Latest news with #MedicalDevicesRules
Time of India
19 hours ago
- Health
- Time of India
National Medical Commission directs colleges to form panels to track adverse events from devices
New Delhi: The National Medical Commission (NMC) has directed all deans and principals of medical colleges across the country to constitute committees for monitoring, assessing and preventing adverse events related to medical devices . In a public notice, the NMC stated that each medical institution must register such a committee with the Indian Pharmacopoeia Commission (IPC). The notice underlined that medical devices have become an indispensable component of modern healthcare, playing a crucial role in the diagnosis, treatment, and management of diseases. Citing incidents wherein medical devices have caused harm to patients, the commission emphasised the need for a robust system to monitor such events and implement corrective measures to prevent their recurrence. In response to this, the Ministry of Health and Family Welfare had launched the Materiovigilance Programme of India (MvPI) in 2015 at the IPC, with the objective of monitoring adverse events and risks associated with medical devices used across the country. The national initiative aims to systematically collect, analyse, and respond to such events, ensuring better patient safety and promoting quality healthcare delivery , the NMC said. Coordinated by the IPC, the programme operates through a growing network of Medical Device Adverse Events Monitoring Centres (MDMCs) established in hospitals and medical colleges. The Medical Devices Rules, 2017 regulate the import, manufacture, sale, and distribution of medical devices in India, including post-market surveillance. The MvPI seeks to ensure the safety of medical devices throughout their lifecycle by promoting systematic reporting and analysis of adverse events. The data generated is shared with the Central Drugs Standard Control Organisation (CDSCO) to support regulatory action and improvements in clinical practice, the notice said. Highlighting the benefits of becoming an MDMC, the NMC said medical colleges are well-positioned to serve as centres for materiovigilance due to their diverse patient base and access to advanced medical technologies. "Becoming an MDMC offers several strategic advantages, including academic recognition, professional development, infrastructure enhancement, policy influence, and enhanced patient safety," the commission noted. The NMC also directed that the name of the committee's Coordinator/Convenor and its members be published on the institution's official website. The Medical Superintendent shall ordinarily serve as Chairperson of the committee. Medical colleges have also been reminded to update the details of their Pharmacovigilance Committee on their respective websites and complete the registration process by July 31.
Hindustan Times
21 hours ago
- Health
- Hindustan Times
Delhi govt cracks down on pharmacies trafficking counterfeit medicines
The health department's drugs control department has begun cracking down on pharmacies outside its hospitals to curb illegal drug sellers and the circulation of counterfeit medicines, people familiar with the matter said on Monday. Officials said there are several establishments in Delhi, especially those operating outside major hospitals, which continue to function without the requisite licence. (Representational image) The drugs control department's recently-established drugs intelligence cell raided two premises in central Delhi on Friday, seizing large quantities of unlicensed medical devices and drugs, said officials, requesting anonymity. 'Acting on a tip, a team of drugs inspectors conducted two raids. The first raid was conducted at a dental supplier medical establishment in Daryaganj. The establishment was stocking a range of medical devices including syringes and catheters and certain drugs including Lignocaine, a class of local anesthetic drugs, for sale and distribution without licences, registrations, or valid purchase records,' said an official who was part of the team that conducted the raid. 'At least 180 types of medical devices along with drug items were seized from the premises,' the official added. 'At the same time, the second raid was conducted an establishment at Nigam Medical Market. The establishment was illegally stocking 58 types of medical devices for sale without registration or licence as mandated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017,' the official said. A second official, requesting anonymity, said there are several establishments in Delhi, especially those operating outside major hospitals, which continue to function without the requisite licence despite clear regulations requiring all drug sellers to obtain proper authorisation. 'The government doesn't allow medical shops to operate without registration and licensing under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017, primarily to ensure public safety and quality control in the sale of drugs and medical devices. Unregulated sale could lead to the distribution of substandard or counterfeit medications, posing serious health risks to the public. As of now, the department has placed special focus on identifying and shutting down such illegal outlets and remains on high alert for any complaints related to counterfeit drugs circulating in the city,' the official said. Referring to the newly set-up intelligence cell at the department, the official added, 'The cell comprises 13 inspectors who gather information from markets and other sources before conducting targeted raids.'
