Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm
Sustainable Trade Development and Voluntary Sustainable Standards
Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.
The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.
Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.
Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.
Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.
Sustainability standards can unlock new markets for developing countries.
Go Green, Go Sustainable
More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.
Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.
Program Objective
Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.
The program is designed on the topic Sustainability Standards based on the WSD Theme.
Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.
Program Details
Topic – Role of Sustainability Standards in International Trade
Date : October 14th 2022 – Friday
Time : 04 30 pm – 06 00 pm
Meeting Mode – Online / Virtual
Meeting Platform – Zoom
Fee : No Registration Fee.
Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.
Recent Regulatory Updates from CDSCO for IVD Medical Devices in India
Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.
In a review meeting held last week, Union Health Minister Mansukh Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.
He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.
As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action
The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon
Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness.
A license is presently required to manufacture or import these 37 categories of medical devices
All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.
IVDs are also Medical Devices and are subject to the same regulatory framework.
In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :
Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07
Outsourcing of Information Technology (IT) Services – Draft Master Direction from Reserve Bank of India
Regulated Entities (REs) have been extensively leveraging Information Technology (IT) and IT-enabled services (ITeS) in their business, products and services with increasing dependence on third parties. Such reliance on IT/ITeS provided by third parties exposes the REs to various risks.
Primary (Urban) Co-operative Banks having asset size of ₹1000 crore and above;
Non-Banking Financial Companies in Top, Upper and Middle Layers;
Credit Information Companies; and
All India Financial Institutions (NHB, NABARD, SIDBI, EXIM Bank and NaBFID)
Purpose: The underlying principle of these Directions is that the RE should ensure that outsourcing arrangements neither diminish its ability to fulfil its obligations to customers nor impede effective supervision by the supervising authority. REs desirous of outsourcing of IT and IT enabled services shall not require prior approval from RBI. However, such arrangements shall be subject to on-site/ off-site monitoring and inspection/ scrutiny by the supervising authority.
These Directions shall apply to material Outsourcing of IT Services arrangements (as defined in para 1.7 below) entered by the REs.
What the Draft document contains ? – Applicability – Purpose – Service Provider – Information Technology (IT) Outsourcing – Material Outsourcing of IT Services: – Criticality of Outsourcing of IT Services – RE’s role in Outsourcing of IT Services- Regulatory and Supervisory requirements – Governance Framework – Role of the Board – Role of the Senior Management – Role of IT Function – Evaluation and engagement of Service Providers – Outsourcing Agreement – Risk Management – Business Continuity Plan and Disaster Recovery Plan – Monitoring and Control of Outsourced Activities – Outsourcing within a Group/ Conglomerate – Additional requirements for cross-border outsourcing – Exit Strategy
Comments : Comments / feedback from REs and other stakeholders may be submitted by July 22, 2022 through email with the subject line ‘Feedback on Master Direction on Outsourcing of IT Services’.
The final Master Direction shall be issued by Reserve Bank after considering the feedback received.
Download the Draft Master Direction Document released by RBI from the button below :
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
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.
Date of Submission: Start Date: 3rd Feb’ 2022 Time: 09:00 AM End Date: 25th Feb’20202 Time: 05:00 PM
In case of any query you may contact the following officials: Medical Device and Diagnostics Mission Secretariat (MDMS) Indian Council of Medical Research Ansari Nagar, New Delhi- 110029 Email: suchita.markan@icmr.gov.in, icmrmdmsoffice@gmail.com, div.itr.icmr@gmail.com Telephone No.: +91-11-26588895 Ext-337
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
MK-1ARS
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.
Training.
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: brijinder@cdac.in
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 .
Semiconductors and Display Fab Ecosystem – PLI Scheme for Manufacturing in India
Program for Development of Semiconductor and Display Manufacturing Ecosystem Notified
In furtherance of the vision of Aatmanirbhar Bharat and positioning India as the global hub for Electronics System Design and Manufacturing, the Cabinet approved the comprehensive program for the development of sustainable semiconductor and display ecosystem in the country with an outlay of Rs.76,000 crore (>10 billion USD). The programme will usher in a new era in electronics manufacturing by providing a globally competitive incentive package to companies in semiconductors and display manufacturing as well as design. This shall pave the way for India’s technological leadership in these areas of strategic importance and economic self-reliance.
