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AI’s Expanding Role in India’s Healthcare Sector

Artificial intelligence (AI) is revolutionizing India’s health sector, addressing age-old concerns such as the scarcity of medical professionals and the need for improved rural accessibility. Realizing the huge potential of AI, the government of India is heavily investing in integrating AI within... Read More

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Quick Indian Regulatory Updates

The Health Ministry of India has initiated an expert panel to monitor and address medical device adverse events to help promote patient safety. The panel will comprise experts from various disciplines of medicine, such as cardiology, neurology, and radiology. These experts will analyze and advise on needed actions to be... Read More

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Quick Asian Regulatory Updates

Japan’s Ministry of Health, Labor, and Welfare (MHLW) granted orphan drug designations to 15 drug compounds on February 28, including Novartis Pharma’s atrasentan for IgA nephropathy. Other drugs given this designation include Alexion’s efzimfotase alfa (hypophosphatasia), HanAll Biopharma’s batoclimab (thyroid eye disease),... Read More

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India Medical Device and Drug Updates

As mentioned in our September newsletter, starting this year India’s CDSCO has issued new draft rules for its device classification catalog. Medical devices are classified at both the State and National level depending on their risk profile. Higher-risk devices (Class C and D) are... Read More

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Quick Asian Medical Device Regulatory News Briefs

India’s DCGI, on January 6 revised the device classification of 4 main device categories.  These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More

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India Strengthens Medical Device Adverse Event Reporting

India’s Drugs Controller General of India (DCGI) has implemented new measures to reinforce the monitoring of medical device related adverse events. This initiative is part of the Materiovigilance Programme of India (MvPI), managed by the Indian Pharmacopoeia Commission (IPC), which is in charge of collecting and analyzing... Read More