THE AUTHORIZATION FOR MARKETING OF DRUG ELUTING STENT IN SRA COUNTIRES

Abstract

Drug Eluting stents are those stents made up of metal which has a layering of drugs like paclitaxel, everolimus and anti-proliferative drugs to do the widening of the arteries which are narrowed. Since the year 2016, the use of drug eluting stent has increased due to its benefits which shows reduces in the occurrence of stent restenosis. The global market of drug eluting stent is expected to reach the revenue of $5614.6 Million by 2024. As the drug eluting stent comes under high-risk medical device, its regulation is very stringent in developed countries like USA and EU, while its regulations tend to become tough in developing countries like India. In USA, DES requires investigational new drug approval for drug and pre-market approval for device which approximately takes 180 days for final market approval of the device. In EU, the DES is required to go through the entire CE marking process and then it can be marketed in the European Union. In India, the device needs to get approval from central licensing authority which is done by stringent device testing. Although the regulatory authorities of various countries process to bring such lifesaving high risk medical devices into the market can be difficult, they also need to develop activities to increase the transparency and effectiveness of the entire process.