Semiconductors and displays are the foundation of modern electronics driving the next phase of digital transformation under Industry 4.0. Semiconductors and display manufacturing is very complex and technology-intensive sector involving huge capital investments, high risk, long gestation and payback periods, and rapid changes in technology, which require significant and sustained investments. The programme will give an impetus to semiconductors and display manufacturing by facilitating capital support and technological collaborations.
The programme aims to provide attractive incentive support to companies / consortia that are engaged in Silicon Semiconductor Fabs, Display Fabs, Compound Semiconductors / Silicon Photonics / Sensors (including MEMS) Fabs, Semiconductor Packaging (ATMP / OSAT) and Semiconductor Design.
Following broad incentives have been approved for the development of semiconductors and display manufacturing ecosystem in India:
Semiconductor Fabs and Display Fabs:The Schemes for Setting up of Semiconductor Fabs and Display Fabs in India shall extend fiscal support of up to 50% of project cost on pari-passu basis to applicants who are found eligible and have the technology as well as capacity to execute such highly capital and resource intensive projects. Government of India will work closely with the State Governments to establish High-Tech Clusters with requisite infrastructure in terms of land, semiconductor grade water, high quality power, logistics and research ecosystem to approve applications for setting up at least two greenfield Semiconductor Fabs and two Display Fabs in the country.
Semi-conductor Laboratory (SCL): Union Cabinet has also approved that Ministry of Electronics and Information Technology will take requisite steps for modernization and commercialization of Semi-conductor Laboratory (SCL), Mohali. MeitY will explore the possibility for the Joint Venture of SCL with a commercial fab partner to modernize the brownfield fab facility.
Compound Semiconductors / Silicon Photonics / Sensors (including MEMS) Fabs and Semiconductor ATMP / OSAT Units: The Scheme for Setting up of Compound Semiconductors / Silicon Photonics / Sensors (including MEMS) Fabs and Semiconductor ATMP / OSAT facilities in India shall extend fiscal support of 30% of capital expenditure to approved units. At least 15 such units of Compound Semiconductors and Semiconductor Packaging are expected to be established with Government support under this scheme.
Semiconductor Design Companies: The Design Linked Incentive (DLI) Scheme shall extend product design linked incentive of up to 50% of eligible expenditure and product deployment linked incentive of 6% – 4% on net sales for five years. Support will be provided to 100 domestic companies of semiconductor design for Integrated Circuits (ICs), Chipsets, System on Chips (SoCs), Systems & IP Cores and semiconductor linked design and facilitating the growth of not less than 20 such companies which can achieve turnover of more than Rs.1500 crore in the coming five years.
India Semiconductor Mission: In order to drive the long-term strategies for developing a sustainable semiconductors and display ecosystem, a specialized and independent “India Semiconductor Mission (ISM)” will be set up. The India Semiconductor Mission will be led by global experts in semiconductor and display industry. It will act as the nodal agency for efficient and smooth implementation of the schemes for setting up of Semiconductor and Display Fabs.
Scheme
Notification
Guidelines
Scheme for setting up of Semiconductor Fabs in India
Scheme for setting up of Compound Semiconductors / Silicon Photonics / Sensors Fab and Semiconductor Assembly, Testing, Marking and Packaging (ATMP) / OSAT facilities in India
A Dedicated Portal For India Semiconductor Mission Launched
The government of India has launched a new portal solely dedicated to the India Semiconductor Mission. This portal will serve as one window for all the works related to applications for the recently announced semiconductors program in the country.
A dedicated portal – https://ism.gov.in for the ISM shall serve as a single window for registering and filing applications under the three schemes viz.
