Abstract

Background: India presents a peculiar case for Drug Eluting Stents (DES). 85% of India's stent need is met through imports which enjoy perception premium in terms of quality. Recently, drug eluting stents' prices were capped to INR 30,000 in India by National Pharmaceutical Pricing Authority (NPPA) of DES to curb soaring high prices. Indian Market offers tremendous opportunities for stent makers. The total market for stents in India is estimated to be of US$ 531 mn by 2016 end and is expected to expand at a CAGR of 14.0% from 2016-2026) [1].

Objective: This paper attempts to study and compare marketing authorization provisions and regulatory standards that need to be met to obtain marketing approval for Drug Eluting Stents in the three regions and provide recommendations for Indian regulatory system.

Discussion: Regulatory authorities of developed countries outline their data expectation in the form of non-binding guidance document for industry; however, there are no such equivalent documents in India. Technical data ranging from specification of ‘stent platform', ‘eluting drug' and the ‘finished product' is furnished to the Regulatory authority prior to grant of marketing authorization. Data in application include both Clinical and Non-Clinical (Bench Tests) information obtained during the course of device development. In USA, a Premarket Application (PMA) should be submitted to FDA. In EU, an application dossier is to be submitted to the Competent Authority and in India marketing authorization application is to be made to the CDSCO. Regulatory authorities of developed countries outline their data expectation in the form of non-binding guidance document for industry however, there are no such equivalent documents in India.

Conclusion: This article enlists and provides a comparative grid of Regulatory requirements of Drug Eluting Stents in the said regions. Any organization involved in regulatory affairs of DES could use this article as point of reference on the subject.

Keywords: Drug Eluting Stents, application dossier, PMA, EMA, CDSCO, Medical Devices, marketing authorization.

Graphical Abstract