The impasse between government think tank Niti Aayog and the Union Ministry of Health and Family Welfare over a controversial medical devices bill may be over according to a recent report filed in The Economic Times. Discord emerged between the two bodies over a proposed regulatory overhaul of medical devices in the country, which would […]
Niti Aayog
Medical devices regulation: Boon or bane?
Central regulation of medical devices is to come into effect in India as of April, it has been reported. Once the shift has come into force at the beginning of the forthcoming fiscal year, all medical devices and equipment for the purposes of “diagnosis, monitoring, treatment, investigations and for supporting or sustaining life” will be […]
Road traffic accidents take a toll
Research published at the end of last year spotlighted the leading cause of premature mortality among young men in India: road traffic accidents. In 2017, 2.2 lakh Indians lost their lives due to injuries sustained on the country’s roads. Males accounted for the overwhelming majority of such fatalities, with 77 percent of road traffic accident […]
AI use in healthcare urged by Niti Aayog
The use of artificial intelligence (AI) has been encouraged in the healthcare sector by government think tank Niti Aayog. Agriculture, education, infrastructure (including smart cities) and smart mobility and transportation were the other sectors where state governments and Union ministries were urged to investigate potential applications of AI. Niti Aayog has previously expressed that by […]
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 […]
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 […]