(i) Scheme for setting up of Semiconductor Fabs in India;
(ii) Scheme for setting up of Display Fabs in India; and
(iii) Scheme for setting up of Compound Semiconductors / Silicon Photonics / Sensors Fab and Semiconductor Assembly, Testing, Marking and Packaging (ATMP) / OSAT facilities in India
The government is expecting 15 to 20 companies to be supported in each category that is Compound Semiconductor and ATMP. It will provide up to 50 percent of Project cost for two semiconductor and two display fabs in the country. The Application window starts January 1 and will be open for 45 days. Support under the scheme shall be provided on pari-passu basis for a period of six years. The capital investment threshold stands at a minimum of ₹20,000 crore, while the revenue threshold is at a minimum of Rs 7,500 Crore in any of the three financial years preceding the year of submission. India presently relies completely on imports for meeting its semiconductor needs.
DoP Announcement – Call for Updating, Listing of Domestic Manufacturers in India
Announcement from DoP to Local Manufacturers of Specific Medical Devices / Equipment
ANNEXURE – I
This Annexure contains the list of Medical Devices/Equipment, for which, the details of local manufacturers are not available, as per the details 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)
LIST-1 of 128 Medical Devices/Equipment
S.No.
Name of Medical Device/Equipment
1
Intra-aortic balloon Pump (IABP)
2
Video Assisted Thoracic Surgery (VATS) and Minimally Invasive Cardiac Surgery instrument set
3
Flow Track Cardiac Output Monitoring (EV1000)
4
Sander’s Jet Ventilator for Emergency Airway
5
ENT Coblator system with standard set of wands
6
Automated Identification and antibiotic susceptibly system
7
Automated Semen Analyzer
8
Histopathology fully automated H& E slide Stainer
9
Fully Automated IHC Stainer
10
Auto PAP cervical cancer screening system with HPV
11
Automatic components preparation machine
12
Visual Field Analyzer
13
Cystoscope paediatric cystoscope
14
Flow Cytometer
15
Flexible cysto-nephoscopy
16
T Piece Resuscitator
17
CO2 Fraction Laser
18
Diode Laser
19
Q-Switched ND YAD Laser
20
Video Bronchoscope set Adult, Paediatric, and Neonatal
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)
Biomimetic Synthetic Absorbable Dural substitute of sizes
82
AO TRS Modular Drive for Drill/Reamer
83
AO TRS Modular Sagittal saw system
84
Battery Oscillator
85
Arthroscopy Systems
86
Navigation System for Neurosurgery & Orthopaedic Surgery
87
Time Lapse Embryo Imaging System
88
Portable Mobile Endoscopy Unit
89
Cryoprobe
90
Isothermal Calorimeter (ITC)
91
Electrical Impedance Tomography
92
FNIRS (Functional Near Infra-Red Spectroscopy) System
93
Automated Hand-Held Analyzer
94
Automated High Throughput Liquid Based Cytology (LBC) System
95
Automated IHC (lmmunoHistochemistryStainer)
96
Automated Slide Stainer for Histopathology
97
3T Digital PET/MR
98
Dual Particle Cyclotron on buyback basis
99
Sweat Collection and Chloride Estimation
100
Automated Bronchoscope Cleaning Equipment
101
Electronics and console for the existing 700 MHz NMR Spectrometer
102
Video bronchoscope with mobility of tip in four directions
103
Freeze Facture System
104
Cryo Plunge Freezing Unit
105
Biological High- Resolution Atomic Force Microscopy
106
Carbon Coater (Evaporator) for grids
107
HemostasisAnalyzer System
108
Auricular Reconstruction Set
109
Thin Layer Chromatography Liner Analyser for lipid analysis
110
