India would need to bring in a dedicated medical devices regulation to thwart sale of substandard equipment, primarily the radiation-emitting products which increases the risk of patient lives.

In the absence of a separate  regulation for medical devices, many overseas manufacturers introduce products in India before they are approved for sale in the country of manufacture. Frequent reports of ‘infant warmers’ catching fire happens only because of inadequate quality and safety considerations during product design and manufacturing, Sanjay Arudi, director, quality & regulatory affairs, GE Healthcare told Pharmabiz in an email.

Another alarming trend, is the import of used or second-hand products by third party players which sans quality refurbishment. Second-hand equipment can be particularly harmful, especially in the case of X-Ray which are radiation emitting equipment. In such devices, the radiation levels could be high and could be fatal in the long-run for both the patient and healthcare provider, he added.

US FDA has established classifications for over 1700 generic types of medical devices. However, in India, only 14 devices are currently regulated by Central Drugs Standard Control Organisation (CDSCO). In addition, X-Ray or radiation emitting devices are regulated for radiation safety by Atomic Energy Regulatory Board (AERB). Majority of devices are either imported or manufactured locally without established quality management systems.

India has a large unorganised medical devices sector. There is an apprehension about third party players undertaking service contracts for X-Ray or radiation emitting devices. The concern is that it could compromise the safety and integrity of the AERB type approval as replacement of parts could be those that are not validated and recommended by the manufacturer. In such cases, the buyer cannot be sure of the repercussions. It could be too late by the time they realise the real impact, he noted.

Indian pharma industry is regulated by Drugs & Cosmetics Act. Medical device industry was unregulated until 2005 when a handful of critical devices like catheters, endo-tracheal tubes etc. came under the purview of CDSCO. These devices are treated on par with drugs though the requirements are very different. “Clubbing medical devices with drugs is like comparing chalk with cheese which are different in nature,” pointed out Arudi.

Pressing the need for a dedicated medical devices regulations, Arudi said that it was also imperative for the government to form a Medical Devices Technical Advisory Board represented by regulators and the industry so that best global practices are incorporated. Its implementation would ensure access to products with high safety and quality standards in the Indian market, said Arudi.