The Cabinet Secretariat has asked the Union Ministry of Health and Family Welfare to examine concerns regarding the safety and quality of coronary stents following a representation by Rajya Sabha MP Dr Ajeet Madhavrao Gopchade.
The concerns relate to three models of India-manufactured drug-eluting coronary stents reportedly withdrawn in Sri Lanka over quality and patient-safety issues.
According to media reports cited in the representation, Sri Lanka’s medical device regulator directed the withdrawal of the stents following concerns involving improper positioning, stent dislodgement, acute stent thrombosis and inadequate expansion. These issues were reportedly identified during an investigation by the country’s medical device evaluation committee.
In his representation dated September 29, Dr Gopchade urged the government to review India’s existing regulatory framework for coronary stents and consider measures to strengthen patient safety. The Cabinet Secretariat subsequently referred the matter to the Health Ministry on October 5.
MP Calls for Stronger Monitoring and Traceability
Dr Gopchade emphasised the need for appropriate clinical decision-making, rigorous device testing and improved monitoring of complications following stent implantation.
He recommended strengthening clinical documentation to ensure coronary stents are implanted only when medically necessary, with alternative treatment options considered wherever appropriate.
The MP also proposed batch- and serial-number-based traceability for implanted stents, stronger post-market surveillance and more effective adverse-event reporting systems.
Review of International Safety Alerts Sought
The representation further called for a mechanism to promptly assess safety alerts, product recalls and withdrawals issued by foreign regulators, particularly when the same or similar medical devices are marketed in India.
Dr Gopchade also highlighted the importance of patient follow-up and long-term safety data to enable early identification of potential device-related complications.
The matter has been referred to the Union Health Ministry for examination. The reported withdrawals in Sri Lanka do not, by themselves, establish that the affected stents have been recalled or found unsafe in India.
