Indian Made Omicron Test Kit

Tata Medical and Diagnostics has developed a kit “OmiSure” for detecting Omicron variants in RT-PCR Tests

Tata Medical and Diagnostics has developed a kit called “OmiSure” that can detect Omicron variants of SARS-CoV2 in nasopharyngeal / oropharyngeal specimens during RT-PCR testing. As per the company’s press release, the test kit is compatible with all standard real-time PCR machines. This kit can detect Omicron variants as well as other variants of SARS-CoV2 reported so far.

Currently, patients with Omicron are detected only after genomic sequencing. This test helped eliminate that step and could make detections during the test. The kit was developed to detect new variants of SARS-CoV2 directly and very specifically. Head of Research and Development , TATAMD said the first target is based on the S gene dropout or S gene target disorder (SGTF) and the second target is based on the S gene mutation amplification (SGMA). The Indian Council of Medical Research (ICMR) has approved the kit.

Presently, the Omicron variant is being detected using test kits developed by US-based Thermo Fisher which uses S-Gene Target Failure (SGTF) technology, which is also used by OmiSure.

In its letter approving the kit, the ICMR stated: “The tests have been performed as per the manufacturer’s instructions. Responsibility for batch-to-batch consistency lies with the manufacturer.”

The company had applied for a license with the Central Drugs Standard Control Organization (CDSCO). The kit will be manufactured by TATAMD at the Sriperumbudur facility in Tamil Nadu once the license is approved by the CDSCO. The company currently has daily capacity of 2,000,000 kits and plan to increase the capacity from 5,000,000 to 10,00,000 by the third week of January. The kits are manufactured in both the domestic and international markets. The company also applied for a patent for this kit .

Download the ICMR Approval here

Source

https://indianewsrepublic.com/tata-medical-and-diagnostics-has-developed-a-kit-omisure-for-detecting-omicron-variants-in-rt-pcr-tests/605532/

https://www.gonewsindia.com/latest-headlines/icmr-approves-first-rt-pcr-kit-to-detect-omicron-variant-by-tata-named-omisure-11809

https://www.icmr.gov.in/ckitevaluation.html

InformationUpdate

Industry Information Updates – Healthcare Sector

NABH Announcements

Announcements from NABH – Fee Remittance Norms & Communication Matrix to be followed by all Applicant / Certified / Accredited Healthcare Organizations

Announcement 1 – Fee Remittance Notification

Kind Attention : All applicant / Accredited / Certified Health Care Organisations under all programs of NABH

In continuation to the previous notice of NABH related to fee payments  issued  on February 16, 2021, many Healthcare Organisations associated with NABH, are still making direct payment to Quality Council of India – NABH. NABH is facing d i f f i cu l t y in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.

To avoid unnecessary wastage of time  and  manpower  in  tracking  the  payments, NABH advises its stakeholders to  make payments  only through  the online portal  using the Payment Gateway  so that the payments  are appropriately  tracked  for  convenience  of all the parties.

In order to facilitate the Healthcare  Organisations  to reconcile  the fee payment  status,  NABH is requesting all the HCOs to follow the below steps with immediate effect:

  1. The HCOs a r e advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
  • HCOs are advised to refrain from depositing cash/cheque/DD directly into  any  account of Quality Council of India.
  • In case the HCO has no other option but Bank Transfer (NEFT/RTGS), it shall be responsibility of the HCO to update the transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction Amount, etc  on  the NABH Portal under the Make Payment category and inform NABH that the Payment was done and get the receipts generated for the payments made.
  • The HCOs are also requested to ensure that the payment details with respect to fee payments of current and previous accreditation cycles have been updated on the NABH portal account of the HCO, if not done earlier.

QCI-NABH plans to stop direct payments into its accounts done through DD/Cheque/Cash Deposit/Offline Bank Transfer (NEFT/RTGS) by March 31, 2022 and is seeking the cooperation from HCOs in this regards.

