ICMR Survey on Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program
Request for Participation In ICMR’s Landscape Study For Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program of Medical Device and Diagnostics Mission Secretariat, ICMR
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical research on the one hand and to the need of finding practical solutions to the health problems of the country, on the other.
The Indian Medical device market is currently valued at USD 11.2 billion and is experiencing a growth rate of 15% CAGR as against growth rates observed by developed countries of about 4% CAGR. India is dependent on imports for its medical device needs with 80% of medical devices being imported. In view of the huge import, dependency and long technology development cycle of medical devices, there is an urgent need for providing holistic support across the medical device development and commercialisation cycle including R&D, scale-up, validation, regulatory compliance, market access etc.
To cater to the above challenges, ICMR has established Medical Device and Diagnostics Mission Secretariat (MDMS) with a vision to support and catalyze research, development and indigenous manufacturing of cost effective medical devices to strengthen health care sector in India and reduce import dependency through a Mission mode consortia approach. ICMR-MDMS aims to conduct a multipronged landscape study inviting medical professionals working at both Government and Private Institutes to provide their opinion on the medical device and diagnostic products as they are the Key Opinion Leaders and the end users of the products.
The objectives of the study are:
(i) To identify various medical devices/sub-sectors/verticals based on unmet healthcare needs and contribute to import dependency in the Country with inherent potential for societal impact. (ii) To strategize, categorize, prioritize, and plan devices/sub-sectors/verticals for extending funding support in a phased manner initially focussing on low end devices, which can deliver volumes and then graduating to high end devices as the program progresses, for accelerating unmet need driven devices and diagnostics product development for wide societal impact. Medical professionals in both Government and private medical colleges/ institution are requested to fill the virtual survey form. The form can be accessed through the link given below. A guidance document is also enclosed for your kind perusal for assisting in filling up the form.
Expression of Interest For Transfer of Technology from CDAC
Announcement from CDAC – CENTRE FOR DEVELOPMENT OF ADVANCED COMPUTING
Centre for Development of Advanced Computing (C-DAC) is the premier R&D organization of Ministry of Electronics& Information Technology (Meity) for carrying out R&D in IT, Electronics and associated areas. More details about C-DAC can be found at www.cdac.in
CDAC, Mohali, originally established as CEDTI (Center for Electronics Design & Technology of India) in the year 1989 is a leading organization of the Ministry of Electronics and IT, Govt. of India for electronics and related technologies. The electronics section has executed several Govt. Of India projects in fields of medical and agriculture. A few products / technologies developed during the course of different projects / initiatives have been refined are being offered for ‘Transfer of technology’. At this point of time, the following products are offered on a non-exclusive basis. After due process as per the CDAC’s ToT policy, the successful bidder shall be provided full technical support to productionise and market the products in Indian markets as per the applicable norms.
Mini Hydroponics system &
Wireless auscultation training system
The technology will be transferred on non-exclusive basis.
The procedure shall involve the following steps –
Call for Expression of interest. The interested Organizations/Entrepreneurs/Agencies can inspect the prototype of the product at CDAC Mohali, before submitting their sealed bid of EoI
The TOT committee will analyze received EoI’s on the basis of Technical and financial position, capability and reputation of the applicants. The short listed applicants shall be asked for submission of their sealed best price (financial) bids.
TOT Committee will do the screening and issue offer letters for TOT to one or more applicants based on highest bid or higher than the certain minimum fixed by the empowered authority.
The selected Organizations/Entrepreneurs/Agencies will pay the TOT fees and sign the agreement for TOT.CDAC will then transfer the technology, hand over all the supporting documents and will provide full technical support and training to the TOT partner.
The ToT package shall contain the following
Document(s) for design and fabrication with block diagram and schematic level explanation of the system.
Bill of Materials of the total system.
Gerber files for PCB design.
Source code of the software.
Test plan and procedure.
Guidelines for field trial and commissioning.
Handholding support for a period of 6 months.
General terms & conditions
The last date for receipt of EoI in the attached template (format) is 6 pm. of 31st January , 2022.
This transfer of technology shall be on a non-exclusive basis.
An expert committee will scrutinize the applications for follow-up action. The applicants may be called for a presentation regarding their strengths and business proposals.
All incidental expenditure incurred in preparation/ submission or presentation of the EoI shall be borne by the participating Organizations/Entrepreneurs/Agencies.
Participation in this EoI does not guarantee any association with C-DAC unless notified by C-DAC in writing.
C-DAC reserves the right of rejecting any offer without assigning reasons.
