DESC:
FORM 2

THE PATENT ACT 1970
(39 OF 1970)
and
THE PATENTS RULES, 2003

NON-PROVISIONAL SPECIFICATION
(See SECTION 10, RULE 13)

TITLE OF THE INVENTION
A SYSTEM AND METHOD FOR ELECTRONICALLY VERIFIED AND VERIFIABLE, GOOD STORAGE AND DISTRIBUTION PRACTICES (eVV GSDP) OF THE PHARMACEUTICAL PRODUCTS IN THE SUPPLY CHAIN USING INTERNET OF THINGS(IOT) AND BLOCK-CHAIN, CLOUD AND MOBILE TECHNOLOGIES FOR DIGITAL ENFORCEMENT AND TRACEABILITY

APPLICANT:
VHS LOGITECH PVT LTD
Unit 18, Plot-25, 1st Floor, Chanchal Smruthi Apartments,
G.D Ambedkar Marg, Katrak Road, Wadala,
Mumbai – 400031,
India

THE FOLLOWING NON-PROVISIONAL SPECIFICATION PARTICULARLY DESCRIBES THE NATURE OF THIS INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED:
CROSS- REFERENCE TO RELATED APPLICATION

This application claims the priority of the provisional application with the serial number 201921026499 filed on 2019/07/02 with the title, “INTELLIGENT CLOUD BASED IOT ENABLED DRUG COUNTERFEIT AND EFFICACY MONITORING SYSTEM” and the contents of which is incorporated in entirety.

A) TECHNICAL FIELD
[0001] The present invention generally relates to protection of drug counterfeiting in the pharmaceutical industry and particularly relates to system and method for managing drug efficacy in the supply chain cycle. The present invention more particularly relates to a system and method for managing drug efficacy by following norms of pharmaceutical good storage and distribution practices (GSDP) of pharmaceutical supply chain eco system.

B) BACKGROUND OF THE INVENTION
[0002] In the pharmaceutical industry, the first important focus is to safe guard the drug counterfeit during transit, at storage or end-consumer receipt. Securing the supply chain is one of the most important challenges confronting manufacturers and other entities involved in supplying pharmaceutical products to the healthcare industry. Various tracking system are proposed in the art with the goal of enhancing patient safety by helping to secure the supply chain. The high number of products in a supply chain makes it difficult to track individual products or groups of products. In addition, the number of different parties (e.g., manufacturer, distributor, pharmacy and hospital) adds to the complexity of tracking pharmaceutical products.
[0003] Additionally, due to the high volume of products in a supply chain, counterfeit goods are often prevalent. Counterfeiters typically generate duplicate packaging and submit the fake product into a distributor’s warehouse. This will result in the distributor unknowingly shipping real and counterfeit items.
[0004] In view of pressures for the pharmaceutical industry to address security and brand protection concerns, it becomes necessary to consider the adoption of new technologies. The key capabilities required to improve overall efficiency and to protect the supply chain, are track and trace and authenticate pharmaceutical products.
[0005] Various systems are proposed in the art to protect counterfeiting of pharmaceutical products. New technologies adopted by healthcare companies will continue to address counterfeit medications head on. For instance, with the rise of handheld devices and quick testing and discovery of counterfeits, keeping potentially harmful drugs out of the supply chain is possible. But none of the proposed system in the art are efficient enough to stop counterfeiting of pharmaceutical products.
[0006] Further, every genuine drug, required to be maintained within a specific environmental condition specifically temperature, humidity and lighting conditions for ensuring its effectiveness per dosage. Conventional storage environment monitoring systems are basically implemented on the basis of the sensor network cable. However, wired sensor network factors way limited by wiring, power supply, installation site, operating and maintenance of the environment, the cost of large and small flexibility and inconvenient to use. And the existing large-scale storage system has a lot of points to be monitored, all wired highlights the shortcomings of this approach.
[0007] In view of the foregoing, there is a need to provide a system and method for protecting drug counterfeit and managing drug efficacy in the supply chain cycle.
[0008] There is also a need for a system and method for managing drug efficacy by following norms of pharmaceutical good storage and distribution practices (GSDP) of pharmaceutical supply chain eco system.
[0009] The above mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.

C) OBJECTS OF THE INVENTION
[0010] The primary object of the present invention is to provide a system and method for protecting drug counterfeit and managing drug efficacy in the supply chain cycle.
[0011] Another object of the present invention is to provide a system and method for managing drug efficacy by following norms of pharmaceutical good storage and distribution practices (GSDP) of pharmaceutical supply chain eco system.
[0012] Yet another object of the present invention is to provide a system and method for safe guarding the drug counterfeit during transit, at storage or end-consumer receipt.
[0013] Yet another object of the present invention is to provide a centralized tracking of ware house, cold store, deep freezers for reporting cold spots and hot spots on a color coded dash board.
[0014] Yet another object of the present invention is to provide a system for monitoring temperature and humidity of the in-transit pharmaceutical product and actionable information being shared and action taken being recorded for enforcing GSDP norms.
[0015] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

D) SUMMARY OF THE INVENTION
[0016] The various embodiments of the present invention provide a system and method for protecting counterfeiting of drug and managing drug efficacy in the supply chain cycle. The system creates a platform for electronically verified and verifiable, good storage and distribution practices (eVVGSDP) for pharmaceutical products. The said system and method enables user to safe guard pharmaceutical products from counterfeit and to manage the drug efficacy in the supply chain cycle. The said system, as a platform creates a digital signature using drug manufacturer’s SKU code and serialized SKU code, batch code, expiry date and other internal data points as an encrypted and pass phrase protected unique QR code for a particular drug, which is then used between one party to other in the supply chain eco-system traversal.
[0017] According to an embodiment of the present invention, the said eVVGSDP platform uses batch production information to validate the drug counterfeit in combination with: digitally signed QR code, drugs supply chain movement/positioning statuses.
[0018] According to an embodiment of the present invention, the said eVVGSDP platform is enabled by Internet of Things (IOT) designed architecture. IOT devices connects to BLE (Bluetooth Low Energy) sensor devices, customized Beacons and further connected to various types of sensor devices over Zigbee, Bluetooth and Wi-Fi communication or connectivity mechanisms to a Gateway (evv programmed gateway - smart phone application) for collecting/reading the monitored environmental conditions such as but not limited to temperature, humidity, lux and location co-ordinates of the particular device. The said collected/read data along with drug information then uploaded on to a cloud server where the said eVVGSDP platform (cloud software system) analyzes all the data based on GSDP norms of specific drug monitoring, compliance tracking and reporting requirements. This is achieved via eVVGSDP tracking and notification rule engine algorithms written as part of the cloud software system.
[0019] According to an embodiment of the present invention, once the norms are cross referenced/checked, plurality of alerts and notifications on the real-time basis for individual drug in-transit or store are generated for different stake holders of the supply chain eco-system at respective steps to bring it to the notice of concern team or person to take preventive or corrective course of action to protect the drug or its efficacy. The said data being in centralized cloud server database storage is always available for historical analysis, tracking, reporting and future referencing for in-depth analysis requirement.
[0020] According to an embodiment of the present invention, the said data collection mechanism along with the eVVGSDP rule engine is defined to build the logistic tracking framework. The said tracking includes important factors and guideline of GSDP for pharmaceutical product such as but not limited to transportation, business case for operational efficiency and the mode of transport data along with the mapped product packet, SKU’s inside the packet and environmental conditions (temperature and humidity) information to provide an in-depth tracing mechanism for the in-transit pharmaceuticals product.
