BS RAWAT
NEW DELHI: The Association of Indian Medical Device Industry (AIMED), while welcoming the Indian government’s move of considering regulating all medical devices has raised concern that many key strategic aspects are missing in minutes of the 82nd meeting of the Drugs Technical Advisory Board (DTAB) held recently.

“We welcome the steps being taken by DTAB. However, we notice with great concern that many key strategic aspects of the road map discussed with the Indian Medical Devices Industry Associations are missing and are not committed anywhere,” said Rajiv Nath, Forum Coordinator of AIMED.

“We request the Government to stick to earlier assurance given to the Industry, initially experimenting with a few electronic devices under MDR, MDR to be amended as per experience gained after six months of introduction and simultaneously draft a Medical Device Patient Safety Bill to be reviewed and passed by Parliament,” stated Mr. Nath.

He added, “While we compliment the Central Drugs Standard Control Organization and Ministry of Health for listening to our requests to bring in a separate regulatory framework and carry forward the initial rolling out of regulations from the launch of Medical Devices Rules, we regret to note certain important strategic directions are missing,” he added.

Let’s hope Ministry of Health will act and stop procrastinating in the need to ensure patient safety and encourage domestic manufacturing that had been negatively impacted in absence of a predictable regulatory environment, Mr Nath said.

“It’s imperative to have a separate Law as Devices are engineering items and not medicines - an X Ray machine by no stretch of imagination can be called a Drug. So, continued attempts to regulate Devices as Drugs is illogical and incorrect,” said Mr. Nath.