New Steel Norms May Disrupt Medical Device Supply Chain in India

India's pharmaceutical and medical device supply chain is on the brink of crisis as confusion surrounding the Ministry of Steel's recent mandate raises questions about the availability of critical components including surgical blades, needles, and endoscopes.

The ministry has now mandated that all raw materials contained in finished and semi-finished steel products must meet the arbitrary standards that the Ministry creates, including BIS Certification — a noticeable change from the earlier standard which only applied to products after they were finished.

"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.

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As a result of this, manufacturers are facing challenges, particularly companies that imported stainless steel capillary tubes, steel strips and specialty pipes in limited quantities. With small volumes, foreign vendors are unwilling to incur the cost of the BIS certifications, preventing their ability to supply Indian companies with what they need.

Industry executives have already expressed concerns that the steel mandate could leave a critical gap, thus stopping the manufacture of a plethora of medical products. The Association of Indian Medical Device Industry (AiMeD) has requested that the ministry make the BIS certification allow low quantities of import without requiring certification and warned there would be disruption to the healthcare system if it can't be arranged quickly.

"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 said.