[0021] According to an embodiment of the present invention, the said eVVGSDP in-transit tracing mechanism takes the input of packet, reference invoice no, start and destination location, path to follow to reach destination (point a to b via..), number of stop locations, each stop duration, packet delivery destinations, SKU’s details inside the packet (quantity, expiry, batch, etc.), temperature check range for each packet, humidity check range for each packet, planned start timestamp, planned reached timestamp, data collection frequency and alerts and notifications hierarchy.
[0022] According to an embodiment of the present invention, the end consumers (hospitals/patients) uses a simple mobile application (Android/iOS) at their site and scan the QR code as mentioned on the packet or particular SKU package to verify the drugs/medicines source to destination travel details and avails the associated temperature and humidity information for establishing the fact that drugs/medicines being delivered through a proper channel, taking care of the important efficacy factors at each and every level.
[0023] According to an embodiment of the present invention, the said eVVGSDP system is a virtual GSDP (good storage and distribution practice) environment replicating the actual warehouse, cold store and deep freezer environment and storage capacity structures; and wherein the aid system allows defining the floors, rooms, racks and boxes for each type of store units where pharmaceutical products are placed under different storage environments. The said system associate a particular manufacturer or group of manufacturer and it’s one specific product or range of products to a floor, room, rack or even up to individual storage boxes (in a rack); and wherein the said storage units are mapped with dedicated wireless sensors or IOT (internet of things) devices such as but not limited to BLE, beacons, Wi-Fi and GPRS based devices, to collect temperature and humidity data from the particular spots and pass it on to the said eVVGSD; and wherein the said system attaches timestamp, location and other details such as but not limited to business location code, floor, room, rack and codes through a smart gateway to monitor a particular SKU storage conditions.
[0024] The various embodiments of the present invention provide a method for electronically verified and verifiable, good storage and distribution practices (eVVGSDP) for the pharmaceutical products in the supply chain. The said method comprises the steps of: creating a digital signature for each of the new drug produced, and wherein the said digital signatures are created by using drug manufacturer’s SKU code and serialized SKU code, batch code, expiry date and other internal data points as an encrypted and pass phrase protected unique QR code for a particular drug, monitoring environmental condition of plurality of pharmaceutical products storage area through a plurality of Internet of Things (IOT) devices, collecting/reading the monitored environmental conditions such as but not limited to temperature, humidity, lux and location co-ordinates of the particular drug, uploading the said collected/read data along with drug information to a cloud server and wherein the said eVVGSDP platform (cloud software system) analyzes all the data based on GSDP norms of specific drug monitoring, compliance tracking and reporting requirements, validating the drug counterfeit in combination with: digitally signed QR code, drugs supply chain movement/positioning statuses using the batch production information and generating plurality of alerts and notifications on the real-time basis for individual drug in-transit or store, once the norms are cross referenced/checked for different stake holders of the supply chain eco-system at respective steps to bring it to the notice of concern team or person to take preventive or corrective course of action to protect the drug or its efficacy; and wherein the said data being in centralized cloud server database storage is always available for historical analysis, tracking, reporting and future referencing for in-depth analysis requirement.
[0025] The various embodiments of the present invention provide a method for protecting counterfeiting of pharmaceutical products and managing pharmaceutical product efficacy in the supply chain cycle. The said method comprises the steps of monitoring entire supply chain, monitoring batch level information and tracking products at SKU level.
[0026] According to an embodiment of the present invention, the step of monitoring entire supply chain further comprises the steps of retrieving a particular drug/medicines batch production till distribution level information, analyzing the complete set of data at any point of time, monitoring any infiltration or unauthorized entry or unaccounted exit, and raising an alarm in a digital way (alerts/notifications via push notifications, SMS and email) to respective stake holders about the missing data links, SCM data mismatch and probable positions of counterfeits.
[0027] According to an embodiment of the present invention, the step of monitoring batch level information further comprises the steps of retrieving data points of batch information comprising batch code, SKU code, expiry date, manufacture info, origin locations, and total quantity produced in a particular batch, retrieving documentation of stock-transfer memos, invoices or returned/expiry good receipts or way bills (in-transit) in each step of the product movement, using batch number as the primary identifier between any successful transaction (forward/backward) along with the SKU Code and quantity of the products being moved, tracing a specific batch number, and validating the said batch number and SKU code associated with the batch number (from source) and quantity moved.
[0028] According to an embodiment of the present invention, the step of tracking products at SKU level further comprises the steps of creating an encrypted QR with serialized SKU codes for each unit of production under any particular batch, creating an unique identifier for each of the SKU /Pack/Vile at the smallest unit possible level, clubbing each of the said encrypted QR serialized code moving in the supply chain (Block chain) as an individual unit/identity, with the batch code and other manufacturer data, linking the location parameter to the above said information for tracking the intended receiver at supply chain level in an on-going transactional basis as the products starts moving from one layer and one location to multiple locations at the other layer, verifying the entire traversal path of the particular SKU , since each SKU is uniquely encoded and raising alarms/alerts and notifications to concern stake holders in case of mismatch
[0029] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating the preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

E) BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:
[0031] FIG. 1 illustrates a block chain (private hybrid block chain) implemented for the drug counterfeit detection, according to an embodiment of the present invention.
[0032] FIG. 2 illustrates a system architecture adopted for protecting drug counterfeit and managing drug efficacy in the supply chain cycle, according to an embodiment of the present invention.
[0033] FIG. 3 illustrates a block diagram of a system for protecting drug counterfeit and managing drug efficacy in the supply chain cycle, according to an embodiment of the present invention.
[0034] FIG. 4 is a block diagram illustrating IoT connection process, according to an embodiment of the present invention.
[0035] FIG. 5 is a block diagram illustrating IoT – BLE device scanning process, according to an embodiment of the present invention.
[0036] FIG. 6 is a block diagram illustrating IoT data reading process, according to an embodiment of the present invention.
[0037] FIG. 7 is a block diagram illustrating IoT-to-Cloud server connectivity, according to an embodiment of the present invention.
[0038] FIG. 8 is a block diagram illustrating IoT based tracking/drug efficacy, according to an embodiment of the present invention.
[0039] FIG. 9 is a block diagram illustrating method of protecting counterfeiting of pharmaceutical products and managing pharmaceutical product efficacy in the supply chain cycle, according to an embodiment of the present invention.
[0040] FIG. 10 is a block diagram illustrating a centralized tracking of ware house, cold store, deep freezers for reporting cold spots and hot spots on a color coded dash board, according to an embodiment of the present invention.
[0041] FIG. 11 is a block diagram illustrating a method of individual spot tracking on a real-time basis of the ware house, cold store and deep freezers in the supply chain cycle, according to an embodiment of the present invention.
[0042] FIG. 12 is a block diagram illustrating a method of tracking in-transit drugs/pharmaceutical products, according to an embodiment of the present invention.
[0043] Although the specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.

F) DETAILED DESCRIPTION OF THE INVENTION
[0044] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
[0045] Distribution is an essential activity in the integrated supply-chain management of medicinal products. Various individuals and entities are generally responsible for the handling, storage and distribution of such products. So it’s very important to have adequate controls over the entire chain of distribution. To maintain the original quality of medicinal products, every party involved in the distribution chain has to comply with the applicable requirement. Each activity in the distribution of medicinal products shall be carried out according to the principles of Good Distribution Practice (GDP) as well as Good Storage Practice(GSP) or in one go GSDP.
