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

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 implants, 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.