Any offer received after due date/time will not be accepted.
There is neither a business guarantee nor any commitment for funding support from C-DAC to the appointed/ Empanelled agencies.
A Committee of experts constituted by the competent authority (Director General, CDAC in congruence with Executive Director, CDAC Mohali) will assess capabilities and strengths of the applicant/industry before finalizing the TOT. The minimum turnover of the organization in last three years and/or the manufacturing capabilities may be fixed as one of the eligibility criteria for short listing o f the applicants.
The shortlisted applicants shall then be invited for financial bidding. C-DAC Mohali reserves the right for asking security fee. Based on value quoted and subject to minimum fixed by committee; one or more of the applicants shall be selected for TOT.
The selected applicant willing to take technology for commercial exploitation will be required to enter into a ToT agreement with C-DAC as per the terms and conditions approved by the competent authority for the purpose.
The decision of the committee/ Director General, C-DAC / Executive Director C-DAC, Mohali shall be binding on all concerned.
Who can apply?
•Organizations/Entrepreneurs/Agencies with experience or interest in Electronics or Information and Communications Technology (ICT)
•Organizations/Entrepreneurs/Agencies willing to take up the local production and manufacturing of Electronic Stethoscope.
How to apply?
Interested Organizations/Entrepreneurs/Agencies may send expression of interest with their details by filling the questionnaire as per Annexure – A along with supporting documents to following address.
The participants may then be asked for financial bidding for the transfer of technology.
Executive Director Centre for Development of Advanced Computing (C-DAC) A 34, Phase VIII Industrial Area, Mohali(Near Chandigarh)Punjab ,INDIA Phone: +91-172-6619000, 2237052-57 Fax: +91-172-2237050-51
Note: For any queries please contact : Ms. Brijinder Kaur Tel: + 91-172-6619073, Email: firstname.lastname@example.org
Download the EoI Document here for more detailed information :
Tata Medical and Diagnostics has developed a kit “OmiSure” for detecting Omicron variants in RT-PCR Tests
Tata Medical and Diagnostics has developed a kit called “OmiSure” that can detect Omicron variants of SARS-CoV2 in nasopharyngeal / oropharyngeal specimens during RT-PCR testing. As per the company’s press release, the test kit is compatible with all standard real-time PCR machines. This kit can detect Omicron variants as well as other variants of SARS-CoV2 reported so far.
Currently, patients with Omicron are detected only after genomic sequencing. This test helped eliminate that step and could make detections during the test. The kit was developed to detect new variants of SARS-CoV2 directly and very specifically. Head of Research and Development , TATAMD said the first target is based on the S gene dropout or S gene target disorder (SGTF) and the second target is based on the S gene mutation amplification (SGMA). The Indian Council of Medical Research (ICMR) has approved the kit.
Presently, the Omicron variant is being detected using test kits developed by US-based Thermo Fisher which uses S-Gene Target Failure (SGTF) technology, which is also used by OmiSure.
In its letter approving the kit, the ICMR stated: “The tests have been performed as per the manufacturer’s instructions. Responsibility for batch-to-batch consistency lies with the manufacturer.”
The company had applied for a license with the Central Drugs Standard Control Organization (CDSCO). The kit will be manufactured by TATAMD at the Sriperumbudur facility in Tamil Nadu once the license is approved by the CDSCO. The company currently has daily capacity of 2,000,000 kits and plan to increase the capacity from 5,000,000 to 10,00,000 by the third week of January. The kits are manufactured in both the domestic and international markets. The company also applied for a patent for this kit .
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:
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.
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.
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.
