Govt exempts imported medical-grade plastic from quality rules to boost syringe, IV production
New Delhi: 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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'Keeping in mind the sensitivity of the raw material required for making syringes, the government has taken this step based on its market intelligence. The industry had also requested it,' a senior government official said.
The exemption applies specifically to EP/USP-grade HDPE used in syringe plungers and IV components. It does not extend to use in packaging or other plastic products, which will still require BIS certification.
The amendment to the 2022 quality control order was issued by the Department of Chemicals and Petrochemicals and follows consultation with BIS. It omits an earlier clause and adds the new exemption in public interest, according to the notification.
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The decision comes amid a steep decline in HDPE imports. According to data from the commerce ministry, HDPE imports fell nearly 42% to $1,151.23 million in FY25 from $1,979.39 million in FY24. Compared to FY23, imports are down 34%, reflecting the impact of regulatory bottlenecks.
Industry executives welcomed the move, saying it offers timely relief to manufacturers that depend on imported EP/USP-certified HDPE, particularly for exports to tightly regulated markets.
'This is a practical decision by the government. Any delay or disruption in accessing EP/USP grade polyethylene could have impacted syringe and IV set production, especially amid rising healthcare demand,' said an executive at a medical device exporter.
Also read | When India's mushrooming quality orders ran into Trump
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