Parakh – Unified Laboratory Network

Launched by DPIIT, Ministry of Commerce, Govt of India – National Network of Laboratories Infrastructure

What is #Parakh ?

#Parakh is a Government of India initiative for mapping of testing and laboratory infrastructure across the country on a unified network of testing laboratories. This is yet another significant step towards enhancing Ease of Doing Business. This portal incorporates all the accredited and recognised laboratories in the country on a Geographic Information System.

This is an interactive and user friendly system to find a Laboratories and Tests based on various parameters a user may require.

This program is a joint initiative of various boards, councils as mentioned below :

MSME
CSIR
DRDO
Textile Committee
NABL
Bureau of Indian Standards
FSSAI
Export Inspection Council, EIC India
APEDA

All types of Testing, Calibration Laboratories which are Recognised and Accredited are found in the portal.

This is an initiative which will benefit all citizens, user communities to have access to information related to various testing labs in the country that tests products or services.

Pandemic crisis has brought out this huge gap in the country’s lab infrastructure related information where no information was available about testing labs for PPEs, Ventilators, various other medical devices, Covid testing labs etc. All stakeholders were shunted from pillar to post hunting to testing labs information. Intense debates, discussions had taken place about lack of information about National Testing Labs Infrastructure. That’s how DPIIT has initiated the process to create the National Network of Laboratories which will immensely benefit not only domestic trade but International Trade as well.

Portal currently has a list of :

  • 6581 laboratories offering testing services related to
    • 60558 products and services
    • following 367209 Test Methods

All Laboratories in the country are open to get their laboratories listed in the portal.

Source – https://parakh.ncog.gov.in/indexpage

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

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/

Medical Testing Labs

Regulations or Accreditations ??? – beginning of a new conundrum

Medical Labs are undoubtedly an important part of the health ecosystem in any country but in India, like many other sectors related to health and safety, they have remained largely unregulated and therefore lacking assurance of quality and reliability.

The Clinical Establishments Act, 2010 intended to fill this gap but unfortunately only 11 states and almost all union territories have adopted the Act till now and from all accounts none has enforced the minimum standards prescribed under it. Therefore, there is not even data on how many medical labs are operating in the country much less any measure of their quality. The role of medical labs came into sharper focus as covid pandemic set in and India scrambled to develop covid testing facilities.The question begs an answer not only in relation to covid testing but for the larger issue of assuring quality of medical labs in general in the country.

Read the informative post by Mr Anil Jauhri, International Conformity Assessment Expert about Medical Labs and whether they need Regulations or Accreditations in the country .

Source : Healthcare Quality News Letter from QAI – http://www.qai.org.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

Laboratory Director Designation – ISO 15189 Standard Requirement

Designation of Lab Director, a QMS Specification, becoming a HR Issue in the Laboratory

Chithambaranathan Sivasubramonian, Associate Consultant

nathan@valueadded.in

Medical Laboratories & the need to create a dedicated Laboratory Director Post / Designation to satisfy QMS requirement

Isn’t this becoming a HR issue

A Laboratory Professional from a client organization reached out to us seeking clarification on Lab Director’s role in Accreditation process. She was asked by the Management to redesignate Lab Director as Lab head in Accreditation documents and she wanted to know if its ok to do so as Accreditation norm is asking for Lab Director designation.

This has triggered an internal discussion at office and we were debating about the need to create / insist on Lab Director’s designation / role in labs seeking accreditation.

Medical Labs were obtaining National / International Certifications, Accreditations all these years and each program has its own spec. However, the global trend in the last few years has shifted towards introducing Minimum Standards for Medical Labs and many countries have rolled out the program. India too has rolled out the Minimum Stds for Labs as Regulatory spec under Clinical Establishments (Registration and Regulation) Act, 2010.

Let’s take the case of a Lab appointing a Lab Director as an accreditation norm and see what is listed out by various National , International Stds for this requirement.

We have the following popular programs for Medical Labs running in our country :

  • Minimum Standards mandated under CEA. Both NABL, QAI offer Certification programs under this scheme in the country.
  • ISO 9001:2015 – Quality Management Systems Certification Program
  • Med Labs Certification Programs offered by NABH
  • Med Labs Accreditation Programs offered by NABL, CAP and QAI

Minimum Standards has mandated the Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories. Clearly defined spec on who should act as Technical head is mentioned. So any Certification program offered by NABL, QAI or any other body has to have the same spec in their Certification, Accreditation criteria as compliance to Minimum Standards is a Regulatory requirement.

ISO 9001:2015 Standard Clause 7 Support talks in general about Personnel competency, training needs etc. No other specification is listed as it’s a generic QMS Standard applicable for all businesses.

NABH Essential Standards for Medical Laboratories program talks about Personnel and its clearly mentioned about the Responsibility of Quality Manager & Technical Manager. But with respect to overall responsibility of the Laboratory Head, NABH Essential Standard for Medical Laboratories hasn’t mentioned anything much. So overall responsibility of Lab Head s not clear enough under this program.   

QAI’s Recognition for Medical Laboratory Program, in Human Resources section – MBBS Doctor or MSc Pathology/Medical Microbiology/Medical Biochemistry are recognized qualification for Authorized Signatory. But there is no evidence of defining the overall responsibility of the laboratory head and the same isn’t clear in the QAI Recognition of Medical Laboratory Program either.      

NABL’s Med Lab Accreditation Program mentions that Laboratory Director/ Head of Laboratory/ Technical Head (howsoever named), shall have the overall responsibility of Operations of the laboratory. Hence Lab Director’s Designation / Role is not mandatory. This is thee specific criteria document on NABL which is NABL 112. But the Standard for this program is ISO 15189:2012 which talks about the need to designate Laboratory Director.

CAP’s Laboratory Accreditation Program has a mandatory specification for Lab Director’s Designation and Role.

When 80-90% of the Labs in the country belong to Small labs category, can all qualify for Certifications, Accreditations. An ideal case is for Small labs to opt for Minimum Standards as 1st step towards the Quality journey before migrating to Certifications, Accreditations Programs. Compliance to Min Stds is also mandatory as it’s a Regulatory requirement.

My Thoughts as a Lab QMS Consultant :

I’m going back to the question asked by the Lab Professional whether its mandatory to have Lab Director Role and Designation in the Accredited Lab.

As a Consultant in healthcare industry, I would say it’s a debatable topic. The requirement depends on the National, International Standards followed by the Med Labs.

I have listed out the personnel spec given by each Standard for Med Labs. Lab Director’s Designation is a hierarchy in the organogram and can’t be maintained by all Labs. Labs can specify their own designations as listed in the NABL 112 Criteria OR criteria.