Advisory for Minimum Essentials Fire Safety Measures

NABH – Advisory for Minimum Essential Fire Safety Measures for All Healthcare Facilities

NABH (National Accreditation Board for Hospitals And Healthcare Providers) has issued an advisory recently on Minimum Essential Fire Safety Measures to be followed by healthcare organizations in the country.

This was the advisory for Minimum Essential Fire Safety Measures applicable to Healthcare Units under all schemes of Certification and Accreditation offered by NABH. These guidelines are meant to ensure patient safety and in no way absolves the organization of fulfilling its statutory obligations with regard to fire safety while implementing Certification, Accreditation Programs in the country.

The Advisory has listed out the scenarios where a Healthcare Organisation has Fire NOC, has No Fire NOC in place. The content of the advisory released by NABH is shared below for information purposes :

Advisory Content :

When the Healthcare Facility has Fire NOC in place, advisory calls for health facilities to check on the compliance to the minimum essential home Act/DHO fire safety measures are in place and or functioning.

Advisory says when the Healthcare facilities don’t have Fire NOC , following steps have to be addressed by a healthcare organisation :

  • Approval/Registration from local health authority Eg: Nursing home Act/DHO
  • If Fire NOC is not applicable, organisation has to provide valid justification for the same.
  • If Fire NOC is applicable, confirm that the organization has applied for fire NOC and there is regular correspondence (at least once in three months) with fire department which is acknowledged. Any correspondence received from the fire department has to be submitted.
  • In the absence of Fire NOC, Third Party Inspection Certificate should be made available.
  • The third-party audit should provide evidence to suggest that statutory norms are adhered to Any Observation by the third party should have been addressed.
  • The third-party inspection certificate is valid for a maximum period of one year
  • Head of the organization/Promoter to give an undertaking on the organization’s letter-head stating that fire safety measures are in place and adhered to at all times.
  • During assessment, verify that the points in the checklist are in place and are functioning

*NABH prescribes that Fire & Life Safety Inspection Certificates under NABCB accreditation issued by NABCB accredited Type ‘A’ Inspection Bodies for Fire & Life Safety Inspections of hospitals/health care providers shall be in accordance with the following:
a. National Building Code of India
b. Model Bill to provide for the maintenance of Fire and Emergency service for the state (2019)
c. Respective State Fire Safety Rules
d. NABH accreditation requirements for fire safety and applicable statutes
e. Any other applicable statutes.

Such Fire & Life Safety Inspection Certificates shall be accepted in lieu of statutory Fire NOC, only for consideration for the purpose of NABH accreditation. This does not absolve the hospitals/health care providers from complying to Fire NOC requirements/any other extent applicable statutes. It shall be sole responsibility of hospitals/health care providers to obtain Fire NOC, as applicable.

NABCB accredited Inspection Bodies shall be required to issue a final Fire & Life Safety Inspection certificate under NABCB accreditation bearing NABCB Accreditation Mark after the inspection is carried out and satisfactory corrective action and resolution of non-conformities, if any.

NABH accreditation requirements for Fire & Life Safety : (in addition to above)

  1. Firefighting equipment like wet riser, hydrants, auto sprinkler, fire alarm system, fire extinguishers of all types and sizes should be available as per table below (adapted from NBC 2016).
  2. Operational and maintenance plan for firefighting equipment including refilling of extinguishers.
  3. Up to date fire drawings to be available. Where applicable, the fire drawings should also specify the location of fire dampers.
  4. Fire detection and smoke detectors exist across all floors. The detectors shall be tested for functionality at regular intervals, and records maintained.
  5. Central fire alarm system is installed at a location which is staffed 24/7.
  6. Fire exit plan for each floor. Exit door should be openable and free from any materials which will obstruct way.
  7. Fire Exit signage on all floors well illuminated/ self-glowing, as per NBC guidelines.
  8. Emergency illumination system in case power goes.
  9. Designated place for assembly of patients and staff in case of fire.
  10. Mock fire drill records and schedule of conduct of drills.

Minimum Requirements for Fire Fighting Installations

Advisory can be downloaded by clicking on the link below.

Source of the Information :
https://nabh.co/Announcement/Revised%20Advisory%20for%20Minimum%20Essential%20Fire%20Safety%20Measures%20-20.09.2022.pdf

Above advisory says that Healthcare organisations need to obtain a Fire and Life Safety Inspection Certificates from Third Parties – Type A accredited Inspection Agencies accredited by NABCB in accordance with NBC 2016 and various other Regulations as mandated under various statutes, Rules, laws of centre , state etc

Hospitals , Healthcare Institutions have to look out for Type A Inspection Bodies (IBs) accredited by NABCB if they don’t have Fire NOC to seek Fire and Life Safety Inspections. Type A IBs have to obtain necessary accreditation scope as per various regulatory requirements, standards in the country. These IBs may have to seek accreditation as per IAF Code 34 ; NACE Code 71 which addresses the Inspection of Buildings activities

At the moment NABCB Accredited IBs with above IAF Scope are not found NABCB Registry. Few IBs may seek Accreditation under above scope to cater to the requirement specified by NABH in future. Healthcare organisations have to refer NABCB’s Registry for more updates on the accredited IBs list.