[0046] The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination, cross-contamination, spurious besides inherent potential for degradation of such products if not maintained and distributed under specified storage conditions.
[0047] The proposed method of the present invention assists to ensure the quality and identity of medicinal products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, digital documentation and record-keeping practices.
[0048] The system of the present invention is intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of biological products from the premises of the manufacturer of the product to the person dispensing or providing medical products directly to a patient or his/her agent. This includes all parties involved in trade and distribution of medicines; including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.
[0049] FIG. 1 illustrates a block chain (private hybrid block chain) implemented for the drug counterfeit detection, according to an embodiment of the present invention. The said block chain is designed and implemented to ensure the data encryption, tracing, individual stake holder’s participation and information retrieval of the pharmaceutical SKUs or products or vile involved in the supply chain is maintained with no compromise on information privacy, data security and manipulation. The said block chain allows any participant to only add information as a block and restricts to remove any information or a block. The said block chain maintains all the batch information (batch code, expiry date, manufacturing date, production location), SKUs involved in the batch (SKU serialized codes), batch movement information (supply chain players handshaking with each other during the product movement from one layer or one place to the others) in an encrypted data set called “Blocks”. The said blocks are connected with each other with linked CRYPTO format forming the “Chain”. The entire chain uses a protected way of connecting or linking with each other and retrieves the already entered information with proper and valid credentials as authorized by the block chain authority. All the participants are allowed join in the block chain as a “Node” upon meeting the required authorization parameters, as set for the block chain participants by the block chain authority. Further, participants are allowed to only use the already entered information to VERIFY the previous traversals and then contribute into the next block as per its required operations. Each block is auto time stamped whenever it gets created. No manual way to interact or modify any block information of the chain via any means.
[0050] FIG. 2 illustrates a system architecture adopted for protecting drug counterfeit and managing drug efficacy in the supply chain cycle, according to an embodiment of the present invention. The said electronically verified and verifiable, good storage and distribution practices (eVVGSDP) platform is based on electronically encrypted data points which are passed on between one stake holders of the pharmaceutical supply chain eco-system member to other over the cloud/internet as a QR code. The said QR code is unique and able to trace products in combination with an algorithm which again take parameters like manufacturer details and production batch details to form a boundary condition within which a particular product has been built/created/manufactured and moving from one point to other in the pharmaceutical supply chain cycle.
[0051] According to an embodiment of the present invention, during the movement of the packet (pharmaceutical product), each of the said packet (pharmaceutical product) is tagged with an unique QR code, with the help of IOT (Internet of Things) based concept involving at-least one digital device with multiple sensors such as but not limited to temperature and humidity, Bluetooth or Wi-Fi or GPRS based communication protocol. The said eVVGSDP system captures and shares the geo-coordinates, temperature and humidity and digitally signed (encrypted) information about the packets and products to the cloud server in a continuous interval through a mobile computing device such as but not limited to a smart phone (with iOS or Android OS).
[0052] According to an embodiment of the present invention, the entire data is stored in a centralized cloud server, and further the said central server also host the eVVGSDP platform with the program to capture and store GSDP (good storage and distribution practices) required data points as an validating or comparing or as a rule engine input.
[0053] According to an embodiment of the present invention, the said rule engine or the eVVGSDP central processing program analyzes all the incoming data from different stake holders with their respective details such as but not limited to; location code, encrypted digital signature informing about the manufacturer, product code, stock keeping unit code ( SKU ) of the drug, batch code, expiry date, manufacturing date and additional information such as but not limited to: person who created the initial data set, from which warehouse/rack/box/ the packaging happened; person who is carrying the consignment; concern person who is next in the cycle to receive the packets; drug efficacy monitoring data such as nut not limited to: temperature and humidity along with time-stamp and geo-coordinates when and where the data being captured.
[0054] According to an embodiment of the present invention, the cloud software system or the central eVVGSDP platform provides a software user interface, accessible over browsers on all computer systems to configure the rules specific to one drug or SKU. One user can specify the required temperature and humidity level at which one drug needs to be monitored continuously for the best GSDP (Good Storage and Distribution Practice). These GSDP data then gets combined with the SKU (Stock Keeping Unit) code of the drug and further combined with other data such as but not limited to; manufacturer and distribution mode data while moving from one premise to other or changing hands from one party to other, it creates the unique QR code in the eVVGSDP system.
[0055] According to an embodiment of the present invention, the said data within the system then transmitted from one player/stake holder to other using the cloud without requiring to change and manual entry errors. The data is always stored in the back-end database with transaction IDs, status flags, created/updated date and created/updated by indicating the hand-shakes or transfer of one set of data from one-stake holders to other. In turn it enables eVVGSDP system to track, trace or monitor all the transaction happening using it as a linked list. Each link in the list comprises of primarily at-least 2-major part, one part drug data set/attributes, and other part address/information about the movement within the stake-holders.
[0056] According to an embodiment of the present invention, the said links are visualized in 2-patterns: First-way: Starts at the manufacturer end of the drug producer, moves to warehouse for storage, then to distributors for making it available to wider part of markets, then from distributors to bulk consumers such as hospitals or retail stores and finally from retailer to an end consumer/patient.
[0057] According to an embodiment of the present invention, the first-way link can be viewed as a single way linked list/cycle. Traceability about the drug producer, number of hopes a SKU batch of drugs made to reach distributor, distributor to which consumer and finally from retailer to which end-consumer along with the exact physical storage points/locations, movements, drug efficacy data points such as temperature and humidity is traceable back and forth. A complete “A to Z” traced path via all the intermediate points as shown in FIG.12.
[0058] Second-way: Starts at the manufacturer end of the drug producer, moves to warehouse for storage, then to distributors for making it available to wider part of markets, then from distributors to bulk consumers such as hospitals or retail stores and finally from retailer to an end consumer/patient. Further, sometimes due to different reasons if the drug/ SKU needs to be returned, eVVGSDP allows following the returning path from end-consumer/patient to retailer and then it continues till an end-point/manufacturer based on the point of failure of GSDP.
[0059] According to an embodiment of the present invention, due to eVVGSDP system, it is also viable and useful to know the entry of counterfeit or reduced efficacy or lost GSDP norms or close by expiry drugs; much earlier in the supply chain ecosystem and follow the return path till the end point/manufacturer.
[0060] According to an embodiment of the present invention, the second-way link can be viewed as a two way linked list/cycle. Traceability about the drug origin, number of hopes a SKU batch of drugs made to reach distributor, distributor to which consumer and finally from retailer to which end-consumer and from where and why it is returning back along with the exact physical storage points/locations, movements, drug efficacy data points such as but not limited to temperature and humidity is traceable during entire process.
[0061] FIG. 3 illustrates a block diagram of a system for protecting drug counterfeit and managing drug efficacy in the supply chain cycle, according to an embodiment of the present invention. The said system involves BLE or Beacon or Arduino devices with temperature, humidity sensors with Bluetooth or Wi-Fi or GPRS based communication facility to communicate data from the physical sensor device/boards to a gateway. The said gateway which is responsible to connect to internet and share the collected data along with the geo location coordinates to the cloud server.
[0062] According to an embodiment of the present invention, the gateway can be an Android/iOS application working on an Android/iOS smart phone with Bluetooth, Wi-Fi and Data connectivity/GPRS/3G/4G or any other internet service provider Wi-Fi to communicate the collected Sensor data to cloud server, or it could be a separate physical device with a communication board fitted on to it, with the similar mobile phone kind of H/W features with or without any screen and OS. The micro-controller of the non-phone based gateway will perform the task of connecting, collecting and processing sensor data via the attached/mounted communication board to cloud server.
