Doctors: Bringing Devices Under Drug Category Will Cause Chaos

BENGALURU, 10 FEB 2019: A new notification issued by the Union health ministry has brought all implantable devices and most diagnostic equipment under the category of drugs. These include machines for x-ray, MRI and CT scans, dialysis, bone marrow cell separator and PET (positron emission tomography) scan equipment.

The notification, which comes into effect from April 2020, says the move was made after consultation with the Drugs Technical Advisory Board.

“Majority of the medical devices are completely unregulated in India. With this move, all implantable and some diagnostic tools will be brought under a regulatory framework, which is important from the perspective of patients’ safety,” said Malini Aisola, co-convener, All India Drug Action Network.

The move has received mixed response from the medical community. “How can an imaging modality be considered a drug? It makes no sense and can only lead to chaos,” said Dr CN Manjunath, director, Sri Jayadeva Institute of Cardiovascular Sciences and Research.

Currently, there are guidelines from Atomic Energy Regulatory Board (AERB), which governs the radiation safety aspects in installation and usage of x-ray machines. “Regulation is fine, but it can’t be unscientific. How can a heart valve or a pace maker be considered as drug?” said Dr Manjunath.

Most of the dialysis machines currently used are from South Korea, Japan, China or Germany. “A machine costs Rs 5-10 lakh and can be used for three patients a day. The regulations that we follow are of the country in which the machine was manufactured and there are no regulations as such by the Centre. It’s a good move to regulate, but this should not result with bribery for every approval,” says Dr Sankaran Sundar, ex-chairman of Indian Society of Nephrology, southern chapter.

Notification lacks clarity: Docs

Doctors pointed out that the notification lacks clarity. “The reagents used in a lab for testing can’t be considered drugs. The issue is more than just terminology issue. How can an MRI machine be considered a drug? The MRI machine that we use are all either made in Europe or the US. There are regulations on their usage and we’re following the same. It becomes a problem if everything is considered a drug. The process of approval would become complex,” says Dr NK Venkataramana, chief neurosurgeon and founder chairman, Brains Hospital.

He added that the move may bring in everything under one roof, including licences, certification, quality control and usage.

Though the government has not yet revealed the pattern of regulation and the need of such a notification, there are possibilities of price capping on advanced tests.

“I don’t know if the government is mulling to bring down the prices of the diagnostic tests through this notification. This needs to be studied further. The CT and MRI scan machines are imported. The government may knock off the import duty on these expensive machines,” said Dr H Sudarshan Ballal, chairman, Manipal Hospitals.

Helps in tracing usage, efficiency

Officials in the health department say most of the medical diagnostic equipment imported and used in India are not in the health ministry’s records. “There is a need to register the diagnostic and scanning machines and other equipment being used in India and further be able to trace them,” said officials. The new rule can enhance efficiency and gives directions on the usage of the devices through data generation.ET Healthworld