Announcement for Environmental Testing Laboratories

Announcement from Ministry of Environment, Forests & Climate Change

MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE – NOTIFICATION

Mandatory NABL Accreditation and OHSAS Certification

The Central Government orders says :

  1. Recognition of private laboratories and recognition of their analysts shall be done by the Central Pollution Control Board here after as per the Environmental Protection Act 1986
  2. All environmental laboratories shall obtain accreditation from the National Accreditation Board
    for Testing and Calibration Laboratories
    Accreditation ISO 17025 :2017 for all criteria testing
    parameters as defined by Central Pollution Control Board along with Certification for Occupational
    Health and Safety Management System – ISO 45001:2018 before submission of application to the
    Central Pollution Control Board for consideration of the said application under the provisions of
    the Act, for –
    (i) fresh or renewal of recognition of laboratory;
    (ii) changes in the name of Government Analysts; and (iii) shifting of laboratory premises.
  3. The recognition of laboratory shall be granted for the validity period of accreditation under ISO 17025:2017 and for the testing parameters accredited therein.
  4. The recognition of laboratory shall be granted for the validity period of ISO 45001:2018 certification from a recognised agency and shall be valid for the same premises of its operation for which the application is made.

Full notification can e downloaded from the link below

Source : http://moef.gov.in/en/

World Accreditation Day 2021

Accreditation Day Greetings to All Stakeholders

World Accreditation Day 2021

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

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

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

Global Businesses are getting into implementing Sustainable Business Solutions, following Sustainable Business Practices. ISO has released many Management Systems Standards in the recent years for businesses to learn, implement internally.

These are linked to CSR Reporting, ESG Reporting and Sustainability Reporting for Listed companies and top 1000 companies with high market capitalisation in stock exchange in India.

Sustainability Accounting Norms are already released globally for reporting in organisations Accounting Audit Reports.

Recently we saw some Global Investors making announcements on their Investment priorities in India where the Investors said their investment decisions will be linked to the sustainable business practices adopted by businesses.

Businesses of all sizes – MSMEs or large scale orgns need to LEARN, UNDERSTAND, IMPLEMENT these solutions internally to ensure the Health and Wellbeing of Communities which will become the Global Priority now.

Its hightime that Accounting Professionals , Management Systems Consultants join hands together to deliver good Sustainable Business Practices, Solutions to businesses .

Value Added , in its 30 years of Consulting journey, had seen the saga of Certifications, Accreditations and impact made by these market place recognition programs on businesses for their business growth. We have facilitated , guided more than 500 + organisations to implement multiple Management Systems Certifications, Accreditation Programs fro many sectors.

It would be interesting to see the rise and Sustainable Business Practices at the market place from now.

We shall be organising series of Knowledge Sessions on these Standards and how these get integrated into the business practices of organisations.

Happy Accreditation Day Celebrations to Industry and Stakeholders !

World Accreditation Day 2021 Celebrations

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

World Accreditation Day 2021

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

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

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

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

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

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

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

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

About Consultants Consortium of Chennai – CCC :

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

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

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

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

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

Webinar Series organised by CCC :

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

Registrations :

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

Program Dates are listed above.

Registration Link :

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

For queries on Regns, email can be sent to :

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

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

Customers Quality Systems – Supply Chain getting Trained

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

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

Customers Quality Systems – Supply Chain getting Trained

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

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

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

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

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

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

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

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

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

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

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

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

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

Some screen shots from the session :

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

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

Some feedback received by the end of the session.

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

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

Posted by :

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

Accreditation of SARS-CoV-2

Announcement from NABL on Covid 19 Testing

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

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

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

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

Download the Announcement from here

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

Medical Testing Labs Quality Infrastructure

Medical Testing Labs Quality Infrastructure in India

Covid 19 Testing Criteria – Introduction of Rapid Antigen Testing by ICMR

ICMR is the Regulator for monitoring Covid Testing Strategy in the country.

Testing Strategy for Testing masses has undergone many changes in a dynamic manner since the beginning of the pandemic in the country.

ICMR has introduced Accreditation of the Med Testing Labs by NABL, as the eligibility criteria for Labs to conduct Testing .