Mannequins (Laerdal) for training of CPR for COVID Preparedness a) Intubation b) Cardio Pulmonary Resuscitation (CPR) c) Peripheral, Central and Arterial Cannulation d) Front of neck Access (Cricothyroidotomy and tracheostomy)
Ilizarov Instrumentation Set Complete with Accessories as
Image analyser cum viral foci counter
Immunoanalyser (Chemiluminescence based) fully automated with UPS back up
In vivo Animal imaging System
Individually ventilated cages/housing system for small animals
Infant Multipurpose Resuscitator cum Operating Beds
Intense Pulse Light Device
Intra Operative Nerve Monitoring
Invasive BP Monitoring System
Inverted Fluorescent Microscope with Live Cell Imaging Capability
Inverted Trinocular Epifluorescence Microscope with Imaging system
IPL (Intense Pulse Light System)
IUD insertion trainer uterus
Karl Fischer Titrator (Semi-Micro Determination of Water)
Laparoscopic Surgery set with High-Definition camera
Laparoscopic Surgery Set with Hysteroscope & resectoscope with High-Definition Camera & Monitor
Laser for existing Confocal Microscope
LEEP System with Smoke Evacuator & integrated cart
Leyla Retractor System
Life Port Kidney Transporter With 05 Sets of Expendables with Each Equipment (PAC)
Liquid Based Cytology System
Liquid Particle Counter
Low Energy Linear Accelerator (LA) System
Magnetic Bead based Multiplex Immunoassay system
Measurement of Lung clearance index (LCI)
Medical Thoracoscope (semi rigid)
Melting- Point Apparatus
Metaphase Finder System with Fluorescence
Micro Needling Radio Frequency Equipment
Microinjection system (Microinjector, Micromanipulator, Pipette puller)
Micro method bilirubin analyser
Microplate multimode reader
Microscope (with Phase Contrast and Camera attachment)
Microvascular Instruments Set
Microwave digestion System
Motor (electric) Dermabrader
MRI 1.5 T
MRI 3T T
MSK-USG with linear transducer
Multimode Microplate Reader and Fluorometer
Multiplex Protein Array System
Multiplex Suspension Array System based on xMAP Technology
NdYag Laser with IPL
ND Yag Laser(1064nm)
Nerve stimulator (intra operative)
Neuro Surgical Drill with all attachments.
Neuropathy analyser-vibration perception threshold + temperature perception threshold
Neurosurgery Operating Table with Accessories
New-born Resuscitation Manikin
Next Generation Sequencer – Higher Version
Next Generation Sequencer – Lower Version
Next generation sequencing machine
Nursing baby with SimPad/Nursing kid with SimPad system
Operating Microscope (Plastic Surgery)/Plastic Surgery Operating Microscope
Ophthalmic Operating Microscope
Orbitrap Proprietary Mass Spectrometer
Orthopantomogram (OPG) unit
Pacemaker Dual Chamber – External
Pacemaker Single Chamber – External
Patient Care Simulator
Patient Care Simulator with Sim Pad
Patient warming System
Paediatric Bronchoscope set
Paediatric cystoscope and resectoscope set/Cystoscope & Resectoscope – Paediatric
Paediatric High Resolution Fibre Flexible Bronchoscope with recorder and Screen Display
Paediatric laparoscopy set
Paediatric rigid Esophagoscope
Physical assessment simulator
Platform pedography system
Point of Care Device for estimation of Cardiac Biomarkers (CKMB, Troponin, BNP, Myoglobin) and PT-INR
Point of Care Machine (Trop I, BNP, CPK-MB, CRP)
Polarimeter with Multi Wavelength
Portable Colour Doppler
Portable colour doppler with echo probe
Portable Echocardiography system
Portable Fluorescence Microscope
Portable Ultrasound & Colour Doppler
Potentiometric Titrator with necessary electrode
Power Assisted Liposuction System
Power Tools for Craniomaxillofacial and hand surgery (Electric micro drill)
Powered Liposuction Set
Preparative floor model refrigerated ultracentrifuge
Protein purification system
Pulsed Field Electrophoresis System
Pure tone Audiometer
QTOF Mass Spectrometer
Quaternary FHPLC (Fast High Pressure Liquid Chromatography) with Fluorescence + visible and PDA detectors with columns and autosampler (Inclusive Software programme + computer + printer+ Online UPS with at least 1 hr backup)
Radiofrequency Generator with integrated vessel sealing and cutting system
Random access medium throughput fully automated chemistry analyser
Real Time PCR machine with standalone UPS unit
Realtime PCR based detection system for specialised pathogens & viruses
Rigid Thoracoscope (VATS)
Semi-automated ELISA system with washers
Semi Rigid Pleurovideoscope
Shaver System cum micro drill
Single Channel transcutaneous oxygen monitor
Single Planar C-Arm Fluoroscope plus DSA with Fluoroscope Compatible OT Table
Small animal behavioural monitoring, tracking and analysis system with accessories (For safety pharmacology)
Super Microsurgery System
Temporary Pace Maker Dual Chamber
Thalassaemia And Hemoglobinopathy Testing/Screening System
Transcranial Magnetic Stimulator
Transcutaneous bilirubin analyser
Transillumination Caries Detector
Triple Quadrupole Mass Spectrometer
Tube feeding simulator (NG, OG and PEG)
Ultra-High Performance Liquid Chromatography
Ultracentrifuge with HEPA filter and necessary rotors
Ultra-Fast Liquid Chromatography
Ultrasonic cutting and Coagulation device
Ultrasound (A+B scan)
Ultraviolet/ Visible Spectrophotometer
UV- vis Spectrophotometer
Vacuum assisted wound closer system
Vacuum Assisted Tissue Processor
Venepuncture and injection arm
Venous Coupler System
Vertical Gel Electrophoresis Apparatus with Western Blotting Apparatus
Video Bronchoscopy system
Video EEG (EEG apparatus 32 channel digital model with Videometery, stimulus evoked response signal
Western Blot Apparatus with Compatible Power Pack
Workstation for Multi-PTM analysis (Proteomics)
Note: List-1 is based on the details, furnished by procuring agencies, till by November 2021 and the List-2 is based on the further details furnished by procuring agencies subsequently.