[0063] According to an embodiment of the present invention, the said gateway application is a program or algorithm implemented in the following way to ensure that it first switches/turn ON the Bluetooth/Wi-Fi/GPRS feature of the mobile computing device (smart phone) upon an authorized user login.
[0064] According to an embodiment of the present invention, the program then obtains the necessary required permission such as but not limited to GPS location service and device storage which would be used in the course of action.
[0065] According to an embodiment of the present invention, the mobile application is designed to communicate with the cloud server via API (Application Programming Interface) to get a list of MAC address and device details which should be only explored/ connected to get the required sensor data. The said MAC address of each device being unique the mobile application is able to identify specific device within multiple Bluetooth/Wi-Fi/GPRS devices. The gateway application upon identification of any one or multiple devices which are authorized over the cloud server to be used for eVVGSDP, requests for connecting to those devices using the UUID/data reading characteristic command of the device to read the Sensor data.
[0066] According to an embodiment of the present invention, the gateway application looks for any nearby available authorized device which is either assigned to a packet/parcel or associated to any storage/cold room/hotspot/clod spot within the monitoring system at every 1.5-min/130secs level (the time is configurable). During the scan process of discover nearby devices, it run up to 39-secs divided into 3-scan calls each at 13-sec interval. This is done in order to ensure the gateway establish a connection to all possible available devices at least once. The said gateway application ensures to check for the list of device it got from the cloud server side to verify and connect. It then ensures to keep a list/count of devices that it managed to connect, in each of its scan iteration of 13-secs. And try to connect to all within 39-secs.
[0067] According to an embodiment of the present invention, once the devices are connected to gateway, using the UUID or data reading characteristic command of the device, the gateway application or program reads the required sensor data such as but not limited to temperature, humidity, battery status of the sensor device and then adds the GPS coordinate data from the mobile device’s in-built GPS sensor or picks it up from the network providers data and puts a time stamp to the entire data row as data recorded date and time. The complete record with device Id, MAC Id, sensor device battery status, temperature, humidity, geo-coordinates, gateway battery status, gateway Bluetooth, Wi-Fi, network availability and data recorded time stamp is stored within the mobile device data base which is set-up/created or present inside the program/APP of the gateway. In some cases the data collected could be written onto a file system or as a data log file inside the memory chip of the gateway device.
[0068] According to an embodiment of the present invention, during the storage of the device data inside the gateway memory or database appropriate logical validations/pre-cautions are taken such as but not limited to: no two records of same time stamp, or no two records of the same device at any given point is allowed to enter into the data store. This is done to capture unique data rows with different time stamps.
[0069] According to an embodiment of the present invention, the collected data from the gateway then transmitted via API (Application Programming Interface) URL to cloud server. Data inside the gateway data store/data base is maintained with a status flag to indicate which portion of data is already sent/ synchronized at cloud server level. Upon successful uploading of data from the gateway to cloud server, an acknowledgement is sent back to the gateway indicating that the upload or transmission being successful. And once the gateway receives this response from server the program marks the set off record as synchronized and hence, it is not sent next time/cycle for synchronization. This gateway to server synchronization process happens at a regular interval process of 6-mins/360-secs (where the said time is configurable).
[0070] According to an embodiment of the present invention, the gateway program clears or deletes the old records which are already being synched to cloud server successfully in order to maintain enough memory space inside the gateway device. In order to keep some safeguarding measures to handle some data transmission loss due to bad network or sudden power failure or sudden switch of the mobile gateway device the program removes all data leaving last 3-days data with status being updated. This will help to bring back or re-start a manual way to synchronize data in case of automatic time scheduler programs fails. There is also a provision of manual clear option to perform the operation if any point of memory management needed to ensure gateway can collect, store and share the IOT/BLE/Wi-Fi/GPRS sensor data under all circumstances.
[0071] According to an embodiment of the present invention, the gateway APP/program/device is built to handle multiple services and characteristics UUID of different IOT/BLE/Wi-Fi/GPRS manufacturer devices, making it suitable to work with multiple types of H/W sensor devices with the mentioned communication protocol. The said eVVGSDP platform is a multi hardware compatible platform.
[0072] According to an embodiment of the present invention, there are at-least 3-different options built in for the gateway application or device to ensure data sharing of the IOT/BLE/Wi-Fi/GPRS sensor devices along with other necessary data to track, trace and monitor is stored, and shared safely to the central cloud server. The data sync happens at login time to App, happens at regular interval of time and can happen through the manual clear option. All the above said data sharing processes from gateway to cloud server happens over a secured and encrypted mechanisms via API, making the gateway APP/program and/or gateway mobile device secured and dependable data aggregator and sharing mechanism.
[0073] FIG. 4 is a block diagram illustrating IoT connection process, FIG. 5 is a block diagram illustrating IoT – BLE device scanning process and FIG. 6 is a block diagram illustrating IoT data reading process, according to an embodiment of the present invention. The said eVVGSDP platform is enabled by Internet of Things (IOT) designed architecture. IOT devices connects to BLE (Bluetooth Low Energy) sensor devices, customized Beacons and further connected to various types of sensor devices over Zigbee, Bluetooth,GPRS and Wi-Fi communication or connectivity mechanisms to a Gateway (evv programmed gateway - smart phone application) for collecting/reading the monitored environmental conditions such as but not limited to temperature, humidity, lux and location co-ordinates of the particular device. The said collected/read data along with drug information then uploaded on to a cloud server where the said eVVGSDP platform (cloud software system) analyzes all the data based on GSDP norms of specific drug monitoring, compliance tracking and reporting requirements. This is achieved via eVVGSDP tracking and notification rule engine algorithms written as part of the cloud software system.
[0074] FIG. 7 is a block diagram illustrating IoT-to-Cloud server connectivity, according to an embodiment of the present invention. The central data processing unit or cloud system of the eVVGSDP is the brain of the entire system or process. This is the part of the system from where all inter connections between all gateways to its respective IoT/BLE/Wi-Fi/GPRS devices are notified/linked/managed. It also serves as the primary program unit where manufacturers, products, medicine type, SKU’s (Stock Keeping Unit), warehouses, cold stores, logistic vehicles, consignments, distributors, delivery persons, hospitals, medicine retail stores, multiple operating locations of each of the mentioned pharmaceutical eco-system players and association between them are managed. Meaning defining their respective attributes, association between the entities and data flow between parties to other managed.
[0075] According to an embodiment of the present invention, the eVVGSDP cloud system/platform enables multiple players of the pharmaceutical supply chain eco-system even if they might be at the same layer of the eco-system to participate in the platform without being worrying or need of sharing one’s data with the other player where the particular entity does not have any kind of association. The data stored, processed and shared over the cloud system are centralized but at the same time safe guarded with authorization, authentication and association between entities or parties involved in supply chain transactions. This process allows the system to keep a track on producers and consumer data movement back and forth. At the same time leverage the central positioning of entire data for cross referencing at any moment with valid authentication and authorization to keep track of drug counterfeit.
[0076] According to an embodiment of the present invention, the said cloud system/program/platform of eVVGSDP also serves as the core program with capability to process all collected data from all different devices, gateways, locations, consignments, manufacturers, distributor, hospitals and patients to produce meaningful actionable insights in terms of tracking the drugs movement, counterfeit and efficacy. The generated actionable insights are shared with respective stake holders via email, SMS and mobile application based push notifications and SMS. Additionally, the said cloud system with its BI (Business Intelligence) analytics capabilities/rule engine based monitoring processes share the drug traceability and monitoring data over different user interfaces of the application. The information which is also segregated according to different stake holders and within the stake holder particular location based information. These information are also allowed to be downloaded in multiple formats such as but not limited to PDF,CSV and XLS formats for user manual analysis.
