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
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
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
Recently, India has come up with the Digital Personal Data Protection (DPDP) Act, which will ensure strict data privacy rules and affect clinical trials and global capability centers (GCCs) of multinational pharmaceutical companies in the country. This law creates its standards of... Read More
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
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
The Drug Controller General of India (DCGI) has already issued a regulation outlining the need for makers, importers, and sellers of drugs, to report adverse events. However, on November 11, to enhance overall supervision, India issued a new pharmacovigilance document to major... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
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
The Delhi High Court has passed landmark orders for the Indian government regarding rare disease treatment, focusing on funding, regulatory reforms, and price controls. The court has ordered the establishment of a National Fund for Rare Diseases (NFRD), with an initial allocation over... Read More