Category: Startups

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 – Program by KIHT

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International Fellowship on Health technology assessment by
KIHT,Visakhapatnam

The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments.

KIHT aims to equip participants with the latest methodologies, best practices, and insights in HTA, empowering them to become leaders in the field.

The 9th International Fellowship on Health Technology is scheduled on 18th to 24th March 2024 at Kalam Convention Center,AMTZ Campus, Visakhapatnam

Program Details are given below:

Date   :  18 – 24 March 2024
Time  :   9.30 am to 5.30 pm
Venue:   Kalam Convention Center C/o AMTZ Campus, Visakhapatnam,Andhra Pradesh- 530031

Program Benefits :

– Conceptual Mastery in HEOR
– Exclusive Insights into Emerging Trends in HEOR
– Proficiency in cutting edge HEOR software
– Access to exclusive Research and Training materials
– Practical knowledge in Study design, Evidence synthesis and Economic modelling
– Exposure to Real world evidence, case studies and applications
– Open discussion with Academicians and Industrial Leaders
– Benefits of mentorship from World renowned Professionals in the field
– Global Networking Precision

Who should attend?

– Healthcare Policy makers and Regulators
– Medical Professionals and Practitioners
– Health Economist and Researchers
– Healthcare Industry and Innovators
– Academicians and Students
– Hospital Administrators

For Fee and other queries: Visit: https://kiht.in/

Contact:
Ms. Kaviya Jeyaram
kaviya.j@kiht.in
+91 8220025552

Mr. Nitturi Naresh Kumar
n.nareshkumar@ibsc-amtz.in
+91 8897330990

Click here to view Agenda

source :https://kiht.in/

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

NSW portal for Medical Devices

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Launch of NSW Portal for Medical Devices

Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation,  examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

All the stakeholders should submit the application for the above 3 activities, through NSWS portal only

Click the link below to read the detailed guide book on How to apply for CDSCO approval

Guide book on How to apply for CDSCO approval

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

Tamil Nadu Global Investors Meet 2024

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Tamil Nadu Global Investors Meet 2024

Tamil Nadu, with its robust educational system and a strong focus on Science, Technology, Engineering, and Mathematics (STEM), is rapidly emerging as a leader in the Global Capability Centres (GCC) landscape. The state’s journey from skill arbitrage to leadership arbitrage in this domain is a testament to its growing prowess and the trust it has garnered globally.

GCCs, which have been a part of India’s business ecosystem for decades, are witnessing a significant surge in Tamil Nadu. Renowned companies like Cognizant Technology Solutions (CTS), Genpact, and Flipkart are notable examples of businesses that have thrived in this space. Moreover, the state is becoming a hub for startups in the GCC sector, further diversifying and strengthening its position.

As of 2015, India was expected to host over 2025 GCCs, highlighting the sector’s rapid growth. Tamil Nadu, in particular, has been pivotal in this expansion, offering a market potential that ranges from $35 billion to $60 billion. The state’s ability to create a large number of GCC leaders, estimated between 5,000 to 25,000, is also noteworthy. This growth is attributed to the shifting of markets from the West to India, leveraging the country’s strong STEM education.

One of the key strengths of Tamil Nadu in the GCC arena is the close gap between engineering and end-users. Product managers in the state work closely with customers, unlike in the past, where GCCs focused only on building certain parts. This proximity enables the development of trusted relationships and a deeper understanding of end-user needs.

Talent acquisition and retention are other areas where Tamil Nadu excels. The state’s educational institutions, startups, and industries collaborate closely, creating a robust ecosystem that supports the growth and development of GCCs. This synergy is critical in understanding and adapting to consumption patterns in the fast-growing digital economy.

Despite these strengths, GCCs in Tamil Nadu have faced challenges. Initially, driving business transformation and achieving cost efficiencies were significant hurdles. However, these have been largely overcome, and today the focus is on co-innovation, joint IPs, and skill development in collaboration with the government and academia. Cultural gaps and trust-building, once significant challenges, are now areas where best practices have been established.

Opportunities abound in Tamil Nadu, especially in engineering R&D. Cities like Chennai and Coimbatore are recognized for their skilled talent, particularly in Tier 2 cities like Coimbatore. The state offers a comprehensive product portfolio, facilitated by the proximity of engineers, product managers, architects, and customers.

Tamil Nadu is also home to various GCCs from major players in diverse sectors, each contributing uniquely to the ecosystem. For example, Optimum Health focuses on simplifying and scaling healthcare innovation, while Reynold Nissan GCC leverages core automotive technology for local and global markets. Standard Chartered Bank and UPS have also established significant GCC presences in Chennai, tapping into the diverse talent pool and collaborative ecosystem.

In summary, Tamil Nadu’s strengths in education, innovation, and a collaborative ecosystem make it an ideal location for GCCs. The state’s ability to adapt to changing global needs, coupled with its focus on co-innovation and talent development, positions it as a leader in the GCC landscape. With continued investment and growth, Tamil Nadu is set to play an increasingly vital role in the global GCC sector.

Click the link below to watch the TNGIM2024 Day 1 & Day 2 sessions: https://www.tngim2024.com/live-event-listing

Source: https://tngim2024.com/

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