The Maharashtra Food & Drugs Administration (FDA) has directed at least 10 companies and their distributors to get a valid drug license for marketing drug eluting stents in the state.
The move follows the Maharashtra FDAs last week offensive against a Netherlands-based company Occam for marketing its drug-eluting stent ‘Xioon’ in Mumbai hospitals without any valid approval from either the Drug Controller General of India or state drug controllers for the past few years. Stents are thin steel wires inserted into blood vessels to remove blockages and drug-coated stents prevent the blockages from recurring in cardiac patients.
The companies and their Indian distributors located in and around Mumbai that have been served notices include Johnson & Johnson’s Cypher Sirolimus-eluting coronary stent), Boston Scientific, Bangalore-based medical devices company Vascular Concepts (pronova), Singapore based Intek and its distributor Elder Pharma (Apollo), B. Braun (Coroflex Please), Meditronix (Endeavour), Sarin of Germany and its distributor Strenco (brand Jenus), Conor Medi Systems of Germany (Indian distributor IUTL) and brand (Coesta) etc.
Talking to Pharmabiz, M Ramesh Kumar, Commissioner, Maharashtra FDA said the companies have been directed to get a license as they are found to have violated the norms related to Section 3-B (4) of the Drugs & Cosmetics Act.
“At least 10 to 20 companies are found in the Indian market, including Chinese and Korean companies. We are in the process of identifying these companies and their distributors in Maharashtra. Of this, some companies have US FDA and EC certification from EU countries. So in order to help the patients using these products, we have given an interim arrangement for these companies to submit their US FDA and EC certification, besides approval from their respective country drug administrations, until the Indian Government takes a decision on such products,” said Ramesh Kumar.
He said the Maharashtra FDA has informed the DCGI about the issue.
The Maharashtra FDA says since the stents have drugs, it is necessary to have a valid drug license for manufacturing and marketing the product in India.