Digital Slide Scanner System
111
Full Endoscopic lumbar IT & ED set
112
Rapid Blood/Fluid Flow warmer
113
Fully Automated Computerized Archival System for Histopathology & Cytology Slides
114
Vacuum Assist Drainage Controller Device
115
VAP Care System
116
Cryoablation Unit
117
3D Printer Hardware with SLA (LFS) TM Technology and Machine interface software
118
Transcutaneous Oxygen Monitor
119
Non-Invasive Jugular Oximetry Monitor
120
Dedicated Solid-state cardiac SPECT Camera
121
Hemodynamic Recorded for Cardio Vascular Lab
122
Gel Documentation System
123
Automatic Colony Counter
124
Droplet Digital Polymerase Chain Reaction System (PCR)
125
Multi-block PCR Machine
126
Integrated Automated Charting System upgradable for ICU Monitoring System
127
Viscoelastic Global coagulation Testing Device
128
Robotic Surgery System with accessories
LIST – 2 of 365 Medical Devices/Equipment
S.No
Name of Medical Device/Equipment
1
3 feet IVF workstation with stereo microscope & camera
2
384 well block, 96-well block and open array real-time PCR system
3
4D Echo Cardiography
4
532 nm Green Laser Console
5
Advanced Flow Cytometer
6
Advanced High Energy Linear Accelerator (LA) System
7
Agarose Gel Electrophoresis System
8
Air Particle Counter
9
Ambulatory blood pressure Monitor Continuous Glucose Monitoring System
10
Anaerobic work station with gas cylinder complete
11
Animal Stimulator Software for Pharmacology
12
Antibiotic Zone Reader
13
Apheresis Machine
14
ATLS Practising Manikin
15
Atomic absorption Spectrophotometer (AAS) with hydride generator
16
AutorefractorKeratometer
17
Autoanalyzer immunoassay (chemiluminescence based) – fully automated with UPS back up
18
Automated bacterial identification system
19
Automated Capillary DNA Sequencer
20
Automated Cell Viability Analyser with computer, printer and UPS
21
Automated Clinical Electrophoresis
22
Automated continuous monitoring standalone blood culture system
23
Automated Coverslipper
24
Automated digital slide scanner
25
Automated liquid handling system for Serial Dilutions
26
Automated Microbial Identification and Antimicrobial Susceptibility Testing System
27
Automated Nucleic Acid Purification system (96 well)
28
Automated Perimeter
29
Automated Protein Purification System (FPLC)-
30
Automated rapid T.B culture and drug sensitivity detection system for 960 samples
31
Automated Real Time qPCR with four sample modules
32
Automated Slide Stainer
33
Automated Tissue Microarrayer & TMA Software
34
Automated Urine Analyser
35
Automated Vascular Doppler Recorder for ABI/TBI/Segmental Pressure
36
Automatic Chemistry Analyzer
37
Basic Transcranial Magnetic Stimulator
38
Battery operated drills
39
Bench top flow cytometer
40
Bench Top Fourier Transform NMR System (Lower version)
41
BERA with ASSR
42
Bio-Fermenter 25-50L
43
Biplane DSA
44
Bipolar Resectoscope with Microprocessor Controlled Electrosurgical Unit
45
Blood & Fluid Warmer HL 90 (PAC)
46
Blood & Fluid Warming Device
47
Blood Bank Management System Using RFID Technology (PAC) (Biolog-id)
48
Blood Gas Analyser
49
BLS Practising Manikin
50
Body Plethysmograph with Diffusion Study
51
bone filler device
52
Bronchoscopy/Oesophagoscope
53
Cardiac autonomic neuropathy analyser
54
Cardiopulmonary Bypass Machine
55
Cardiotocography Machine
56
C-arm Image Intensifier with DSA and Radiolucent Table
57
Cartridge base nucleic acid amplification system (CBNAAT)-16 cartridge module
58
CATH Lab including All accessories and EP
59
CELL COUNTER (3 PART DIFF.)
