Training Program on ISO 15189:2022 Standard

Medical Education and Learning Point (MELAP) is conducting the following Training programs in Chennai

4 days Onsite Training program on IA&QMS as per ISO 15189:2022 standard

Medical Education and Learning Point (MELAP) in collaboration with Dept of Biochemistry – Madras Medical College ( MMC ) is conducting 4 Day IA & QMS / QC training program as per the New version of standard ISO 15189 : 2022. This course is Accredited by NBQP, Division of QCI

Program Details are given below:

Date & Time    : 27th – 30th March  2023  9.30 am to 4.00 pm

Venue              : Madras Medical college – Chennai

Regn Fee         : For Doctors / Senior Resident – Rs.11000 (incl of tax)

                          For Technical staff / PG Students – Rs.9000 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Onsite 2 day Refresher course as per ISO 15189:2022  Standard for those who have already done 2012 version (Accredited by NBQP, Division of QCI)

Medical Education and Learning Point (MELAP) in collaboration with Department of Regenerative Medicine & Research, Govt Stanley Hospital Chennai is conducting a 2 day refresher course as per ISO 15189:2022  Standard

Program details are given below

Date                :           24th & 25th March2023

Venue             :           Department of Regenerative Medicine & Research, Govt Stanley

Hospital Chennai

Regn fee          :           Rs.6500 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Seats are limited & available on first come basis only

Enrolment of Medical Colleges as ADR monitoring centers under PvPI

NMC Mandate Enrolment of Medical Colleges as ADR monitoring centers under PvPI

Aiming to uplift regulatory standards for the overall collection, analysis and monitoring of Adverse Drug Reactions (ADRs) from the Public, National Medical Commission (NMC) has directed all medical colleges, standalone PG Institutions to enrol themselves as Adverse Drug Reaction Monitoring Centers with the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Program of India (PvPI) at the earliest.

Indian Pharmacopoeia is functioning as the National Co-ordination Centre, Pharmacovigilance Programme of India to collect, analyse and monitor the adverse drug reactions from the Indian population to promote Patient Safety and Safeguard the health of patients by ensuring that the benefits of the use of medicines outweigh the risk associated with its use

The collected ADRs data is a significant source of evidence of recommendations of regulatory interventions regarding the safety of medicines to the Central Drugs Standard Control Organisation (CDSCO)       

In order to achieve the above objective, IPC has so far enrolled 652 Adverse Drug Monitoring Centres (AMCs).

In the 22 nd Meeting of the Governing Body of India Pharmacopoeia Commission held on 14.10.2022 under the chairmanship of the Secretary (HFW) it has been decided that all Medical colleges/ hospitals under the National Medical Commission should also be enrolled as AMCs with IPC.

Accordingly, all Medical colleges/hospitals under the National Medical Commission are directed to get themselves enrolled with Indian Pharmacopoeia Commission (IPC) as AMCs at the earliest.

Source:https://medicaldialogues.in/

Centre releases endorsement guidelines

Endorsements Know-hows!’ for celebrities, influencers and virtual influencers on social media platforms’.

The Department of Consumer Affairs under the Ministry of Consumer Affairs, Food and Public Distribution has released a guide ‘Endorsements Know-hows!’ for celebrities, influencers and virtual influencers on social media platforms’

The guide is released in alignment with the guidelines set by the Consumer Protection Act of 2019. The Act established guidelines for protecting consumers from unfair trade practices and misleading advertisements. The Department of Consumer Affairs has published Guidelines for prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 on 9th June 2022. These guidelines outline the criteria for valid advertisements and the responsibilities of manufacturers, service providers, advertisers, and advertising agencies. These guidelines also touched upon the celebrities and endorsers. It states that misleading advertisement in any form, format or medium is prohibited by law.

The “Endorsement Know-hows!” specify that

  1. Disclosures must be prominently and clearly displayed in the endorsement, making them extremely hard to miss.
  2. Any celebrity, influencer or virtual influencer who has access to an audience and can influence their purchasing decisions or opinions about a product, service, brand, or experience must disclose any material connection with the advertiser.
  3. This includes not only benefits and incentives, but also monetary or other compensation, trips or hotel stays, media barters, coverage and awards, free products with or without conditions, discounts, gifts and any family or personal or employment relationship
  4. Endorsements must be made in simple, clear language and terms such as “advertisement,” “sponsored,” or “paid promotion” can be used. They should not endorse any product or service and service in which due diligence has been done by them or that they have not personally used or experienced.

Source:https://resource.cdn.icai.org/72658srsb58573.pdf

Announcement – ICAI issues Social Audit Standards

Social Audit Standards – Sustainability Reporting

The Institute of Chartered Accountants of India (ICAI) has issued the Social Audit Standards (SAS) for the members. These Social Audit Standards will be applicable from the date of their hosting on ICAI website. (SAS 100 should be read in conjunction with the “Preface to the Social Audit Standards” and “Framework for the Social Audit Standards”, issued by the ICAI

This Social Audit Standard relates to the thematic area of “eradicating hunger, poverty, malnutrition and inequality’’. The Standard aims to provide the Social Auditor with the necessary guidance in relation to independent impact assessment engagement of Social Enterprises engaged in eradicating hunger, poverty, malnutrition and inequality and the audit steps and procedures that should be applied while conducting the social impact assessment. The Standard sets out the minimum requirements to be followed while conducting impact assessment. Laws or regulations may establish additional requirements which should be followed, as applicable.

