OHSAS Standard

Webinar on OHSAS Standards for Businesses – Jan 28th 2022, Friday – 4 PM – 5 30 PM

Covid 19 outbreaks still continue and businesses struggling with hybrid work options.

Businesses and Enterprises have the responsibility to protect the health and safety of their workers.

Helping employees return to work, safely and confidently, during the coronavirus (COVID-19) pandemic is no easy task for any organisation.

Creating a Safer Work Place is the need of the hour and businesses have to focus on introducing Safe Work Place Practices, Systems to offer an assurance to the employees that they continue to work on safer environment and work place has provision to take care of their health and wellbeing.

Many Businesses focus on growing their business responsibly. That means safety is not negotiable – it’s their number one priority.

Safety is about people – caring about people, and ensuring their wellbeing, is the foundation of what it means to be a sustainable business. 

Global Markets have started releasing OSH, OHSAS guidance documents for businesses to follow. Proposed Labour Code in India – OSH Code, also mandates work place health and safety of employees.

Considering the need to provide more assurance to Employees to return to work, to remain working in a safe work place, businesses have started looking for Tools, Guidelines etc to implement best practices to address these needs. Occupational Health and Safety Standard is an International Standard that helps businesses to implement well defined Management Systems to protect employees health and wellbeing.

Andhra Chamber of Commerce is organising a Program on OHSAS by inviting Team from Bureau of Indian Standards to present OHSAS Standards requirements to the industry . This is a Knowledge Sharing Session from Andhra Chamber of Commerce.

Andhra Chamber invites participation from the industry , business units of all sizes to register for the same.

There is no participation fee and the session is open to industry and other stakeholders too.

Program Details :

Date – Jan 28th 2022, Friday
Time – 4 00 PM – 5 30 PM

Regn Link :

https://us02web.zoom.us/meeting/register/tZ0vde2tpjsrHtJ76ZF3jJsvM-CzpqeogaJ4

Contact Details :

Secretariat – Andhra Chamber of Commerce
andhrachamber1@gmail.com
044 – 24315277/78/79

Indian Made Omicron Test Kit

Tata Medical and Diagnostics has developed a kit “OmiSure” for detecting Omicron variants in RT-PCR Tests

Tata Medical and Diagnostics has developed a kit called “OmiSure” that can detect Omicron variants of SARS-CoV2 in nasopharyngeal / oropharyngeal specimens during RT-PCR testing. As per the company’s press release, the test kit is compatible with all standard real-time PCR machines. This kit can detect Omicron variants as well as other variants of SARS-CoV2 reported so far.

Currently, patients with Omicron are detected only after genomic sequencing. This test helped eliminate that step and could make detections during the test. The kit was developed to detect new variants of SARS-CoV2 directly and very specifically. Head of Research and Development , TATAMD said the first target is based on the S gene dropout or S gene target disorder (SGTF) and the second target is based on the S gene mutation amplification (SGMA). The Indian Council of Medical Research (ICMR) has approved the kit.

Presently, the Omicron variant is being detected using test kits developed by US-based Thermo Fisher which uses S-Gene Target Failure (SGTF) technology, which is also used by OmiSure.

In its letter approving the kit, the ICMR stated: “The tests have been performed as per the manufacturer’s instructions. Responsibility for batch-to-batch consistency lies with the manufacturer.”

The company had applied for a license with the Central Drugs Standard Control Organization (CDSCO). The kit will be manufactured by TATAMD at the Sriperumbudur facility in Tamil Nadu once the license is approved by the CDSCO. The company currently has daily capacity of 2,000,000 kits and plan to increase the capacity from 5,000,000 to 10,00,000 by the third week of January. The kits are manufactured in both the domestic and international markets. The company also applied for a patent for this kit .

Download the ICMR Approval here

Source

https://indianewsrepublic.com/tata-medical-and-diagnostics-has-developed-a-kit-omisure-for-detecting-omicron-variants-in-rt-pcr-tests/605532/

https://www.gonewsindia.com/latest-headlines/icmr-approves-first-rt-pcr-kit-to-detect-omicron-variant-by-tata-named-omisure-11809

https://www.icmr.gov.in/ckitevaluation.html

InformationUpdate

Industry Information Updates – Healthcare Sector

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0

OSH Code 2020

New Labour Codes – Occupational Safety, Health and Working Conditions Code, 2020

The central government has notified four labour codes, namely, the Code on Wages, 2019, on August 8, 2019, and the Industrial Relations Code, 2020, the Code on Social Security, 2020, and the Occupational Safety, Health and Working Conditions Code, 2020 on September 29, 2020.

The Code of OSH which deals with Occupational Safety, Health and Working Conditions at Work Places assumes highest significance as businesses have to refocus on Work Place Health and Safety Conditions to protect the health of workers due to ongoing pandemic crisis and health issues that are faced by workers, employees at work places.

This is a post of OSH Code written by A A Srinivasan, Principal Consultant highlighting the key features of OSH Code . Businesses have to work towards implementing the code requirements based on Rules released by State Governments.

The article is published the E Bulletin of Andhra Chamber of Commerce – Dec 2021 issue and the same is shared here for reference

About the Author :

A A Srinivasan is the Principal Consultant and well versed with Mgmt Systems Standards implementation requirements of various National, International Certifications and Accreditations Programs with hands on experience across many sectors.

Contact – srinivasanaa@valueadded.in

Materiovigilance Programme of India

Webinar on Key role of Medical Technology/ Medical Device Industries in Materiovigilance Programme of India

Materiovigilance Programme of India, Indian Pharmacopoeia Commission!    

