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Time of India
5 days ago
- Time of India
CDSCO notifies draft standard evaluation protocols for issuing IVD licenses
New Delhi: India's medical device regulator, CDSCO in collaboration with the Indian Council of Medical Research (ICMR) has issued draft standard protocols for evaluating In-Vitro Diagnostics (IVDs) devices quality and performance, to be used for issuing licenses. The protocols are meant to be followed by the country's IVD manufacturers testing labs and the regulator has sought stakeholders' comments over the notified draft by August 25. 'These protocols are now being placed in the public domain for comments from relevant stakeholders. This window of opportunity will close on 25th August 2025, and, once finalized, there will be minimal scope for change in these documents,' the notice reads. The 180-page document details the standard performance evaluation and field evaluation protocol for 15 types of IVDs including Dengue, Malaria, Influenza virus, Nipah virus, Chandipura virus, SARS-CoV-2 molecular detection differentiation assay, among several others. In Vitro Diagnostics (IVDs) are medical devices used to test samples such as blood, urine, or tissue outside the human body, to diagnose diseases, conditions, or infections, and to monitor a person's health based on predefined bio markers. Under the Medical Device Rules of 2017, 'Licensure of In-Vitro Diagnostics (IVDs) requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance.' The evaluation protocol helps to test the device safety, sensitivity, and accuracy, to validate the device clinical and analytical performance, required for issuing the product license, thereby allowing its usage in the country. In India the ICMR develops evaluation protocols to standardize the process of assessing the performance of diagnostic kits, particularly In Vitro Diagnostics (IVDs) and the CDSCO oversees the evaluation and enforcement of the protocols.


Indian Express
21-07-2025
- Indian Express
Has Chandipura changed its pattern? ICMR teams visit Gujarat as samples of all 14 deceased children test negative for virus
With samples of children, who died of suspected Chandipura virus over the last few weeks, testing negative for the infection, teams of the Indian Council of Medical Research (ICMR) visited Gujarat earlier in July in a bid to study the 'changing pattern' of the viral encephalitis. The teams collected samples of sandflies, domestic animals and residents from villages where suspected Chandipura deaths among children have been reported since June this year. the ICMR teams camped in four districts of the state – Panchmahal, Rajkot, Bhavnagar and Valsad – and studied the pattern of the virus. According to officials in Panchmahal, the ICMR team visited the district last week to gather samples of sandflies, ticks, mosquitoes and other vectors along with the that of domesticated animals and cattle, rats and human beings from the areas where four deaths have been reported. Panchmahal Chief District Health Officer Dr Vipul Gamit told The Indian Express, 'The ICMR team has gathered samples of those in the vicinity of the family that witnessed a death in the last month. They will be studied for antibodies — IgM and IgG — to understand the spread of the virus. There is a changing pattern in the virus… the same case with Japanese encephalitis, which in the recent past, has not been detected positive in laboratory tests.' Dr Gamit said that much like 2024, the Chandipura suspected cases —that later turned out to be negative after tests in Gujarat Biotechnology Research Centre (GBRC) — emerged sporadically from villages that were unrelated to one another. 'In one case, of a five-year-old boy from Panchmahal who died, and later tested negative, the other two children living in the same house — his cousins aged 7 and 8 — did not have any symptoms and are doing well,' Dr Gamit said, adding that the symptoms include high-grade fever, convulsions, followed by diarrhoea with 'little or no time' for medical response. 'Once the respiratory organs are involved, the children cannot be saved,' he added. Teams of ICMR also visited Bhavnagar, Valsad and Rajkot to collect samples of the vectors and other residents in close proximity to the deceased. Officials of the Gujarat government's medical department said that the ICMR will take the samples to its laboratory in Puducherry to check if the pattern of the virus has changed in the current season. An official said, 'The sudden increase in the number of negative cases of acute encephalitis syndrome (AES), which are not showing a positive report, has prompted the ICMR to send across a team this year to study the pattern of the virus. Specific villages in certain areas where the cases have been high have been selected by the ICMR teams for the study.' Vadodara's SSG hospital has recorded 14 deaths out of the 24 cases, including a 1.5 year old infant from Dahod, of suspected Chandipura reported this year. In-charge Medical Superintendent and Dean of Baroda Medical College, Dr Ranjan Aiyer, said, 'Every year, around June, in the month of monsoon, Chandipura cases occur due to vectors and sandflies, especially among people living in mud houses in rural areas… This year, we received unknown virulent cases of around 24 children, who presented similar symptoms, particularly in areas of Panchmahal-Dahod and even Madhya Pradesh. They deteriorated very rapidly despite a paediatric team treating them.. However, all samples have tested negative for Chandipura.' What is Chandipura virus? Chandipura virus belongs to the Rhabdoviridae family, which includes rabies. It is transmitted by sandflies and mosquitoes, including Aedes aegypti, which is also a vector for dengue. The virus resides in the salivary glands of these insects and can be transmitted to humans or domestic animals through bites. The infection can lead to encephalitis and inflammation of the brain's active tissues. The symptoms include high-grade fever, convulsions, followed by diarrhoea with 'little or no time' for medical response, according to Panchmahal Chief District Health Officer Dr Vipul Gamit. The Chandipura virus was discovered in 1965, in the blood of two individuals suffering from febrile sickness, in a hamlet of the same name near Nagpur, Maharashtra.


Time of India
05-07-2025
- Time of India
Brain fever claims lives of four children
Vadodara: Three children died in Panchmahal district and one in Dahod due to viral encephalitis during one week. The latest death was of a one-year-old boy from Dahod district at the SSG Hospital (SSGH) in Vadodara. The first deaths were reported from three different talukas in Panchmahal district. In all, four children were affected due to encephalitis in the district. While one of them was brought to SSGH and is under treatment there, three others died. The deceased children from Panchmahal are all boys, including two three-year-olds from Khajuri village in Godhra taluka and Jambudi in Halol taluka. An eight-year-old from Dokva in Shehra taluka also died due to encephalitis in the district. An eight-year-old girl from Betiya in Godhra taluka was admitted to the SSGH. Panchmahal chief district health officer (CDHO) Dr Vipul Gamit told media persons that the reports of the three deceased arrived and they tested negative for Chandipura virus. Serious cases of viral encephalitis due to the virus are reported in the district ahead of the monsoon. The test reports of the girl from Betiya admitted to SSGH are awaited. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Esse novo alarme com câmera é quase gratuito em Vargem Alegre (consulte o preço) Alarmes Undo Teams of experts from different institutes and departments surveyed houses in the localities from where cases were reported. Sandflies, which make homes in the cracks in walls of houses, spread Chandipura virus. SSGH officials said a one-year-old boy from Zalod in Dahod district died due to viral encephalitis at the hospital on Saturday. Three children are being treated at the hospital even as one was discharged on Saturday. Officials said that early treatment of high-grade fever cases can avoid complications.