Accessibility of Testing Labs to communities became the biggest stumbling block. Lots of calls, conversations across the markets asking for testing access. Urban markets stopped responding at some point, as the pressure became too much. Semi urban and rural markets didn’t have any access to testing at all.

Why are the labs not doing testing ?
Why is it that the testing facilities are not accessible to all ?
Who can actually do the Testing ?
Where are Testing Labs ?

The above were the questions asked by many on daily basis.

I have written an article in the News Letter of Andhra Chamber of Commerce about ICMR’s announcement about allowing only Accredited Labs in the country to do testing, the current Quality Infrastructure of Medical Labs in the country which actually determines the eligibility of the labs to qualify for testing. Its this lack of Quality Testing Infrastructure in the country that has restricted Medical Labs to qualify for Covid 19 Testing criteria.

ICMR has recently relaxed the norms to increase accessibility of basic Covid screening Test to all and introduced Rapid Antigen Test (Screening Test) as well to reduce the dependence on RTPCR Testing. This will ensure that screening test is made available to all.

Sharing the article published in Andhra Chamber of Commerce’s News Bulletin here .

Source : https://andhrachamber.com/pub/E-Bulletin_May_2021.pdf

About the Author

Ms Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd

Email – rama@valueadded.in

Announcement from NABL

QR Code in Test Reports / Calibration Certificates Made Mandatory

Mandatory QR Code in Test Reports issued by Medical Labs Announcement from NABL

QR Code on the Medical Test Reports Medical laboratories may note that, in a memorandum issued on 13.05.2021 by the Ministry of Civil Aviation, Government of India, it is mandatory for travellers flying abroad to carry their negative RT-PCR test report having QR codes linking to the original report.

Medical Laboratories should provide QR code on all test reports issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report online. This will prevent the manipulation of test results & the usage of fake test reports.

Laboratories to ensure that all the requirements of ISO 15189, NABL, regulators are met. Authorized test results in a tamper-proof and non-editable test report will build trust in laboratory results.

Download the advisory from NABL here

Mandatory QR Code on the Test Reports issued by Testing Labs / Calibration Certificates issued by Calibration Labs

Labs should provide QR code on all test reports/calibration certificates issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report/calibration certificate online.

This will prevent the manipulation of test results/calibration data & the circulation of forged test report/calibration certificate in the market. Interest of the consumer / end user of the product and the reputation /Image of the lab are also protected.

Download the advisory from NABL here

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

Biobanks Accreditation Program

ISO 20387:2018 Standard

What is a Biobank ?

A Biobank is a depository for biomaterials from a representative portion of a human population.

The Biobank acts as a vault with intricate detailed information pertaining to the individuals from whom
biological materials have been collected.

Data collection and proper cataloging cataloging are essential components for the success of a Biobank

Types of Biobanks :

  • Tissue bank – (i) Surgical tissues (ii) Transplant tissues
  • Cancer / Tumor bank
  • Cord blood / Stem cell bank
  • Blood bank – Dried Blood Spots
  • Body fluids – (i) Synovial (ii) Urine (iii) Sputum (iv) Buccal scrapings (v) Sperm
  • DNA / RNA bank
  • Cornea bank

Utilities of Biobanks :

Routine work – health centers, hospitals, blood transfusion centers and Public / Private pathological laboratories.

Research work – biomedical experiments for a particular disease in a specific population.

Epidemiological work – monitoring in susceptible populations after disease outbreak, poisoning and / or pollution

Source : https://www.euindiacoop.org/2009/downloads/nk_ganguly.pdf

About the International Standard :

ISO has released an Accreditation Standard – ISO 20387:2018 for Biobanks. This Standard was developed to promote confidence in biobanks. The standard covers requirements that allow biobanks to demonstrate their competence in being able to provide biological material and associated data that meets the needs of research and development organisations.

A biobank is a biorepository that accepts, processes, stores and distributes biological material and associated data for use in research and clinical care. This biological material can come from human, animal or plant sources.

The accreditation process will cover collection (or acquisition), reservation, quality control, storage and distribution of biological material. It will also include a review of the management system underpinning these processes.