This Annexure contains the list of Medical Devices/Equipment, with the details of available local manufacturers, as collated from the Domestic Medical Device manufacturing Associations such as AiMED & ADMI and KIHT (based on the details of medical devices, as furnished by the procuring agencies)
Note: The details, as received from the Associations, are incomplete and hence, the concerned local manufacturers are requested to give their full details, as requested in the Notice, to the mail id given in the announcement – email@example.com
DoP lists around 500 medical devices and equipment for which it could not identify any local manufacturers
Even though the government had way back in 2017 announced preference to Make-in India products under public procurement, the Department of Pharmaceuticals (DoP) has identified around 500 medical devices for which there is no data on the local manufacturers available even after its attempt to collect data from the domestic manufacturers association.
If no information is received till the end of December, the DoP will further proceed with the action, arriving that the local manufacturers are not available for these medical devices. This comes at a time when there has been a huge push towards Make in India projects and domestic industries have been demanding more preference to the local manufacturers.
For another 237 products it was able to collate data from the domestic medical devices manufacturing associations.
The Department of Promotion of Industry and Internal Trade (DPIIT) has issued the Public Procurement (Preference to Make in India) Order, 2017, on September 16, 2020, following which the DoP had issued guidelines on February 16, 2021 for implementation of the Order related to procurement of goods and services in medical devices.
The DoP received various representations from the procuring agencies under the Government of India with regard to non-availability of Class I and Class II suppliers for identified medical devices or equipment. An exercise was done by the Department to ascertain the local manufacturers from different sources for these identified medical devices and equipment, including from the domestic manufacturers association.
“However, recognising that the manufacturers of the identified medical devices may be spread across the country and may not be member of any manufacturers Association and also to give a reasonable opportunity, the said medical devices/equipment, as received from the procurement agencies are being put in public domain to collect details of local manufacturers,” said a latest public notice issued by the DoP.
It has sought details including name of the manufacturing entity, address of registered office and manufacturing location, contact details, email ID and phone numbers, local content percentage of the medical devices, specifications of the medical device equipment and whether it is registered with the government e-Marketplace portal, for smooth implementation of the public procurement policy which gives preference to domestic manufacturers with sufficient local content.
If no information is received in the email-ID provided by the Department latest by December 31, 2021, further action will be taken, arriving that local manufacturers are not available for these medical devices/equipment.
For details of the specifications of the medical devices or equipment in the list, the manufacturer may contact agencies like Central Medical Service Society of Ministry of Health and Family Welfare, Employees State Insurance Corporation of Ministry of Labour, All India Institute of Medical Sciences, New Delhi, Procuring agencies of Ministry of Railways, Director General of Armed Forces Medical Services and HLL Infra Tech Services Ltd of Ministry of Health.
The list 1 of 128 medical devices and equipment for which public procurement agencies were not able to identify local manufacturers include intra-aortic balloon pump, video assisted thoracic surgery and minimally invasive cardiac surgery instrument set, flow track cardiac out monitoring device, ENT Coblator system and standard set of wands, among others. The list 2 of 365 medical devices and equipment include 4D echocardiography, ambulatory blood pressure monitor continuous glucose monitoring system, animal simulator for pharmacology, antibiotic zone reader, blood bank management system using RFID technology, among others. The List 1 was based on details furnished by the procuring agencies till November, 2021 and the List 2 was based on further details submitted subsequently.
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.
Outcome of COP26 for India and Abroad – Webinar from Service Export Promotion Council
Announcement from SEPC :
We are Organising a webinar on COP26. A business unit can sell its carbon points and gets incentives on financing and special offers in most of the member countries.
Any kind of environmental steps that a company takes is monetary benefit to them, especially if they are exporting. How to do this can be learnt through this session . Plus there will also be a session on all services and incentives by SEPC.