Govt asks IVD kit makers to report adverse events; aims to collate info

Releases draft format for adverse events for rapid identification and rectification of potential device failures

The Indian Pharmacopoeia Commission (IPC), which sets standards for all drugs that are made, sold and consumed in India, has come out with a draft format for reporting of adverse events due to in-vitro diagnostic (IVD) medical devices -- such as pregnancy test kits and blood glucose test kits.

 

It would be useful for rapid identification and rectification of device failures, felt industry. The IPC has asked all IVD manufacturers, regulatory authorities, healthcare professionals, and other stakeholders to provide their feedback and comments on the draft proposal by March 5.

 

“The content of this draft reporting form is not final and the text may be subjected to revision before being finalised by the MvPI,” the IPC said.

 

This comes months after the Drugs Controller General of India (DCGI) called for timely reporting of adverse events related to medical devices.

 

The recent draft format for IVD, released in collaboration with the Central Drug Standards Control Organisation (CDSCO) and IVD manufacturers associations, aims at stricter surveillance of adverse events from IVD devices such as false positives which can lead to incorrect treatment decisions and delayed diagnosis.  

 

The IVD device market is estimated to expand from $1.69 billion in 2023 to $2.34 billion by 2030 in India.

 

According to the draft, the reporting format has been designed to be used by domestic manufacturers, importers, distributors, pathology laboratory, blood donation centres, government program in-charge and healthcare professionals with direct/indirect knowledge of adverse events related to IVD devices.

 

It was also clarified that the reporter’s identity would be confidential.

 

DCGI had last year also directed all medical device manufacturers and licence holders to report any adverse events related to lifesaving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform, which monitors such matters associated with medical devices in India.

 

Welcoming the move, Pavan Choudary, chairman, Medical Technology Association of India (MTaI) said that a standardised adverse event reporting format will strengthen patient safety and product reliability.

 

“Prompt reporting of adverse events allows for the rapid identification and rectification of potential device failures, mitigating risks to patients and preserving trust in medical technologies,” he added.

 

Rajiv Nath, forum coordinator, AIMED -- an umbrella association of Indian manufacturers of medical devices -- said that serious adverse reporting of medical devices including IVDs is common in most countries where medical products are regulated.

 

“Self-reporting of adverse effects is a way to provide feedback to the government for seeking systemic correction of chronic or specific issues reported that may need intervention,” he said.

 

He however added that these reports are not to be used for witch hunting or shooting the messenger but encouraging systemic improvements.

 

“This is usually not used for reporting non serious events or product complaints,” Nath said.