60
Cell Counter (6 parts)
61
Cell Morphology Biosensor
62
Cell Saver
63
Chemiluminescence & Gel imaging & analysis system
64
Chemiluminescence enzyme immunoassay processing system (CLEIA)
65
Chemiluminescence and fluorescence doc imaging system (chemidoc imaging system)
66
CHNS Analyzer
67
Close Sterility Test System
68
CO2 Laser
69
Coaxial Ophthalmoscope Rechargeable
70
Colour Doppler
71
Colour Doppler (2D & 3D)
72
Colour Doppler 4D
73
Colour Doppler with all general-purpose probes
74
Combined Ultrasonic Cutting, Coagulation & Vessel sealing System
75
Complete Chromatographic Unit for paper & TLC
76
Computer Assisted Semen Analyzer
77
Computerized Biofeedback Machine
78
Cone Beam Computed Tomography
79
Continuous Glucose Monitoring System
80
CR System
81
Cranial Stabilization system
82
CRRT Machine
83
Cryo -Microtome (1 in class B)
84
Cryo Surgical System
85
Cryotherapy
86
CT 128 Slice
87
CT 256 Slice
88
CT Simulator System
89
Cyclotron
90
Cystoscope-resectoscope-VIU-Cystolithotripsy-TURis Adult set
91
Densitometer with computer
92
Derma scope
93
DEXA Scanner (BMD)
94
Difficult Airway management simulator
95
Digital Colorimeters
96
Digital Fundus Camera
97
Digital Non-Mydriatic Fundus Camera
98
Digital Polarimeter Multi wavelength with printer
99
Digital Refractor Meter
100
Digital Slide Scanning System with Research Grade Microscope and Image Analysis Software
101
Disintegration Test Equipment (1 basket for 6 tablets)
102
Dissolution Apparatus
103
Dissolution Apparatus with Auto Sampler
104
Dissolution media preparation and delivery system
105
DNA Sequencer (24 Capillary) +Computer
106
DNA Sequencer (96 Capillary) +Computer
107
Double beam UV spectrophotometer (UV-Vis, variable wavelength, glass and quartz cuvettes with data analysis software and computer interface and power back-up)
108
Double door autoclave 200 L
109
Drug Discovery Suite
110
Dual action Ultrasonic plus Pneumatic lithotripter
111
ECHO and USG Machine
112
Echocardiography 2D machine
113
Elbow & Ankle Arthroscopy
114
Electro Convulsive Therapy (ECT) machine
115
Electrohydraulic Urology operation theatre tables
116
Electrolyte analyser
117
Electron Microscope
118
Electronic Blood Cell Counter with six-part differential
119
Elevated grossing station
120
ELISA (Demonstration)
121
Elisa reader with washer and shaker
122
Elispot Reader
123
Embryonic/Foetal development model
124
Endomotor – Endodontic Electric Motor
125
Endoscopic sinus surgery set Xenon head light with camera system
126
Endoscopic Ultrasound
127
ENT Operating Microscope
128
ENT Workstation
129
ESWL
130
ETO machine 100 lit
131
ETO Sterilizer
132
Excimer Coronary laser Atherectomy System with Catheter (50)
133
Fenestrated adapter
134
Fibre Optic Light Source
135
Fibreoptic bronchoscope with monitor and recording facility for adult and paediatric
136
Fibre-optic Video Bronchoscope
137
Fibro Scan
138
Flexible rhino-pharyngo-laryngoscope
139
Flow cytometry with Cell Sorter
140
Fourier-Transform Infrared Spectroscopy
141
Fragment Analyser/On Chip Electrophoresis Devices
142
FT-Infrared Spectrophotometer with ATR and Pellet Press
143
FT-Infrared Spectrophotometer with Pellet Press
144
FTIR with ATR Arrangement
145
Full body pregnancy simulator
146
Full size Inhalation Exposure System
147
Fully Automated Cell Counter (3 part)
148
Fully Automated Coagulometer
149
Fully automated Gel Documentation system with UPS back up
150
Fully Automated Haemoglobin HPLC System (Model: Variant II Haemoglobin Testing System) (PAC)
151
Fully Automated Multiplex Film Array Syndromic System (Model: Film Array TORCH 2.0)
152
Fully Automated Rotary Microtome with accessories
153
Gamma Camera
154
GAS Chromatography – Mass Spectrometer with flame Ionization detector (GC-MS with FID)
