Work Place Health and Safety Guidelines

Mandatory Vaccination for Industrial Workers and Families – Announcement from TN Govt

It is now mandatory for employees as well as their family members to take both doses of Covid-19 vaccine to access workplaces or industries, the Tamil Nadu government has notified today. Notification is issued by TN Health Department (TN DPH).

These guidelines on Covid-appropriate behaviour for workplaces, industries, and factories have mandated many instructions to be followed by businesses at work places.

Key Guidelines :

  • All staff and family members must be vaccinated with two doses OF CIVID 19 vaccine
  • All workplaces and industries with more than 300 employees or 10,000 sqft space should appoint a qualified health inspector, ‘at their own cost’, for monitoring and to coordinate/implement health activities on the premises. 
  • Covid-19 health team must be created on the premises and awareness measures must be held for employees
  • Screening process must include asking the employee for any Covid-19 related symptoms, if family members have symptoms, checking body temperature and checking if the staff is quarantined for having symptoms. 
  • Guidelines say that mask-wearing is mandatory at all workplaces, and administrations must monitor mask compliance through supervisors and managers, including CCTV monitoring. “Anyone without mask must be sent out of the workplace, guideline says.
  • Guidelines insist on maintaining social distancing, hand-washing facilities, and hand sanitation as well to be maintained at work places.
  • In canteen and dining area, the workers must be divided into groups and meals and tea timings should be split across the groups.
  • In quarters and dorms, Covid appropriate behaviour must be followed .

Download the Guidelines Released by TN DPH from here :

Source :

https://www.newindianexpress.com/cities/chennai/2021/jul/25/both-covid-vaccine-doses-must-for-staff-family-members-health-dept-2335008.html

The Occupational Safety, Health and Working Conditions Code, 2020 No. 37 of 2020 announced by Ministry of Labour and Employment has mandated implementation of OSH Code at work places by businesses.

Work Place Health and Safety from now onwards will have more dimension towards Health related focus than the Safety focus that earlier Factories Act had earlier.

Work places should focus on creating Health and Hygiene monitoring teams and more and more employees should be trained towards internalising the practices from now. Businesses should have to focus towards internalising Mental Health Counsellors too slowly and gradually.

All these are interlinked to Work Place Productivity and businesses will have to slowly start addressing multiple challenges that may arise at work place on people related issues.

INFOSAN Alert dated 01st July 2021 – FSSAI announcement

Detection of Salmonella in dried Oregano from Chile [Updated on:05-07-2021]

International Food Safety Authorities Network (INFOSAN) Alert

International Food Safety Authorities Network – INFOSAN issued an alert regarding the detection of Salmonella in Sweden in dried oregano from Chile. The International Food Safety Authorities Network (INFOSAN) is a global network of national food safety authorities, managed jointly by FAO and WHO.

This product has been imported to India by Keya Foods International PVT LTD and distributed within India. 

The Food Safety and Standard Authority of India (FSSAI) on July 1, 2021 has advised all states food authority to recall the dried Oregano from the market, as the INFOSAN detected of Salmonella in dried Oregano from Chile. 

Therefore, All the state food authorities are advised to take necessary actions including complete recall of the product from the market. All the consumers are advised not to consume the product and return back if purchased, to the store/shop of purchase. 

Download FSSAI notification from here

Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.

Report by Niti Aayog

Study on the Not-for-Profit Hospital Model in India

The “Not-for-Profit” Hospital Sector has the reputation of providing affordable and accessible healthcare for many years. This sector has done yeoman service over the years with some institutions from even before Independence. Although various institutions have been established for different purposes, this sector provides not only curative healthcare, but also preventive healthcare, and links healthcare with social reform, community engagement, and education. They utilize the resources and grants provided to them by the Government to provide cost effective healthcare to the population without being overly concerned about profits.

However, this sector remains largely understudied, with a lack of awareness about its services in the public domain. Hence Niti Aayog has conducted a study on “Not for Profit Hospital Model” in India. This report was released yesterday.

The aim of this study is to understand the operating model of some of the prominent institutions across the country, including their premise of service, human resource availability, cost containment levers, and the challenges they face.

This study will facilitate policymakers in deciding how they can assist this sector to sustain, grow, and in turn, help reach the unreached sections of society.

