Come April 2020, the sale, manufacture and import of eight more types of critical medical devices will be regulated by the government to check the supply of faulty equipment
The union government in a notification issued on Friday, February 08, 2019 said that medical devices, all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators, will be treated as drugs for human beings with effect from April 1, 2020.
Once regulated, the Central Drugs Standard Control Organisation (CDSCO) will become the reviewing authority which will have the final say for import, manufacture and sale of implantable medical devices.
Speaking in regards with this decision Mahesh Zagade, Former FDA Commissioner Maharashtra, stated, “These equipments should have come under the regulation of the central government much earlier. If a device is faulty and causes injury or death, then a fine and jail-term should have been put in place. And now it will be done once this regulation comes into effect. But apart from regulation, this has to be properly executed and implemented.”
He added, “Earlier since these devices weren’t under the Drugs and Cosmetics Act, 1940, it wasn’t possible for the NPPA to cap their prices. But now after this move the NPPA will be able to decide a fair price for all these newly included equipments and devices.”
The move is aimed at regulating quality of these commonly used devices which are critical to healthcare.
These devices will now require the same checks and balances as drugs.
According to public health experts, the medical device industry is ridden with loopholes; regulation thus is extremely important. The recent controversy over Johnson & Johnson’s alleged faulty ASR hip implant has brought to light the loopholes of the medical devices industry.
While speaking to My Medical Mantra, Vijay Vojhala, a patient who was affected by a faulty hip implant and has been fighting this case against Johnsons & Johnson since the last eight years said, “This should have been regulated by the union government a long time back. The government took a lot of time to come to this decision. But now, since it has taken this step, it should also take the civil society into consideration.”