[0077] According to an embodiment of the present invention, in the eVVGSDP cloud system, at first it creates an entity with at least one operating location and authenticated user to manage the entity’s master data/set-up or configurations. Then a set off users or operating location of the entity can be further created or configured. Each entity within the system is truly unique. It assigns a unique ID to each entity and thereafter all the data/information created for the particular entity at the first level tagged with the entity unique ID. And there after it’s mapped to authorized users and location IDs of the entity. There by restricting the data visualization to user, location and entity specific. No two entity data row will be same at any given time. Hence, protecting the data integrity and ensuring isolation. The users within the same entity even restricted by the association at location authorization and privilege basis and get access only to their “Need to know” data/information.
[0078] According to an embodiment of the present invention, at the same time, being all data is centrally managed and located over cloud server, one master controlling authority can have the authorization to process and analyze all data points across the platform to ensure or safe guard or detect drug counterfeits, GSDP (Good Storage and Distribution Practices) being followed, recorded and stored by all the eco-system players correctly at their respective control areas. eVVGSDP platform makes it possible.
[0079] According to an embodiment of the present invention, the eVVGSDP platform enables data transfer along with the physical drug transfer from one stake holder to other in an electronic manner and record it with appropriate tags in the database, which thereafter can be restored or queried or referenced on any day with a simple key or combination of keys. Making verified data transfer and verifiable storage pattern/media/process/option to trace it back. All the process involving the electronic medium like computers, QR codes, software programs, sensors and mobile devices.
[0080] According to an embodiment of the present invention, the process technically starts with registration of an entity as a manufacturer/distribution/ retailing entity on the cloud system. After the logical entity setup the required manufacturer, products, SKU’s and medicine types needs to be configured/entered in the cloud system for the particular entity. The required setup to create a logical representation of the warehouse/storage/ cold room is created with help of the cloud software. Each warehouse/storage/cold room is then divided further into logical portioning named as rack and box as per the physical layout or co-relating to physical rack system present inside the actual store/storage place.
[0081] FIG. 8 is a block diagram illustrating method of protecting counterfeiting of pharmaceutical products and managing pharmaceutical product efficacy in the supply chain cycle, according to an embodiment of the present invention. The QR Code for each of the above mentioned data points/information set is generated by the system. These QR codes are then used in the physical product, SKU or warehouse, floor, room, rack, box level. The lowest being a box, the QR consists of all the required information embedded into it. This is to ensure any person storing or retrieving the drugs/ SKU’s from a particular position with the help of eVVGSDP validation process, is following the correct/exact process step and doing the right job.
[0082] According to an embodiment of the present invention, once the logical software program based master set up and warehouse creation is completed each SKU is associated with one unique code and can be further associated up to an individual serialized SKU code given by manufacturer or can be generated by the system. Each SKU gets associated with a box which in turn gets linked or mapped to a manufacturer, product, medicine type, rack, room, floor, warehouse and location. All these information is present as an encrypted QR code. The QR code is printable and printed on to the box level for scanning and determining the correctness of storage and removal of the correct SKU from correct box.
[0083] According to an embodiment of the present invention, further as per the GSDP (Good Storage and Distribution Practices) SOP for the given SKU, the required temperature, humidity and other parameter ranges for monitoring are defined and linked/mapped as well. This mapping serves as the base for SKU level GSDP monitoring and input for the alert and notification cloud rule engine system.
[0084] According to an embodiment of the present invention, the environmental parameter monitoring need is configured for individual SKU for a specific product SKU that can be defined in the master set-up in the cloud software system while setting up the entity level configuration. This ensures that the eVVGSDP can monitor or follow up the GSDP requirements for the SKU not only in the storage/store room/cold room/warehouse but also during in-transit process inside a container, vehicle, and shipments and inside the delivery person’s package.
[0085] According to an embodiment of the present invention, the encrypted QR coded information during SKU movement from one stake holder to another over the cloud system using mobile application based verification and authentication processes ensures to enforce the integrity and traceability of the products, SKU s, in transit shipments and storage level information centrally on the cloud platform dash board.
[0086] According to an embodiment of the present invention, in order to establish the process of a centrally captured, processed and tracked digital GSDP or evv(Electronically Verified and Verifiable) system for the pharmaceutical supply chain eco-system stake holders to act against the drug counterfeit, maintain the efficacy of the drugs and distribute it safely within the prescribed SOP (standard operating procedure) for particular product SKU’s the following implementations are made into the considered eVVGSDP cloud Platform.
[0087] According to an embodiment of the present invention, the eVVGSDP cloud platform brings all different stake holders as an entity or participants on to the cloud system. The said master data for each entity being setup. Along with the above mentioned master data, the cloud system also takes the associates of any particular entity. Depending upon the role at which one entity is participating in the supply chain eco system, the association primarily divided into 2-groups are linked or configured. One group is external associates. 2nd group is internal associates.
[0088] According to an embodiment of the present invention, the said “External Associates” are those entities from where one party either receives the incoming supplies or to whom it sales. In the system, one can publish different external associates it is dealing with from both incoming and outgoing SKU’s movement point of view. This helps to make a digital information pass through from one party to other by entering at the source point. Thereafter at the receiving end the party needs only to verify or validate and accept. This establishes the digital foot prints of movement between parties. The Information which is passed on between parties includes Invoice, Transport/Logistic oriented data points on top of manufacturer, product, SKU, batch and expiry details. This ensures traceability of the drugs. Applied digitally verification process during transition between two parties as well as can be helpful to back trace or establish the authenticity by ensuring the data it verifiable at any given time using some of the above mentioned key entries. Achieved due to cloud data store and historical data search/filter algorithm.
[0089] According to an embodiment of the present invention, likewise, when one party is dealing within its own branches/branch offices in a multi-location operating environment, within one country or outside, based on the legal entity type are defined as “Internal Associates”. Data and information wise the process flow in cloud system remains same as that of “External Associates” with one difference of tagging it as an intra transaction within a party. This is to ensure better isolation and data integrity in the cloud data store and retrieval system.
[0090] According to an embodiment of the present invention, the combination of “External and Internal Associates” data transfer and traceability within the cloud system brings an end to end traceability within the pharmaceutical supply chain from source to end-consumer. Sharing the complete path a drug or product or batch or list of SKU’s traversed from one starting point till end point involving either different External associates or Internal associates.
[0091] Further, in order to establish the tracking or traceability factor in eVVGSDP, the said system implements the following logic or process flow:
First Process: “Stock-in”, it ensures that when one party is receiving drugs/ SKU’s from other party it is recorded and tagged. It is tagged as whether came through an external associate directly via system to system digital transfer or external associate manual entry point. It can be an entry point from internal associate as well. In any case, the supply chain continues to be traced. In this process invoice, transport/logistic, manufacturer/supplier/seller, product, SKU, batch and expiry and storage details are stored as one unique transactional record (UTR). Based on the UTR, an encrypted QR code is generated for the entire incoming SKU’s. The QR codes are then pasted on the SKU packages as a label giving it an identity and keep mark of it digitally in the complete cloud supply chain process.
