Category: Services Sector

Clinlab India 2024 Conference – Industry Update

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CLIN LAB INDIA 2024 CONFERENCE @Mumbai on
14th March 2024

MEDICAL FAIR INDIA is India’s leading Trade Fair for the Medical and Healthcare Industry. For the last 28 years, Medical Fair India has been successfully addressing the various needs of Hospitals, Health Centres & Clinics.  With participation from over 20 countries, MEDICAL FAIR INDIA provides an opportunity to position your brand among competitors and further increase your level of visibility. MEDICAL FAIR INDIA acts as a platform where connections are made and business relationships are nurtured.

ClinLab India is the exhibition & conference on the topic of laboratory medicine, Point of Care Testing, molecular diagnostics and clinical chemistry. The show is aimed to promote the recent developments and market trends in the in-vitro diagnostics (IVD) sector and allied areas.

ClinLab India brings together the leaders in the medical laboratory industry designed to create maximum interaction and meeting opportunities where manufacturers, dealers and distributors can promote their brands, meet potential customers and entertain existing clients. 

The year 2024 holds a lot of promise for the Indian IVD industry. Technology is also going to be a critical growth factor. The Indian start-up ecosystem is aggressively targeting the IVD-MedTech segment, and we will see some compelling solutions from them soon

This is the 5th Edition of ClinLab India.

Conference Theme 2024 :
Driving Global Dominance through Innovations :
– IVD Industry’s Role in Economic Growth

𝗪𝗵𝗲𝗻 ?
📅 Date: 14th March 2024 – Thursday
⏲ Time: 10 00 am – 5 00 pm
🌆 Venue: Bombay Exhibition Centre, Mumbai

𝗪𝗵𝗼 𝗦𝗵𝗼𝘂𝗹𝗱 𝗔𝘁𝘁𝗲𝗻𝗱 ?

IVD , Biotech companies – Management & Technical Personnel, Healthcare Services – Management & Technical Teams from Clinical Labs/Hospitals/Blood Banks/CROs/Medical Colleges/Home Healthcare Companies and Other Healthcare Organisations , Startups, Innovators from Biotech space, Other stakeholders, Government Representatives

𝐅𝐨𝐫 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐔𝐩𝐝𝐚𝐭𝐞𝐬, please visit :

https://www.medicalfair-india.com/special-shows-clin-lab-india

Download Clinlab Conference Brochure
Download Clinlab Conference Agenda

Conference Entry by Prior Registration.

Delegate Fee : INR 1100 per participant (including GST). Fee includes Lunch & Hi Tea

𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 :

𝗦𝘁𝗲𝗽 𝟭 :

Make the payment using the QR code shared below

Step 2:
Click the ‘Register here” button given below and fill up the delegate registration form. Please mention the payment reference number in the form 

Register here

For more information about Expo, visit : https://www.medicalfair-india.com

For enquiries related to Conference Partnerships, Stalls booking inside Diagnostics Pavilion , delegate registration enquiries, pls write to :

VermaA@md-india.com / +91-124-4544507
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

For conference delegate registration enquiries, please write to :
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

Source: https://events.healthcare/

“SANJEEVANI”- HEALTHCARE AND WELLNESS EXPO

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“SANJEEVANI”- HEALTHCARE AND WELLNESS EXPO – Organised by Services Export Promotion Council (SEPC)

SEPC with the support of the Ministry of Commerce has been taking the steps to expand the horizon of healthcare services to attract medical value tourists from across the world, the global landscape of MVT being so dynamic in nature has thrown up new challenges. The competitive environment has completely taken a new dimension. Many countries have emerged as strong competitors to India in terms of cost advantage and India needs to reorient its positioning in the global market. Having the largest pool of doctors in the world, world class hospitals, post treatment care centres, wellness centres for post and preventive healthcare measures and all related infrastructure, India is well poised to aptly position itself as a destination for “Responsible and Credible Healthcare.”

In order to give impetus to this new initiative of repositioning, Services Export Promotion Council, with the support of Ministry of Commerce and Industry, Government of India, is organizing SANJEEVANI (India Heals) – An International Event on Medical Tourism from 28th March 2024 to 30th March 2024 at Chennai Trade Centre, Nandambakkam, Tamil Nadu.   Two editions of India Heals were organized to showcase the competence, affordability and advantage India offered in the healthcare services sector.  The renaming of India Heals as SANJEEVANI, the life infusing herb, adds a significant dimension of trust and care for life in our repositioning of India as a destination for healthcare.

