Quality of medical devices like X-ray machines to improve under proposed law

To  improve the quality of high-end medical devices and equipment such as implants, X-ray machines, MRI and CT scan equipment and dialysis machines, the government wants to expand the list of devices under the purview of drug law. By bringing it under the drug law devices will be sold only after clinical trials have been conducted and safety reports have been cleared by the regulator in India.

Eight new categories of medical devices will be added under the definition of drug, which will be directly regulated under the Drugs and Cosmetics Act. This has been suggested by the Central Drugs Standard Control Organisation (CDSCO), the drug quality regulator under the health ministry, according to media reports.

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At present, only 23 medical devices qualify as drugs and are monitored for quality. All other medical devices are sold without quality checks or clinical trials.

The list proposed by CDSCO includes implantable medical devices, MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator.

“This will be notified in the official Gazette of India and it will come into force after a period of twelve months from the date of its publication,” the regulator said in a public notice inviting comments from all stakeholders by mid-July. The move assumes significance as increasing number of such products are entering the market with several variants and brands.

Many of these products are life-saving devices, priced exorbitantly and used in critical care. Medical device market in India is pegged at around $7 billion, growing annually at 10-12%. Estimates show medical technology sector has the potential to touch $50 billion by 2025, the news report said.


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Currently, India imports around 80% of the medical devices.


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