The Cabinet Secretariat has directed the Union Health Ministry to examine safety and quality concerns involving coronary stents manufactured in India after reports that three drug-eluting stent models were withdrawn in Sri Lanka. The development follows a representation by Rajya Sabha MP and medical doctor Ajeet Madhavrao Gopchade, who called for stronger regulatory oversight, improved traceability and better monitoring of complications associated with implanted cardiac devices.

In his representation dated September 29, 2026, Gopchade referred to reports that Sri Lanka’s medical device regulator had ordered the withdrawal of three India-made drug-eluting coronary stent models following quality concerns identified during an investigation by its medical device evaluation committee. The reported issues included improper positioning, stent dislodgement, acute stent thrombosis and failure of the stents to expand properly.

The Cabinet Secretariat reportedly issued its direction to the Health Ministry on October 5, 2026. The review is intended to examine whether India’s existing regulatory framework requires further strengthening. The reported withdrawal in Sri Lanka does not, by itself, establish that the same products have been recalled or declared unsafe in India.

Gopchade has called for stronger clinical documentation to ensure that stents are implanted only when medically indicated, alongside robust batch- and serial-number tracking for every implanted device. He has also urged the government to strengthen post-market surveillance, adverse-event reporting and patient follow-up.

Another key recommendation is to establish a mechanism for promptly reviewing safety alerts, recalls and withdrawals issued by foreign regulators when the same or similar devices are marketed in India. Such a mechanism could help regulators assess potential risks and determine whether further investigation or corrective action is necessary.

The concerns come amid wider scrutiny of medical device safety. A retrospective study examining reports submitted to India’s National Coordination Centre under the Materiovigilance Programme of India between 2020 and 2022 analysed 10,542 medical-device adverse-event reports, including 2,075 associated with cardiac stents.

The study found that 93% of reported stent-associated adverse events were classified as serious, while 5% of the reports resulted in death. These figures concern reported adverse events and do not represent the incidence of complications among all patients receiving stents.

Coronary stents are used during angioplasty to help keep narrowed or blocked arteries open and restore blood flow. The Health Ministry’s examination could bring renewed attention to device quality, clinical decision-making and long-term safety monitoring in India’s cardiovascular care system.