Materiovigilance Program of India (MvPI) News Letter
Indian Pharmacopoeia Commission has released its News Letter – Materiovigilance Program of India Volume 5 – Issue 1 recently.
Sharing the same for information
News Letter
Category: Startups
EGA 2023 – Application Now Open
Envirocare Green Awards 2023
Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment.
EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care.
The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.
The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.
The application for this award is online and is open for across the globe under the following categories:
1. Individual / s
2. Private Ltd / LLP / MSME
3. Public Sector / Large Corporates
4. Non Government Organisation NGO / Cooperatives
5. Government Organisation / Municipal
6. Academia
7. Others
To apply please click here for online Google Form:https://forms.gle/ZfWBjSR8PA6W5Bqe7
The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA
Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in
For regular updates on EGA 2023 , visit https://lnkd.in/eDiKu3R
Best Practices in Social Sector
NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023”
NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023” in collaboration with the United Nations Development Programme.
To commemorate 75 years of India’s independence and highlight and laud the efforts of Union Ministries and State Governments, this compendium includes 75 case studies cutting across 14 key social sectors. The case studies have been sourced from all States/ Union Territories and 30 Ministries and Departments of the Government of India.
The seventy-five best practices highlight models which are innovative, sustainable, replicable and impactful. The aim of this exercise has been to synthesise lessons for the future to expand, enhance and improve life at the grassroots level. Due care was taken to ensure that the cases identified are spread over diverse themes, including education, health and nutrition, e-governance and digitization, agriculture, women’s empowerment, sports, and financial inclusion, among others.
Source: https://niti.gov.in/node/3568
Certification Schemes from AMTZ
Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme
| Program on Healthcare Textiles Processing Facility Certification Scheme The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again. Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis. This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider. These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI). Date: 27th May 2023 Time: 3:00 pm to 6:00pm IST Mode – Virtual Mode / Webinar |
Announcement – AMR Quest 2023
AMR Quest 2023-The Call for Applications is now open! Apply by 15th June 2023
The Centre for Cellular and Molecular Platforms(C-CAMP) is excited to announce C-CAMP AMR Quest 2023 and invites applications from innovators and start-ups working in the domain of Antimicrobial Resistance.
C-CAMP AMR Quest is one of its kind events to attract, identify, reward, and foster the innovators who are working towards the development of solutions to tackle AMR and present opportunities for funding and commercialization. The ideas can be from any domain of AMR like Non-traditional therapeutics, Preventatives, Diagnostics, and Direct Acting Small Molecules.
The exciting rewards associated are (*conditions apply):
- Acceptance into the 3-month C-CAMP AMR Accelerator Program 2023. In this, an opportunity will be provided to develop the solution further with mentorship in the domains of science, business, regulatory, patent law, fundraising, etc
- Acceptance into one week C-CAMP AMR Innovators School 2023.
- Participation in any one of the following International Conferences/Programs, with all costs covered:
- The 8th AMR Conference Novel Antimicrobials & AMR Diagnostics cocci and Staphylococcal Infections. Congress Center Basel, Switzerland on 6-7 March 2024.
- The 34th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2024, Barcelona, Catalonia, ES on 27 – 30 April 2024
- Mentorship for seeking funding opportunity through CARB-X funding round.
- Spotlight in C-CAMP’s social media platforms.
- Opportunity to attend appropriate C-CAMP workshops & events.
C-CAMP AMR Quest 2023 is open to Individuals (Including researchers, scientists, post-doctoral fellows, academicians, students, and individual innovators), startups, SMEs, and Large Companies.
Link to apply: https://forms.gle/z46DZi7bbxzpgSZJ9
Last date to apply: 15th June 2023
For further queries write to us at amr@ccamp.res.in
Workshop by IBSC – AMTZ
Workshop on Indian Medical Device Regulations
IBSC – AMTZ is organising a Workshop on Indian Medical Device Regulations
Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices
LEARNING OBJECTIVE
- Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
- Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
- To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices.
