Indian-made stents under scrutiny after complications in Sri Lanka
The Indian Cabinet Secretariat is investigating the safety of Indian-made coronary stents following reports of complications in Sri Lanka. A Rajya Sabha MP has called for stricter pre-market testing and improved clinical documentation to ensure patient safety.
Why it matters
This highlights critical regulatory gaps in medical device manufacturing and the potential impact on international trade and public health standards.
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.
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