Notification from CDSCO

Fresh Notification – Voluntary Registration & Labelling Norms from CDSCO for Medical Device Industry

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. CDSCO has called for feedback , suggestion from the industry to the proposed amendments.

Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification below.

NOTIFICATION – New Delhi, the 12th October, 2021

G.S.R. 729(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to

The Under Secretary (Drugs Regulation),
Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,
New Delhi – 110011
or
emailed at – drugsdiv-mohfw@gov.in.

DRAFT RULES

(1) (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

(2) In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 19B, in subrule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

Download the Notification from CDSCO

Source : CDSCO

Voluntary Registration

Voluntary Registration of Medical Devices & Labelling Norms – Medical Device Sector – Fresh Announcement from CDSCO

Medical Device Industry has recently sent a representation to the Regulator – CDSCO, to consider timeline extensions to the Voluntary Registration Program announced by the Regulator in April 2020. Though the 18 months timeline offered by the Regulator came to an end on Sep 30th 2021, many MSME businesses couldn’t complete the process . Regulator has forwarded the request to Ministry . A Session with Regulator organized by industry was attended by more than 1000 members and industry and various other key stakeholders raised many pertinent issues requesting the regulator’s office to look into. One of the key issues raised during industry meet was ISO 13485 Certification process and challenges in completing the exercise to obtain “Authentic ISO 13485 Certificates” .

Industry is waiting for further instructions from Regulator’s office on the timelines extension to the Voluntary Registration Process.

Fresh Notification from #CDSCO

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. The announcement is more specific to ISO 13485 Certificates and the Self declaration to be given by Industry to Regulators about the roadmap to complete the certification process.

CDSCO has called for feedback , suggestion from the industry to the proposed amendments. Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification.

Download the notification from here

Request the industry, stakeholder to share feedback with Regulators, Industry Associations etc to the proposed amendments.

FAQs Session With CDSCO

Medical Device Regulations – Non Notified Devices – Voluntary Registration ProcessSeptember 19th 2021, Sunday – 4 PM – 5 PM

Let Our REGULATOR Speak to You !

Do Join Us to get answers to your FAQs on Voluntary Registration Process !

Voluntary Registration Process rolled out by CDSCO for Non Notified Devices is coming to an end by Sep 30th 2021. Industry Forums are receiving so many FAQs from various stakeholders over the last 2 months asking many questions on Voluntary Registration Process and raising wide range of questions on WHAT HAPPENS FROM OCTOBER 1ST 2021.

Hence AIMED (Association of Indian Medical Device Industry) is organising a session to enable the industry, stakeholders to get their FAQs addressed from the Regulator.

Some of the FAQs raised by stakeholders are captured below and we invite industry, stakeholders to register and join the session to discuss pertinent issues , challenges faced, if any.

This program is the initiative of AIMED , a leading Industry Platform for Make in India Manufacturers representing the Voice of the Industry.

Program Information :

Some FAQs from Industry which need information from CDSCO :

Registration Details :

Who Should Attend ?

Program is Open for all Industry Members, Stakeholders like Manufacturers, Traders, Distributors, Startups, Med Tech Businesses etc.

There is NO REGISTRATION FEE but Prior Registration is a MUST.

Registered Participants shall get Email Confirmation 2 days before the session from Consultants Consortium of Chennai .

Registration Link

Download the program collaterals from here

Contact Co-ordinates :

Ms Rama Venugopal
Email – contact@ccc-consultants.org
WhatsApp – +91 9840870532

Mr D Srikanthan
Email – secretariat@ccc-consultants.org
WhatsApp – +91 9003056539

Clarification on the Role of NABL in Enforcing Regulations

Announcement from NABL – National Accreditation Board for Testing and Calibration Laboratories

Clarification on the Role of NABL in Enforcing Regulations

Accreditation is the independent evaluation of Conformity Assessment bodies against recognised normative documents like Standards, Regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence. Through the application of national and international Standards, Government, Procurers and Consumers can have confidence in the results of accredited Conformity Assessment Bodies.

Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to Medical Laboratories.

Laboratory Customers, Regulatory Authorities, Organizations and Schemes using peer assessment, Accreditation bodies, and others use these documents in confirming or recognizing the competence of laboratories.

The results from Accredited Laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.