Biobanks, which hold hundreds of millions of biological samples – including those from humans, animals, plants, and microbes – help the global scientific community further everything from crop production to personalized medicine. Biobanks vary widely in terms of the kinds of biological material they hold, the activities they undertake, the services they provide, and their geographical location, size, and structure.

This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.

Why Accreditation of Biobanks needed ?

Businesses seek Certifications or Accreditations to various Quality Management Systems programs on Voluntary basis to demonstrate their conformance to Quality and Safety Management Systems. Sometimes these Certifications or Accreditations become mandatory when these are regulated by Regulators in the country.

Biotech is an emerging sector in India and this segment is witnessing fastest growth in the last one decade in the country. We have mushroom growth of Startups, young businesses and growth stage businesses in biotech sector. Many ventures are related to R&D domain too.

Biobanks have been steadily growing in the country and infact 15-20 years ago , many Cord Stemcell Banks were asking for specific Certifications, Accreditations related to their domain. We had only ISO 9001:2008 Std way back then and we were offering ISO 15189:2007 for testing related requirements of these banks. Some centers opted for AABB Accreditation from USA. Apart from these, there was no specific standard available for biobanks.

ISO has released an exclusive Standard for Biobanks now and this is an Accredtitation Standard developed exclusively for Biobanks. Bioresearch will attract lot of attention globally now and bio based organisations need to have effective Quality Management Systems in place to demonstrate their process and systems efficiencies, technical competencies on an ongoing basis.

Who is offering Accreditation for this Standard in India ?

Quality and Accreditation Institute is offering Accreditation to Biobanks in the country.

QAI is organising an Implementors Program on the standard and the details are as follows :

ISO 20387:2018 Accreditation Standard for Biobanks

Source : http://www.qai.org.in/

Financial and Technical Assistance Schemes for Patent Filing and Quality Testing

Maharashtra Based Startups-CPY-CPY

Maharashtra State Innovation Society (MSInS), Govt. of Maharashtra is pleased to announce the launch of 2 key schemes to support startups in Maharashtra. Below are some details of these schemes:

  1. Intellectual Property Rights Support Scheme: With the objective of spreading awareness and providing assistance for IPR (Intellectual Property Rights), this scheme aims to offer financial assistance of up to INR 2 Lakhs for a domestic patent application and up to INR 10 Lakhs for an international patent application, subject to 80% contribution by MSInS, on a reimbursement basis.

Under this scheme, DPIIT-recognized startups incorporated in Maharashtra, with a revenue of less than Rs. 1 crore and funding of less than INR 3 crores shall be eligible for domestic patent support. DPIIT-registered startups incorporated in Maharashtra, with a revenue of less than INR 5 crores and funding of less than INR 3 crores shall be eligible for international patent support. In case the startup has raised funds of more than INR 3 crores, MSInS shall support up to 50% of the total cost (instead of 80%). Apart from financial support, technical assistance (for example access to empaneled attorneys, etc.) will also be provided in this scheme.

  1. Quality Testing and Certification Support Scheme for startups: Testing and certification of products for quality and assurance are an important and critical part of business for startups. However, these costs are high for startups in their formative years. The Scheme ensures that Government of Maharashtra will be reimbursing a part of quality testing costs incurred by Startups at NABL or BIS recognised labs.

Under this Scheme, DPIIT-recognized startups incorporated in Maharashtra, with a lifetime annual revenue in any financial year of less than INR 1 crore and funding of less than INR 3 crores shall be eligible for support of maximum up to INR 2 lakhs, subject to maximum 80% contribution by MSInS. 

This Scheme shall increase the competence of startups in product development and will also help them become more competitive in the domestic and export markets.

