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The Central government's move to mandate Indian Standards for certain stainless steel components used by the medical devices manufacturers for their finished products may hit the production of several critical devices in the country.
The ministry of steel has mandated Indian Standards to be followed for input materials which are part of the Quality Control Order for Steel and Steel products, stating that the Bureau of Indian Standards registration would be necessary for import of these input materials.
Several manufacturers have submitted their representations to the government seeking exemption from such certifications for import of stainless steel strips and tubes, and stainless steel capillary tube, since many of these products are customised and some of them do not even have a publicised standard from the BIS.
Taking the concerns into consideration, the Association of Indian Medical Device Industry (AiMeD), in a letter to the ministry of steel, said, "We therefore, request you please give NOC/exemption to import stainless steel strip without BIS registration as well as seeking for their downstream product without BIS registration of inputs." Access to quality raw material is essential for meeting international standards, it added.
While there have been efforts to source stainless steel strips from local manufacturers such as Tata Steel, Jindal, BSL, Anil Metal, Stelco, and Mecon Ltd, the required specification for manufacturing the Stainless Steel capillary tubing is not available in India. Even if they produce the material, it would not be sustainable or economical at times to produce small batches of tubing.
"Domestic strips lack suitable burrs on edges for consistent welding, have poor surface aesthetics, and do not meet dimensional standards, resulting in unacceptable welding inconsistencies and leakage. 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," said Rajiv Nath, forum coordinator, AiMeD.
One of the companies said that the its overseas supplier based in Switzerland is ready to register their specific stainless steel strips with the BIS to produce high precision surgical blades to match the international standards, but BIS is not having this applicable standard. Without a published standard, the foreign supplier is handicapped to get BIS registration, it informed.
Another company said that while its Japanese supplier has obtained BIS registration for stainless steel strip under a particular standards, but there is now an additional requirement for registration of their input raw material as per the order on June 13, 2025. This specialised steel capillary tube is not manufactured in India and it would require an NOC or exemption to avoid disruption of manufacturing of medical devices.
"Production of surgical blades, needles, IV cannulas , endoscopes , scalp vein sets etc may get disrupted if supply chain is not maintained . It’s easier to import finished products and steel components rather than strips and tubing needed to make value added medical devices - the make in India strategy has gone awry," said Nath.
"What’s more important? To protect value added manufacturing or a handful of raw material producers in India who do not make everything that we need nor the quality that we need to be globally competitive," he added.
As medical devices are already regulated for quality under Medical Devices 2017 Rules and products need to be made to BIS having a QCO on inputs is needless regulations and the unmaking of medical devices in India - if India needs to be prepared for the next pandemic we need to building resilient supply chains in a coordinated manner by exempting medical devices from QCO’s on inputs and machinery, he elaborated.
Usually a six month public input notice is given against a draft notification and then again a 6 month transition period is provided for implementation, to enable smooth implementation. However, for this order, the industry has been provided only a few days, said Nath.
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