Many Government Agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards.

NABL Accreditation is increasingly being used by Regulators and Government to ascertain the Quality of Products. Accredited CABs can objectively state conformance of product or service to specified requirements.

NABL is a Voluntary Accreditation body and has no Regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable Regulator.

In all cases, it is the responsibility of Laboratory to abide by the National & State Statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions/ Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time.

Download the announceement from here

Source : https://nabl-india.org/

The above announcement from NABL clarifies its role as Accreditation body to various stakeholders at market place. Regulators , Governments normally rely on Accreditation Bodies for Conformity Assessment procedures. Accreditation bodies are not Regulators and can’t step into shoes of Regulators. This confusion is often seen at market place where Accreditation bodies and Regulators Roles are understood wrongly , get mixed up often. Frequent communication from Apex bodies , Accreditation bodies clarifying the role of ABs, CBs etc throws so much clarity to the industry, stakeholders too. Markets still mix up Accreditations and Certifications. Lot of confusion prevails between Voluntary Recognition Programs and Mandatory Recognition Programs. FAQs list is very long and apex bodies can release communication often on all the FAQs.

Improving Global Competitiveness of Indian businesses is the key focus of Govt of India and businesses need to show compliance to various Conformity Assessment Procedures of Importing Countries. Understanding all these matter as most of these protocols are International Protocols too.

Country is witnessing lot of FDI and many new global businesses are setting up shop in India. International businesses need clarity and clear communication on conformity assessment too as Technical Regulations are linked to International Accounting Standards as well.

Clinical Establishments Act

National Council for Clinical Establishments – Updated News

National Council for Clinical Establishments met recently and held discussions related to implementation of CEA and Minimum Standards.

Meeting was held to review the work done by the National Council so far, status of implementation of the
Act by the States/UTs and defining further Roadmap and consideration/decisions of specific agenda points.

Some of the key highlights of the meeting are captured below :

Hospitals

Inclusion of provision of mini oxygen plant/PSA plant and norms of oxygen availability as part of the minimum standards for hospitals for implementation under CE Act.

a. It was agreed that the primary focus should be to ensure availability of Oxygen as per requirement for all the services envisaged to be provided by the hospital. At least one third of total number of beds should be oxygen beds. Atleast 48 hours (preferably 72 hours) of oxygen of the total calculated oxygen requirement of the hospital should be available at any given time, as backup.

b. Oxygen requirement may be calculated as per the ME Division norms of oxygen cylinders based on Oxygen/ICU beds – NRBM/NIV/HFNC/Ventilator Bed capacity in the hospital for management of COVID-19, as mentioned in DO letter dated 21-6-2021 as at Annexure 1 c. Regarding the “establishment of Mini Oxygen Plants in hospitals and Clinical Establishments having more than 50 beds”, following action points were recommended:

i. Every new clinical establishment/hospital having more than 50 beds may be mandated to install Mini-Oxygen/PSA plants of appropriate capacity and specifications for their registration under Clinical Establishments Act, 2010.

ii. For the existing hospitals having more than 50 beds, a time period of 6 months (desirable) and 1 year (mandatory) may be given for compliance to the condition of installation of MiniOxygen/PSA plant.

iii. Accordingly it is recommended that this requirement may be included in the minimum standards for Hospitals and a notification in this regard may be considered to be issued by the MoHFW, as amendment to the Clinical Establishments (Central Govt ) Rules under the Clinical Establishments Act, 2010.

iv. The same advice as at points 3C (i), (ii) and (iii) above may be disseminated to the States/UT not covered by Clinical Establishments Act 2010 for enforcement under the respective State Clinical establishments Act or Disaster Management Act.

v. All small hospitals i.e 50 beds or less should also build infrastructure and add capacities to meet their oxygen requirements for the services envisaged to be provided by them, as per the type of the hospital.

vi. National Health Systems Resource Centre (NHSRC) is carrying out the revision of Indian Public Health Standards (IPHS) under NHM, accordingly they may clearly define oxygen requirements for various categories of hospitals ranging from 50 to 500 bedded in the revised IPHS guidelines.