COURSE AGENDA
- Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
- Classification of Medical Devices
- Basic Requirements
- Content Requirements for Technical Documentation
- Validity of Conformity Assessment and Certification, Transition Periods
- Requirements for Manufacturers, Importers, Distributors and Service Partners
TARGET AUDIENCE
- Medical device manufacturers
- Consultants
- Regulatory Affairs Specialists
- Expert advisors in medical devices regulatory affairs
- Working biomedical engineers / medical device professionals
- Pursuing Students are also eligible
Fee: INR 3,540 including 18% GST
CANDIDATES WILL BE PROVIDED WITH IBSC CERTIFICATE
LAST DATE FOR REGISTRATION: 30th May 2023
TRAINING DURATION: 2 DAYS (9th & 10th June 2023)
LOCATION: Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990 | +91-7075737284
WhatsApp Link: https://wa.me/918897330990
WhatsApp Link: https://wa.me/917075737284
trainings@amtz.in
Announcement by MoHFW on CROs
Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022
Ministry of Health and Family Welfare issued a Notification regarding Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022 on 11th May 2023 to amend the New Drugs and Clinical Trials Rules, 2019. They shall come into force on the date of their final publication in the Official Gazette unless otherwise specified.
in rule 2, in sub-rule
(1), after clause (i), the following clause shall be inserted, namely:—
“(ia) ‘Clinical Research Organization’ means a body commercial or academic or of other category owned by an individual or an organisation having status of legal entity by whatsoever name called to which the sponsor may delegate or transfer some or all of the tasks, duties and/or obligations regarding clinical trial, such transfer or delegation of contractual transfers or obligations must be in writing.”
After Chapter V, the following Chapter shall be inserted, namely:— CHAPTER VA CLINICAL RESEARCH ORGANISATION
38A. Registration of Clinical Research Organisation
38B. Application for Registration of Clinical Research Organisation
38C. Grant of registration to Clinical research organisation
38D. Validity period and renewal of registration of Clinical Research Organisation
38E. Conditions of registration
38F. Inspection of Clinical Research Organisation registered with Central Licencing Authority
38G. Suspension or cancellation of registration of Clinical Research Organisation
In the Eighth Schedule, after Form CT-07A, following Forms shall be inserted, namely
Form CT-07B Application for Registration / Renewal of Clinical Research Organisation
Form CT- 07C Grant of Renewal of Registration of Clinical Research Organisation
After the Eighth Schedule, following Schedule shall be inserted, namely NINTH SCHEDULE – REQUIREMENTS AND GUIDELINES FOR REGISTRATION OF CLINICAL RESEARCH ORGANISATION
Objections and suggestions which may be received from any person within 15 days from the date on which the copies of the Gazette of India containing these draft rules are made available to public;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare,Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
Guidelines – AMD-CF Scheme
Govt releases Guidelines for scheme for Assistance to Medical Devices Clusters
The Department of Pharmaceuticals (DoP) has come out with the guidelines for the scheme for Assistance to Medical Device Clusters for Common Facilities (AMD-CF) with proposed financial outlay of Rs. 300 crore to offer financial assistance to strengthen the existing and new medical device clusters through creation of common infrastructure facilities
The Scheme, with two sub-schemes, is expected to help in boosting the domestic manufacturing capacity and improving the quality of clusters for sustainable growth of the medical devices sector.
The scheme further intends to support central or state governments, institutions, or organisations to establish or strengthen the testing laboratories for medical devices to meet the needs arising due to the roll out of the licensing regime of the Medical Devices Rules (MDR), 2017.
The Scheme has two components or sub schemes – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF) – and would be running for three years from 2023-24 to 2025-26. The tenure of the scheme is from the financial year 2023-24 to the financial year 2026-27.
Both the sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore (Rs. 48 crore in the first year, Rs. 128 crore in the second and Rs 64 crore in the third year) for the common facilities and Rs. 60 crore (Rs. 18 crore for the first, Rs. 30 crore for the second and Rs. 12 crore for the third year) for the testing facilities.
Assistance for Common Facilities is planned to strengthen the medical devices clusters’ capacity for their sustained growth by creating common infrastructure facilities.
Medical devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facilities and the clusters promoted by the State governments, are expected to benefit from the sub-scheme.
There shall be a minimum of five medical device manufacturing units as members of SPV. Clusters promoted by state governments may not need to form an SPV.
The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV.
For Common Infrastructure Facilities for medical device clusters, the limit of support will be 70 per cent of the approved project cost or Rs. 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC).
The sub scheme is expected to have benefits including improvement in quality of medical devices, regulatory compliance specified for medical devices, increased availability of trained personnel for the clusters, increased competitiveness of units in the cluster and reduction in the manufacturing cost of the devices.
The sub scheme on assistance for Testing Facilities is aimed at strengthening availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices, and national or state level government of private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including in vitro diagnostic medical devices under MDR, 2017 can apply for the assistance.
The guideline proposes a Technical Committee constituted by the DoP to assist the SSC, which will have one representative each from the Central Drugs Standard Control Organisation (CDSCO), industry and academia, and ICMR, and two representative experts having knowledge and experience in the process development, R&D, product design, testing of medical devices or medical devices manufacturing from relevant institutes such as NIPER, IISc, IITs, Sree Chitra Thirunal Institute of Medical Sciences and Technology, and CSIR, among others.
