Food Safety and Standards Regulations, 2022

Food Safety and Standards Regulations, 2022 – Notification – 34456/2022/REGULATION-FSSAI

FSSAI has issued a Notification (34456/2022/REGULATION-FSSAI) containing draft of certain regulations which the Food Safety and Standards Authority of India proposes to make in super session of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

Articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.

Categories covered under these regulations include: (a) Health Supplements (HS) (b) Nutraceuticals (Nutra) (c) Food for Special Dietary Use (FSDU) (d) Food for Special Medical Purpose(FSMP) (e) Prebiotic food and Probiotic food (Pre-Pro)

The draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation@fssai.gov.in

Source link: https://www.fssai.gov.in/upload/uploadfiles/files/Draft_Notification_Health_29_06_2022.pdf

Advisory from National Medical Commission

Advisory from National Medical Commission ( Administration Section )

National Medical Commission has issued an advisory note on 27th July 2022 to all Medical Colleges and Institutions to install cameras in their Institute premises at prescribed locations with the suggested specifications given in the advisory note.

Source link: https://www.nmc.org.in/MCIRest/open/getDocumentpath=/Documents/Public/Portal/LatestNews/20220727062249.pdf

Health Facility Registry

Ayushman Bharat Digital MissionHealth Facility Registry

Health Facility Registry is a comprehensive repository of health facilities of the country across modern and traditional systems of medicine.  It includes both public and private health facilities including hospitals, clinics, diagnostic laboratories and imaging centers, pharmacies, etc.

Registration will enable health facilities to get connected to India’s digital health ecosystem and allow their listing on a national platform

Who can Register

• Hospital and Clinic
• Diagnostic Laboratory
• Imaging Centre
• Pharmacy
• Cathlab
• Dialysis Center
• Blood Bank
• Modern Medicine ( Allopathy)
• Unani
• Dentistry
• Siddha
• Physiotherapy
• Homeopathy
• Ayurvedha
• Sowa – Rigpa

Benefits of Registration

 Unique & Trustable Identity – Facility ID for identification of health facilities across the ABDM ecosystem
 Ease of doing business – Digitisation of services
 Online Presence & Discoverability – Listing of health facilities on a national platform
 Unified Digital Services – Access to telemedicine, digital health records and HMIS solutions

How to Register?

Login to https://facility.abdm.gov.in/#

• Sign Up as a Facility Manager – Create your Facility Manager ID i.e your Healthcare Professional ID linked to Aadhaar (Your aadhaar must be lined to your mobile number to create your Health ID)
• Select type of facility to view Registration process – Government / Private / PPP
• Search your Healthcare facility
• Fill Registration Form – Enter Facility details, services offered and infrastructure details
• Review and Submit Form for verification
• Verification by District Verifier

User manual for Registration:

SIB SHInE Fellowship 2022 – 2023 Program

School of International Biodesign-Synergising Healthcare Innovation and Entrepreneurship (SIB SHInE) fellowship 2022 – 2023 Program

Calling out to passionate graduates for DBT’s prestigious Biodesign Program Fellowship

IIT Kanpur and KGMU Lucknow jointly are inviting applications for School of International Biodesign-Synergising Healthcare Innovation and Entrepreneurship (SIB SHInE) fellowship program

About SIB SHInE Program

The program is based on the philosophy of 4Cs ie.., Clinical Immersion, Conception, Creation and Corroborations.

The year-long fellowship will provide the fellows an in-depth understanding of biomedical product development – from the identification of clinical opportunities to the initiation of a new venture.

Access SIB SHInE Program Brochure:

Know more: https://www.sibshine.com/

Deadline: 29th July 2022 (Midnight)

Contact: 
SIB SHInE
IITK KGMU Biodesign Program
sib_shine@iitk.ac.in
Address:
SIDBI Building, Indian Institute of Technology, Kanpur, 208016

Training Program in Social Science and Public Health Research Ethics

Short-Duration Intensive Training Program in
Social Science and Public Health Research Ethic

Greetings from Health, Ethics, and Law (HEaL) Institute for Training, Research and Advocacy; and Forum for Medical Ethics Society (FMES), Mumbai.

We with our co-hosts –  Indira Gandhi Institute of Development Research (Deemed to be University), Mumbai and  Vidhayak Trust, Pune – are pleased to announce our flagship ‘Short-Duration Intensive Training Program in Social Science and Public Health Research Ethics’ on Tuesday between September 6, 2022, and October 25, 2022, (Every Tuesday during this period between 1600 and 1930 hrs on a at virtual platform.). Please note that all sessions will be live ones steered by experts allowing direct interactions between course participants and the faculty and course directors. These are not pre-recorded sessions.