The upcoming “Sanjeevani 2024” aims to establish a platform fostering enduring partnerships among countries, particularly in the identified champion and focus Healthcare Service Sector. The exhibition anticipates the participation of over 100 Indian companies from the Medical Tourism and healthcare service sector, with over 5000 domestic visitors expected to attend. The event will showcase diverse segments including:

  • Hospitals/Medical centre
  • MVT Facilitators
  • Health Tech Companies
  • Medical Devices
  • Wellness & Ayurvedic centre
  • Medical Insurance Companies
  • Hair Transplant Clinics and Cosmetic Surgeries Hospitals
  • Medical Insurance Companies

Program Details:

Date : 28th March 2024 to 30th March 2024
Locatin : Chennai Trade Centre, Nandambakkam, Tamil Nadu.  

“Sanjeevani” is designed to foster business opportunities through focused B2B Sessions, distinguishing itself with innovative formats and value additions. With the invaluable support from Indian Missions abroad, the event anticipates the participation of over 150 Foreign Delegates worldwide.

For more information you can visit: https://www.servicesepc.org/sanjeevani/

To reserve space under the “Sanjeevani 2024”, please register here

Register here

To read sponsorship brochure and program brochure, click here:

Sponsorship Brochure
Program Brochure

For more query regarding stall sell you can reach the following :

Mr. Mayank Sharma, E-mail Id– mayank.Sharma@servicesepc.org / Mobile – 8349417890

Mr. Desh Raj, E-mail:Id – desh.raj@servicesepc.org  / Mobile – 8010215260

Mr. Dalip Chopra, E-mail Id – dalipchopra65@gmail.com / Mobile – 9873548997

Mr. Mohit Arora, E-mail Id – mohit.arora@servicesepc.org  / Mobile – 7827517525

Source : https://www.servicesepc.org/

One Day National Conference on Standards, Certifications & Regulations

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One Day National Conference on Standards, Certifications & Regulations – Andhra Chamber of Commerce

Andhra Chamber of Commerce, a 95 year old Chamber of commerce with headquarters in Chennai, is organising a One day National Conference on Standards , Certifications and Regulations covering following sectors :

– Agri and Food Products
– Gems and Jewellery
– Leather and Footwear

Program covers sessions on Global Market Opportunities for Businesses and various applicable Domestic and International Standards, Certifications and Regulations the businesses have to comply with, while exporting products.

Program Details are given below :

Date : February 23, 2024 – Friday
Time : 10 am to 5 30 pm
Location : Hotel Ramada Plaza, Guindy, Chennai

Who Should Attend ?

Food & Agri Product Companies, Producer Groups : This is an opportunity for Farmers, FPOs, Producer groups, such as cooperatives, consortiums, and producer organizations, Manufacturers, Exports, Traders, Distributors, Retailers, Resellers, Startups, Innovators, Ecommerce companies, Testing labs, other key stakeholders etc from Food and Agri Products space to understand more about Export Opportunities and related Regulations, Standards , Certifications, Product Testing norms that businesses have to meet to Go Global.

Registration :

There is NO FEE. Program is open for industry members, other stakeholders from respective sectors, but prior registration is a must.

𝐃𝐞𝐥𝐞𝐠𝐚𝐭𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐋𝐢𝐧𝐤 :
https://bit.ly/3T7QdcQ

Do visit Chamber Page for more info, updates
http://www.andhrachamber.com/

It’s an initiative from Chamber to sensitise industry on an ongoing basis about International Trade Opportunities and market access norms that businesses have to comply with

For more details, please contact :

Mr Barnabas Immanuel
Program Co-ordinator
Phone : 24315277/78
Mob:7305063885
Email : andhrachamber1@gmail.com
acc@andhrachamber.com

Click here for Program Brochure
Click here to register

Industry Update – Addendum to NABL 112

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Addendum to NABL 112 document in respect of ISO 15189:2022 version

ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical lab environments. It is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.

This standard promotes the welfare of patients and satisfaction of laboratory users.

NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189: Medical laboratories- Requirements for Quality & Competence

NABl has released the addendum document to NABL 112. Table specifying the applicability of this document to different clauses of ISO 15189:2022 are given below

ISO 15189: 2022 RequirementRefer NABL 112 Issue No. 4 Requirements
5.1 Legal entity
5.2 Laboratory Director		Page No. 10 – Organization and management responsibility
6.7 Service agreements   Agreement with laboratory users Agreement with POCT operatorsPage No. 11 – Service Agreements  
6.8.2 Referral laboratories and consultants
6.8.3 Review and approval of externally provided products and services      		Page No. 11 – 4 Examination by referral laboratories  
5.3.3 Advisory activitiesPage No. 12 – Advisory services
8.4 Control of records   Creation of records Amendment of records Retention of recordsPage No. 13 – Control of records  
8.8 EvaluationsPage No. 14 – Evaluation and audits
6.2 Personnel5.1 Personnel
6.3 Facilities and environmental conditions5.2 Accommodation and environmental conditions
6.4 Equipment
Equipment requirements
Equipment acceptance procedure
Equipment instructions for use
Equipment adverse incident reporting
Equipment records

6.5 Equipment calibration and Metrological traceability

6.5.2 Equipment Calibration  

6.6 Reagents and consumables
Receipt and storage
Acceptance testing
Inventory Management
Instructions for use
Adverse Incident Reporting		5.3 Laboratory equipment, reagents and consumables  
7.2 Pre-examination processes  
Primary Sample collection and handling
Sample transportation
Sample receipt
Pre-examination handling, preparation and storage		5.4 Pre-examination processes  
7.2 Examination processes  
Verification of examination methods
Validation of examination methods
Evaluation of Measurement Uncertainty
Biological reference interval and clinical decision limits Documentation of examination procedures		5.5 Examination processes  
7.3.7 Ensuring the validity of examination results Internal quality Control External quality assessment Comparability of examination results5.6 Ensuring quality of examination results  
7.3 Post examination processes   Reporting of results Post-examination handling of samples5.7 Post examination processes  
7.4.1 Reporting of results
Critical result reports
Special considerations for results
Automated selection, review, release and reporting of results Requirements of reports
Amendments to reported results		5.8 Reporting of results  
7.4.1.2 Result review and release5.9 Release of results
7.6 Control of data and information management  
Authorities and responsibilities for Information management Information Systems management
Downtime plans
Off site management		5.10 Laboratory information management  
Click here to read the Amendment

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

Regulatory Guidelines for Sampling of Drugs

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REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES

Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices vide their circular dated 9th feb 2024.

This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc.

This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.

The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:

 Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.
 Ensuring that existing control methods are satisfactory.
 Investigating the Not of Standard Quality (NSQ) Product.
 Identifying Unapproved Products/ Without License sales outlets.
 Identifying Spurious drugs in distribution chain
 Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Home/

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices

The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820). This new rule aims to:

Harmonize with international standards, specifically the ISO 13485:2016 standard for medical device quality management systems. This will streamline processes for manufacturers who export to other countries.

Modernize the requirements, reflecting best practices in quality management and aligning with current technologies and approaches.

Increase flexibility for manufacturers, allowing them to tailor their quality systems to their specific needs while still meeting essential safety and effectiveness requirements.

Key points of the QMSR:

Incorporation by reference of ISO 13485:2016: This means that manufacturers can largely follow the ISO standard to meet the FDA’s requirements, with some additional clarifications and modifications outlined in the QMSR.

Focus on risk management: The QMSR emphasizes a proactive approach to identifying and mitigating potential risks throughout the product lifecycle.

Quality by design: The QMSR encourages manufacturers to build quality into their products from the start, rather than relying on inspections and testing to catch problems later.

Increased transparency: The QMSR requires manufacturers to maintain more comprehensive documentation and make certain information available to the FDA upon request.

Important dates:

Publication date: January 31, 2024

Effective date: February 2, 2026

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

Source: https://www.fda.gov/

Carbon Credit Trading Scheme 2023

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Carbon Credit Trading Scheme 2023: Summary and December 2023 Amendments

Original Scheme (June 2023):

Objective: Establish a domestic carbon market to incentivize greenhouse gas (GHG) emission reduction and removal in India.

Compliance Mechanism: Entities exceeding designated emission intensity benchmarks must surrender carbon credits or pay penalties.

Credit Issuance: Entities undertaking projects that reduce or remove GHGs (e.g., renewable energy, afforestation) could get certified carbon credits.

Trading Mechanism: Initially limited to compliance market, allowing entities to buy and sell credits for compliance purposes.

Implementation: Phased approach, starting with specific sectors and expanding gradually.

Key Amendments (December 2023):

Introduction of “Offset Mechanism”: Allows non-obligated entities to register projects for generating carbon credits through voluntary emission reduction or removal activities.

