Industry Calls for BIS Exemption Amid New Steel Ministry Rules

Medical device manufacturers are facing potential supply chain disruptions due to new regulations from the steel ministry, mandating that raw materials used in steel products must meet Indian standards. This change has raised concerns among industry leaders about the feasibility of compliance, especially for imported materials like hot rolled steel and ingots, which now require BIS certification.

Challenges in Compliance and Operational Hurdles

Manufacturers argue that the low annual demand for specific steel components makes BIS certification commercially unviable for international suppliers. Hindustan Syringes & Medical Devices, for instance, relies on specialized stainless steel capillary tubes from Korean suppliers, for which certification is not economically feasible. The company has requested an exemption from the BIS requirement to avoid operational challenges.

Potential Impact on Healthcare System

The Association of Indian Medical Device Industry (AiMeD) has warned of possible disruptions to the healthcare system, emphasizing the lack of locally available stainless-steel strips that meet the required specifications for manufacturing medical devices. The association highlighted the risk to production quality and delivery commitments, particularly for exports, without access to these specific materials.