Procedure for submission of cough syrups for Testing

Mandatory Testing of Cough Syrup before ExportProcedure for submission of cough syrups for Testing

Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments

Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.

The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments

In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable

Source: https://www.dgft.gov.in/CP/?opt=notification

Certification Schemes from AMTZ 

Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme 

Program on Healthcare Textiles Processing Facility Certification Scheme  

The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again.   

Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme    This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis.

This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider.  

These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).


Date: 27th May 2023

Time: 3:00 pm to 6:00pm IST

Mode – Virtual Mode / Webinar

How Venture Capital Is Fuelling Innovation In Molecular Diagnostics In India

How Venture Capital Is Fuelling Innovation In Molecular Diagnostics In India

Molecular diagnostics, involves the detection and analysis of specific molecules such as DNA, RNA, and proteins in order to diagnose diseases and conditions with greater precision and accuracy. 

Some of the key advantages of this Molecular diagnostics are

  • Higher sensitivity and specificity
  • Early detection
  • Personalised treatment
  • Cost, sensitivity and speed mix

According to Suraj Nair, Project Lead and Researcher, Deep Science Technologies at Ankur Capital, “Early detection of infectious diseases is key to ensuring appropriate treatment and safeguarding the health of individuals. Molecular diagnostics tools with very high sensitivities and specificities are best suited in this regard and are expected to see widespread adoption over the next decade.”

The global molecular diagnostics market was worth $9.2 Bn in 2020 and is expected to reach $23.9 Bn by 2030, with a CAGR of 9.86% from 2021 to 2030. On this side of the globe, the Indian molecular diagnostics market was valued at around $920 Mn in FY 2020 and is estimated to grow at a CAGR of approximately 10% until FY 2026

8X Ventures conducted research to consolidate the prime areas where different stakeholders need to play their part in building the molecular diagnostics infrastructure in the country. 

  • Increased Startup Activity: VC activity was comparatively lower in India when the first-generation companies such as Medgenome and Molbio Diagnostics started, hence scaling has taken time. On the other hand, new-age startups such as DNome have a comparative advantage of scaling things faster with funding support and the push from the ecosystem. 
  • VC Investment: Both large and small VC players have set up the precedence, and a lot of unconscious VCs will follow suit. Though they will have to catch up with the mechanics of this space — diagnostic lab developers, care staff, intermediaries, government regulators and more while providing strategic guidance to the startups. 
  • Customer Adoption: With widely available solutions, the customer adoption J-curve is expected to activate. This could lead to increased demand for better and cheaper technology, such as LAMP MDx, which is currently underutilised. Additionally, there is a need for improved point-of-care diagnostic infrastructure. 
  • Government Support: The power to develop the infrastructure and resources required for molecular diagnostics, such as laboratory facilities, a skilled workforce, and funding for research and development, lies with the government of India and its collaboration with the private sector and academic institutions

Given the demography of India, VCs need to step up their game and understand the holistic development of molecular diagnostics, keeping all levels of stakeholders involved in their studies. The initial and follow-on capital for R&D is critical to the success of the early-stage capital-intensive phase of molecular diagnostic startups in India

source:https://inc42.com/resources/how-venture-capital-is-fuelling-innovation-in-molecular-diagnostics-in-india/

One Person Company (OPC)

NABL accepts the “One Person Company (OPC)” as a legal entity of CAB

NABL accepts the “One Person Company (OPC)” as a legal entity of CAB under the Companies Act 2013.

An OPC has features of a Company along with the benefits of a Sole Proprietorship.

An OPC can have just one single member and one Director. The Director and member can also be the same person. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013.