Download the notification from NABH here

Announcement 2 – Communication Matrix Released for the benefit of all Applicant / Certified / Accredited HCOs

NABH has earlier issued NABH communication matrix – NABH/Notification/Communication/2020/2049 dated 25th September 2020

All the applicant and accredited/ certified HCOs that are listed in the NABH portal have the provisions for making communications with the officials of NABH through “REMARKS COLUMN”. All HCOs are requested to utilise “REMARKS” for communicating/ raising queries regarding status of their applications for accreditation/ certification to ensure transparency as well as for records.

HCOs are also requested to refrain themselves from communicating through emails or telephonically. It is practically not possible to reply to each mail or phone call individually. Moreover, neither your communication nor reply from NABH is captured for the case record purpose.

In case, the queries of the HCOs submitted through remarks on the portal are not replied within three working days, emails to Program Heads may be sent, along with contents of email copied at on-line portal remark column. The list of all programs of NABH and the responsible Program Head with contact details are listed in the notification released by NABH.

Download the notification from NABH

Source : https://nabh.co/index.aspx

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0

Outcome of COP26 for India and Abroad

Outcome of COP26 for India and Abroad – Webinar from Service Export Promotion Council

Announcement from SEPC :

We are Organising a webinar on COP26. A business unit can sell its carbon points and gets incentives on financing and special offers in most of the member countries.

Any kind of environmental steps that a company takes is monetary benefit to them, especially if they are exporting. How to do this can be learnt through this session . Plus there will also be a session on all services and incentives by SEPC.

Registration Link

https://us02web.zoom.us/webinar/register/WN_LBV79wNvRyOaFET1oIRidQ

Medical Equipment Expo

India International Medical Equipment Expo – Invitation Dec 11th – Dec 13th 2021

Announcement from Andhra Pradesh Medtech Zone

Dr Jitendra Sharma, MD & CEO, AMTZ is inviting you to the IIME Expo, scheduled to happen from the 11-13th Dec 2021 , hosted at Kalam Convention Centre, Vizag, celebrating 3 years of completion of AMTZ.

A unique platform for Medical devices & Equipment manufacturers, Hospital Infrastructure and consumables to meet and network with the Medical Fraternity including Hospital Owners/Management, Consultants, Surgeons & Physicians, Speciality centres etc under one roof.

Exhibitor Product Profile

Profile of exhibit based on Sutures & Sealing Devices, Patient Monitoring Devices, 3D Printers, Machines / Systems, Medical Furniture, Surgical Equipment, Endoscopy Equipment, Dialysis Machines, Lab Equipment, Consumables, Uniforms/Garments, Autoclave, EtO, Drapes, Surgical Equipment, Endoscopy Equipment, Manikins, Gloves, Drug Delivery / Extraction disposables, X-ray, Ultrasound, Digital Imaging, Helicopters & Private Jets, EMS Technology Solutions.

The event will see dignitaries from the Government of India, champions of med-tech, business leaders and hospitals congregating to celebrate our collective success. 

Venue :
India International Medical Equipment Expo 2021
Sat, 11 Dec 2021 – Mon, 13 Dec 2021
Kalam Convention Center
Visakhapatnam, India

Kalam Convention CenterAMTZ Campus, Pragathi Maidan, Siddeswaram, Nadupuru Reserve Forest, Visakhapatnam, Andhra Pradesh 530032

Directions – https://maps.google.com/maps/dir//Kalam+Convention+Center+AMTZ+Campus,+Pragathi+Maidan+Siddeswaram,+Nadupuru+Reserve+Forest+Visakhapatnam,+Andhra+Pradesh+530032/@17.6297358,83.1590403,16z/data=!4m5!4m4!1m0!1m2!1m1!1s0x3a396d5bec015829:0xf36d219478d9473f

Looking forward to seeing you.