Second Process; “Stock-out”, begins with the requirement of moving the SKU’s from one associate (Internal or External) to other, as it would require within the supply chain cycle to move from start to end-point. At the start of the stock-out process the data points such as associate details, invoice, transaction type (internal/external), needed SKU’s for the particular shipment/consignment are captured. Further, the data is being made available to the concern team at the down chain operations to verify, validate and process the correct SKU’s in correct order, the system process a FIFO (First in First Out) principle taking expiry date of SKU’s as the deciding parameter. The QR codes which are generated using UTR helps at this point to select the correct SKU’s from the correct box/storage location. In case if particular quantity needed to be supplied vs. quantity available in one particular UTR does not match (not available in sufficient numbers) the next set off SKU’s available is/are automatically allocated using FIFO principle by the cloud system/algorithms based on UTR entries.
[0092] According to an embodiment of the present invention, upon the valid and verified SKU’s are collected/packed for a particular consignment/shipment, the system captures additional information such as linking it with IOT devices, delivery / logistic /transport details. Once all these data are tagged, the system generates another encrypted QR code and UTR for transfer out records. Adding digital foot print and mechanism to keep track of the GSDP process for drugs/ SKU’s during In-Transit process.
[0093] According to an embodiment of the present invention, once the second process completes the next steps of actual delivery starts and which is also authenticated and system captures the data of actual start time, concern person and etc data points.
[0094] According to an embodiment of the present invention, during the in-transit process, the IOT (Internet of Things) devices collect temperature, humidity data on a regular interval (as pre-configured based on GSDP monitoring SOP) and share it with the IOT gateway APP/program.
[0095] According to an embodiment of the present invention, the gateway device (can be a mobile device as well) adds the geo-coordinates based on GPS or network location provider options of the used hardware (H/W) as gateway. The gateway further keeps a track of the environmental data recording date and time; it adds the timestamp for each of the stored record and shares it with cloud system/server on regular intervals.
[0096] According to an embodiment of the present invention, the cloud system/platform with data on threshold limits (need of temperature and humidity) of SKU s, keeps an eye using a scheduler program thread, keeps processing the incoming data records of IOT devices via gateway. Brings GSDP need based monitoring system.
[0097] According to an embodiment of the present invention, in addition to the above, using the geo-coordinates as made available gateway to cloud system, few other algorithm made to work under the system to keep a check on the path followed by the logistic/consignment/shipment and process the data in accordance to predict the distance, time/duration to reach from source to end-point.
[0098] According to an embodiment of the present invention, the said information is used for predictions like; if there would be any chance of any fluctuation can happen to the environmental conditions of the SKU due to the dependency on the ice pack / infrastructure within which deliveries between one player to other is happening.
[0099] According to an embodiment of the present invention, the above data analysis are observed via a thread program of the cloud system at regular interval and upon getting a diversion from the specified limits, it generates human actionable alerts and notifications. These actions are notified as SMS, E-mail, push notifications over a mobile APP. The actions which are needed to ensure GSDP sop are followed, maintained and or pre-cautionary measures are taken to protect drug efficacy. The actions taken by any particular person involved on arrival of alerts or notification is also captured and monitored.
[00100] According to an embodiment of the present invention, the said entire process is verifiable at each level of transaction and point of time, making electronically verified and verifiable GSDP a reality.
[00101] According to an embodiment of the present invention, the said system is also design to protect drug counterfeit and unauthorized cross selling of drugs/ SKU’s by parties outside their permissible permit and location constraints. In order to achieve it, the cloud platform considers the associated entity’s operating location and price restrictions product/ SKU wise. Upon the stock transactions initiation from one party to other happens using the above mentioned stock-in process, the UTR with the batch code, SKU code and link between the associates are tagged for each and every transaction. Each transaction then analyzed at every next step of stock transfer or sale or return process to link the data back. The link verification involves associate code, location code, batch code, SKU code, total no. of item produced in the given batch, items arrived from source and location and item transferred to entity and location; kind of data points, to ensure the correct product/SKU is/was actually getting moved at under the prescribed norms at the same time, there is no additional or new quantity getting added by manipulating or coping any specific information. The cloud system at any given point of time can link or traverse the path of batch added/produced at the manufacturer side, with total quantity and all the transactions between various supply chain eco-system stake holders which might have happened during the normal course of SKU’s movement and calculate any particular SKU’s holding at each level for a particular batch. And reconcile it against the total quantity or holding matching to the quantity initially produced/manufactured for the specific product/ SKU under the give batch. All of it done digitally using the stock-in and stock-out UTRs which gets created in the mentioned eVVGSDP system automatically as part of the system’s process and data flow.
[00102] According to an embodiment of the present invention, the said system notifies to respective stake holders immediately about the mismatch; if found less then it indicates/generate alerts of theft, if found elsewhere then it indicate/generate alerts of misplaced or sold elsewhere unauthorized, If found more, then it indicate/generate alerts of counterfeit drugs being entered into the system and along with all these information, the eVVGSDP system indicate using the UTR under which location the observation is done. This helps to identify the involved parties and transactions, batches, SKU’s on immediate basis. This makes the UTR process and information to be made secured. Hence, the system implements the encrypted QR code mechanism. This process enables the program to encode the data and generate a QR code which cannot be readable by any human or other program without knowing the decrypt logic/algorithm. Some basic information of the QR code which needed to read by the humans to follow the process in a comfortable way is being generated/provided/mentioned along with the encrypted QR codes. The QR codes get scanned by eVVGSDP system’s mobile application or programmed interfaces to decrypt end to end data and trigger the necessary actions points based on the stage of the data flow within the system.
[00103] According to an embodiment of the present invention, the said entire process works seamlessly under a combination of IOT Devices, gateway program/app, gateway devices, user interfacing app/programs, cloud storage and analysis platform without sharing any kind of complexities to end-users. Each level of users is enabled with their required set off feature access, based on authority, role and restrictions. It makes the system simple to use and interact from a user point of view as well, as all the features are basically on a need to know basis assignments which one need to follow as part of the roles and responsibility within the organization/entity to ensure the GSDP is followed and digitization or electronic recording of the data is being done.
[00104] According to an embodiment of the present invention, one of the critical users of this system is end-consumer (Hospital/Patient) who is finally consuming the drug/ SKU. The eVVGSDP data being available on cloud or digitally makes it convenient and easy for end-consumers to also verify or validate or compare the SOPs or in-transit data from a drug efficacy point of view at ease of their finger tips over the computer, laptop or any mobile device using the eVVGSDP consumer interface. Transparency and traceability reaches to the beneficiary with accurate and fastest way (nearly real-time basis).
[00105] According to an embodiment of the present invention, the consumer interface of the eVVGSDP allows seeing the data over maps, graphs, pie-chart, and tabular format over email, browsers or mobile application based, depending upon the type and role of user. The said interface allows user to refer historical transaction data points, generate analysis reports consisting some key data point comparisons, search information about drug GSDP or counterfeit based on different requirements using QR codes, SKU Code or keying in the SKU name, product name, serialized SKU code etc. This improves the usability and accessibility part of the eVVGSDP system to bring the electronically verified and verifiable aspects.
[00106] According to an embodiment of the present invention, the said system provides a user mobile application for validating and inter-connecting layer. The eVVGSDP platforms one of the most important aspect is the user involved electronic sign off or verification process implementation, which comes to user at ease of using an mobile App, fewer entry/key-in options and major validations are done using QR or BARCODE scans of the encrypted QR codes created with combination of data points to form UTR of the cloud system. A seamless integration between the cloud systems to mobile application using APIs ensures the trust, validity, authorization of the data received/passed through is achieved and authenticated users are only allowed to operate on it.