Further NHSRC may define the capacity/specifications of equipment/ MiniOxygen/PSA plants to meet the oxygen requirement along with ensuring sustained Oxygen supply in Government Health facilities under NHM as a part of IPHS. They may consider defining the standards separately for difficult/remote/ inaccessible areas, if deemed necessary

Medical Testing Laboratories

Issues related to minimum standards for Medical Diagnostic Laboratories under the Clinical Establishments Act, 2010 (w.r.t suggestions received in respect of inclusion of PhD genetics and PhD scientists in minimum standards for Medical Diagnostic Laboratories)

The Council members were informed that the amended Gazette Notification in respect of Human resource requirements for Medical Diagnostic Laboratories has already been issued on 14-2-2020, which includes provision of MSc and MSc Phd with specified qualification and experience. They are permitted to conduct the tests, generate and sign test reports as authorized signatory for the specified types of tests of their domain area in the specified category of Laboratory, without recording any opinion or interpretation of the test results.

All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. The Gazette notification is available in public domain on the website of the Act. The participants endorsed the same.

The National Council approved the draft of Minimum Standards for Collection Centres, as finalized by the subcommittee and circulated with the agenda.

Online Health Portals :

The National Council considered the issue of regulation of online health services aggregator and related service providers under Clinical Establishments Act and their standards etc. It was noted that there is no specific provision for their regulation under the Act

a. The National Council endorsed the following recommendations of the “subcommittee for drafting standards for collection centre”

o Public to be made aware of such illegal online health aggregators

o Need to frame IT / Digital laws/rules to regulate them by the Ministry of Electronics and IT. Ministry of Health and Family may take it up with them and also consult Ministry of Law and Justice in this regard.

o The online Lab service aggregators and service providers should have a registration number and provide information regarding the lab where the samples are being sent for testing.

It was noted that a letter has been written by MoHFW to all States and UTs in this regard; however the respective States/UTs are required to take the necessary steps to regulate them.

It was recommended that all online service providers should have a linkage with the registered clinical establishments. Thus only a registered clinical establishment may be permitted to provide online services. MoHFW may issue necessary instructions to States /UTs in this regard. This may be enforced by the District Registering Authority at the district level and the State Council for clinical establishments at State level.

It was approved that a subcommittee under JS (Padmaja Singh), the Secretary of National Council may further examine the issue of regulation of online health aggregators in detail in consultation with stake holders and Law ministry, for taking appropriate action in the matter.

Patient Rights :

Inclusion of Additional Charter of patients’ rights in minimum standards.

The National Council for Clinical Establishments approved for inclusion of the following additional patient rights, as per NHRC Advisory, in the already approved list of patient rights.

Statutory Compliances

It was recommended to include AERB license as part of statutory requirements in the minimum standards as a pre-requisite for issuance of registration under CE Act, wherever applicable. Further it was approved to include AERB license in list of documents to be uploaded for grant of permanent registration to the clinical establishments, wherever applicable.

Full details of minutes covering list of Patient Rights and various other points discussed during the council meet, can be downloaded from here :

Work Place Health and Safety Guidelines

Mandatory Vaccination for Industrial Workers and Families – Announcement from TN Govt

It is now mandatory for employees as well as their family members to take both doses of Covid-19 vaccine to access workplaces or industries, the Tamil Nadu government has notified today. Notification is issued by TN Health Department (TN DPH).

These guidelines on Covid-appropriate behaviour for workplaces, industries, and factories have mandated many instructions to be followed by businesses at work places.

Key Guidelines :

  • All staff and family members must be vaccinated with two doses OF CIVID 19 vaccine
  • All workplaces and industries with more than 300 employees or 10,000 sqft space should appoint a qualified health inspector, ‘at their own cost’, for monitoring and to coordinate/implement health activities on the premises. 
  • Covid-19 health team must be created on the premises and awareness measures must be held for employees
  • Screening process must include asking the employee for any Covid-19 related symptoms, if family members have symptoms, checking body temperature and checking if the staff is quarantined for having symptoms. 
  • Guidelines say that mask-wearing is mandatory at all workplaces, and administrations must monitor mask compliance through supervisors and managers, including CCTV monitoring. “Anyone without mask must be sent out of the workplace, guideline says.
  • Guidelines insist on maintaining social distancing, hand-washing facilities, and hand sanitation as well to be maintained at work places.
  • In canteen and dining area, the workers must be divided into groups and meals and tea timings should be split across the groups.
  • In quarters and dorms, Covid appropriate behaviour must be followed .

