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/

Mandatory Hallmarking of Gold Jewellery

Has come into force from 16th June 2021 – Announcement from Ministry of Commerce

Mandatory Hallmarking of Gold Jewellery has come into force from today – 16th June, 2021.

Key announcements made by Ministry of Commerce :

  1. Hallmarking will be initially be starting from 256 districts of the country which have Assaying Marking Centres.
  1. Jewellers with annual turnover upto Rs 40 lac will be exempted from mandatory Hall Marking.
  1. Export and re-import of jewellery as per Trade Policy of Government of India – Jewellery for International Exhibitions, Jewellery for Government approved B2B Domestic Exhibitions will be exempted from mandatory Hall Marking.
  1. Gold of Additional carats 20, 23 and 24 will also be allowed for Hall Marking.
  1. Watches, fountain pens and special types of jewellery viz. Kundan, Polki and Jadau will be exempted from Hall Marking.
  1. Jewellers can continue to buy back old gold jewellery without hallmark from consumers.
  1. In order to give adequate time to the manufacturers, wholesalers and retailers of Gold Jewellery, there would be No penalties till August end.

Old jewellery can be got hallmarked as it is, if feasible by the jeweller or after melting and making new jewellery.

A committee constituting of representatives of all stake holders, revenue officials and legal experts will.be formed to look into the issues that may possibly emerge during the implementation of the scheme.

Ministry has announced that constructive suggestions are always welcome and implementation should be effective.  It may be noted that Hallmarking of Gold Jewellery was earlier set to begin from 15th June 2021.

Under Hallmarking scheme of Bureau of Indian Standards, Jewellers are registered for selling hallmarked jewellery and recognise testing and Hallmarking centres. BIS (Hallmarking) Regulations, were implemented w.e.f. 14.06.2018. Hallmarking will enable Consumers/Jewellery buyers to make a right choice and save them from any unnecessary confusion while buying gold.

At present, only 30% of Indian Gold Jewellery is hallmarked.

The Hallmarking of jewellery / artefacts is required to enhance the credibility of gold Jewellery and Customer Satisfaction through third party assurance for the marked purity/fineness of gold , consumer protection. This step will also help to develop India as a leading gold market center in the World.

It is to be noted that there has been 25% increase in A&H centers in the last five years. The number of A&H centers have increased from 454 to 945 in the last five years. At present 940 Assaying and Hallmarking centers are operative. Out of this 84 AHCs have been setup under Govt. subsidy scheme in various Districts.

Presently A&H Centre’s can hallmark 1500 articles in a day, the estimated hallmarking capacity of A&H Centre’s per year are 14 crore articles (Assuming 500 articles per shift &300 working days).

According to World Gold Council, India has around 4 lakh jewellers, out of this only 35,879 have been BIS certified.

Source : https://pib.gov.in/PressReleseDetail.aspx?PRID=1727399

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/

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/

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/

Parakh-Unified Laboratory Network

Govt of India initiative for mapping of labs and testing infrastructure in the country

“PARAKH” portal is a Government of India initiative for mapping of laboratory infrastructure across the country on a unified network of laboratories. This is a step towards enhancing Ease of Doing Business. This portal incorporates all the NABL accredited and Government recognized laboratories in the country on a Geographic Information System. This is an interactive and user friendly system to search laboratories and avail laboratory services, based on various parameters a user may require.

DPIIT Team said this portal should help to reduce compliance burden of the labs.

This may be the first step towards strengthening National Laboratories Quality Infrastructure in the country.

Source : DPIIT

Extension of Validity of NABH Certificate

NABH Notification

As per the notification  dated 22nd March 2021 (NABH/Notification/2021/1923), NABH  has decided to further extend validity of Accreditation/Certification for a further period of 3 months (i.e. till 30.06.2021) or till the decision on the renewal application is taken by NABH, whichever is earlier.

The accredited/certified hospital ought to have completed the renewal process (paid the application fee, annual fee) and showed the willingness to undergo the assessment. Further, all the terms and conditions for eligibility of extension of validity mentioned in earlier issued notification dated 25th June, 2020 will apply.

Information Source : https://www.nabh.co/Important_links.aspx

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