Indian-made stents under scrutiny after complications in Sri Lanka

Rajya Sabha MP Ajeet Madhavrao Gopchade has urged a review of coronary stent safety standards after reports of complications involving Indian-made devices in Sri Lanka

NEW DELHI: The Cabinet Secretariat has taken up concerns over the safety and quality of coronary stents with the Union health ministry after a Rajya Sabha MP sought intervention following reports of complications involving Indian-made devices in Sri Lanka.In an October 5 letter, Cabinet Secretary T V Somanathan acknowledged a representation from Rajya Sabha MP Dr Ajeet Madhavrao Gopchade, a medical doctor, said it had been forwarded to the department of health and family welfare for appropriate action and a reply.Gopchade’s September 28 representation cited media reports that Sri Lanka’s regulator had directed the withdrawal of three models of Indian-manufactured drug-eluting stents over concerns including improper positioning, stent dislodgement, acute stent thrombosis and failure to expand properly.

The reported issues were identified during an investigation by Sri Lanka’s Medical Device Evaluation Committee, according to the letter.The MP cautioned that the reported concerns might not all ultimately be substantiated, but said they warranted scrutiny of existing safeguards for device performance, clinical appropriateness and the detection of complications after implantation.The representation calls for more stringent pre-market testing of stents and delivery systems, including assessments of durability, deployment, expansion and dislodgement.

It also seeks stronger clinical documentation to ensure stenting is performed only when medically indicated and alternatives are considered where appropriate.A key recommendation is end-to-end traceability through batch and serial numbers for every implanted stent, allowing affected devices and patients to be identified quickly if a safety alert emerges. The MP has also sought stronger adverse-event reporting, particularly for stent thrombosis, migration, incomplete expansion, deformation and delivery-system complications.The representation further calls for a mechanism to swiftly review safety alerts, recalls and withdrawals issued by foreign regulators when the same or similar devices are marketed in India. Better patient follow-up and long-term safety data collection have also been proposed to detect emerging risks early.

Citing regulatory guidance from the US, the UK and Canada, Gopchade highlighted the importance of engineering and durability testing, clinical evidence, traceability and timely regulatory action when safety signals emerge.

He urged the health ministry and the Central Drugs Standard Control Organisation (CDSCO) to examine the issues with cardiology experts and other stakeholders.The Cabinet Secretariat’s communication does not establish that the government has accepted the allegations, ordered a formal investigation or approved new regulatory measures. The reported concerns also do not, by themselves, establish that similar complications have occurred in India.