Expanded Scope: Bureau of Energy Efficiency (BEE) to recommend sectors and methodologies for credit generation under the offset mechanism.

Project Validation: Emphasized importance of robust validation process for projects registered under the offset mechanism.

Steering Committee: Membership expanded to include diverse stakeholders.

Impacts of Amendments:

a.Increased opportunities for entities to generate and trade carbon credits beyond mere compliance.

b.Potential to attract more investments in green projects and accelerate India’s climate goals.

c.Enhanced transparency and credibility of the scheme through strengthened project validation.

d.Broader stakeholder involvement in scheme governance.

Additional Notes:

The scheme is still under development with specific details like credit pricing and trading platform yet to be finalized.

The success of the scheme will depend on effective implementation, robust monitoring, and ensuring environmental integrity of credits.

This summary provides a general overview. For deeper understanding, refer to official documents and news articles

Click her to read the Original Notification

Source:https://beeindia.gov.in/sites/default/files/CCTS.pdf

Click here to read the amendment to original notification

Source:https://beeindia.gov.in/sites/default/files/CCTS%20Notification.pdf

Information Updates

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GRI Launches New Biodiversity Reporting Standard

The Global Reporting Initiative (GRI), one of the leading organizations promoting standardized ESG reporting releases updated Biodiversity Standard (GRI 101: 2024) to help companies disclose their biodiversity impacts and management measures.

This new standard provides a comprehensive framework for companies to report on their biodiversity impacts and take action to address them, contributing to a global effort to conserve and protect biodiversity.

Key Points:

  • New standard aligns with recent global biodiversity initiatives like Kunming-Montreal Framework and TNFD recommendations.
  • Enables reporting on:
    — Supply chain impacts
    — Location-specific impacts with detailed site information
    — Direct drivers of biodiversity loss (land use, climate change, etc.)
    — Impacts on society and human rights
    — Management of these impacts
  • Standard effective January 2026, early adopter pilot starting now.

Source:https://www.esgtoday.com/gri-launches-new-biodiversity-reporting-standard/

Source: https://www.esgtoday.com/

Gen – AI – IMF report

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Gen-AI: Artificial Intelligence and the Future of Work

The IMF staff discussion note, “Gen-AI: Artificial Intelligence and the Future of Work” provides a comprehensive analysis of the impact of AI on labor markets globally.  Key points of the report are shared below :

Artificial Intelligence (AI) has the potential to reshape the global economy, especially in the realm of labor markets.

Advanced economies will experience the benefits and pitfalls of AI sooner than emerging market and developing economies, largely due to their employment structure focused on cognitive-intensive roles.

There are some consistent patterns concerning AI exposure, with women and college-educated individuals more exposed but also better poised to reap AI benefits, and older workers potentially less able to adapt to the new technology.

Labor income inequality may increase if the complementarity between AI and high-income workers is strong, while capital returns will increase wealth inequality.

However, if productivity gains are sufficiently large, income levels could surge for most workers. In this evolving landscape, advanced economies and more developed emerging markets need to focus on upgrading regulatory frameworks and supporting labor reallocation, while safeguarding those adversely affected. Emerging market and developing economies should prioritize developing digital infrastructure and digital skills

Click here to read the IMF report

AMD – CF schemes for Medical Device Clusters

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Assistance to Medical Device Clusters for Common Facilities (AMD-CF)

The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore

About AMD-CF Scheme

AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector

The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time

The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of 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

The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.

SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

Components / Sub schemes of AMD – CF Scheme

There are two components / sub schemes to this AMD – CF scheme :

1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.
2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices

Financial outlay of the Schemes :

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 for the common facilities and Rs. 60 crore for the testing facilities

Tenure of the Scheme :

The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.

Incentives Under this Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.

In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.

Any expenditure above the prescribed limit shall be borne by the elected applicant

Benefits of the Sub Schemes are :

i. Improvement in quality standards of medical devices
ii. Improvement in regulatory compliance specified for medical device
iii.Increased availability of trained personnel for Medical Devices clusters
iv.Increased competitiveness of Medical Devices units in cluster
v. Reduction in the manufacturing cost of Medical Devices

Notice for Invitation of Applications:

The Department has now invited applications from eligible applicants under the Scheme AMDCF.

The eligible applicants may apply through online mode only. The link is https://amdcf.udyamimitra.in/.

The detailed guidelines of the Scheme is available at https://pharmaceuticals.gov.in/schemes.

The last date for filing of the application is 10.02.2024.

Click here to read the AMD-CF Guidelines

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