This report covers :
Objective of the Study
Approach
Criteria for Classification of Hospitals
Methodology
Key Findings
Challenges Faced by the Not-for-Profit Hospitals
Proposed Policy Interventions to Promote the Not-for-Profit Hospital Sector

Full report can be downloaded from here :

Source : http://niti.gov.in/

Parakh – Unified Laboratory Network

Launched by DPIIT, Ministry of Commerce, Govt of India – National Network of Laboratories Infrastructure

What is #Parakh ?

#Parakh is a Government of India initiative for mapping of testing and laboratory infrastructure across the country on a unified network of testing laboratories. This is yet another significant step towards enhancing Ease of Doing Business. This portal incorporates all the accredited and recognised laboratories in the country on a Geographic Information System.

This is an interactive and user friendly system to find a Laboratories and Tests based on various parameters a user may require.

This program is a joint initiative of various boards, councils as mentioned below :

MSME
CSIR
DRDO
Textile Committee
NABL
Bureau of Indian Standards
FSSAI
Export Inspection Council, EIC India
APEDA

All types of Testing, Calibration Laboratories which are Recognised and Accredited are found in the portal.

This is an initiative which will benefit all citizens, user communities to have access to information related to various testing labs in the country that tests products or services.

Pandemic crisis has brought out this huge gap in the country’s lab infrastructure related information where no information was available about testing labs for PPEs, Ventilators, various other medical devices, Covid testing labs etc. All stakeholders were shunted from pillar to post hunting to testing labs information. Intense debates, discussions had taken place about lack of information about National Testing Labs Infrastructure. That’s how DPIIT has initiated the process to create the National Network of Laboratories which will immensely benefit not only domestic trade but International Trade as well.

Portal currently has a list of :

  • 6581 laboratories offering testing services related to
    • 60558 products and services
    • following 367209 Test Methods

All Laboratories in the country are open to get their laboratories listed in the portal.

Source – https://parakh.ncog.gov.in/indexpage

World Accreditation Day 2021 Celebrations

Word Accreditation Day Celebrations 2021 – Organised by Consultants Consortium of Chennai

World Accreditation Day 2021

Theme – Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs)

09 June 2021 marks World Accreditation Day (#WAD2021), a global initiative established by IAF and ILAC to promote the value of accreditation. This year’s theme is Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs). 

The SDGs are at the core of the United Nations’ 2030 Agenda for Sustainable Development, a broad and ambitious plan of action with the overarching objective of leaving no one behind. Accreditation, in collaboration with other quality infrastructure institutions, provides the technical foundations that are critical to the functioning of developed and developing societies. It enables industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, and health and environmental protection.

IAF and ILAC have published a joint WAD 2021 statement by the IAF and ILAC Chairs, a brochure and a poster:

In addition, three videos with the themes of People, Planet and Prosperity will be released on the IAF-ILAC Youtube channel in mid-May. These three pillars group the SDGs according to common goals and are reflective of publications from UNIDOOECD and UNDP.

The Public Sector Assurance and Business Benefits websites, which contain case studies, research and supporting materials demonstrating the benefits and value of accreditation, also now feature an option for searching by SDG. 

While the COVID-19 pandemic may again disrupt physical WAD events, we encourage everyone to celebrate with us online using the hashtag #WAD2021 and to contact your local accreditation body for further details on local media and online seminars and programs they may be organising.

Source : https://www.iaf.nu/articles/World_Accreditation_Day_2021/685

About Consultants Consortium of Chennai – CCC :

Consultants Consortium of Chennai (CCC) is an Association of Management Systems Consultants, registered under the Tamil nadu Societies Registration Act, 1975.

The Key Objective of CCC is to work in alignment with the National Quality Mission launched by the Government of India by educating the industry about the role and importance of Standards, Certifications and Regulations in the country as well as in the global markets.

CCC strives to encourage Responsible Consulting through Members of its Association and focus is to Standardize Consulting Practices in alignment with changing market and industry needs in a dynamic manner.

The focus is also to identify areas and industries in which the consultants in the profession of Management Systems Consulting can contribute to the betterment of the society and the country and to promote Management Systems Consulting in such areas or industries.

One of the core objectives is to collaborate with various Industry platforms, Trade Associations, Chambers of Commerce, Management Associations, Apex Bodies of Government or Quasi Government Organization to contribute to the betterment of the industry initiatives, which will in turn contribute to the betterment of the society.

