REGULATORY REQUIREMENTS FOR POST-MARKETING SURVEILLANCE OF DRUG-ELUTING STENTS AS PER CDSCO IN INDIA COMPARISON WITH MHLW JAPAN

*Dr. P. Ashok Kumar, Ganesh S. U., Sangeetha S., Puneeth N., Vinay H. Gowda, Shalini V.

ABSTRACT

Drug-eluting stents (DES) are established coronary devices that combine a mechanical scaffold with local delivery of an antiproliferative agent. Although contemporary DES have substantially reduced restenosis and repeat revascularization, late device-related events and performance in broader real-world populations require continued post-marketing surveillance (PMS). This contemporary review compares the regulatory and PMS approaches to DES in India and Japan, using the submitted project document as the primary source. In India, the framework centers on the Central Drugs Standard Control Organization (CDSCO), the Medical Devices Rules, 2017, and the Materiovigilance Programme of India (MvPI), with complaint handling, adverse-event reporting, periodic safety activities, and field safety corrective actions forming the principal post-market mechanisms. Japan operates under the Pharmaceuticals and Medical Devices Act through the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), with Good Vigilance Practice, Good Post-Marketing Study Practice, structured post-market studies, and re-examination providing a more formal longitudinal evidence-generation framework. The source document summarizes Japanese post-market data from a 2,010-patient cobalt-chromium everolimus-eluting stent cohort, in which 3-year major adverse cardiovascular events were reported at 6.8%, and Indian multicenter evidence reporting a 1-year unadjusted mortality of 3.8% with DES versus 5.0% with bare-metal stents. These findings are presented as source-derived evidence rather than as a new pooled analysis. Both countries emphasize lifecycle safety, but their surveillance infrastructures differ in structure and intensity.

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