They said they were unable to follow the rules recently mandated by the ministry of steel saying raw material used in the manufacture of finished and semi-finished steel products must comply with Indian standards.
Earlier, foreign suppliers only needed BIS certification for finished steel products. Under the new rule, materials like hot rolled steel, ingots manufactured by other countries for Indian buyers will have to get BIS certification. The manufacturers have written to the ministry of steel seeking exemption for the import of stainless steel capillary without BIS certification.
Several manufacturers ET spoke to said they have to rely on imports for certain steel pipes, tubes, steel strips, steel capillary tubes as the annual quantity is less and it is not commercially feasible for the vendor to proceed with BIS certification for these low quantities.
For example, Hindustan Syringes & Medical devices, the leading maker of disposable and auto disposable syringes, is dependent on a Korean supplier for a specialised stainless steel capillary tube. “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.
The Association of Indian Medical Device Industry (AiMeD), a lobby group, has written to the ministry saying the healthcare system may face disruption as they are unable to import necessary stainless steel.”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. ET has seen a copy of the letter.”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,”the letter said.
