Workshop on Pharmacovigilance

Workshop –Cum-Training program on Pharmacovigilance

Indian Pharmacopoeia Commission is organising a Workshop cum Training Programme on Pharmacovigilance for NABH Accredited Hospitals on Monday, July 11, 2022 between 9 am to 1 pm at Shekhar Hospital, Uttarpradesh

Total seats: 50, Registration will be accepted based on first come first serve basis.

Registration fee is Rs.1180 inclusive of GST. Last date for registration is July 6 2022.

WAD 2022 Event Update from CCC

World Accreditation Day Conference – Post Event Update

World Accreditation Day Conference 2022 – Post Event Update

WAD 2022 Conference jointly organised by International Accreditation Services (IAS), USA; Bureau of Indian Standards and Consultants Consortium of Chennai ended on June 10th 2022 with a positive a note.

Two days conference held on June 9th and 10th had eminent speakers from India and abroad , from various sectors , sharing rich insights about Standards, Certifications, Accreditations, Inspections & Regulations related to Sustainability and Environment across the globe.

Two days of intense learning sessions came to an end on June 10th.

Conference had 324 delegates registering for multiple sessions across two days and the feedback received from them is very encouraging.

The conference is supported by many Trade and Industry Platforms as listed below :

Sharing few pictures of the event for reference :

Session Videos are shared here for industry and stakeholders benefit. Please check the links below

INAUGURAL SESSION :
Theme – Sustainability in Economic Growth and the Environment

TECHNICAL SESSION 1:
Theme – Sustainable Standards for a Safer World

TECHNICAL SESSION 2 :
Theme – ESG Rating for Sustainability Initiatives

TECHNICAL SESSION 3 :
Theme – Sustainability Initiatives in Food Sector

TECHNICAL SESSION 4 :
Theme – Sustainable Healthcare Initiatives

TECHNICAL SESSION 5 :
Theme – Incorporating Sustainability in Educational Institutions

PHDCCI Conference

Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)

Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:

Day & Date: Friday, 24 June 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights
• Regulation of medical devices and recent amendments
• Steps to Licensing for Class A & Class B Devices/Products
• QMS requirements for Medical Devices
• Demonstrating Product Compliance as per MDR-17
• Challenges faced by Medical Devices Manufacturers

Key Speakers
• Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications
• Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi
• Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

You may send your questions to rimneet.kaur@phdcci.in prior to the session.
The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

Conference on Medical Devices

National Conference on “Management & Ensuring Safety of Medical Devices” on 9th July 2022

Objective & Targeted audience:

This training program is organised to sensitise among Biomedical/Service engineers from State/Union territory medical services Corporation, Biomedical engineers working in government/private/corporate sector in southern India, Biomedical engineering students & other stakeholders to initiate the reporting mechanism and to ensure active participation in reporting incidents related to medical equipment.

Delegate Registration Process :
Registration Fee:
For Industry delegates: Rs 2000/-
For Healthcare professionals: Rs 1000/-
For Students & other stakeholders: Rs 500/-

Last date for registration is on or before 20 June 2022 at 5:00 pm

Registration Link –

OHSAS Standard

Webinar on OHSAS Standards for Businesses – Jan 28th 2022, Friday – 4 PM – 5 30 PM

Covid 19 outbreaks still continue and businesses struggling with hybrid work options.

Businesses and Enterprises have the responsibility to protect the health and safety of their workers.

Helping employees return to work, safely and confidently, during the coronavirus (COVID-19) pandemic is no easy task for any organisation.

Creating a Safer Work Place is the need of the hour and businesses have to focus on introducing Safe Work Place Practices, Systems to offer an assurance to the employees that they continue to work on safer environment and work place has provision to take care of their health and wellbeing.

Many Businesses focus on growing their business responsibly. That means safety is not negotiable – it’s their number one priority.

Safety is about people – caring about people, and ensuring their wellbeing, is the foundation of what it means to be a sustainable business. 

Global Markets have started releasing OSH, OHSAS guidance documents for businesses to follow. Proposed Labour Code in India – OSH Code, also mandates work place health and safety of employees.

Considering the need to provide more assurance to Employees to return to work, to remain working in a safe work place, businesses have started looking for Tools, Guidelines etc to implement best practices to address these needs. Occupational Health and Safety Standard is an International Standard that helps businesses to implement well defined Management Systems to protect employees health and wellbeing.

Andhra Chamber of Commerce is organising a Program on OHSAS by inviting Team from Bureau of Indian Standards to present OHSAS Standards requirements to the industry . This is a Knowledge Sharing Session from Andhra Chamber of Commerce.

Andhra Chamber invites participation from the industry , business units of all sizes to register for the same.

There is no participation fee and the session is open to industry and other stakeholders too.

Program Details :

Date – Jan 28th 2022, Friday
Time – 4 00 PM – 5 30 PM

Regn Link :

https://us02web.zoom.us/meeting/register/tZ0vde2tpjsrHtJ76ZF3jJsvM-CzpqeogaJ4

Contact Details :

Secretariat – Andhra Chamber of Commerce
andhrachamber1@gmail.com
044 – 24315277/78/79

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

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

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

OSH Code 2020

New Labour Codes – Occupational Safety, Health and Working Conditions Code, 2020

The central government has notified four labour codes, namely, the Code on Wages, 2019, on August 8, 2019, and the Industrial Relations Code, 2020, the Code on Social Security, 2020, and the Occupational Safety, Health and Working Conditions Code, 2020 on September 29, 2020.

The Code of OSH which deals with Occupational Safety, Health and Working Conditions at Work Places assumes highest significance as businesses have to refocus on Work Place Health and Safety Conditions to protect the health of workers due to ongoing pandemic crisis and health issues that are faced by workers, employees at work places.

This is a post of OSH Code written by A A Srinivasan, Principal Consultant highlighting the key features of OSH Code . Businesses have to work towards implementing the code requirements based on Rules released by State Governments.

The article is published the E Bulletin of Andhra Chamber of Commerce – Dec 2021 issue and the same is shared here for reference

About the Author :

A A Srinivasan is the Principal Consultant and well versed with Mgmt Systems Standards implementation requirements of various National, International Certifications and Accreditations Programs with hands on experience across many sectors.

Contact – srinivasanaa@valueadded.in