Tag: Healthcare

Procedure for submission of cough syrups for Testing

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Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing

Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments

Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.

The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments

In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable
Click here to read the Notification

Source: https://www.dgft.gov.in/CP/?opt=notification

EGA 2023 – Application Now Open

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Envirocare Green Awards 2023

Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment. 

EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care. 

The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.

The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.  

The application for this award is online and is open for across the globe under the following categories:

1. Individual / s

2. Private Ltd / LLP / MSME

3. Public Sector / Large Corporates

4. Non Government Organisation NGO / Cooperatives

5. Government Organisation / Municipal

6. Academia

7. Others

To apply please click here for online Google Form:https://forms.gle/ZfWBjSR8PA6W5Bqe7

The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA

Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in

For regular updates on EGA 2023 , visit  https://lnkd.in/eDiKu3R

Ethical Guidelines for the Application of AI

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Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare by the ICMR

Artificial Intelligence (AI) and Machine Learning (ML) are certainly the game-changer in the space of healthcare. A wide variety of exciting and future-looking applications of AI/ML techniques and platforms are available now. Identification of disease, screening, making diagnosis, medical imaging, intelligent health operations management, personalized medicine to digital surveillance for public health, outbreak prediction, and drug discovery are only some of the emerging uses of AI/ML.

However, AI as data-driven technology has many potential ethical challenges which include algorithmic transparency and explainability, clarity on liability, accountability and oversight, bias and discrimination

The Indian Council of Medical Research (ICMR) has come up with the country’s first Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare to provide an ethical framework for the development of AI-based tools which will benefit all stakeholders. These guidelines apply to AI based tools created for all biomedical and health research and applications involving human participants and/or their biological data.

The purpose of the Guideline is to provide an ethics framework which can assist in the development, deployment, and adoption of AI-based solutions for biomedical research and healthcare delivery. The guidelines are intended for all stakeholders involved in research on artificial intelligence in healthcare, including creators, developers, technicians, researchers, clinicians, ethics committees, institutions, sponsors, and funding organizations.

The document includes separate sections addressing ethical principles for AI in health, guiding principles for stakeholders, ethics review process, governance of AI use for healthcare and research, and informed consent process involving human participants and their data. The guideline has been formulated after extensive discussions with subject experts, researchers and ethicists

Click here to read Ethical Guidelines

Source:https://main.icmr.nic.in/content/ethical-guidelines-application-artificial-intelligence-biomedical-research-and-healthcare

CAHO Webinars

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Webinar on Understanding Technical Regulations and Standards

Healthcare services rely on a number of products – from drugs to medical devices to food to electronic items. Many of these items not only need to be of high quality but also safe to use.

Since many products have health and safety implications, they are or should be regulated while others may not need to be regulated but quality needs to be assured.It is therefore necessary for healthcare industry to understand the world of what are called technical regulations and standards, how it should go about procurement of products it needs and what kind of certificates it should rely on

CAHO is hosting a webinar on the topic Understanding Technical Regulations and Standards by Mr.Anil Jauhri , (Former CEO,National Accreditation Board for Certification Bodies (NABCB)) on 23rd March 2023 between 4.00 to 5.30 pm.

Click here for Registration

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region

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Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:

➢ Accounting and Auditing Services

➢ Educational Services

➢ Healthcare Services

➢ Architectural, Construction & Related Engineering, Environmental Services

➢ KPO/ ITO Services

➢ Logistics Services

➢ Tourism Services

➢ Entertainment Services

➢ Other Professional services

Benefits you may get while participating at BSM to ASEAN region.

• Focused pre scheduled 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.

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) 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

Click here to read more
Click here for Itinerary Details
click here for Registration

Announcement – ICAI issues Social Audit Standards

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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.

Click here to read the Standard

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

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

Admission Open – ISO 13485:2016 – Lead Auditor Training

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ISO 13485:2016 – Lead Auditor Training Program (Medical Device Quality Management Systems )

Indian Biomedical Skill Consortium (IBSC) is conducting Lead Auditor Training Program on ISO 13485:2016 standard.

Program Details are given below:

Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )

Certificate: CQI & IRCA Certified Course

Duration: 5 Days (23rd – 27th January 2023)

Last date for Registration : 12th January 2023

Location: Kalam Convention Center, AMTZ Campus, Vizag

Program Details: https://ibsc-amtz.in/coursedetails/23

For quotation send email to n.nareshkumar@ibsc_amtz.in
➖➖➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

Source: https://ibsc-amtz.in/

Announcement from NABH

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LATEST NOTIFICATION FROM NABH ON IMPLEMENTATION PLAN OF 3RD EDITION OF NABH SHCO ACCREDITATION STANDARDS

Announcement from NABH

NABH has released a notification on implementation of 3rd Edition of NABH SHCO Accreditation Standards.

Key information from the notification is shared below :

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

The effective date of Implementation of the third edition standards for SHCO would be as below:

a.     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. The onsite compliance shall be verified during next on-site assessment (which can be either surveillance or renewal assessment).

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

c.      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.

d.     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 1st September 2024.

Download the Notification

Source: https://nabh.co/

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

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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.

Click Here to Read More

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

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