Program Announcement from IPC

Indian Pharmacopoeia Commission (IPC), an Autonomous Institution of Ministry of Health and Family Welfare, Government of India functions as National Coordination Centre (NCC) for Materiovigilance Programme of India (MvPI) since January 2018 with the primary objective of ensuring patient/user/third party safety from medical devices and IVDs. Materiovigilance Programme of India (MvPI) has the responsibilities to monitor, collate and analyse the adverse event associated with use of medical devices in Indian population and suggesting regulatory bodies to take appropriate action.

NCC-MvPI is jointly organizing a webinar entitled “Key role of medical technology/ medical device industries in Materiovigilance Programme of India” in association with CDSCO and AIMED on December 10, 2021 via digital/virtual platform.

The objective of the webinar is to spread awareness on materiovigilance among marketing authorization holders (MAHs) including Importers, distributors of medical devices and healthcare professionals across India in order to strengthening of the materiovigilance pan India.

In this regard, we are requesting you to participate or kindly nominate officials who are associated with post marketing surveillance of medical devices in your organization. You can also percolate this information to other appropriate organizations so that they will get benefited. We look forward to your support for making this event a grand success.

The necessary information is attached herewith for your reference.

Who should attend ?

Manufacturers, Distributors, Importers, Regulators of medical devices, Healthcare Professionals and Researchers can attend this webinar.

Registration Details :

  • Registration fee: Rs. 7 000 /- (Including 7 8% CST) per participant.
  • Registration maximum for 7 00 participants will be accepted, based on “First come first serve basis”.
  • Payment shall be made by NEFT/Online mode to Indian Pharmacopoeia Commission, Bank of
    Baroda, Sanjay Nagar, Ghaziabad, Bank Account Number: 27 860 7 000 7 3540, Branch IFSC Code: BARBOSANGHA (fifth character is zero), Type of Bank Account: Super Saving, MICR Code of Bank: 7 7007 2204.

Regn Enquiry :
Mr. Maneesh Soni
NCC-MvP1, IPC : +91-9977484175
E-mail: mvpi.ipcindia@gmail.com

For more information:
https://www.ipc.gov.in/news-highlights/904-webinar-on-key-role-of-medical-technology-medical-device-industries-in-materiovigilance-programme-of-india-in-association-of-cdsco-and-aimed.html

Contact :
Dr. Shatrunajay Shukla, Ph.D., M.S. (Pharm.)
Materiovigilance Programme of India (MvPI)
Indian Pharmacopoeia Commission
(Ministry of Health & Family Welfare, Govt. of India)
Sector-23, Raj Nagar, Ghaziabad-201 002, India
Mobile: +91-8840864320,9643460668
(+91)-0120-2800500; 2783400; 2783401
Fax: 0120-2783311
Website: www.ipc.gov.in

Medical Equipment Expo

India International Medical Equipment Expo – Invitation Dec 11th – Dec 13th 2021

Announcement from Andhra Pradesh Medtech Zone

Dr Jitendra Sharma, MD & CEO, AMTZ is inviting you to the IIME Expo, scheduled to happen from the 11-13th Dec 2021 , hosted at Kalam Convention Centre, Vizag, celebrating 3 years of completion of AMTZ.

A unique platform for Medical devices & Equipment manufacturers, Hospital Infrastructure and consumables to meet and network with the Medical Fraternity including Hospital Owners/Management, Consultants, Surgeons & Physicians, Speciality centres etc under one roof.

Exhibitor Product Profile

Profile of exhibit based on Sutures & Sealing Devices, Patient Monitoring Devices, 3D Printers, Machines / Systems, Medical Furniture, Surgical Equipment, Endoscopy Equipment, Dialysis Machines, Lab Equipment, Consumables, Uniforms/Garments, Autoclave, EtO, Drapes, Surgical Equipment, Endoscopy Equipment, Manikins, Gloves, Drug Delivery / Extraction disposables, X-ray, Ultrasound, Digital Imaging, Helicopters & Private Jets, EMS Technology Solutions.

The event will see dignitaries from the Government of India, champions of med-tech, business leaders and hospitals congregating to celebrate our collective success. 

Venue :
India International Medical Equipment Expo 2021
Sat, 11 Dec 2021 – Mon, 13 Dec 2021
Kalam Convention Center
Visakhapatnam, India

Kalam Convention CenterAMTZ Campus, Pragathi Maidan, Siddeswaram, Nadupuru Reserve Forest, Visakhapatnam, Andhra Pradesh 530032

Directions – https://maps.google.com/maps/dir//Kalam+Convention+Center+AMTZ+Campus,+Pragathi+Maidan+Siddeswaram,+Nadupuru+Reserve+Forest+Visakhapatnam,+Andhra+Pradesh+530032/@17.6297358,83.1590403,16z/data=!4m5!4m4!1m0!1m2!1m1!1s0x3a396d5bec015829:0xf36d219478d9473f

Looking forward to seeing you.

Book Your Booth Now : https://lnkd.in/gRAd8rBa

Downloads:

E- Brochure: https://lnkd.in/gZUE2v-H
Floor Lay-out: https://lnkd.in/g8WK3cZq
Branding Opportunities: https://lnkd.in/geXQqNbu

Contact Co-ordinate:

Mr Harish
Director- ICEXPO
+91 8977924225)

USFDA Announcement

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests – Announcement from USFDA

The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test.

This announcement provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations.

The FDA will list tests on this page as the FDA’s analyses identify tests for which performance may be impacted for known SARS-CoV-2 variants.

Information Update in USFDA Portal covers the following :

Genetic Variations: Background and Considerations

General Information for Clinical Laboratory Staff and Health Care Providers

Omicron Variant: Molecular Tests That May Be Impacted

Other Variants: Molecular Tests that May Be Impacted

Resources

The FDA will update this page as significant new information becomes available.

Source : https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests?utm_medium=email&utm_source=govdelivery

Update date : 06/12/2021