The Drug Controller General of India's (DGCI) proposed rules for the medical devices seek manufacturers of the devices to submit documents related to their safety.
The Drug Controller General of India’s (DGCI) proposed rules for the medical devices seek manufacturers of the devices to submit documents related to their safety. Manufacturers of X-ray, MRI and other critical medical devices would need to submit safety documents to the government. Earlier, several medical devices, including cardiac stents and orthopedic implants, were brought under the purview of the Drugs and Cosmetics Act. The CDSCO has now sought feedback from stakeholders to include more devices.
As per current regulations under the Medical Device Rules 2017, devices are categorised into Classes A to D, from low risk to high risk. The first two are under the purview of state regulators and the higher-risk categories under the Central Drugs and Standards Control Organisation (CDSCO). Devices follow standards laid down under the Bureau of Indian Standards Act, 1985, or as notified by the Ministry of Health and Family Welfare.
The DGCI has designed the proposal to include all implantable medical devices, like CT scan, MRI, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator, under the purview of the Drug and Cosmetics Act of 1940, The Indian Express reported. It plans to include such devices under section 3 (b) (iv) of the Act. The section lays down the definition of the drug in a more broad way. It includes 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.”
The inclusion of these devices is seen as a major push for medical safety in the country. Many incidents have been reported when people lost their lives due to malfunctioning of the machines. The case of a Mumbai man sucked inside an MRI machine even when it was switched off had alarmed the government.
The safety data would include all information about material components of the devices, its source. The data whether it is safe for use by patients and technicians without exposing them to any threat would also be available. The clearance would only be granted once the devices clear the set standards by the government.
The amount of radiation from an X-ray machine is a serious question and the evaluation of the device becomes necessary. The devices which are inserted inside the body also need thorough trails.
The proposed rules would require the machines to undergo trials if safety documents are not submitted by the manufacturers. It means if companies don’t have data available, they would need to conduct clinical trials on their machines to establish their safety and efficacy.
It is not clear what the government has planned for the machines already in use, as it would be difficult for the regulation with retrospective effect, or recall of the machines. However, the government hopes once a company has failed to give the data and this has been made public, the establishments where the machines are in use would contact the manufacturers for redressal.