The Social Auditor should conduct a desk review of existing documents to gain further insight into the evaluation procedure and impact assessment.

The social auditor should review the evaluation questions addressed through Questionnaires, In – depth Interviews and Focused Group Discussions to assess the responses received from various stakeholders and to understand what has changed.

The Social Auditor should review the project/program documents to frame the evaluation criteria for assessing impact. Such key metrics may be collated from base-line, mid-line (monthly / quarterly) and end-line assessment (if available), respectively at the beginning, middle and end of the reporting period/project/program to effectively understand and evaluate impact.

The Social Auditor should identify the inherent limitations of the evaluation process which might have an influence on the impact assessment.

Source – https://resource.cdn.icai.org/72658srsb58573.pdf;

Source: https://www.taxscan.in/icai-issues-social-audit-standards/245984/

Webinar on Electrical Safety in Hospitals

Webinar on Electrical Safety in Hospitals and Medical Locations (Part – 2)

The webinar will explain about the safety measures to be adopted in Hospitals and Medical locations to get safety of patients, doctors and nurses working in medical locations and fire due to short circuit.

The webinar is specially designed for Bio Medical Engineers and working professionals in Hospitals.

Dr. Vijay Agarwal, President CAHO will make the opening remarks followed by technical sessions by CAPE Engineers. The program is hosted by Mr. K P Dominic, B&G.

Date and Time of the program : 21 Jan 2023 11 Am onwards

Notification – FSSAI – Instant Renewal of License/ Registration

FSSAI – Ease of Doing Business : Instant Renewal of License/ Registration

The Food Safety and Standard Authority of India, (FSSAI) has issued a notification on 11th January 2023 regarding Ease of Doing Business: Instant Renewal of License/ Registration.

To streamline the process of licensing / registration and its renewal, Food Authority has decided the following:

With effect from 12th January 2023, Renewals of License and Registrations have been made instant [without requiring the approval of authorities] subject to the following:

(i)         No change in the existing details of the license/registration shall be allowed 

(ii)        Validity of the Renewal:

a) For License: This renewal of the license shall be for 1 year

b) For Registration: Renewal shall continue as per existing provision i.e. for 1-5 years, based on the selection and payment made by the FBO in the application.

(iii)       FBOs whose licenses/ registrations have been suspended/canceled, shall not be allowed to renew their license/registration.

(iv)       Further, i.e. November 10, 2022, the FoSCoS system ensures that FBO (Manufacturers and Importers) shah file annual returns with penalties (if any), before renewal, for FY 2021-22 onwards.

(v)        A declaration to be submitted by Food Business Operator (tick in the checkbox) has been added in FoSCoS as follows namely: –

a) I/We have complied with all the permissions/rules, which are applicable to my food business and the premises of the food business such as CGWA NOC etc.

b) I/We do not possess more than one active license/ registration for any other food businesses at the same premises.

Validity of the New License and Registration

New License – The Validity of the new License is now restricted to only 1  year instead of the existing provision

For Registration – Validity shall be continued as per the existing provision.

There shall be no late fee of Rs. 100 per day  

The renewal of license and registration shall be available as early as 180 days prior to the expiry date

Now FBOs are required to self – declare the compliance regarding the points in the inspection checklist at the time of renewal.

The Order shall be applicable on applications submitted on or after January 12, 2023

Source: https://www.fssai.gov.in/

ISO 15189:2022 FOR MEDICAL LABS PUBLISHED

ISO 15189:2022 – Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE : International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.

The main changes are as follows:

  • Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
  • Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
  • Increased emphasis on risk management.

Introduction

The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.

This document contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of this approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment.

The requirements for risk management are aligned with the principles of ISO 22367.

The requirements for laboratory safety are aligned with the principles of ISO 15190.

The requirements for sample collection and transport are aligned with ISO 20658.1

This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.

The format of this document is based on ISO/IEC 17025:2017.

The medical laboratory is essential to patient care; activities are provided within an ethical and governance framework, that recognizes the obligations of healthcare providers to the patient. These activities are undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients. Activities include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of patient samples, selection of examinations that are fit for intended use, examination of samples, sample storage, as well as subsequent interpretation, result reporting and advice to laboratory users. This may also include the provision of results to the patient, arrangements for urgent testing and the notification of critical results.

While this document is intended for use throughout the currently recognized medical laboratory disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.

The use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.

The comparability of patient examination results between medical laboratories, regardless of city or country, is facilitated when medical laboratories conform to this document.

