a key raw material used in making disposable syringes and IV cannulas, from mandatory quality certification under Bureau of Indian Standards (BIS).

The move, notified by Ministry of Chemicals and Fertilizers, aims to prevent supply disruptions in the medical devices sector amid concerns that mandatory BIS norms were declining imports of USP or EP-grade HDPE.