India’s medical device industry is grappling with mounting uncertainty after the Ministry of Steel’s new mandate requiring that raw materials used in finished and semi-finished steel products-such as surgical blades, needles, and endoscopes-must comply with Indian Standards and carry Bureau of Indian Standards (BIS) certification.
Previously, foreign suppliers only needed BIS approval for finished steel products. Under the revised rules, upstream inputs like hot-rolled steel and ingots from overseas vendors must also be certified before entering Indian manufacturing supply chains.
Manufacturers, particularly those producing high-precision products like syringes and needles, warn that the policy could lead to shortages, disrupt healthcare services and damage export prospects. Many rely on specialized imported stainless steel capillary tubes, often procured in small volumes that make BIS certification economically and operationally unfeasible. Industry bodies have requested exemptions for such niche imports.
The Association of Indian Medical Device Industry (AiMeD) has told the Ministry of Steel that domestic suppliers-including Tata Steel, Jindal, and BSL-cannot consistently produce the small-batch, specification-grade stainless steel required for certain devices. Without access to these imports, manufacturers risk compromising product quality, failing to meet global standards, and missing delivery deadlines for international customers.
Business groups say the mandate has already inflated compliance costs and strained supply chains. They warn that unless relief, stakeholder consultations, or targeted exemptions are introduced, the rules could even force some factories to shut down-threatening both domestic supply and India’s position in the global medical device market.