Certification Programs

NABH CERTIFICATION OF ABDM HEALTHCARE SOLUTIONS – Draft Standards

PUBLIC NOTICE FOR COMMENTS ON DRAFT NABH CERTIFICATION OF ABDM HEALTHCARE SOLUTIONS (CAHS-1)  

Announcement from NABH

National Health Authority (NHA) in collaboration with National Accreditation Board for Hospitals (NABH) and Quality Council of India (QCI) has initiated a project, ‘Certification of ABDM Health Solutions – V1.0’ (CAHS-1) to certify HMIS/LMIS/Clinic solutions that have been integrated within Ayushman Bharat Digital Mission (ABDM) Sandbox. This ensures that essential features are provided to support integrated digital healthcare. The first draft of the standards is ready and is being placed for the comments, suggestions, objections by the stakeholders. The comments are invited on the following link. 

Feedback form: https://forms.gle/4CY35qrY5WEndvWr5  

The draft standards are available on the following links: 

1. First version of HMIS essential features 

https://drive.google.com/file/d/1bb3Tj7ylLyFJ5Bu9wYJ7JspsK8mkZ290/view?usp=sharing

2. First version of LMIS essential features  

https://drive.google.com/file/d/1obMLcyhppoX87t6WvZIh0uxjQai94DBK/view?usp=sharing

3. First version of Clinics essential features  

https://drive.google.com/file/d/1TZGkoFbqRVqiUXX7WkM7g2YPgpkiww1_/view?usp=sharing

The last date for receiving comments is 8th February 2023.   

Source – https://nabh.co/Announcement/Public%20Notice%20for%20NABH%20Certification%20Of%20ABDM%20Healthcare%20Solutions%20(CAHS%20-1).pdf

Do refer the draft standards and share your feedback .

Announcement – ICAI issues Social Audit Standards

Social Audit Standards – Sustainability Reporting

The Institute of Chartered Accountants of India (ICAI) has issued the Social Audit Standards (SAS) for the members. These Social Audit Standards will be applicable from the date of their hosting on ICAI website. (SAS 100 should be read in conjunction with the “Preface to the Social Audit Standards” and “Framework for the Social Audit Standards”, issued by the ICAI

This Social Audit Standard relates to the thematic area of “eradicating hunger, poverty, malnutrition and inequality’’. The Standard aims to provide the Social Auditor with the necessary guidance in relation to independent impact assessment engagement of Social Enterprises engaged in eradicating hunger, poverty, malnutrition and inequality and the audit steps and procedures that should be applied while conducting the social impact assessment. The Standard sets out the minimum requirements to be followed while conducting impact assessment. Laws or regulations may establish additional requirements which should be followed, as applicable.

The Social Auditor should conduct a desk review of existing documents to gain further insight into the evaluation procedure and impact assessment.

The social auditor should review the evaluation questions addressed through Questionnaires, In – depth Interviews and Focused Group Discussions to assess the responses received from various stakeholders and to understand what has changed.

The Social Auditor should review the project/program documents to frame the evaluation criteria for assessing impact. Such key metrics may be collated from base-line, mid-line (monthly / quarterly) and end-line assessment (if available), respectively at the beginning, middle and end of the reporting period/project/program to effectively understand and evaluate impact.

The Social Auditor should identify the inherent limitations of the evaluation process which might have an influence on the impact assessment.

Source – https://resource.cdn.icai.org/72658srsb58573.pdf;

Source: https://www.taxscan.in/icai-issues-social-audit-standards/245984/

Notification

Guidelines on Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022

The Central Consumer Protection authority (CCPA) under the Department of Consumer Affairs has notified ‘Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022’ with an objective to curb misleading advertisements and protect the consumers, who may be exploited or affected by such advertisements.