155
GC- Electron capture detector (ECD)
156
GC- Flame Ionization detector (FID&NPD)
157
GC/MS
158
GC-HS
159
GC-HS with FID detector
160
GCMS-MS (QQQ) with HS
161
Gel electrophoresis horizontal with compatible power pack and accessories
162
GLC with Head Space
163
Gluteal IM Injection model
164
Gradient PCR Machine
165
Gradient Thermal Cycler with standalone UPS
166
Grossing Station
167
Hand foot UV phototherapy device
168
Hand held Doppler (vascular)
169
Handheld ICG Fluorescence Imaging System (Burns and Plastic Surgery Block)
170
Harmonic scalpel
171
HDR Brachytherapy
172
Hemo Analyser
173
Haemodialysis Machine with SLED
174
High Content Screening System
175
High Dimensional Flow Cytometry Analyser
176
High End Virtual Simulator for Intraocular Surgery Training (Eyes Surgical; Simulator-VR Magic) (PAC)
177
High Performance Liquid Chromatography – Analytical with Auto Injector
178
High performance Thin Layer chromatography (HPTLC)
179
High Resolution GCMS /MS
180
High Resolution Manometry
181
High Resolution Orbitrap Mass Spectrometer
182
High Through put Real Time PCR
183
High throughput single cell analysis system
184
High-Performance Liquid Chromatograph with PDA/DAD/RI/FLD
185
High-Performance Liquid Chromatograph with PDA/RI/FLD
186
High-Performance Liquid Chromatograph with Ultraviolet Detector/High-Performance Liquid Chromatograph with UV Detector
187
High-Performance Liquid Chromatography- Analytical with auto injector
Ilizarov Instrumentation Set Complete with Accessories as
207
Image analyser cum viral foci counter
208
Immunoanalyser (Chemiluminescence based) fully automated with UPS back up
209
In vivo Animal imaging System
210
Incinerator
211
Individually ventilated cages/housing system for small animals
212
Infant Multipurpose Resuscitator cum Operating Beds
213
Intense Pulse Light Device
214
Intra Operative Nerve Monitoring
215
Invasive BP Monitoring System
216
Inverted Fluorescent Microscope with Live Cell Imaging Capability
217
Inverted Trinocular Epifluorescence Microscope with Imaging system
218
Ion Chromatograph
219
IPL (Intense Pulse Light System)
220
IUD insertion trainer uterus
221
Karl Fischer Titrator (Semi-Micro Determination of Water)
222
Laparoscopic Surgery set with High-Definition camera
223
Laparoscopic Surgery Set with Hysteroscope & resectoscope with High-Definition Camera & Monitor
224
Laser for existing Confocal Microscope
225
Lasik Machine
226
LCMS
227
LCMS MS
228
LC-MS/MS (QQQ)
229
LEEP System with Smoke Evacuator & integrated cart
230
Leyla Retractor System
231
Life Port Kidney Transporter With 05 Sets of Expendables with Each Equipment (PAC)
232
Liquid Based Cytology System
233
Liquid Particle Counter
234
Low Energy Linear Accelerator (LA) System
235
Lymphovascular Microscope
236
Magnetic Bead based Multiplex Immunoassay system
237
Measurement of Lung clearance index (LCI)
238
Medical Thoracoscope (semi rigid)
239
Melting- Point Apparatus
240
Mercury analyser
241
Metaphase Finder System with Fluorescence
242
Micro Needling Radio Frequency Equipment
243
Microinjection system (Microinjector, Micromanipulator, Pipette puller)
244
Micro method bilirubin analyser
245
Microplate multimode reader
246
Microscope (with Phase Contrast and Camera attachment)
247
Microvascular Instruments Set
248
Microwave digestion System
249
Motor (electric) Dermabrader
250
MRI
251
MRI 1.5 T
252
MRI 3T T
253
MSK-USG with linear transducer
254
Multimode Microplate Reader and Fluorometer
255
Multimode Reader
256
Multiplex Protein Array System
257
Multiplex Suspension Array System based on xMAP Technology
258
Nanobio Spectrophotometer
259
NdYag Laser with IPL
260
ND Yag Laser(1064nm)
261
Nerve stimulator (intra operative)
262
Neuro Surgical Drill with all attachments.