The Print
a day ago
- Health
- The Print
National Medical Commission directs colleges to form panels to track adverse events from devices
The notice underlined that medical devices have become an indispensable component of modern healthcare, playing a crucial role in the diagnosis, treatment, and management of diseases. In a public notice, the NMC stated that each medical institution must register such a committee with the Indian Pharmacopoeia Commission (IPC). New Delhi, Jul 14 (PTI) The National Medical Commission (NMC) has directed all deans and principals of medical colleges across the country to constitute committees for monitoring, assessing and preventing adverse events related to medical devices. Citing incidents wherein medical devices have caused harm to patients, the commission emphasised the need for a robust system to monitor such events and implement corrective measures to prevent their recurrence. In response to this, the Ministry of Health and Family Welfare had launched the Materiovigilance Programme of India (MvPI) in 2015 at the IPC, with the objective of monitoring adverse events and risks associated with medical devices used across the country. The national initiative aims to systematically collect, analyse, and respond to such events, ensuring better patient safety and promoting quality healthcare delivery, the NMC said. Coordinated by the IPC, the programme operates through a growing network of Medical Device Adverse Events Monitoring Centres (MDMCs) established in hospitals and medical colleges. The Medical Devices Rules, 2017 regulate the import, manufacture, sale, and distribution of medical devices in India, including post-market surveillance. The MvPI seeks to ensure the safety of medical devices throughout their lifecycle by promoting systematic reporting and analysis of adverse events. The data generated is shared with the Central Drugs Standard Control Organisation (CDSCO) to support regulatory action and improvements in clinical practice, the notice said. Highlighting the benefits of becoming an MDMC, the NMC said medical colleges are well-positioned to serve as centres for materiovigilance due to their diverse patient base and access to advanced medical technologies. 'Becoming an MDMC offers several strategic advantages, including academic recognition, professional development, infrastructure enhancement, policy influence, and enhanced patient safety,' the commission noted. The NMC also directed that the name of the committee's Coordinator/Convenor and its members be published on the institution's official website. The Medical Superintendent shall ordinarily serve as Chairperson of the committee. Medical colleges have also been reminded to update the details of their Pharmacovigilance Committee on their respective websites and complete the registration process by July 31. PTI PLB HIG HIG This report is auto-generated from PTI news service. ThePrint holds no responsibility for its content.
The Hindu
05-07-2025
- Health
- The Hindu
KCS notified as authorised body to inspect medical devices manufacturing facilities
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified the Kalam Institute of Health Technology (KIHT) Certification Services (KCS) as the State's first regulatory body authorised to inspect the manufacturing facilities for Class A and Class B medical devices, according to a release here. Among the 14 such notified bodies nationwide, KCS is the only one operational in Andhra Pradesh and Telangana, marking a milestone in the region's quality management capabilities. Founded in July 2017, the KIHT, located on the AMTZ campus, is a Central government project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policy-making and knowledge repository. Founded in April 2022, the KCS is accredited by the National Accreditation Board for Certification Bodies (NABCB). The organisation offers comprehensive services, including ISO- 13485 certification, quality systems audit, risk management training, and CE‐mark consultancy — making it a full service hub for manufacturers seeking to meet global regulatory standards. This approval brings immediate benefits to domestic manufacturers, particularly the MSMEs, by eliminating the need for audits outside the State — resulting in significant time and cost savings. It also reinforces Andhra Pradesh's MedTech credentials, supporting national campaigns like 'Make in India' and 'ACI manufacturing', while making the region highly attractive for future investments. This significant milestone empowers KCS to conduct independent regulatory audits for medical device manufacturers in accordance with the Medical Devices Rules (MDR)-2017 for Class A (low risk) and Class B (moderate risk), the release added, while underscoring the State's reputation as a business-friendly hub, ready to meet rising global demand in healthcare.
New Indian Express
27-04-2025
- Health
- New Indian Express
Land identified for Tamil Nadu's first Medical Devices Testing Laboratory in Coimbatore
COIMBATORE: After around three months of no progress, the Coimbatore district administration has identified land for constructing the state's first Medical Devices Testing Laboratory at Kavundampalayam. Revenue department land, spanning around 1.28 acres, has been identified for the project. "A portion of the land (around 50 cents) has been earmarked to construct the Kavundampalayam police station while the rest would be allocated to the drug administration department. The joint committee comprising the district administration and the drug administration department, along with the health officials, visited the location at Jeeva Nagar in Kavundampalayam on Thursday and held a discussion about the possibilities of establishing the laboratory," said sources, adding that the land will be officially handed over to the drug administration department soon. Testing A and B category medical devices at government-owned laboratories are a part of the Medical Devices Rules, under the Drug and Cosmetics (D&C) Act, which came into force in January 2018. However, the drug administration department in Tamil Nadu has not performed any tests on medical devices due to the lack of a specialised laboratory in the state. Based on a request from the state government, the central government approved the plan to establish a well-equipped NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory for testing medical devices, including in-vitro diagnostics, at Coimbatore. In a Memorandum of Understanding (MoU) between the central and state governments under the Strengthening of State Drug Regulatory System scheme, Rs 29.67 crore was allocated for the project in mid-2024-25, in a fund sharing ratio of 60:40 by the centre and the state, respectively. Even though it was announced in December 2024, there was no progress. Recently, Health Minister Ma Subramanian announced the project during the discussion on demands for grants in the Assembly. On April 22, a TNIE report highlighted that the delay in allocating land had affected the progress of setting up the lab. District Collector Pavankumar G Giriyappanavar had also assured that the land identification process will be wrapped up at the earliest.
