Govt releases imported medical degree plastic of quality rules to increase spray, IV production | Today news

New Delhi: The Government has released pharmaceutical degree high-density polyethylene (HDPE), a critical raw material used to make disposable syringes and IV canulas, of compulsory quality certification among the Bureau of Indian Standards (BIS). The move, notified by the Ministry of Chemicals and Fertilizers, aims to prevent the provision of the offer in the medical devices sector amid concerns that mandatory bis norms delay the import of EP/USP grade HDPE. These specialized degrees, which are largely from overseas, are not manufactured domestically on scale and are essential to ensure uninterrupted production of essential medical equipment. ‘The government has taken this step based on its market intelligence in mind to keep in mind the sensitivity of the raw material needed to make syringes. The industry also requested it, ‘said a senior government official. The exemption specifically applies to EP/USP degree HDPE used in spraying comers and IV components. It does not extend to using in packaging or other plastic products, which will still need BIS certification. The amendment of the 2022 quality control order was issued by the Department of Chemicals and Petrochemicals and follows consultation with BIS. This leaves an earlier clause and adds the new release in public interest, according to the notice. The decision comes amid a sharp decline in HDPe imports. According to the data from the Ministry of Trade, HDPE imports dropped almost 42% to $ 1,151.23 million in FY25 of $ 1,979.39 million in FY24. Compared to the FY23, imports are 34%lower, reflecting the impact of regulatory issues. Industry managers welcomed the move, saying it provides timely relief to manufacturers who depend on the imported EP/USP certified HDPE, especially for export to strictly regulated markets. “This is a practical decision by the government. Any delay or disruption in access to the EP/USP polyethylene may have affected the spray and the production of IV, especially amid the increasing demand for healthcare,” an executive officer said at an exporter of medical devices. India largely imports the medical degree HDPE used in syringes and IV sets from South Korea, Singapore, the US, Saudi Arabia and Germany.