Don't stunt the stent, med devices sector

Three Indian-made coronary stent models, manufactured by Meril Life Sciences, have been withdrawn from the Sri Lankan market, after an investigation by the country's National Medicines Regulatory Authority found critical failures in performance. This isn't the first time that India-manufactured drugs and medical devices have been found to be deficient, cases of contaminated cough syrup being a recent example.

Central Drugs Standard Control Organisation (CDSCO), which also regulates medical devices, is auditing specific manufacturing facilities and their practices, and has suspended faulty batches. These measures help contain the problem at hand. But long-term systemic measures are needed. Stricter pre-market control by mandating clinical trial sizes, bench testing protocols for high-risk implants, and robust post-market surveillance are necessary. GoI must mandate rigorous, proactive post-implantation tracking, rather than relying only on voluntary hospital reporting. Considering the considerable share of exports, the government can establish real-time data-sharing protocols, so that international safety alerts trigger automatic risk assessments domestically.

With a 32% share, India dominates the Asia-Pacific coronary drug-eluting stent market. But quality concerns and recalls will stunt growth. Exports of medical devices have grown from $2.5 bn in 2020-21 to $4.14 bn in 2024-25. Fixing the quality issue is essential to sustaining this sector. Completing CDSCO's overhaul and strengthening it must also be a priority. The proposed legislation, currently under interministerial review, must ensure that the regulator is independent, and 2017 Medical Devices Rules updated. Safeguarding quality must be a priority for reputational reasons.