The guidelines seek to ensure that consumers are not being fooled with unsubstantiated claims, exaggerated promises, misinformation and false claims. Such advertisements violates various rights of consumers such as right to be informed, right to choose and right to be safeguarded against potentially unsafe products and services

Keeping in view the sensitiveness and vulnerability of children and severe impact advertisements make on the younger minds, several preemptive provisions have been laid down on advertisements targeting children. Guidelines says that advertisement targeting children shall not feature any personalities from the field of sports, music or cinema for products which under any law requires a health warning for such advertisement or cannot be purchased by children

Guidelines also stipulates that disclaimer shall not attempt to hide material information with respect to any claim made in such advertisement, the omission or absence of which is likely to make the advertisement deceptive or conceal its commercial intent and shall not attempt to correct a misleading claim made in an advertisement.

Similarly, clear Guidelines are laid for duties of manufacturer, service provider, advertiser and advertising agency, due diligence to be carried out before endorsing and others. Guidelines aims to protect consumer’s interest through bringing in more transparency and clarity in the way advertisements are being published, so that, consumers are able to make informed decisions based on facts rather than false narratives and exaggerations. 

Penalty for violating the Guidelines are also clearly outlined. CCPA can impose penalty of upto 10 lakh rupees on manufacturers, advertisers and endorsers for any misleading advertisements. For subsequent contraventions, CCPA may impose a penalty of upto 50 lakh rupees. The Authority can prohibit the endorser of a misleading advertisement from making any endorsement for upto 1 year and for subsequent contravention, prohibition can extend upto 3 years.

Source: https://consumeraffairs.nic.in/en/latestnews/guidelines-prevention-misleading-advertisements-and-endorsements-misleading

Buyer Seller Meet

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb– 04th Mar 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, India is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb. – 04th Mar. 2023 covering following sectors which have demand in ASEAN region:

➢Hotel & Tourism Services
➢Educational Services
➢Healthcare Services
➢Architectural, Construction & Related Engineering Services
➢Entertainment Services (Including AVCG)

Benefits to participants on participating at BSM to ASEAN region.

• Focused prescheduled B2B meetings in each country
• Understand the market potential from experts in ASEAN region.
• Networking Opportunities with potential buyers in ASEAN region.
• Generate business leads and sign MOUs for collaborations.
• Meetings with relevant government and related stakeholders

The tentative programme for this BSM is given in Annexure A for your kind reference.

An estimate of expenditure heads which has to be managed by the participants are –

  • Flight tickets: For 4 countries, approximate cost would be INR ,1,59,000
  • Hotel stay: Approximately USD 130 -165 USD per night.
  • Total Cost approximately for all 4 Countries – INR3,35,000.

SEPC shall share the details of travel partners for this delegation with participants separately.

MAI Support to Participants:

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry.

Registration Link: https://tinyurl.com/7v5byhr6

European Green Deal

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

European Green Deal Announcement

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

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

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

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

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

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

Key elements :

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

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

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

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

Next steps

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

Download here for full announcement

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

World Standards Day 2022 Program

Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm

Sustainable Trade Development and Voluntary Sustainable Standards

Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.

The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.

Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.

Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.

Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of  environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.

Sustainability standards can unlock new markets for developing countries.

Go Green, Go Sustainable

More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.

Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.

Program Objective

Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.

The program is designed on the topic Sustainability Standards based on the WSD Theme.

Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.

Program Details

Topic – Role of Sustainability Standards in International Trade

Date : October 14th 2022 – Friday

Time : 04 30 pm – 06 00 pm

Meeting Mode – Online / Virtual

Meeting Platform – Zoom

Fee : No Registration Fee.

Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.

Registration Link

Click the button below for registration

Upon registration, registered delegates will receive meeting link.

Contact

For enquiries, pls email to

contact@ccc-consultants.org

secretariat@ccc-consultants.org

CDSCO Notification on Resellers

Registration by Medical Device Distributors, Stockists, Exhibitors or Resellers made a must under Medical Device Regulations

Ministry of Health and Family Welfare (MoHFW) has asked Distributors, traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country.