[00107] According to an embodiment of the present invention, the eVVGSDP system along with the above mentioned 3-layers namely; device/hardware/things layer and a cloud or central processing layer consists of the third important layer as validation and inter-connecting layer. This is achieved via the mobile application program enabled to run as an Android or react native or Flutter or any other compatible/Native based platform to support iOS (iPhones).
[00108] According to an embodiment of the present invention, the said layer plays the role of a bridge between the data/information handshake between different user roles and responsibilities. Or can visualize it to be the bridge, enabling data transfer from cloud layer/server to on-field operators/ground level requirements. This makes the process tracking or enforcing certain activities of validation easy to capture at physical level and record it digitally using the QR code scanner implemented program.
[00109] According to an embodiment of the present invention, the mobile application requires login, the user credentials are verified over cloud system to authenticate and authorize details to share the required data set for a single or multiple list of locations, and within that respective operational features. The features which are assigned to a role as per one’s accountability and responsibility requirement to ensure GSDP are followed stringently. The mobile application brings in the capability to record it digitally or electronically which is stored over the cloud data store/ database and can be verified or referred back at any point of time.
[00110] According to an embodiment of the present invention, the validation and inter-connection process of GSDP is implemented seamlessly at various level of the supply chain eco-system of the pharmaceutical/drugs in the mentioned eVVGSDP using the APP. For example: verification using QR codes; at the point of storage to check whether the correct and dedicated room, rack, shelf/box are used for different SKU’s as planned or assigned. The verifications are electronically signed off by the user who is logged in, attached with the date and time of verification; additionally the system attaches the location and other related data points to ensure one authorized person has done the verification job as required/needed. This in turn helps to apply GSDP at the grass root level of storing correct SKU at correct place and at right temperature.
[00111] FIG. 9 is a block diagram illustrating IoT based tracking/drug efficacy, according to an embodiment of the present invention. The said APP’s in-built encrypted QR code, scan and verify based stock-check and stock-in process on consignment or drug arrival for store/warehouse/cold room/storage purpose makes it easy and digitally records the stock inward data points without much human entries at all. This feature makes it much more accurate, safe and reliable digital data for further processing without Error. And enforces on the ground operation to record in an easy to prove electronic way of who has done the inspection or verification or stored the drugs correctly.
[00112] Similarly, in the event of drugs has to be packaged or prepared to move out from the central warehouses/manufacturing store/any store room shelves as a forward consignment/shipment from one location to other (can be between internal associates or between external associates); the app’s stock check-out, consignment scan, vehicle consignment link processes which are in turn linked to the cloud system to get validated data of stock movements involving the supply chain business processes kicks-in to establish one secured way of transacting and validating the stock-outward needs. The process which is built in accordance to ensure GSDP compliance requirements should be monitored helps in associating the IOT layer/devices for drug efficacy tracking and other processes to improve the drug movement tracking, counterfeit verification and providing the ground staff with easy to use mobile tool to adhere to compliance, record it and analyze any data at any point of time.
[00113] According to an embodiment of the present invention, the mobile application based stock checkout process ensures that all SKU’s which needs to be packed or packaged or ordered by the upper layer to be processed for a consignment/shipment are actually verified in terms of picking the right stock/ SKU s, with right batch code, with correct expiry dates from the correct shelves/store/room/location. All these done using simple 2 or 3 encrypted QR code scan feature of the mobile APP, in integration to the cloud system API. On the scan, the encoded data gets transmitted using an API call to cloud system/program of eVVGSDP. Then it gets decrypted to get the actual value by the system and matched for the authenticity and returns back the required response in terms of what the user should know or in some cases the validation responses as whether the correct medicines/drugs are being picked up from the right places. The process being handled electronically, signed-off digitally by the authorized user performing the task along with other required parameters such as date and time of verification and location.
[00114] This helps the eVVGSDP system to keep track of each UTR of drug movements or tagged from all the aspects of date, time, who placed/picked-it up where last time and what is/was the environmental condition found/recorded at that point of time. Brings in the efficiency to the cloud system to filter or search faster for SKU s/drugs, counterfeit reconciliation using quantity produced vs. quantity moved through or present with different supply chain players at given point of time vs. current transaction. On the simple assumption of eVVGSDP platform, that if all producers’ source data came inside the system and moved out from one step/player/entity/party to other using one encrypted coded electronic process. And at the receiving end, the receivable being accepted or added into the system as part of the receiver’s data after a digital hand shake/verification process. The processes are recorded or being tagged at each level cannot be altered by any one person in between, if it that happens, the said system would generate alert/notification or notify the stake holders immediately. The eVVGSDP counterfeit protection is based on the fact that a certain quantity gets produced for a particular SKU /drug under a particular batch code and at any given point of time, drug produced/manufactured under one batch should equate to all the addition of SKU of same batch code present with different supply chain stake holders such as distributors, wholesalers or agents and all SKU’s which has been sold out via one of end level supply chain eco-system player such as hospital, clinic and medicine stores. The principal point over here is: drugs/ SKU’s change hand between one party to another inside of the supply chain, no new addition happens. The eVVGSDP protects the incoming of any new SKU via its stock-in encrypted UTR/QR code and association linking basis to ensure entire data set of one particular drug for an particular batch code only moves from one location to other, one party to other within the provide authorized and authenticated framework. Protecting the ghost entries or avoid any foreign entries being made on ADHOC basis, without being able referenced back or linked back to source. For example; if one manufacturer produced certain drug/ SKU under a particular batch as 10,000 piece/bottle/box/units etc. And then it starts moving within the supply chain to multiple internal and external associates. At any given point of time: the SKU of the batch if verified or summed up across different eco-system player who purchased it, stored it or sold it, the Total number should be equal to 10,000 units. The eVVGSDP program ensures, to do the check-points during each possible step of transaction where a foreign or human entry can be made, first of all the system tries to avoid all possible human entry points for drug/ SKU’s oriented data, but at some cases where it is required for user interaction/intervention the system/program validates the SKU, batch code, quantity originally provided to the consumer in down chain vs. quantity presently getting deled with.
[00115] According to an embodiment of the present invention, in case the program detects a mismatch, it brings the unaccepted case/units to different stake holders in various forms of mobile application notification, emails and analytics dash board as potential point/transaction when someone tried to manipulate/breach the supplied SKU’s against with some counterfeits.
[00116] According to an embodiment of the present invention, the automatic processed flow based tracking and quick alerts to take immediate actions to prevent drug counterfeit using data points.
[00117] Further, in other cases also, the FIFO principle based eVVGSDP cloud program along with the mobile application based process of quick stock check and stock-out process using the QR code scan based mechanism brings faster stock reconciliation and expiry stock checks in a batch wise manner for SKU’s at ease of just a QR scan. This process is making correct drug discovery and supply to consumer error free. And helping in providing/selecting the effective drug; in terms of storage timeline (expiry basis) and environmental condition basis for the consumers/receivers. This process improves supply chain intra losses due to expiry stocks, return and disposal processes. Also, helps indirectly to protect environment as lesser expiry drugs to be processed / managed or wastage better for the environment.
[00118] According to an embodiment of the present invention, the user mobile application layer also brings in the efficiency towards the logistic or transportation or end mile delivery team and process. It allows start/record data/information of consignments/shipments over a simple QR code scan which is provided as a packaging label on top of the box(s) or consignments. The QR code scan provides the cloud system data around, who is picking up the packet/parcel/consignment from where; at what time and which IOT device is linked to monitor it. And at the same time the cloud system replies back the particular person performing the task with information such as; whether the correct box is picked-up, where to deliver (delivery address), contact number (no other info), path/route to each the destination, expected time of arrival, total distance to be travelled and etc.