Book Your Booth Now : https://lnkd.in/gRAd8rBa

Downloads:

E- Brochure: https://lnkd.in/gZUE2v-H
Floor Lay-out: https://lnkd.in/g8WK3cZq
Branding Opportunities: https://lnkd.in/geXQqNbu

Contact Co-ordinate:

Mr Harish
Director- ICEXPO
+91 8977924225)

Organic Certifications

Organic Produce Certifications – European Commission’s decision to delist Five Certifications Bodies from India over high levels of ETO

ETO level higher than permissible limits – Reason for Delisting

The European Commission has decided to derecognise five certifying bodies (CBs) from giving clearance or ratifying exports of Indian organic products for their failure to meet the ethylene oxide (ETO) norms in consignments, particularly sesame (til/gingelly).

A draft of the European Union Committee on Organic Production (COP) on derecognising the five CBs or certifying agencies was issued in October for comments from various stakeholders. These comments were taken up last week before it took a final call.

With all the European Union (EU) members supporting the move, the COP decided to derecognise the five CBs – four from the EU and one from the US – on November 30.

The decision comes despite hectic lobbying by the EU, the US trade bodies and consultants against any action against the five. Instead, they sought action against the Agricultural and Processed Food Products Export Development Authority (APEDA).

The EU derecognised the five CBs, which certified over 80 per cent of the organic products exports to the EU, as they had certified some 90 shipments against which the EU Organic Farm Information System (OFIC) issued notifications for ETO level being excess than permitted level 0.1mg/kg.

The five CBs are ECOCERT India Pvt Ltd, CU Inspections Ltd, Indian Organic Certification Agency (Indocert), Lacon Quality Certifications Pvt Ltd – all based in EU – and the US-based OneCert International Private Ltd.

The blacklisting will come into force from January 1, 2022, and will be valid until APEDA removes them from the “high risk category” list they have been placed after being found at fault.

APEDA, which is the competent authority in India to supervise organic certification processes, has also suspended OneCert’s accreditation for one year, while ECOCERT, CU Inspections, IndoCert have been barred from registering any new processor or exporter.

In addition, APEDA has also asked Aditi Organic Certifications to not register any new processor or exporter. The five CBs have also been imposed ₹2-5 lakh penalties.

In its draft, the EU COP said, “Since October 2020, a large number of consignments totalling thousands of tonnes allegedly organic sesame seed contaminated with ethylene oxide have been imported from that third country, in particular from operators controlled by the control bodies supervised by India…”

ETO is considered carcinogenic for humans by the EU and a few other countries, and it is strictly monitored to ensure that shipment of any product conforms to the norms. In the case of India, the presence of the chemical exceeded far more than the permitted level, which the EU felt posed a health risk to its consumers.

The EU derecognition of the five agencies also means that their names should not appear in APEDA’s list of CBs recognised by it. The derecognition is unlikely to affect exports of organic products – as feared by the EU and US trade bodies – from India as there are 28 other CBs, Indian and foreign, that can fill in the void.

Source : https://newonnews.com/ec-ratifies-move-to-derecognise-five-agencies-certifying-organic-exports-from-india/

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe. Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Wellbeing is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure availability of Responsible Supply Chain as a Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe.

We, in India too are seeing a huge surge in exports as well as in imports of Products and Services and how do we ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

European Union is the largest market for Indian Exporters and businesses strive hard to create market space for their products and services. Earning and Retaining Customer Loyalty, Recognition and Reputation at market place is not an easy ride for any business. Its the reasonability and duty of industry bodies, industry associations to work in coordination with Regulators like APEDA and ensure that wrong trade practices by businesses, Certification Agencies should be questioned.

Regulators, Accreditation Bodies, Certification Agencies, Industry , Consultants are the key stakeholders to this process and all have to work in alignment , incordination to ensure that Responsible Supply Chains are made available for domestic as well as for global markets.

Issuance of Certifications is an Assurance to the market place that Products that are Certified for Quality are Safe for Consumption. When this process gets compromised, consumers faith and trust on Quality will erode.

