NEW DELHI : Following pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) has mandated that manufacturers of medical devices and in-vitro devices submit their safety reports online.
The directive, issued on 19 March by the Drugs Controller General of India, Rajeev Raghuvanshi, has directed the online submission of Period Safety Update Reports, aimed at improving post-market surveillance data evaluation. This is part of efforts to overhaul India’s drug regulation framework and enhance safety transparency.
Mint has seen a copy of this order.
An email sent to the health ministry remained unanswered till press time.
“The facility of offline submission of applications in hard copy or any other mode will not be available for processing from 01.04.2024,” the order said.
A PSUR is a vital pharmacovigilance document that assesses the risk-benefit balance of a drug product after its authorization, providing a comprehensive analysis based on all available information, including new data. This report determines whether additional studies are necessary or if modifications are needed.
To simplify operations for the medical device industry, CDSCO had launched the National Single Window System (NSWS) on 1 January 2024. This platform, initially covering three activities aligned with the Medical Devices Rules of 2017, was developed by the central government to create a one-stop shop for all investor permissions, facilitating business processes. The NSWS encompasses all required permits and clearances.
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Published: 20 Mar 2024, 06:30 PM IST