Category: Testing Laboratories

Awareness programme

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Awareness programme on
Good Clinical Practice Professional Certification Scheme (GCPPCS)
November 07, 2023 11:00 a.m. to 01:10 p.m. IST

Translational Health Sciences and Technology Institute (THSTI), Department of Biotechnology, Ministry of Science and Technology, Government of India announces the rollout of the Good Clinical Practice Professional Certification Scheme (GCPPCS) awareness webinar series.

This new initiative, believed by us, is the first-in-globe, based on the International ‘Personnel Certification’ standard (ISO 17024:2012). It was launched by the Clinical Development Services Agency (CDSA)- THSTI, , and dedicated to the nation on 75th Independence day by Dr. Renu Swarup, Ex-Secretary, Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India in the presence of Dr. Pramod Garg, Ex-Executive Director, THSTI, DBT.

A series of awareness webinars have been scheduled for the prospective clinical research professionals. The first webinar will be held on November 07, 2023, 11:00 a.m. to 01:10 p.m. IST.

We invite all interested professionals – ethics committee members, clinical researchers or clinical trial team members, investigators involved in clinical research or trial, personnel working in the area of regulatory affairs, pharma, biotech, research institutes, academia, and other personnel working in this area to kindly register.

The registered participants will receive e-Certificates (Certificate of attendance).

There is no fee for attending this webinar. The flyer containing all relevant information is given below. 

last date of registration is 05, November , 2023 Sunday till 17:00 pm IST

The link to register online: https://forms.gle/6P4tvExCMxzMa9CP6

We request you to kindly circulate this information among your friends and colleagues and request them to register. If you need any assistance, please contact gcppcs.cdsa@thsti.res.in

CME On Pharmacology on 15th July 2023 – Announcement

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CME on PHARMACOLOGY – TOPIC : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES on 15th July 2023

Government of Karnataka Shri Atal Bihari Vajpayee Medical College & Research Institute, Bengaluru formerly called Bowring & Lady Curzon Medical College & Research Institute, DEPARTMENT OF PHARMACOLOGY jointly organised with NCC-MvPI, IPC & RTC-MvPI NIMHANS, Bengaluru conducting CME on 15thtJuly 2023

Topic : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES

Mode : Hybrid

Time : 9 am to 4 pm

Fee : Rs. 200

Venue: Lecture Hall 3, SABVMCRI, Bengaluru

Contact : Dr. Nishitha S B @ 9591040864

Who can register: Medical, Dental, Nursing, AHS , Paramedical, Pharmacy, AYUSH, Physiotherapy – faculty/Students, Health Department Officials & Industry Professionals

Registration Link : REGISTRATION FORM (google.com)

For any queries please contact Dr. Nishitha SB: 9591040864 / Dr. Poorvi M: 7259349749
Email: amcsabvmcri@gmail.com

Click here to read more

New Drugs and Clinical Trial Rules (2023)

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New Drugs and Clinical Trial Rules (2023) 

New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.

Need for new regulations:

  • Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
  • The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.

Key-highlights of the Amendment:

  • The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
  • These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies

Technologies suggested as alternatives:      

To avoid animal use for clinical trials, technologies can be used effectively which includes;

  • Technologies developed using human cells or stem cells: These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
  • ‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, to mimic blood flow inside the body.
    • These systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.
  • USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
    • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.
Click here to read more

Notification given by FSSAI

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FSSAI issued a Directions to all FSSAI Notified laboratories for Organic Testing

The Food Safety and Standards Authority of India has given a Direction to all FSSAI Notified Laboratories for Organic Testing under section 43(1) and 43(2) of FSS Act 2006.

All the FSSAI Notified laboratories are directed for the following:

a. To review their current capabilities and take the necessary steps to enhance the infrastructure and scope of the testing for organic products.

b. To make an application to APEDA for recognition of the laboratory for testing organic products.

c. To apply to National Referral Laboratory of APEDA for participation in proficiency testing as a pre-requisite to qualify for pre-export testing of organic products.

Click here to read the Notification

Source: https://www.fssai.gov.in/

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

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

How Venture Capital Is Fuelling Innovation In Molecular Diagnostics In India

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How Venture Capital Is Fuelling Innovation In Molecular Diagnostics In India

Molecular diagnostics, involves the detection and analysis of specific molecules such as DNA, RNA, and proteins in order to diagnose diseases and conditions with greater precision and accuracy. 

Some of the key advantages of this Molecular diagnostics are

  • Higher sensitivity and specificity
  • Early detection
  • Personalised treatment
  • Cost, sensitivity and speed mix

According to Suraj Nair, Project Lead and Researcher, Deep Science Technologies at Ankur Capital, “Early detection of infectious diseases is key to ensuring appropriate treatment and safeguarding the health of individuals. Molecular diagnostics tools with very high sensitivities and specificities are best suited in this regard and are expected to see widespread adoption over the next decade.”

The global molecular diagnostics market was worth $9.2 Bn in 2020 and is expected to reach $23.9 Bn by 2030, with a CAGR of 9.86% from 2021 to 2030. On this side of the globe, the Indian molecular diagnostics market was valued at around $920 Mn in FY 2020 and is estimated to grow at a CAGR of approximately 10% until FY 2026

8X Ventures conducted research to consolidate the prime areas where different stakeholders need to play their part in building the molecular diagnostics infrastructure in the country. 

  • Increased Startup Activity: VC activity was comparatively lower in India when the first-generation companies such as Medgenome and Molbio Diagnostics started, hence scaling has taken time. On the other hand, new-age startups such as DNome have a comparative advantage of scaling things faster with funding support and the push from the ecosystem. 
  • VC Investment: Both large and small VC players have set up the precedence, and a lot of unconscious VCs will follow suit. Though they will have to catch up with the mechanics of this space — diagnostic lab developers, care staff, intermediaries, government regulators and more while providing strategic guidance to the startups. 
  • Customer Adoption: With widely available solutions, the customer adoption J-curve is expected to activate. This could lead to increased demand for better and cheaper technology, such as LAMP MDx, which is currently underutilised. Additionally, there is a need for improved point-of-care diagnostic infrastructure. 
  • Government Support: The power to develop the infrastructure and resources required for molecular diagnostics, such as laboratory facilities, a skilled workforce, and funding for research and development, lies with the government of India and its collaboration with the private sector and academic institutions

Given the demography of India, VCs need to step up their game and understand the holistic development of molecular diagnostics, keeping all levels of stakeholders involved in their studies. The initial and follow-on capital for R&D is critical to the success of the early-stage capital-intensive phase of molecular diagnostic startups in India

source:https://inc42.com/resources/how-venture-capital-is-fuelling-innovation-in-molecular-diagnostics-in-india/

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 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
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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

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