Makers of X-ray, MRI machines may have to submit papers on safety

09/07/2018

Manufacturers of X-ray, MRI and PET machines currently in the market may soon be asked to submit documents related to safety and performance to the government. If they fail to do so, the machines will have to undergo clinical trials to establish their safety and performance.
The Drug Controller General of India has drawn up a proposal to include all implantable medical devices and other high-end equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940. The section lays down that the definition of drug would also include “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board”.
In a notice issued last week, the Central Drugs and Standards Control Organisation (CDSCO) sought stakeholder comments within three weeks on the decision to include eight medical devices under that head. The equipment that have been listed are all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator. The proposal was discussed by the Drugs Technical Advisory Board (DTAB) in its 79th meeting held on May 16. DTAB is the highest technical body on drugs and medical devices that helps CDSCO in regulation of medicines and equipment.
Drug Controller General of India Dr Ishwar Reddy said: “Currently these devices are not regulated. Of the 3,000 odd medical device products in the market, we regulate just about 15. We have sought feedback on the proposal. Once it is notified, manufacturers will have to submit data on the safety and performance of the devices. If they cannot do so, then clinical data will have to be generated for the devices to continue in the market.”
Earlier, several other medical devices, including cardiac stents and orthopaedic impla nts, were brought under the purview of the Drugs and Cosmetics Act and the government subsequently brought some of those devices under price control. However, Dr Reddy said it is unlikely that the present lot, even when regulated, would be subjected to price caps “However, prices of these tests can be regulated under the Clinical Establishments Act,” he added.

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