Important dates:

Closing date for receipt of application forms: Monday, August 15, 2022

Selection notification to applicants: Thursday, August 25, 2022

Training program: Tuesdays between September 6 and October 25, 2022

About the course: The course curriculum has a legacy of 15 years to which a number of scholars including those trained in bioethics have contributed. Over time they developed research ethics case studies from the Indian context. These serve as one of the key resources for the course.  Because these are live sessions (and not pre-recorded), content of each session is carefully curated to cover contemporary issues and ethical dilemmas building on the most recent scholarship in the concerned thematics.

The course aims to equip course participants with knowledge and skills in research ethics. They would serve on significant human resources to take the learnings to their own ecosystem and facilitate knowledge transfer in research ethics.

This ethics training would help to develop an ability to use moral judgment. This training is aimed at enabling public health students and researchers; and public health practitioners to apply public health ethics frameworks and principles to reason out new, difficult, or ambiguous cases/situations/scenarios toward resolving the issue at hand in morally discerning ways.

Please find enclosed the program brochure and flyer for your ready reference. Watch out for the space on FMES’s HEaL Institute website (https://fmesinstitute.org/) for updates such as session faculty, and additional webinars on special themes.

For any further questions or clarification, please write to us at fmescentre.events@gmail.com or

call on Mob.: 7506265856

Source Link : https://fmesinstitute.org/wp-content/uploads/2022/07/SSPHRE.pdf?utm_medium=email&utm_source=sendpress&utm_campaign

Contact :
Dr Sunita Sheel, Director, HEaL Institute, Mumbai
Prof Srijit Mishra, Indira Gandhi Institute of Development Research, (Deemed to be University), Mumbai
Forum for Medical Ethics Society
O-18, Nav Bhavna Premises Co-operative Society Ltd.
422 Veer Savarkar Marg, Prabhadevi
Mumbai 400 025, India

Ophthall 2022 Practice Development Conference

Fifth Edition India’s Only Practice Development Conference For Ophthalmologists and Eye Hospital Managers

About the Programme :

Ophthall 2022 is the fifth edition India’s only Practice Development Conference for Ophthalmologists, and Eye Hospital Managers. Ophthall 2022 would offer an insight into Practice Development and focus on business of Ophthalmology which regular conferences rarely do.

Though Practice Development is need of the hour, this important subject is not taught in Medical Colleges. The day an Ophthalmologist steps into practice, he becomes an entrepreneur and must play multiple roles which he is not prepared to. Ophthall 2022 will educate the Ophthalmologists about the business skills which are required to run a successful Ophthalmology Practice.

The effective management of an ophthalmology practice is nearly as intellectually challenging – and interesting – as the practice of ophthalmology itself. This practical two-day meet will be a knowledge sharing platform for Ophthalmologists to learn the essential skills of practice development from more than 40 Expert practice development specialists (Industry Experts and Ophthalmologists)

Ophthall 2022 would follow an unconference format and would break all traditional conference formats. We will have TED Talk like sessions, Panel Discussions, Fireside Chats and Round Table sessions which would address all issues of Practice Management and would enable our Delegates to take their practice to the next level.

While attending Ophthall 2022 you will also be able to participate in our Partner Events India Ophthalmology Expo and India International Optical Expo and purchase Equipments and Consumables at specially negotiated price for your Eye Hospital.

Ophthall 2022 will create networking Opportunities for Mentorship, Investment, Partnership and guidance to run a effective Ophthalmology Practice to all attendees.

Programme Date : July 16th & July 17th 2022
Programme Time : 9.30 am – 5.30 pm IST

For More Information about Ophthall 2022 please contact

Mr Hari
M: +91-8754517944
info@ophthall.in

Workshop on Patient Safety and Quality Improvement

Education/Interactive Workshop on Documentation Requirement for Patient Safety and Quality Improvement

NABH is organising a Workshop on Documentation Requirement for Patient Safety and Quality Improvement on Sunday, July 17, 2022 between 2 pm to 6 pm.

Like all quality management systems documentation is an essential component of NABH accreditation. NABH standard require various documentation. Documentation which provides correct, complete, current, and consistent information and also effectively meet customer and stakeholder’ requirements should exist in an organisation who is aspiring to implement quality standards.

Who should attend?

