In a move aimed at ensuring uninterrupted supply of critical medical devices, the Indian government has removed mandatory quality certification requirements for specific imported plastic materials used in producing syringes and IV cannulas.
The exemption, announced by the Ministry of Chemicals and Fertilizers, pertains to pharmaceutical-grade high-density polyethylene (HDPE), particularly EP/USP-certified variants used in syringe plungers and IV components. These high-quality materials are mostly imported, as domestic production remains limited.
Previously, the mandatory Bureau of Indian Standards (BIS) certification had slowed down imports, causing concerns over potential supply disruptions. Responding to these industry concerns and based on internal assessments, the government has amended the 2022 quality control order to exclude these specific grades of HDPE from the certification mandate. However, the exemption does not apply to HDPE used for packaging or other general plastic uses, which must still comply with BIS norms.
This regulatory adjustment follows a sharp decline in HDPE imports, which dropped by 42% in FY25 to $1.15 billion from $1.98 billion in FY24. Imports are also down 34% compared to FY23, largely due to the impact of the quality control requirements.
Industry representatives have welcomed the change, stating that it will help maintain steady production of essential medical supplies and support export commitments, especially to countries with stringent regulatory standards. EP/USP-grade HDPE used in India’s medical device manufacturing is primarily sourced from nations such as South Korea, Singapore, the United States, Saudi Arabia, and Germany.