263
Neuropathy analyser-vibration perception threshold + temperature perception threshold
264
Neurosurgery Operating Table with Accessories
265
New-born Resuscitation Manikin
266
Next Generation Sequencer – Higher Version
267
Next Generation Sequencer – Lower Version
268
Next generation sequencing machine
269
Nursing baby with SimPad/Nursing kid with SimPad system
270
OAE (screening)
271
Operating Microscope
272
Operating Microscope (Plastic Surgery)/Plastic Surgery Operating Microscope
273
Ophthalmic Operating Microscope
274
Orbitrap Proprietary Mass Spectrometer
275
Orthopantomogram (OPG) unit
276
Osmometer
277
Pacemaker Dual Chamber – External
278
Pacemaker Single Chamber – External
279
Patient Care Simulator
280
Patient Care Simulator with Sim Pad
281
Patient warming System
282
PCNL set
283
Paediatric Bronchoscope set
284
Paediatric cystoscope and resectoscope set/Cystoscope & Resectoscope – Paediatric
285
Paediatric High Resolution Fibre Flexible Bronchoscope with recorder and Screen Display
286
Paediatric laparoscopy set
287
Paediatric rigid Esophagoscope
288
PET CT
289
Phaco Machine
290
Physical assessment simulator
291
Platform pedography system
292
Pneumatic lithotripter
293
Point of Care Device for estimation of Cardiac Biomarkers (CKMB, Troponin, BNP, Myoglobin) and PT-INR
294
Point of Care Machine (Trop I, BNP, CPK-MB, CRP)
295
Polarimeter with Multi Wavelength
296
Portable Colour Doppler
297
Portable colour doppler with echo probe
298
Portable Echocardiography system
299
Portable Fluorescence Microscope
300
Portable Ultrasound & Colour Doppler
301
Potentiometric Titrator with necessary electrode
302
Potentiometric Titrimeter
303
Power Assisted Liposuction System
304
Power Tools for Craniomaxillofacial and hand surgery (Electric micro drill)
305
Powered Liposuction Set
306
Preparative floor model refrigerated ultracentrifuge
307
Protein purification system
308
Pulsed Field Electrophoresis System
309
Pure tone Audiometer
310
QTOF Mass Spectrometer
311
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)
312
Radiofrequency Generator with integrated vessel sealing and cutting system
313
Raman Spectroscope
314
Random access medium throughput fully automated chemistry analyser
315
Real Time PCR machine with standalone UPS unit
316
Realtime PCR based detection system for specialised pathogens & viruses
317
Rigid Bronchoscope
318
Rigid Thoracoscope (VATS)
319
Semi-automated ELISA system with washers
320
Semi Rigid Pleurovideoscope
321
Shaver System cum micro drill
322
Single Channel transcutaneous oxygen monitor
323
Single Planar C-Arm Fluoroscope plus DSA with Fluoroscope Compatible OT Table
324
Small animal behavioural monitoring, tracking and analysis system with accessories (For safety pharmacology)
325
Spectrofluorometer
326
Spectrophotometer
327
Super Microsurgery System
328
Temporary Pace Maker Dual Chamber
329
Temporary Pacer
330
Texture Analyzer
331
Thalassaemia And Hemoglobinopathy Testing/Screening System
332
Thermal Cycler
333
Tissue Morcellator
334
TMT machine
335
TOC analyser
336
Transcranial Magnetic Stimulator
337
Transcutaneous bilirubin analyser
338
Transillumination Caries Detector
339
Triple Quadrupole Mass Spectrometer
340
Tube feeding simulator (NG, OG and PEG)
341
Tympanometer
342
Ultra-High Performance Liquid Chromatography
343
Ultracentrifuge with HEPA filter and necessary rotors
344
Ultra-Fast Liquid Chromatography
345
Ultrasonic Aspirator
346
Ultrasonic cutting and Coagulation device
347
Ultrasound (A+B scan)
348
Ultrasound machine
349
Ultraviolet/ Visible Spectrophotometer
350
Uretero-renoscope- Adult
351
Uretero-renoscope-Paediatric
352
Urodynamic System
353
Uroflowmetry
354
UV- vis Spectrophotometer
355
UV/Visual spectrophotometer
356
Vacuum assisted wound closer system
357
Vacuum Assisted Tissue Processor
358
Venepuncture and injection arm
359
Venous Coupler System
360
Vertical Gel Electrophoresis Apparatus with Western Blotting Apparatus
361
Video Bronchoscopy system
362
Video EEG (EEG apparatus 32 channel digital model with Videometery, stimulus evoked response signal
363
Western Blot Apparatus with Compatible Power Pack
364
Workstation for Multi-PTM analysis (Proteomics)
365
XRD
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.
Annexure-II
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 – pppmii-dop@gov.on
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.
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.