NABL Announcement

CLARIFICATION ON UNIQUE LABORATORY REPORT (ULR) NUMBER

Accredited testing laboratories, calibration laboratories and Reference Material Producers may note the clarification on the use of ULR number released by NABL recently.

Key Highlights about the announcement :

Government electronic Marketplace (GeM) accepts test reports issued by NABL accredited laboratories along with the products which are uploaded on the GeM portal.

Similarly for product / equipment which is to be used after calibration, the calibration certificates issued by NABL accredited calibration laboratories are accepted. RM document from NABL accredited RMP is required to be uploaded along with any (certified) reference material on GeM portal.

To authenticate the test reports / calibration certificates / RM documents, GeM has sought the co-operation of NABL in getting the data on reports mapped with the claim of the sellers. To facilitate such mapping, an 18-digit ULR number has to be mentioned on all reports issued by testing & calibration laboratories and RMPs. This number will be in addition to the report number of the laboratory / RMP and will have to be mentioned in all reports issued with accredited scope only.

This system is not mandatory for test reports issued by bulk petroleum product manufacturer’s laboratories, test reports of non-commodities like air, waste water and similar environmental parameters and results related to veterinary testing, dope testing & forensic testing.

For testing and calibration laboratories, discipline (example- Biological / Mechanical) and group (example- Water /

Dimension) as applicable needs to be mentioned before the product and parameters in the reports. (Please refer NABL 120)

For RMP, category and sub-category needs to be mentioned before the product / parameters in the document. (Please refer NABL 191).

It is reiterated that the ULR system has to be followed in line with the current version of NABL 133.

This system is not to be used in reports containing parameters outside the scope of NABL accreditation.

Read the full notification issued by NABL here :

Announcement

Announcement from NABL on CABs

Sharing the recent announcement from NABL on CABs.

There is a fast track focus at the market place to seek Certifications fast. This trend is more visible at the market place now. Fast tracking , resorting to various acts as listed in the announcement is not a healthy sign for the industry.

Certificates , Certifications are of no use, of no relevance when the users, payers, for the services don’t experience “the showcased Quality of Service”. There is a structure , methodology that needs to be followed while seeking Quality Systems Certifications.

The sudden rush for Certificates must be driving businesses to resort to unhealthy practices is what is understood from the notification !

Sharing this here to as information update for industry to take cognizance of the notification.

World Quality Month Programs

WORLD QUALITY MONTH – INDUSTRY CONNECT KNOWLEDGE SERIES – WEBINARS

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe.

Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Well being is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure Responsible Supply Chain as Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe. 

India too is seeing a huge surge in exports as well as in imports of Products and Services and how do to ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

It is in this context that Consultants Consortium of Chennai (CCC) is rolling out series of Knowledge Sessions to Celebrate the November Month of Quality by connecting Industry and Stakeholders to various sessions which are the need of the hour programs.

CCC has scheduled 6 sessions spread , across the month of November, starting from November 11th 2021 till end of the month. Multiple sessions covering various sectors are scheduled.

CCC will keep communicating and inviting all stakeholders and industry to the sessions. Sessions will have the support of industry, academia, young entrepreneurs, innovators forums and various other stakeholder organizations.

This information is being shared to facilitate industry, academia, startups, Management Systems Consultants and various other stakeholders to register for the sessions . 

Sessions are conducted through Virtual Mode and there is NO REGISTRATION FEE.

SESSION 1 – NOVEMBER 11TH 2021, THURSDAY- 4 :00 PM – 5:30 PM

TOPIC – RESPONSIBLE QUALITY CERTIFICATIONS

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

SESSION 2 – NOVEMBER 13TH 2021, SATURDAY – 4 :00 PM – 5:30 PM

TOPIC – Accessing Global Markets – Role of Private Certifications in Food Sector

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

WORLD QUALITY MONTH SERIES – SUPPORTING BY INDUSTRY ASSNS, CHAMBERS