Covestro India welcomes Government’s move to implement quality standardization of medical devices
Covestro, one of the world’s leading producers of advanced and high-performance polymers has welcomed the health ministry’s attention to improve safety and quality of medical devices under a single regulatory framework for all medical devices under Central Drugs Standard Control Organization (CDSCO). India has approximately 800 medical device manufacturers, but standard regulation for materials used in medical devices still remains a major concern for the health sector. Currently, only 37 categories of medical devices are regulated in India under the Indian Medical Device Rule (IMDR 2017). India’s medical devices industry has grown from $2.2 billion to $ 5.2 billion at a compounded annual growth rate (CAGR) of 15.8%.
Covestro India urges the government to chalk out a roadmap for improving the safety of medical device end-users and patients with inputs from industry experts and associations. “Since medical devices are vital to life, there is a serious need to draw mandatory guidelines to be met by every manufacturer and importer of medical devices. Advancements in medical technology require innovation in materials that help break new ground in safety and Covestro has been making healthcare future-ready with innovations in versatile polycarbonates used for diverse medical and wellness devices with direct patient contact”, says Mr. Anand Srinivasan, Head Of Polycarbonates, Covestro India.
“Covestro has been providing polycarbonate material solutions to global medical device manufacturers for over 50 years . Formulation consistency, a reliable global supply network, a broad portfolio of biocompatible medical grades fulfilling ISO 10993 standards, along with strong techincal and regulatory support are provided to device manufacturers worldwide. This helps our customers keep up with tightening medical device industry regulations while delivering innovativeproducts, including wearable devices and self administered drug delivery, for the treatment of chronic diseases,” said Dr Douglas Hamilton, Global Marketing Leader of Healthcare Industry, Polycarbonate Division.
Covestro India is also making efforts to bring stakeholders of the healthcare community onto a common platform to help bring focus on increased safety of patients using medical devices. Through various initiatives, Covestro India aims to bring attention to the characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specification, labeling and other technical aspects of policy criteria.