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All medical devices to be centrally regulated

The Union Health Ministry has put into place plans to regulate all medical devices, bringing a greater level of oversight and — in theory — quality control to this sector of India’s health system.

Medical device - Stent Image ID: 72283970 (L)

The proposal will come into effect as of December 1st, bringing all medical devices – covering every aspect of the medical process from diagnosis to treatment – under central surveillance. The proposal even covers medical devices used within animals.

The Health Ministry issued a gazette notification indicating that all medical devices including software, equipment, accessories and contraceptives will be regulated under the Drugs and Cosmetics Act. Consequently, firms will have to seek approval from the Drugs Controller General of India to manufacture, import and sell any medical device in the country. The proposal even covers medical devices used within animals.

Though not explicitly stated, this may fall in line with plans to price cap various medical devices in the same way as cardiac stents and knee implants have been regulated. Such a course of action would likely be poorly received, as the initial round of price capping was heavily criticised by many in the medical community. Results of the price capping in terms of savings to the patient are dubious, as many private hospitals simply increased the cost of the procedure — rather than the medical devices themselves — to make up for lost profits.

At the very least, the plan to regulate all medical devices could offer an improvement to overall quality of devices should the plan be properly implemented. Due to the currently irregular monitoring of devices, there remains the possibility that faulty or lapsed-quality products slip through the net. In a medical context, such lapses could mean life or death for a patient — warranting greater oversight.

Indeed, devices already in place in Indian hospitals are often dysfunctional. Ventilators, for example, in some hospitals are no longer working, placing a greater burden on the limited numbers available — in some cases meaning the use of the device is unavailable due to a lack of numbers. In this instance, oversight into devices already in place, as well as those being manufactured and imported, could aid in keeping hospitals running efficiently.

The central regulation may be a logistical hardship for current importers and manufacturers in the short-term. However, the benefits of a greater level of scrutiny of such vital devices makes the decision a welcome one.


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