1. Medical and Nursing professionals 
2. AYUSH  professionals
3. Administrators
4. Healthcare Management Students
5. Quality Managers

Why one should attend?
1.This training will provide knowledge with which one can create required documents for his / her organisation. This workshop is also going to equip the participant with knowledge about system documentation and how to create hierarchy of policy then procedure and then Work instructions or Standard Operating Procedures (SOP). All documentation moves from one level to the next. The first tier of documentation is the policy. This is the document that defines what will be done and why. Policy needs to be clear, precise and practical, and easy to understand. The second tier of documentation is procedures. Procedures describe the methods that will be used to implement and perform the stated policies. Work instructions or Standard Operating Procedures (SOP) are usually department, machine, service, or task oriented and describe how a job will be done. The instructions are the most detailed of the documentation hierarchy.

2. What constitutes Good Documentation? How to

·  Approve, review and update documents.
·  Changes & current revision status of documents identified
·  Keep relevant versions of applicable documents available at points of use
·  Ensure that documents remain legible and readily identifiable
·  Ensure that documents of external origin identified and their distribution controlled
·  Prevent unintended use of obsolete documents, and archiving.

3. This training will strengthen the understanding of quality principles hence enabling well trained professional to become “Champions” in quality and to apply them to improve quality & work flow.

4. Trained Professionals will learn how quality can reduce errors and hence increase patient safety.

Course material and certificate for participants

Each workshop participant receives course contents including learning and reference material. The workshop will be a combination of theory, demos and panel discussions and will involve active participation.

At the successful completion of workshop candidates will be provided certificate of participation.

Workshop Fee:

The registration can be done by filling the registration format at our web-site (www.nabh.co/login). Registration fee (non-refundable & non-transferable) is Rs. 4,000/- + GST@18% (Total Rs. 4720/). Fees concession of 10% is being provided for the members of Quality Council of India (http://www.qcin.org/nbqp/PMS/).  

Limited seats are available only first come first serve basis. To ensure your participation through online registration.

Programme Date : 17th July, 2022
Programme Timings: 02.00 pm to 06.00 pm

For registration and any other related query please contact      

Mr. Vikash Chaudhary
Administrative Officer
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor, 4 – A, Ring Road, I P Estate,
New Delhi – 110002
Tel: +91 11 42600622 
Fax: +91 11 233 23 415
Email: vikash@nabh.co

PHDCCI Conference

Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices

Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:

Day & Date: Friday, 15 July 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights

• 7 Basic Quality Management Principles
• Overview of the Certification process and
• Importance of 13485 Certification from Compliance perspective

Key Speakers

• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi
• Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZYtdOyspjsuGNEyI95QZr_wRhoB9giV413X

You may send your questions to rimneet.kaur@phdcci.in prior to the session. The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

MDR 17 – An Interactive Session with Regulators

Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17

Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17

Date : 23rd July 2022 Saturday
Time : 3 pm – 5 pm
Meeting : Online Meeting

Program Objective:
Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.

Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.

Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.

AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.

Target Audience

Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu

Program Details:

Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .

There is NO REGISTRATION FEE. However , prior registration is a must.

For Enquiries about the Program :
Ms Rama Venugopal, Jt Coordinator,
AIMED – South India
jt.coordinator.south@aimedindia.com

Hub Co-ordinator
NHHID Hub, Anna University, Chennai
au.nhhid@gmail.com
For more details about the NHHID, Anna University , pls visit – https://www.nhhid.org

DRAFT OF NEW DRUGS, MEDICAL DEVICES AND COSMETICS BILL 2022

DRAFT OF NEW DRUGS, MEDICAL DEVICES AND COSMETICS BILL 2022

The Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly. Review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology.

The Government has time and again emphasized the need to review obsolete laws and to periodically repeal and amend laws, for which Bill are being brought before the Parliament.

The work of review and updating of Drugs and Cosmetics Rules, 1945 was vigorously taken up from the year 2016.

In light of recommendations of the Central Government and the felt need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill. As per recommendations of the Committee. Ministry of Health and Family Welfare, Government of India proposes a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, technology. In this regard, a draft bill has been prepared, a copy of which is enclosed.

It has been decided to solicit suggestions/comments/objections from the public/ stakeholders with regard to the said draft Bill.

The suggestions/comments/objections may be forwarded within 45 days from the date of issue of this Notice by email to drugsdivmohfw@gov.in or by post to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room No. 434, C Wing, Nirman Bhawan, New Delhi – 110011.

The suggestions/comments/objections received on the above email/address within the period of 45 days from the date of issue of the Notice, shall be taken into consideration for finalization of the notification.

A detailed Notice is available in the following link.
https://main.mohfw.gov.in/newshighlights-97

Source link: 
https://main.mohfw.gov.in/sites/default/files/Drugs%2C%20Medical%20Devices%20and%20Cosmetics%20Bill.pdf