Union Health Minister Dr Harsh Vardhan is taking cognisance of a tragedy in a hospital in the Rajasthan city of Kota, with more than 100 children dying in the span of a single month in a single hospital. The Union Minister has written to Rajasthan Chief Minister Ashok Gehlot, concerning the government-run JK Lon Hospital […]
Medical devices
The Medical Devices Bill, explained
Government-run think tank Niti Aayog will roll out the Medical Devices Bill according to media reports, marking a significant overhaul of the regulatory apparatus surrounding medical devices in India. “Niti has been engaged in developing a Medical Devices Bill. The purpose of the draft Bill is to ensure that medical devices in lndia are safe […]
Medical device safety crisis in Tamil Nadu?
At the national level, medical device safety is a significant issue. Tami Nadu is no exception. “A medical ventilator can be life-saving when a person can’t breathe properly or when they can’t breathe on their own at all,” Healthline reports. Yet in Tamil Nadu’s hospitals, a shocking number of the devices may not be fit […]
OpEd: A Balanced TMR to Address Healthcares Twin Aspects of Affordability and Quality
One of its fastest-growing sectors, India’s healthcare industry is expected to cross the US$372 billion mark by FY 2022. Increase in private investments since the government allowed cent percent foreign direct investment (FDI) in medical devices is seen as one of the policy decisions strengthening India’s dream of having a niche in quality care delivery. […]
Unsafe medical devices to get a Rs 1 crore penalty
The efforts of government think tank Niti Aayog to improve transparency and quality within the medical sector includes a Rs 1 crore fine for firms who import or manufacture unsafe medical devices. Per draft legislation, the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, a National Register of Medical Devices would be devised wherein each […]
FDA India: A single regulator on the cards?
A single regulator for food, medical devices, and medicines is on the cards in India, as the government think tank Niti Aayog has proposed a body analogous to the Food and Drugs Administration (FDA) in the United States. At present, food safety is overseen by the Food Safety and Standards Authority of India (FSSAI) and […]
Opposition to Central medical device regulation
Government think tank Niti Aayog has voiced opposition to the Health Ministry’s proposal to bring the regulation of medical devices under the authority of the Central Drugs Standard Control Organisation (CDSCO), effectively bringing the manufacture and sale of all medical devices into the purview of the Centre. The Union Health Ministry has put into place […]
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. The proposal will come into effect as of December 1st, bringing all medical devices – covering every aspect of the medical […]
New hope for dry eye disease?
A new device could lead to improved outcomes for people with dry eye disease, a condition with a significant footprint in India. Dry eye disease is a condition which, in its severest form, can lead to blindness. It is typically the result of dysfunctional tear-producing glands, which leaves no lubricated or moist layer covering the […]
Kozhikode: Medicines sales to hospital resume after standoff over unpaid fees
The impasse over sales to a hospital in Kozhikode, Kerala has ended following resolution of an issue concerning non-payment of outstanding dues. Distributors ceased sales of medicines and medical devices such as surgical equipment to the Kozhikode Government Medical College Hospital (KGMCH) over the weekend. Suppliers had already stopped distributing cardiac stents to the facility […]