The accredited CABS which are under Proprietorship are given a transition period till 31.12.2023 to align with any one of the legal entities specified in the Notification

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

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

Workshop on Indian Medical Device Rules 2017

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Duration: 2 Days (31st March & 1st April)

Location: Kalam Convention Center, AMTZ Campus, Vizag

Fee: INR 3,540 (Including GST)

Registration link: https://ibsc-amtz.in/coursedetails/25

Last Date For Registration: 25th March 2023
➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990
WhatsApp Link: https://wa.me/918897330990
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:

➢ Accounting and Auditing Services

➢ Educational Services

➢ Healthcare Services

➢ Architectural, Construction & Related Engineering, Environmental Services

➢ KPO/ ITO Services

➢ Logistics Services

➢ Tourism Services

➢ Entertainment Services

➢ Other Professional services

Benefits you may get while participating at BSM to ASEAN region.

• Focused pre scheduled 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.

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) 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

GCLP Workshop @ Chennai

Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023

GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.

This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop

Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop

Learning Objectives:

  • Basic principles of the GCLP and their relation to patient care services or clinical research.
  • Implementing GCLP essentials to establish a quality system and its maintenance.
  • Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards

Workshop Scope:

  • Overview and essentials of ISO 15189:2012.
  • Overview and essentials of new standard – ISO 15189:2022.
  • Overview and essentials of NABL-112 guidelines document.
  • Overview and essentials of ICMR-GCLP 2021 guidelines.
  • Special reference to the following key components:
    o Quality System Essentials (QSEs).
    o Establishment, management and monitoring of quality system.
    o Quality indicators and continual improvement.
    o Issues with EQAS/PT, Issues with facility operation.
    o Internal Quality Audit (IQA) – common NCs and its closures.
    o Lab accreditation associated challenges and overcoming the challenges.
    o Biosafety and infection control.
    o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard.
    Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.

Registration:
The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077

The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: https://forms.gle/yASYBXXqKnp7NmdN8. Out station participants need to book accommodation on their own

Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.


Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: GCLPSAVEETHA@gmail.com

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

Announcement – Digital Health Incentive Scheme (DHIS) by NHA

Digital Health Incentive Scheme (DHIS) by NHA

The National Health Authority (NHA) has announced a Digital Health Incentive Scheme (DHIS) for the stakeholders of the digital health ecosystem. The scheme aims to give a further boost to digital health transactions in the country under the Ayushman Bharat Digital Mission (ABDM). The incentives under this scheme would be provided to hospitals and diagnostic labs and also to the providers of digital health solutions such as Hospital/ Health Management Information System (HMIS) and Laboratory Management Information System (LMIS).

Under the DHIS, the eligible health facilities and digital solutions companies shall be able to earn financial incentives of up to Rs. 4 crores based on the number of digital health records they create and link to ABHA (Ayushman Bharat Health Account). This incentive can be availed by the health facilities (hospitals and diagnostic labs) registered with ABDM’s Health Facility Registry (HFR) and fulfilling the eligibility criterion specified under the scheme.

Important points under ABDM’s Digital Health Incentive Scheme are:

  1. Incentives would be provided to the following entities:
    1. Health Facilities having 10 or more beds
    2. Laboratory/radiology diagnostics centres
    3. Digital Solution Companies (entities providing ABDM enabled digital solutions)
  2. The incentives shall be provided on the basis of the number of ABHA-linked transactions i.e. the digital health records created and linked to ABHA.
Healthcare FacilityBase Level Criteria   Incentives
Hospitals50 Transactions per bed per monthRs. 20 per additional transaction above the base level
Diagnostic facilities /Labs500 Transactions per monthRs. 15 per additional transaction above the base level
  1. Digital Solution Companies (DSCs) will be given an incentive of 25% of the incentive amount received by the eligible health facilities using their digital solutions.
  2. For the ABHA linked transactions done by facilities not eligible for direct incentives (Clinics/ Small Hospitals/ Health Lockers/ Teleconsultation Platforms etc.), an incentive would be provided to Digital Solution Companies.
Cost Incentives for Digital solution (HMIS and LMIS) Companies
For every Transaction by hospitals/labs using their software and receiving incentives under this policy25% of the corresponding incentive amount received by the eligible facilities
For other Transactions (including by health lockers, Teleconsultation platforms, small clinics etc.), provided the transactions are more than 200 per monthRs. 5 per Transaction