The DoP will provide overall policy, coordination and management support for the implementation of the Scheme, while the proposals under the scheme will be considered for approval by the SSC, which will be headed by the Secretary of DoP as the Chairperson, and will have members including the Drugs Controller General of India, Financial Advisor of DoP, Joint Secretary (Schemes and Medical Devices), DoP, representatives of the Ministry of Micro, Small and Medium Enterprises (MSME), the Ministry of Electronics and Information Technology (MeitY), the Department for Promotion of Industry and Internal Trade (DPIIT), and the director or the deputy secretary (Schemes) of the DoP.
Industry Update
Centre Notifies National Medical Device Policy 2023
The Union government on 27th April 2023 notified the National Medical Device Policy 2023, aiming to establish India as a global leader in manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market over the next 25 years.
It outlines a regulatory mechanism, protocol for setting up standards for medical devices, price control, research and development (R&D), and a code of ethics for industry associations to ensure the ethical marketing of medical devices
According to the notification, the policy will guarantee access to patent-centric, innovative, and affordable healthcare products of exceptional quality for improved healthcare outcomes. It seeks to facilitate the growth of the medical devices sector to cater to both the Indian and global markets while promoting safety and quality. The policy provides a roadmap for the accelerated growth of the medical devices sector.
The policy plans to promote innovation and R&D, including joint R&D projects involving academic institutions and industry under the proposed ‘National Policy on R&D and Innovation in the Pharma-MedTech Sector in India’. This approach fosters collaboration between academic institutions and the medical devices industry.
Furthermore, the policy seeks to attract investments in the sector, adding to existing schemes and interventions to promote indigenous manufacturing, build competitiveness, and develop an ecosystem for manufacturing.
Source:https://www.livemint.com/
https://pharmaceuticals.gov.in/policy/national-medical-device-policy-2023
National Health Claims Exchange (HCX)-Sandbox
National Health Authority (NHA) invites participation on the ‘National Health Claims Exchange (HCX)-Sandbox’ under Ayushman Bharat Digital Mission (ABDM)
The National Health Authority (NHA) invites contributors and developers from the open community, especially those working in the Health Insurance and Healthcare Provider space to test, contribute and become a participant in the Health Claims Exchange Ecosystem by onboarding on the HCX – Sandbox Environment. NHA announced HCX as a new initiative under the Ayushman Bharat Digital Mission (ABDM) on 23rd September 2022 and subsequently worked with various groups to come up with Health Insurance Exchange specifications.
The current health insurance claims settlement process in the country is mostly manual, non-digital and laborious in nature posing challenges at every stage. The current process of exchanging claims lacks standardization across the ecosystem with most data exchange occurring through PDF/manual methods and processes vary significantly among Insurers, TPAs, and Providers leading to high cost of processing each claim.
To tackle these key challenges and streamline the process of claim settlement, NHA has developed a national Health Claims Exchange (HCX) to enable interoperability of health claims. The HCX serves as a protocol for exchanging claims-related information among various actors, including payers, providers, beneficiaries, regulators, and observers. It is designed to be interoperable, machine-readable, auditable, and verifiable which helps ensure that the information being exchanged is accurate and trustworthy.
HCX will act as a gateway (with validation and routing capabilities) for the ecosystem wherein the Insurers/ TPAs shall send responses for each FHIR based e-claim submitted by providers via the HCX through standard protocols (APIs).
With a vision to standardize the claims process, HCX will lead to reduction in operational overheads and increase the trust among payers and providers through a transparent and rule-based mechanism, it will reduce claims processing cost, expedite pre-authorization or patient discharge approvals, improve patient experience, better visibility for tracking the claims and have better quality data for industry and regulators.
To ensure the success and adoption of the claims network, it is essential to onboard participants on the HCX ecosystem, therefore it is requested that all interested solution providers, payers, and provider to actively participate and utilize the services of the HCX – Sandbox, the key goal of the sandbox is to help the ecosystem test its specific components against the communication standards and get certified to become a part of the system.
The interested participants can submit an online application to express their interest to access the HCX sandbox on https://sbxhcx.abdm.gov.in/. On successful verification, the approved participants are added to the HCX sandbox and provisioned with the necessary credentials to access the sandbox environment. The link also provides all necessary documentation for participation along with the HCX specifications and FHIR profiles.
The FHIR Implementation Guide (IG) for ABDM has been updated to support HCX specifications. The preview of the IG is hosted at – https://www.nrces.in/preview/ndhm/fhir/r4/hcx-profile.html.
Source: https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1917688