It’s a good move to encourage healthcare businesses to show compliance and adherence to Regulatory, Statutory requirements by offering Safety and Assurance to the users of healthcare facilities and Employees as well.

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

Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Social Audit Standards issued by ICAI

Exposure Draft on Compendium of Social Audit Standards issued by ICAI

In order to regulate the profession of Social auditors, the Sustainability Reporting Standards Board of ICAI has developed the draft preface to the social audit standards as specified in the notification dated July 25, 2022 issued by SEBI .

“Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) (Third Amendment) Regulations, 2022” dated July 25, 2022, has been issued in The Gazette of India regarding formation of Social Stock Exchange . The notification defines Social Stock Exchange as “A separate segment of a recognized stock exchange having nationwide trading terminals permitted to register Not for Profit Organizations and/ or list the securities issued by Not-for-Profit Organizations in accordance with provisions of these regulations.”

As per the above notification, The Institute of Chartered Accountants of India (ICAI) has been entrusted with the responsibility of being Self- Regulatory Organization for regulating the profession of Social auditors

In this regard, Sustainability Reporting Standards Board of ICAI has developed following :

• (i) Draft Preface to the Social Audit Standards
• (ii) Draft Framework for the Social Audit Standards
• (iii) Draft Social Audit Standards (SAS) on all the sixteen thematic areas specified in the above mentioned notification.

The downloadable version of the Exposure Draft is available at: https://resource.cdn.icai.org/71191srsb57193.pdf
Comments on this exposure draft are sought by ICAI latest by August 26, 2022

  1. Electronically Click on https://forms.gle/eFUnUZcXFzJzyCRC7 to submit comment online (Preferred method)
  2. Email: Comments can be sent to: sustainability2022@icai.in

Source: https://www.icai.org/post/srsb-ed-compendium-of-social-audit-standards-for-comments

NHA Joins hands with QCI to Accredit ABDM Compliant Healthcare Solutions

National Health Authority (NHA) joins hands with Quality Council of India (QCI) to accredit ABDM compliant healthcare solutions like HMIS/LMIS

The National Health Authority (NHA) has onboarded the Quality Council of India (QCI) for six months to accredit and rate HMIS (Health Management Information System)/ LMIS (Laboratory Information Management System) solutions that have integrated with Ayushman Bharat Digital Mission (ABDM).

NABH will undertake the responsibility of accrediting and rating the ABDM compliant solutions on various parameters, including ease of usage, user interface, pricing, number of modules/features and value for money/pricing so that prospective purchasers may get credible information.

The purpose of this initiative is to encourage innovations by streamlining delivery of health tech services in a significant way. To develop a framework to ensure that ABDM compliant digital healthcare solutions are accredited and rated and to adequate information is available to consumers for choosing one solution over another.

Accredited health tech solutions will help healthcare organizations manage their patient journeys and business more methodically in accordance with ABDM standards. And ultimately, this initiative will help the citizens of India get better and more timely healthcare and help India become one of the leaders in digitization of healthcare in the world”

This accreditation exercise will be conducted in a phased manner. Phase I shall focus on accreditation and rating of HMIS solutions successfully integrated with ABDM. Subsequent phases shall include other subjective parameters and other categories of healthcare solutions like LMIS, Health Lockers, Health Tech,PHR (Personal Health Records) apps etc.

Source : Posted On: 04 AUG 2022 6:12PM by PIB Delhi

Pharma Sector Global Standards

Government of India launches scheme for pharma sector to step up capacity, upgrade to global standards

Move from Volume to Value

Support to Pharma clusters and MSME units to enhance quality and technology improvement

In the launch event of DoP’s Strengthening of Pharmaceuticals Industries – Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare urges the Pharma Industry to make India a global leader in pharma sector and utilize the scheme to upgrade MSMEs to high standards.

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries at Dr Ambedkhar International Convention Centre, Janpath, New Delhi, in the presence of  Minister of State for Chemicals & Fertilizers and New & Renewable energy Shri Bhagwanth Khuba amidst the strong presence of pharma MSME industry players and representatives of major Pharma Associations. 

The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

The Scheme provides for credit linked capital and interest subsidy for Technology Upgradation of MSME units in pharmaceutical sector, as well as support of up to Rs 20 crore each for common facilities including Research centre, testing labs and ETPs in Pharma Clusters. SIDBI will be the Project management Consultant for implementing the scheme.

