Under a proposal by the Drug Controller General of India (DGCI), manufacturers of medical equipment such as X-ray, MRI and PET machines will have to submit documents on safety and performance. If they do not, the machines will have to undergo trials. As the Central Drugs and Standards Control Organisation (CDSCO) seeks feedback from stakeholders, a look at how such devices are governed and how that could now be set for change.
Regulation now & proposed
Regulation is currently under the Medical Device Rules 2017, under which 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 CDSCO’s. Devices have to conform to standards laid down under section 3 of the Bureau of Indian Standards Act, 1985, or as notified by the Ministry of Health and Family Welfare.
Now, the DGCI proposes to include 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 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… after consultation with the Board”, a reference to the Drugs Technical Advisory Board.
What that means
The inclusion would mean that these devices — any implantable medical device, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator — would not only have to abide by the standards set, but also require submission of safety and efficacy data.
Safety data includes information about all material components of a device, their source and purity. It also includes clinical data about whether the machine is safe for use by patients and technicians without exposing them to undue risks. Efficacy data would cover results from tests done by the machine.
Apart from the fact that some devices are to be inserted into the body, safety is a concern for handlers too because of the effect of the radiation or strong magnetic fields used to generate diagnostic data. In Mumbai last year, a man was killed when he was swept off his feet and flung against an MRI machine, even though it was switched off. How much radiation an X-ray machine should use without exposing the body to carcinogenic effects, too, is a crucial question. As for efficacy, even the simple blood pressure machine needs standardisation every few years for readings to be accurate.
What devices need
Clearance would be subject to data. That is why companies that do not have the data available would need to conduct clinical trials on their machines to establish their safety and efficacy before they can be allowed to sell. The revised rules would come into effect 12 months after their notification.
As for machines already in use in hospitals, it is difficult for regulation with retrospective effect, or for recall of any given the volumes. However, once a company has failed to give the data and this has been made public, institutions where those machines are in use would, the government hopes, contact the manufacturer seeking redress.