New Delhi, June 13 -- The government has exempted pharmaceutical-grade high-density polyethylene (HDPE), a critical raw material used in making disposable syringes and IV cannulas, from mandatory quality certification under the Bureau of Indian Standards (BIS).

The move, notified by the Ministry of Chemicals and Fertilizers, aims to prevent supply disruptions in the medical devices sector amid concerns that mandatory BIS norms were slowing imports of EP/USP-grade HDPE. These specialised grades, largely sourced from overseas, are not manufactured domestically at scale and are vital to ensure uninterrupted production of essential medical equipment.

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