The Chemicals and Fertilisers Ministry rolled out the schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI). SIDBI will be the project management consultant for implementing the scheme

Union Minister for Chemicals and Fertilisers Mansukh Mandaviya said the schemes envisage technology upgradation, setting up of common research centres and effluent treatment plants in clusters for the pharma MSMEs and Small companies should be able to upgrade their facilities to global manufacturing standards.

The scheme has three components:

 Assistance to Pharmaceutical Industry for Common Facilities (APICF) – would strengthen the existing pharmaceutical clusters’ capacity for sustained growth. It provides for an assistance of up to 70 per cent of the approved project cost or Rs 20 crore, whichever is less.

 Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – would facilitate pharmaceutical MSMEs with proven track record to upgrade their technology. The scheme has provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs 10 crore with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis

 Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry. The scheme is aimed at creating a database of pharma and medical device sectors

Information Source : https://www.moneycontrol.com/news/trends/current-affairs-trends/government-launches-scheme-for-pharma-sector-to-step-up-capacity-upgrade-to-global-standards-8862561.html

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1843560

Regulatory Updates for IVDMD

Recent Regulatory Updates from CDSCO for IVD Medical Devices in India

Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.

In a review meeting held last week, Union Health Minister Mansukh Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.

He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action

The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness.

A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year,  while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

IVDs are also Medical Devices and are subject to the same regulatory framework.

In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc5Mw==

PCR Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mg==

Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mw==

Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software – 2022-May-05

Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit – 2022-May-05

Classification in IVD medical devices under the provision of MD Rules 2017 -2021-Jul-23

Source – https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/

Consumers to ensure they purchase Products bearing ISI Mark

Over 450 products under the ambit of mandatory certification

For a number of products, compliance to Indian Standards is made compulsory by the Government of India taking into cognizance various considerations viz. public interest, protection of human, animal or plant health, safety of environment, prevention of unfair trade practices and national security.

As on date, over 450 products are under the ambit of mandatory certification.

Consumers must ensure that they purchase these products bearing ISI Mark.

The key consumer products under mandatory certification include Cement, Electric iron, Electric immersion water heater, Domestic Food Mixer, Switches, Helmets, Domestic Pressure Cookers, Automotive tyres, Tubes, Packaged drinking water, LPG stoves, LPG cylinders, Toys etc. The key consumer electronic products under compulsory certification include Mobile phones, Laptops, TV, Power adapters, Power banks, Digital camera etc.

For these products, the Government makes it mandatory for manufacturers to follow Indian Standards and obtain BIS certification. The Indian Standards formulated by BIS form the basis for Product Certification Schemes, which provide Third Party Assurance of Quality of products to consumers.

BIS implements Quality Control Orders (QCOs) issued by the Government which ensure that the notified products conform to the requirements of the relevant Indian Standard(s).

The information on QCOs issued by the Central Government can be obtained from BIS website (www.bis.gov.in) under the following link Conformity Assessment -> Product Certification -> Products under Compulsory Certification.

After the date of commencement of the QCO, no person can manufacture, import, distribute, sell, hire, lease, store or exhibit for sale any product(s) covered under the QCO without a Standard Mark except under a valid certification from BIS. As the QCOs are equally applicable to Indian manufacturers as well as foreign manufacturers, the Indian consumers are assured of the quality of such products manufactured in India as well as imported to the country.

QCOs are issued by various Line Ministries (Regulators) under the Central Government depending upon the product(s)/ product categories being regulated through the Order, after having stakeholder consultations. Any person who contravenes the provisions of the Order shall be punishable under the provisions of sub-section (3) of section 29 of the BIS Act, 2016 with imprisonment or with fine or with both.

Source: https://pib.gov.in/PressReleasePage.aspx?PRID=1847501
Posted On: 02 AUG 2022 5:57PM by PIB Delhi

Medical Device Regulations Update

No extension in deadline for registration of medical devices to manufacturers – Announcement from Union Health Minister

Medical Devices in India will come under the licensing regime from October 1 as notified by the Central Government. Class A and B Device manufacturers, importers have to in compliance with MDR 17 and should have Registration and Licensing in place before Oct 1 2022 to have market access.

Union Health Minister Shri Mansukh Mandaviya has stated in a recent press release that there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe. He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration for seamless process.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action after Oct 1 , 2022. The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon.

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

Source :
https://health.economictimes.indiatimes.com/news/policy/no-extension-in-deadline-for-registration-of-medical-devices-mandaviya-to-manufacturers/93112960?utm_source=twitter_web&utm_medium=social&utm_campaign=socialsharebuttons