NHA is organising public webinars starting from Dec 23, 2022 to provide detailed overview of the scheme. The schedule and link for the webinars will be available on the website https://abdm.gov.in/dhis

Source: https://abdm.gov.in/DHIS

European Green Deal

European Green Deal: Carbon Border Adjustment Mechanism (CBAM) Agreement

European Green Deal Announcement

Agreement reached on the Carbon Border Adjustment Mechanism (CBAM)
Brussels, 13 December 2022

The Commission welcomes the political agreement reached this morning between the European Parliament and the Council on the Carbon Border Adjustment Mechanism (CBAM). The CBAM is the EU’s landmark tool to put a fair price on the carbon emitted during the production of carbon intensive goods that are entering the EU, and to encourage cleaner industrial production in non-EU countries.

Today’s agreement will be complemented by the revision of the Emissions Trading System (ETS), with negotiations taking place later this week, and that will align the phase-out of the allocation of free allowances with the introduction of CBAM to support the decarbonisation of EU industry.

Climate change is a global problem that needs global solutions. As the EU raises its own climate ambition, and as long as less stringent climate policies prevail in many non-EU countries, there is a risk of so-called ‘carbon leakage’. Carbon leakage occurs when companies based in the EU move carbon-intensive production abroad to countries where less stringent climate policies are in place than in the EU, or when EU products get replaced by more carbon-intensive imports.

By making sure that a price is paid for the embedded carbon emissions generated in the production of certain goods imported into the EU, the CBAM will make sure the carbon price of imports is equivalent to the carbon price of domestic production, thereby ensuring that the EU’s climate objectives are not undermined. The CBAM is designed in such a way that it is compatible with WTO rules.

President von der Leyen said: “I welcome the political agreement reached this morning on the Commission’s proposal for a Carbon Border Adjustment Mechanism. This is a central part of our European Green Deal, preventing the risk of carbon leakage. It is a huge step forward, as we raise our climate ambitions.”

Key elements :

The CBAM will initially apply to imports of certain goods and selected precursors whose production is carbon intensive and at most significant risk of carbon leakage: cement, iron and steel, aluminium, fertilisers, electricity and hydrogen. With this enlarged scope, CBAM will eventually – when fully phased in – capture more than 50% the emissions of the ETS covered sectors. Under this political agreement, the CBAM will enter into force in its transitional phase as of 1 October 2023.

The gradual phasing in of CBAM over time will allow for a careful, predictable and proportionate transition for EU and non-EU businesses, as well as for public authorities. During this period, importers of goods in the scope of the new rules will only have to report greenhouse gas emissions (GHG) embedded in their imports (direct emissions), without making any financial payments or adjustments. The agreement foresees that indirect emissions will be covered in the scope after the transitional period, on the basis of a methodology to be defined in the meantime.

Once the permanent system enters into force, according to a schedule to be defined in the revised EU ETS rules currently under negotiation, importers will need to declare each year the quantity of goods imported into the EU in the preceding year and their embedded GHG. They will then surrender the corresponding number of CBAM certificates. The price of the certificates will be calculated depending on the weekly average auction price of EU ETS allowances expressed in €/tonne of CO2 emitted.

A review of the CBAM’s functioning during its transitional phase will be concluded before the entry into force of the definitive system. At the same time, the product scope will be reviewed to assess the feasibility of including other goods produced in sectors covered by the EU ETS in the scope of the CBAM mechanism, such as certain downstream products and those identified as suitable candidates during negotiations. The report will include a timetable setting out their inclusion by 2030.

Next steps

Given the close links between the new CBAM and the review of the EU ETS, currently under negotiation in ‘trilogue’ between the co-legislators, the final technical details of the mechanism’s functioning will need to be clarified. Once the text has been finalised, the European Parliament and the Council will have to formally adopt the new Regulation before it can enter into force.

Download here for full announcement

Source : https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7719