Medical product manufacturers face potential supply disruptions due to new steel ministry regulations, which require raw materials used in steel products to meet Indian standards.Industry leaders expressed concerns about their inability to comply with the latest rules that mandate BIS certification for imported raw materials like hot rolled steel and ingots. Previously, this certification was only necessary for finished steel products from foreign suppliers. Manufacturers have petitioned the steel ministry to exempt stainless steel capillary imports from BIS certification requirements.Several manufacturers interviewed indicated that importing specific steel components remains essential, as low annual requirements make BIS certification commercially unviable for international vendors, a sreported by ET.Hindustan Syringes & Medical devices, which relies on Korean suppliers for specialised stainless steel capillary tubes, faces operational challenges. “This is a low volume material hence making the BIS certification process is not feasible both economically and operationally. We have therefore requested the ministry of steel for exemption of the BIS requirement for the import,” said Rajiv Nath, MD, HMD.The Association of Indian Medical Device Industry (AiMeD) has warned of potential healthcare system disruptions in a letter to the ministry. “Despite efforts to source stainless-steel strip from local manufacturers such as Tata Steel, Jindal, BSL, Anil Metal, Stelco, and Mecon Limited, the required specification for manufacturing SS capillary tubing is not available in India as it is not sustainable or economical to produce small batches of tubing,” the letter stated. “Manufacturing medical devices to global standards requires this specific stainless steel. Without it, the production, product quality, and delivery commitments, especially for exports, are at risk,” the letter further noted.