When a laboratory seeks accreditation, it should select an accreditation body which operates in accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical laboratories.

Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.

Source : https://www.iso.org/standard/76677.html

Transition Timeline Announcement

ILAC Announcement – 8th

ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.

Further a resolution was endorsed at the ILAC General Assembly to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:

ILAC Resolution GA 26.08

As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period

At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.

The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017

Posted on 08th December 2022

Source :https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/

Transition Timeline Announcement of NABL

NABL has released transition announcement for Accredited Medical Testing Labs in the country

Notification

Guidelines on Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022

The Central Consumer Protection authority (CCPA) under the Department of Consumer Affairs has notified ‘Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022’ with an objective to curb misleading advertisements and protect the consumers, who may be exploited or affected by such advertisements.

The guidelines seek to ensure that consumers are not being fooled with unsubstantiated claims, exaggerated promises, misinformation and false claims. Such advertisements violates various rights of consumers such as right to be informed, right to choose and right to be safeguarded against potentially unsafe products and services

Keeping in view the sensitiveness and vulnerability of children and severe impact advertisements make on the younger minds, several preemptive provisions have been laid down on advertisements targeting children. Guidelines says that advertisement targeting children shall not feature any personalities from the field of sports, music or cinema for products which under any law requires a health warning for such advertisement or cannot be purchased by children

Guidelines also stipulates that disclaimer shall not attempt to hide material information with respect to any claim made in such advertisement, the omission or absence of which is likely to make the advertisement deceptive or conceal its commercial intent and shall not attempt to correct a misleading claim made in an advertisement.

Similarly, clear Guidelines are laid for duties of manufacturer, service provider, advertiser and advertising agency, due diligence to be carried out before endorsing and others. Guidelines aims to protect consumer’s interest through bringing in more transparency and clarity in the way advertisements are being published, so that, consumers are able to make informed decisions based on facts rather than false narratives and exaggerations. 

Penalty for violating the Guidelines are also clearly outlined. CCPA can impose penalty of upto 10 lakh rupees on manufacturers, advertisers and endorsers for any misleading advertisements. For subsequent contraventions, CCPA may impose a penalty of upto 50 lakh rupees. The Authority can prohibit the endorser of a misleading advertisement from making any endorsement for upto 1 year and for subsequent contravention, prohibition can extend upto 3 years.

Source: https://consumeraffairs.nic.in/en/latestnews/guidelines-prevention-misleading-advertisements-and-endorsements-misleading

Buyer Seller Meet

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb– 04th Mar 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, India is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb. – 04th Mar. 2023 covering following sectors which have demand in ASEAN region:

➢Hotel & Tourism Services
➢Educational Services
➢Healthcare Services
➢Architectural, Construction & Related Engineering Services
➢Entertainment Services (Including AVCG)

Benefits to participants on participating at BSM to ASEAN region.

• Focused prescheduled B2B meetings in each country
• Understand the market potential from experts in ASEAN region.
• Networking Opportunities with potential buyers in ASEAN region.
• Generate business leads and sign MOUs for collaborations.
• Meetings with relevant government and related stakeholders

The tentative programme for this BSM is given in Annexure A for your kind reference.

An estimate of expenditure heads which has to be managed by the participants are –

  • Flight tickets: For 4 countries, approximate cost would be INR ,1,59,000
  • Hotel stay: Approximately USD 130 -165 USD per night.
  • Total Cost approximately for all 4 Countries – INR3,35,000.

SEPC shall share the details of travel partners for this delegation with participants separately.

MAI Support to Participants:

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry.

Registration Link: https://tinyurl.com/7v5byhr6

Notification – UGC asks higher education institutions to get registered on BioRRAP

Biological Research Regulatory Approval Portal (BioRRAP)

The integrated portal – Biological Research Regulatory Approval Portal (BioRRAP)-has been initiated by the Government of India (GOI) to provide regulatory information to researchers and to facilitate approvals.

The University Grants Commission (UGC) has asked higher educational institutions and their affiliated colleges/institutions to get registered on Biological Research Regulatory Approval Portal (BioRRAP).

According to UGC, it is one-of-a-kind digital gateway intended to make science and scientific research more accessible as well as make it easier to create businesses. The information on international research projects as approved by all line Ministries/Departments of GOI is expected to be integrated with BioRRAP (with unique BioRRAP ID for each proposal).

With regard to Research Projects by entities falling under the category of Central/State Government, the relevant approvals will be dealt with by the concerned Ministry of the Government of India. State Governments have been requested to forward all such proposals to the concerned line Ministry of Government of India

In respect of Non-Government Organizations, the Health Ministry’s Screening Committee, operated by DHR/ICMR, that has been reconstituted by the Ministry of Health and Family Welfare will review the research projects involving international collaboration/funding in health research including studies in humans, animals, plants & environment.

UGC advised the higher educational institutions to follow the above provisions strictly and get registered on the portal

Source:https://odishatv.in/news/education/ugc-asks-higher-education-institutions-to-get-registered-on-biorrap-193363