How to Apply

Applications are open now on first come first serve basis. Please visit MSInS website to check for eligibility and apply.  For any queries please email to team@msins.in or call on 02235543099

Registration

For more details, visit Maharashtra State Innovation Society @

https://www.msins.in/event-details/190

https://www.msins.in/

Pharmacovigilance in Hospitals

Reporting of Adverse Drug Reactions (ADRs) in Hospitals in India

Dr Srivatsan Bashyam, Principal Consultant

Email: srivatsan@valueadded.in

Virtual Training on Pharmacovigilance for NABH Accredited Hospitals was conducted by IPC – Indian Pharmacopoeia Commission , recently to create an awareness on Pharmacovigilance and Reporting of adverse drug reactions (ADRs).This write up prepared is based on the training given by IPC Team and various experts like Dr. Jai Prakash  Officer-in-Charge, PvPI, Mr Prashant Paschal, Assistant Director NABH QCI New Delhi, Dr. Vandana Roy AMC Coordinator MAMC-New Delhi, Dr. Rahul Shukla AMC Coordinator Yashoda Super Speciality Hospital, Kaushambi,  Ghaziabad  and my own search from various sources.

Pharmaceutical medicines are designed to cure, prevent or treat diseases; however, no medicine is without side effects and there are also risks particularly adverse drug reactions (ADRs) which can cause serious harm to patients.

It is been reported that adverse drug reactions (ADRs) are poorly reported in developing country including India. It is estimated that only 2-4% of adverse drug reactions (ADRs) are reported and only 10% of serious adverse drug reactions are reported world wide.

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human and helps in to reduce the harm to future patients.

What is ADR:

The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”

In addition to Drugs the vaccines, Medical Devices, Biosimilars, Diagnostic Agents are considered for ADR.

Classification of ADR:

Adverse drug reactions are classified into six types (with mnemonics):

Type A :dose-related (Augmented), 
Type B : non-dose-related (Bizarre),
Type C : dose-related and time-related (Chronic),
Type D : time-related (Delayed),
Type E :withdrawal (End of use),
Type F : failure of therapy (Failure).

A simple and common method of classifying ADRs is to divide them into two types – Type A and Type B. This is also known as the Rawlins–Thompson classification.

REACTIONTYPE A ‘AUGMENTED’TYPE B ‘BIZARRE’
Pharmacologically predictableYesNo
Dose-dependentYesNot clearly
IncidenceCommonUncommon
DetectionEarly in clinical developmentPost-licensing
MortalityLowHigh
ManagementReduce doseDiscontinue therapy

Who are at Risk of ADR :

  • Elderly

Patients taking medication from specific classes like –

  • Anti diabetics and Hypoglycemic Agents
  • Cardiovascular Drugs
  • Psychotropic Drugs
  • Anticonvulsants
  • Antineoplastic
  • Corticosteroids

Reporting of ADR:

All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to National Coordination Centre (NCC) or Adverse Drug Reaction Monitoring Centres (AMC).There are around 34 AMC centers in India. The pharmaceutical companies can also send individual case safety reports for their product to NCC.

Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.The mobile Android application for ADR reporting has also been made available to the public.

Analysis of ADR:

There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.

The WHO-UMC causality criteria [WHO].

CausalityConditions (all conditions need to be complied with for each causality criterion)
CertainEvent/laboratory test abnormality with plausible time relationship to intake of a drug
Cannot be explained by disease or other drugs
Response to withdrawal plausible
Event definitive pharmacologically or phenomenologically
Rechallenge satisfactory, if necessary
ProbableEvent or laboratory test abnormality, with reasonable time relationship to drug intake Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Rechallenge not required
PossibleEvent or laboratory test abnormality, with reasonable time relationship to drug intake Could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear
UnlikelyEvent or laboratory test abnormality, with a time to drug intake that makes a relationship improbable
Disease or other drugs provide plausible explanations
Conditional/ unclassifiedEvent or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/ unclassifiableReport suggesting an adverse reaction
Cannot be judged because information is insufficient or contradictory
Data cannot be supplemented or verified

How to make the Hospital Adverse Drug Reaction Monitoring Centres (AMC):

The Hospital can send letter of intent to INDIAN PHARMACOPOEIA COMMISSION.
National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI),MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA
SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002.
Tel No: 0120- 2783392, 2783400, 2783401, Fax: 0120-2783311
e-mail: pvpi.ipc@gov.in, lab.ipc@gov.in, Web: www.ipc.gov.in