Download the Guidelines Released by TN DPH from here :

Source :

https://www.newindianexpress.com/cities/chennai/2021/jul/25/both-covid-vaccine-doses-must-for-staff-family-members-health-dept-2335008.html

The Occupational Safety, Health and Working Conditions Code, 2020 No. 37 of 2020 announced by Ministry of Labour and Employment has mandated implementation of OSH Code at work places by businesses.

Work Place Health and Safety from now onwards will have more dimension towards Health related focus than the Safety focus that earlier Factories Act had earlier.

Work places should focus on creating Health and Hygiene monitoring teams and more and more employees should be trained towards internalising the practices from now. Businesses should have to focus towards internalising Mental Health Counsellors too slowly and gradually.

All these are interlinked to Work Place Productivity and businesses will have to slowly start addressing multiple challenges that may arise at work place on people related issues.

INFOSAN Alert dated 01st July 2021 – FSSAI announcement

Detection of Salmonella in dried Oregano from Chile [Updated on:05-07-2021]

International Food Safety Authorities Network (INFOSAN) Alert

International Food Safety Authorities Network – INFOSAN issued an alert regarding the detection of Salmonella in Sweden in dried oregano from Chile. The International Food Safety Authorities Network (INFOSAN) is a global network of national food safety authorities, managed jointly by FAO and WHO.

This product has been imported to India by Keya Foods International PVT LTD and distributed within India. 

The Food Safety and Standard Authority of India (FSSAI) on July 1, 2021 has advised all states food authority to recall the dried Oregano from the market, as the INFOSAN detected of Salmonella in dried Oregano from Chile. 

Therefore, All the state food authorities are advised to take necessary actions including complete recall of the product from the market. All the consumers are advised not to consume the product and return back if purchased, to the store/shop of purchase. 

Download FSSAI notification from here

Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.

FSSAI’s mandate for Food Businesses in the country

FBOs to mention FSSAI Licence No. on Invoice / Bills from Oct 1st, 2021

Come 1st October 2021 Food Business Operators (FBO) to mention FSSAI License or Registration number on every invoice.

The Food Safety and Standards Authority of India (FSSAI) has made it mandatory for the FBO’s to declare the 14-digit FSSAI License or Registration number on cash receipts/purchase invoices/cash memo /bills etc.

As per the order dated 8th June 2021, FSSAI mentioned that declaration of the License or Registration number will facilitate the consumers to complain about any grievance with the FBO. Since complaints remain unresolved due to lack of specific information, this move will help consumers who can lodge an online complaint against a particular food business using the FSSAI number.

The Food Safety and Standards Authority of India (FSSAI) has issued a latest order in this regard 8th June 2021 which can be downloaded here.

Licensing and Registration Authorities are directed to widely publicise the policy and shall ensure its implementation mandatorily with effect from October 2, 2021, the FSSAI order says

Mentioning of FSSAI number shall also improve the overall awareness, the Regulator said. If not mentioned, it will indicate non-compliance or non registration/licensing by the food business.

Stating that the food business ecosystem is large, the regulator said 14-digit FSSAI number of any food business operator is not “easily visible and available on consumer/service recipient.”

If the FSSAI number is not available to consumers, expecting him to complain with complete coordinates is an uphill task. Even regulators find it difficult to trace the origin of complaint and attend to it promptly.

No database can be created without a unique locator code, which in case of food safety is the FSSAI number.

Presently, FSSAI number is compulsory to be displayed on packaged food labels but the issue lies especially in case of establishments such as restaurants, mithai shops, caterers, even retail stores.

Further, the regulator said that it is amending the Food Safety and Standards (FSS) Licensing and Registration of Food Businesses Regulations to mandate display of ‘food safety display boards’ at all times at prominent places in case of restaurants.

However, there remains a deficit of mechanism for consumer to know the FSSAI number of the service/product provider.

In case of pre-packaged food where the manufacturer’s FSSAI number is printed on the pack, there exist a deficit of track and trace mechanism whereby the path of the package from a manufacturer to consumer can be traced. The invoice helps establishing this trail. With mentioning of the FSSAI number will help in improving traceability for food products, the regulator added.

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/