In a notification dated September 30 2022, the Union Ministry of Health and Family Welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need to obtain a Certificate of Registration. These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022.

These rules shall come into force on the date of their publication in the Official Gazette.

Key points from the Notification released :

In the said rules, after rule 87, the following rules shall be inserted, namely:—

“87A. Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1) The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas as may be specified.

(2) Any person who intends to sell, stock, exhibit or offer for sale or distribute a  medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution.

(3) The application made under sub-rule (2) shall be accompanied with

  • a fees specified in Second Schedule;
  • self certificate of compliance with respect to Good Distribution Compliance;
  • details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card;
  • documentary evidence in respect of ownership or occupancy on rental of the premises;
  • details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:—
    • hold a degree from a recognized University/Institution; or
    • is a registered pharmacist; or
    • has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with sale of medical devices;
  • brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and
  • an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.

(4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate in Form MD42, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days from the date the application is made under sub-rule (2).

(5) If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such appeal.

87B. Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1)The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.

(2) The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.

(3) The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.

(4) The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity.

(5) Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained. 

(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing.

(7) All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.

(8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.

87C. Validity of registration certificate.— (1)A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority:

Provided that, if the registration certificate holder fails to pay the required registration certificate retention fee on or before due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within six months:

Provided further that in the event of non-payment of such fee within the period referred to in the first proviso, the registration certificate shall be deemed to have been cancelled.

87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause as to why such an order should not be passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the registration certificate.

(2) A registration certificate holder whose registration certificate has been suspended or cancelled by the State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government and the State Government, shall after giving the registration holder an opportunity of being heard, confirm, reverse or modify such order, with reasons to be recorded in writing.”.

Notification also contains other information like application format (MD 41), MD 42, fee details etc .

Download the notification here

NABH – Notification – 3rd Edition of NABH Standard

NOTIFICATION – IMPLEMENTATION PLAN OF 3 rd EDITION OF THE NABH SHCO ACCREDITATION STANDARDS

The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022

NABH has released notification on Implementation plan of 3rd Edition of the NABH SHCO Accreditation Standard as follows:

• All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date.

• All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023

• For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.

• NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022

The whole process of transition will be completed by 1st March, 2023.

source: NABH/Notification/SHCO/3rd Edition/Imp/2022/7379 dt 7.9.22

Notified Bodies registered with CDSCO under MDR 2017

List of Notified Bodies registered with CDSCO under MDR 2017

CDSCO has released the list of Notified Bodies registered with CDSCO under Medical Devices Rules 2017 to carry out audit of manufacturing site under the provisions of said rules.

Please click the link below to know the list of registered Notified Bodies

NHA issues hardware guidelines for effective implementation of Ayushman Bharat Digital Mission

NHA issues hardware guidelines for healthcare institutions at State/ UT level to facilitate effective implementation of Ayushman Bharat Digital Mission

The National Health Authority (NHA) issued hardware guidelines across States and Union Territories for healthcare institutions like hospitals, clinics and health and wellness centres to promote digitization in hospitals.

The guidelines provide a basic framework to States/UTs for planning, assessment and procurement of the IT hardware (including IT specifications of various hardware equipment) to operate applications compliant with Ayushman Bharat Digital Mission (ABDM).

The guidelines on the IT hardware specifications to support this ecosystem is available at https://abdm.gov.in:8081/uploads/Hardware_Guidelines_ABDM_e162cf7a7b.pdf. The document will help the States/ UTs in assessing the hardware requirements while planning and procurement of IT assets for healthcare institutions of all scales.

The guidelines published by NHA is suggestive and recommendatory in nature. States/UTs and the health facilities have the flexibility to modify these guidelines based on local requirements and circumstances.

Source: Posted On: 22 AUG 2022 4:17PM by PIB Delhi
source link: https://pib.gov.in/PressReleseDetailm.aspx?PRID=1853603