In a major breakthrough for India’s medical device sector, the government has stepped in to avert a looming healthcare and supply chain crisis  The intervention, led by the Department of Pharmaceuticals (DoP) and the Ministry of Steel, comes as a major relief to manufacturers grappling with challenges around the import of specialized stainless steel (SS) used in the production of critical surgical tools such as blades, scalpels, capillary tubing, and medical-grade wires.

The Association of Indian Medical Device Industry (AiMeD), spearheaded by Forum Coordinator Mr. Rajiv Nath, had raised concerns regarding the disruption caused by the lack of BIS (Bureau of Indian Standards) certification for certain special grades of SS strip and related raw materials. These materials are currently not manufactured in adequate quality or quantity within the country.

Thanks to the proactive efforts of the Secretary of Pharmaceuticals, a high-level meeting was held with the Secretary of the Ministry of Steel, Joint Secretary (Steel), and the Managing Director of SAIL (Steel Authority of India Ltd).

Based on the deliberations, the following interim measures were agreed upon in principle:

1. One-Year Reprieve on Import of Special SS Grades
   Imports of special grades of stainless steel strip, used in surgical blades and scalpels, will be allowed for one more year until BIS standards for these materials are finalized.
2. Six-Month Extension for Overseas Imports
   Manufacturers sourcing stainless steel strip from international vendors who in turn source hot rolled steel from BIS-compliant mills have been given a six-month window to continue imports.
3. NOC for Import of Niche Raw Materials
   No Objection Certificates (NOC) will be issued, based on Department of Pharmaceuticals’ recommendations via EPC, for import of small-volume, low off-take products like capillary tubing and stainless steel wire cut lengths by actual medical device manufacturers, not traders.

In a statement, Mr. Rajiv Nath expressed his gratitude, saying:

“We are very thankful to the government for being responsive and empathetic to our genuine concerns and for averting a potential supply chain and healthcare crisis. We will now work closely with SAIL to indigenise the production of these special stainless steel materials strips, tubing, and wires to reduce long-term import dependence.”

It also reflects the government’s willingness to engage constructively with stakeholders and ensure uninterrupted access to essential medical supplies.

This intervention not only safeguards the operations of domestic medical device manufacturers but also strengthens India’s self-reliance mission (Atmanirbhar Bharat) in the critical healthcare infrastructure domain.