Webinar Series organised by CCC :

CCC has organised #WAD2020 successfully. Same initiative is planned by CCC for 2021 as well.
CCC has tentatively scheduled a week long sessions with following topics :

Registrations :

Entry is free for all Management Systems Consultants, Technical Experts, Industry Experts, Professionals, Industry Members, Academia , Students, Members of Trade & Industry Associations

Program Dates are listed above.

Registration Link :

Prior Regn is a MUST for Participation. All regd participants will get email confirmations 2 days before the commencement of the sessions.

For queries on Regns, email can be sent to :

Ms Rama Venugopal – contact@ccc-consultants.org – +919840870532
Mr D Srikanthan – secretariat@ccc-consultants.org – +919003056539

Do visit CCC Website for regular updates – http://ccc-consultants.org/wad-2021-celebrations/

Emergency Credit Line Guarantee Scheme (ECLGS) expanded

ECLGS 4.0 for onsite oxygen generation, wider coverage of ECLGS 3.0 and increase in tenorfor ECLGS 1.0

ANNOUNCEMENT MADE ON 30 MAY 2021 BY PIBECLGS Scheme

On account of the disruptions caused by the second wave of COVID 19 pandemic to businesses across
various sectors of the economy,Government has further enlarged the scope of Emergency Credit Line
Guarantee Scheme as under:

(i) ECLGS 4.0:100% guarantee cover to loans up to Rs.2 crore to hospitals/nursing homes/clinics/medical colleges for setting up on-site oxygen generation plants, interest rate capped at 7.5%;

(ii) Borrowers who are eligible for restructuring as per RBI guidelines of May 05, 2021 and had availed loans under ECLGS 1.0 of overall tenure of four years comprising of repayment of interest only during the first 12 months withrepayment of principal and interest in 36 months thereafter will now be able to avail a tenure of five years for their ECLGS loan i.e. repayment of interest only for the first 24 months with repayment of principal and interest in 36 months thereafter;

(iii) Additional ECLGS assistance of upto 10% of the outstanding as on February 29, 2020 to borrowers covered under ECLGS 1.0, in tandem with restructuring as per RBI guidelines of May 05, 2021;

(iv) Current ceiling of Rs. 500 Cr. of loan outstanding for eligibility under ECLGS 3.0 to be removed, subject to maximum additional ECLGS assistance to each borrower being limited to 40% or Rs.200 crore, whichever is lower;

(v) Civil Aviation sector to be eligible under ECLGS 3.0

(vi) Validity of ECLGS extended to 30.09.2021 or till guarantees for an amount of Rs.3 lakh crore are Issued. Disbursement under the scheme permittedup to31.12.2021.

The modifications in ECLGS,would enhance the utility and impact of ECLGS by providing additional support
to MSMEs, safeguarding livelihoods and helping in seamless resumption of business activity. These changes
will further facilitate flow of institutional credit at reasonable terms.

Detailed operational guidelines in this regard are being separately issued by the National Credit Guarantee Trustee Company (NCGTC).

Sources : https://pib.gov.in/PressReleasePage.aspx?PRID=1708709

More Information available at :

ECLGS Website – https://www.eclgs.com/

Download the Operational Guidelines of the Scheme from here

Download the FAQs on the scheme from here

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
Click Here for More Updates

Accreditation of SARS-CoV-2

Announcement from NABL on Covid 19 Testing

Accepting applications for accreditation of SARS-CoV-2Announcement Released on 25th May 2021

NABL is accepting applications from laboratories performing Real Time RT PCR Test, RT LAMP Assay, CRISPR – Cas9 based assay, Isothermal Nucleic Acid Amplification test (Closed System) for SARS-CoV-2. Laboratories may apply directly for accreditation of SARS-C0V-2 by different methods.

The laboratories which have been granted accreditation for Real Time RT PCR Test for other RNA viruses during the Final Assessment are advised to apply for accreditation of SARS-CoV-2 during the Onsite Surveillance or earlier.

The laboratories which have been granted accreditation for Real Time RT PCR Test for other RNA viruses during scope extension are advised to apply for accreditation of SARS-CoV-2 during the Renewal of accreditation or earlier.

Download the Announcement from here

Source : https://nabl-india.org/news-announcements/