Category: Medical Testing Labs

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

Best Practices in Social Sector

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NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023”

NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023” in collaboration with the United Nations Development Programme.

To commemorate 75 years of India’s independence and highlight and laud the efforts of Union Ministries and State Governments, this compendium includes 75 case studies cutting across 14 key social sectors. The case studies have been sourced from all States/ Union Territories and 30 Ministries and Departments of the Government of India.

The seventy-five best practices highlight models which are innovative, sustainable, replicable and impactful. The aim of this exercise has been to synthesise lessons for the future to expand, enhance and improve life at the grassroots level. Due care was taken to ensure that the cases identified are spread over diverse themes, including education, health and nutrition, e-governance and digitization, agriculture, women’s empowerment, sports, and financial inclusion, among others.

Click here to read the document

Source: https://niti.gov.in/node/3568

Certification Schemes from AMTZ 

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Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme 

Program on Healthcare Textiles Processing Facility Certification Scheme  

The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again.   

Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme    This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis.

This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider.  

These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).


Date: 27th May 2023

Time: 3:00 pm to 6:00pm IST

Mode – Virtual Mode / Webinar
Program Agenda
Click here to Register

Conference on Telehealth

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SMART Hospitals India Conference 2023 at Medical Fair India, Pragati Maidan, New Delhi

SMART Hospitals India Conference 2023 at Medical Fair India, New Delhi

Conference Theme 2023

Telehealth : Where SMART Technologies connect with healthcare settings for better patient outcomes

Healthcare Service Providers are increasingly adopting multiple digital health initiatives for better patient connect and seamless delivery of patient care. FUTURE SMART Healthcare Establishments focus on providing solutions to meet the rising needs of SMART PATIENTS across the globe.

Smart Hospitals Business Sessions this year are designed to create focused discussions around TELEHEALTH Technologies as listed below

Session 1 – Telehealth Technologies , Solutions for Better Patient Care in Healthcare Settings in India

Session 2 – Delivering Quality Care through Telehealth Quality System Program in Clinical Settings

Session 3 – Health Technology Assessments and Regulatory Requirements of Telehealth Solutions in India

Program Date :

Date: 29th April 2023 – Saturday
Time: 10:00 a.m. – 5:00 p.m.
Venue: Hall 5, Pragati Maidan, New Delhi

For more information on program, registration links, do visit – https://www.medicalfair-india.com/en/Special_Shows/Smart_Hospitals

Prior registration is a must to attend the conference.

For enquiries related to Conference Partnerships, Stall bookings in the Expo, enquiries, 𝗽𝗹𝘀 𝘄𝗿𝗶𝘁𝗲 𝘁𝗼 :

VermaA@md-india.com / +91-124-4544507


For enquiries related to Delegate Registration to the Conference, please write to :

Ms Rama Venugopal
Vice Chairperson – SMART Hospitals Conference
Email – info@smarthospitals.events
WhatsApp – +91 7338992778 / +91 9840870532

One Person Company (OPC)

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NABL accepts the “One Person Company (OPC)” as a legal entity of CAB

NABL accepts the “One Person Company (OPC)” as a legal entity of CAB under the Companies Act 2013.

An OPC has features of a Company along with the benefits of a Sole Proprietorship.

An OPC can have just one single member and one Director. The Director and member can also be the same person. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013.

The accredited CABS which are under Proprietorship are given a transition period till 31.12.2023 to align with any one of the legal entities specified in the Notification

click here to read the Notification

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

Workshop on NEC 2023

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Two days workshop on National Electrical Code of India

NFE in association with BIS is conducting a 2-Days workshop across multiple locations in India, including Chennai, Mumbai, Bangalore, Hyderabad & Ahmedabad. In Chennai, the workshop is scheduled on 20th & 21st April 2023 at L&T, Manapakkam, Chennai.

Free for the NFE Members and for Non – NFE Members Rs.2500 plus GST

To know more about the workshop and its schedule feel free to connect with NFE at info@nfees.org/nec@nfees.org or visit their website at http://www.nfees.org

Click here to register https://lnkd.in/gJZXxreB

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

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Workshop on Indian Medical Device Rules 2017

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Duration: 2 Days (31st March & 1st April)

Location: Kalam Convention Center, AMTZ Campus, Vizag

Fee: INR 3,540 (Including GST)

Registration link: https://ibsc-amtz.in/coursedetails/25

Last Date For Registration: 25th March 2023
➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990
WhatsApp Link: https://wa.me/918897330990
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

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

GCLP Workshop @ Chennai

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Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023

GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.

This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop

Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop

Learning Objectives:

  • Basic principles of the GCLP and their relation to patient care services or clinical research.
  • Implementing GCLP essentials to establish a quality system and its maintenance.
  • Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards

Workshop Scope:

  • Overview and essentials of ISO 15189:2012.
  • Overview and essentials of new standard – ISO 15189:2022.
  • Overview and essentials of NABL-112 guidelines document.
  • Overview and essentials of ICMR-GCLP 2021 guidelines.
  • Special reference to the following key components:
    o Quality System Essentials (QSEs).
    o Establishment, management and monitoring of quality system.
    o Quality indicators and continual improvement.
    o Issues with EQAS/PT, Issues with facility operation.
    o Internal Quality Audit (IQA) – common NCs and its closures.
    o Lab accreditation associated challenges and overcoming the challenges.
    o Biosafety and infection control.
    o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard.
    Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.

Registration:
The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077

The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: https://forms.gle/yASYBXXqKnp7NmdN8. Out station participants need to book accommodation on their own

Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.


Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: GCLPSAVEETHA@gmail.com

Click here to register
Click to Download Brochure

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