Cdsco

Bione removed the rapid testing kit from its website following the CDSCO notice

All medical devices, including implants and contraceptives, will be brought under the lens of CDSCO in a phased mannerThe increased scrutiny on medical devices comes in the aftermath of Johnson & Johnson’s faulty hip implants

A sample of Torrent Pharma’s anti-hypertension drug Lorvas also failed the testDuring the inspections in Dec, the CDSCO also found a counterfeit sample of Abbott India’s Udiliv 300

The impending investigation by India’s apex drug regulator follows the US-based company initiating a voluntary recall of a single lot of its baby talc in the US last week, the official said

The increased scrutiny on medical devices comes in the aftermath of Johnson & Johnson’s faulty hip implantsOnce these devices are classified as drugs, the Central Drugs Standards Control Organization (CDSCO) will be responsible for regulating them

India imports almost 80% of its API requirement from ChinaOnce the list of such APIs are prepared, it will be submitted to the Department of Pharmacueticals

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft notification mandating the sameIndia’s drug regulatory authority also proposes to amend the Drugs and Cosmetics (D&C) Rules, 1945 to implement the newly proposed system

The move seeks to offset India’s growing reputation as a source of counterfeit medicinesGlobally, there are stringent regulations against fake drugs and medical devices, which could cause injury or fatality to patients

Import, sale and manufacture of implantable medical devices needs to be certified by CDSCDTAB decided to notify all medical devices as drugs under the Drugs and Cosmetics Act

App will also enable users to report injuries and problems related to medical devices