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Doctors: Bringing devices under drug category will cause chaos


BENGALURU : A brand new notification issued by means of the Union well being ministry has introduced all implantable devices and maximum diagnostic apparatus beneath the class of gear. These come with machines for x-ray, MRI and CT scans, dialysis, bone marrow cell separator and PET (positron emission tomography) scan apparatus.

The notification, which comes into impact from April 2020, says the move used to be made after session with the Drugs Technical Advisory Board.

“Majority of the clinical devices are completely unregulated in India. With this move, all implantable and some diagnostic gear shall be introduced beneath a regulatory framework, which is essential from the standpoint of sufferers’ safety,” stated Malini Aisola, co-convener, All India Drug Action Network.


The move has won mixed response from the clinical community. “How can an imaging modality be considered a drug? It is unnecessary and can simplest result in chaos,” stated Dr CN Manjunath, director, Sri Jayadeva Institute of Cardiovascular Sciences and Research.

Currently, there are tips from Atomic Energy Regulatory Board (AERB), which governs the radiation safety facets in installation and utilization of x-ray machines. “Regulation is okay, but it could’t be unscientific. How can a middle valve or a tempo maker be considered as drug?” stated Dr Manjunath.

Most of the dialysis machines lately used are from South Korea, Japan, China or Germany. “A system costs Rs 5-10 lakh and can be used for 3 sufferers a day. The regulations that we apply are of the country through which the system used to be manufactured and there are not any regulations as such by means of the Centre. It’s a smart decision to keep watch over, but this must now not end result with bribery for each and every approval,” says Dr Sankaran Sundar, ex-chairman of Indian Society of Nephrology, southern chapter.

Notification lacks readability: Docs

Doctors identified that the notification lacks readability. “The reagents utilized in a lab for checking out can’t be considered medication. The issue is more than simply terminology issue. How can an MRI system be considered a drug? The MRI system that we use are all either made in Europe or the USA. They are regulations on their utilization and we’re following the similar. It turns into an issue if the entirety is thought of as a drug. The technique of approval would turn into advanced,” says Dr NK Venkataramana, leader neurosurgeon and founder chairman, Brains Hospital.

He added that the move may bring in the entirety beneath one roof, together with licences, certification, quality keep watch over and utilization.

Though the government has now not but published the trend of law and the need of any such notification, there are possibilities of price capping on complex checks.


“I don’t know if the government is mulling to convey down the prices of the diagnostic checks via this notification. This must be studied additional. The CT and MRI scan machines are imported. The government may knock off the import duty on those expensive machines,” stated Dr H Sudarshan Ballal, chairman, Manipal Hospitals.


Helps in tracing utilization, efficiency


Officials in the well being department say many of the clinical diagnostic apparatus imported and utilized in India don't seem to be in the well being ministry’s information. “There is a wish to check in the diagnostic and scanning machines and other apparatus being utilized in India and further be capable to trace them,” stated officers. The new rule can improve efficiency and provides directions on the use of the devices via information generation.




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