[00119] According to an embodiment of the present invention, the said process as part of GSDP ensures connecting the in-transit drugs/ SKU’s from the ground level or on actual operational field to cloud system. It shares the real-time geo-coordinates and environmental condition as being maintained within the consignments from the mobile application to cloud server. The information captured and shared over the said mobile application based consignment management process helps the person involved in ensuring the drug delivery happens under guided GSDP norms.
[00120] According to an embodiment of the present invention, the mobile application in coordination with the cloud system/program shares the alert and notification about any violations at SKU level of the consignment to the person carrying/responsible for the in-transit drugs, if there is any temperature or humidity spike/violations observed during transit. Also, it provides effective procedures/mechanism to maintain the environmental conditions within the consignments such as; when to start taking pre-cautionary measures, when to check the AC of the vehicle or when to change the ice-packs all based on data. This brings in the GSDP best practices to the ground level with data backed verification and tracking process (map based) on a real-time basis. The captured data can be analyzed or view further over the cloud platform for futuristic or better planning.
[00121] According to an embodiment of the present invention, the user APP, not only helps supply chain eco-system players of the pharmaceutical, but also helps the end consumers such as hospital, doctor and patient to be an informed consumer with entire data from source to destination being captured, verified and verifiable. The mobile application provides an interface for the end consumer as well to scan or enter the QR code or SKU serial code of the particular drug to check the authenticity and traversal path if needed. The user can also track the route information, GPS path and during in-transit view how the GSDP followed across till the end-point. The eVVGSDP platform is capable of providing manufacturing till end-consumer (patient) delivery point GSDP data. Bringing the highest level of transparency and assurance towards drug efficacy following the GSDP sops (standard operating procedure) norms. And this can be viewed on a nearly real-time basis or can be referred back to any historical data any point any time.
[00122] FIG. 10 is a block diagram illustrating a centralized tracking of ware house, cold store, deep freezers for reporting cold spots and hot spots on a color coded dash board and FIG. 11 is a block diagram illustrating a method of individual spot tracking on a real-time basis of the ware house, cold store and deep freezers in the supply chain cycle, according to an embodiment of the present invention. The said eVVGSDP enabled system is designed to create a virtual GSDP (Good Storage and Distribution Practise) environment replicating the actual warehouse, cold store and deep freezer environment and storage capacity structures. The system allows defining the floors, rooms, racks and boxes for each type of store units where pharmaceutical products are kept under different storage environments. The platform enables to associate a particular manufacturer or group of manufacturer and it’s one specific product or range of products to a floor, room, rack or even up to individual storage boxes (in a rack). The same storage units are also mapped with dedicated wireless sensors or IOT (Internet of Things) devices (BLE, Beacons, Wi-Fi and GPRS based devices) to collect temperature and humidity data from the particular spots and pass it on to the eVVGSDP platform via the smart gateway along with the timestamp, location and other details such as business location code, floor, room, rack and codes making the monitoring of a particular SKU storage conditions feasible.
[00123] According to an embodiment of the present invention, as per the GSDP norms; the storage environment requirements are different for different kind of pharmaceutical products ranging from -25`C to +25`C known as cold chain required pharmaceutical products and normal room temperature products. The norms also specify the threshold limits for those product lines. The efficacy of biologics and bio-similar pharmaceutical products, blood banks, stem cells and vaccine are the most important life saving category products gets impacted because of temperature and humidity excursions. This needs to be monitored and managed on a 24x7 manner with highest degree of transparency and focus. The negligence on the storage part impacts the medication efficacy and hence increases economical as well as emotional burden on the patient/consumer and family. In the event of a mass wrong doing this above can be life threatening to large number of lives. This also brings loss of reputation and finance to pharmaceutical companies working towards developing effective medications. Hence, monitoring of cold store, warehouse, deep freezer and other mediums which is used in pharmaceutical product storage is highly important as per GSDP norms. At the same time, following the guidelines of the rules, it is required to have the provision of notifying the concern person(s)/team(s) about the violations, record the violation timestamp, record the actions taken to rectify it, record the person involved in verifying and taking the action and producing the information during auditing process or in the event of any mishap being reported in an quick manner. The monitoring information according to GSDP needs to be recorded and maintained in hourly, daily, weekly, monthly manner.
[00124] According to an embodiment of the present invention, the said eVVGSDP platform enables the entire requirement of GSDP norms digitally or electronically by involving IOT (Internet of Things) devices, smart gateway to capture the temperature, humidity, geo-coordinate information on a minimum interval such as but not limited to 3-mins level from each spot (hot spot or cold spot) and integrate these information with associated storage location (floor, room, rack and box) as well as with the particular product, manufacturer’s instructions for ensuring the best storage conditions for the medicines/drugs to be considered as no efficacy loss, safely stored and properly distributed. The complete monitoring data is analyzed using eVVGSDP platform in an automated way with the help of a rule engine. The rule engine is a cloud based data analytics algorithm which can be setup from the user interface to define different rules for different products needing different storage conditions, threshold limits and alarm setups. The temperature and humidity value range with min-max limits, threshold limit to generate and notify, hierarchy of notification are configured in the rule engine. The said eVVGSDP platform continuously records and analyzes the temperature and humidity data in accordance to the expected range; it not only sends the alerts/notification to concern stake holder when it sees an immediate up (excursion) or down (freezing), but also, allows to study the patterns and predict if there could be any excursion or freezing going to happen in the next sometime, helping to manage the storage and in-transit medicines effectively for best efficacy. The alerts and notifications generated by eVVGSDP platform connects to stake holder over the email, SMS or in mobile application based push notifications with a provision to record the action being taken by the concern stake holder(s). This data is also stored, monitored and analyzed by eVVGSDP platform to escalate at the operational level and help the audit/compliance team check the defined SOPs vs. actual implementation towards the most effective way of storing and distributing medicines as per prescribed norms. All of the said processes are monitored and enforced in an electronic or digital way. The eVVGSDP platform (cloud system, smart gateway and APP) are externally connected to physical alarm system such a siren or bell to ring loudly and attract the attention of the stake holder(s) to ensure action is taken when reported. Hence, enforcing GSDP digitally or electronically.
[00125] FIG. 12 is a block diagram illustrating a method of tracking in-transit drugs/pharmaceutical products, according to an embodiment of the present invention. The said eVVGSDP platform retrieves necessary information being required to be monitored while the drugs/medicines moves from one location to other between the same or two or multiple parties to move forward in the supply chain cycle to reach the patient/customer. The said platform enables to use IOT (Internet of Things) devices with temperature and humidity sensing capabilities and communication capabilities like GPRS/2G or BLE (Bluetooth) to communicate directly to cloud platform or using one smart (APP Based Software driven) gateway to eVVGSDP platform for further monitoring and analysis of the temperature, humidity data in accordance to GSDP norms and notify the concern parties with push notifications, SMS, emails about the transit consignment. The transit mode can be on road, ship or air cargo or last mile delivery within city via delivery personals.
[00126] According to an embodiment of the present invention, the said eVVGSDP platform is termed as “Coolgix”.

G) ADVANTAGES OF THE INVENTION
[00127] The said eVVGSDP platform based supplying medicines / drugs, vaccines and other environmental parameter dependent critical or high value supplies ensures that; delivery happened in a safe, secured and verifiable way. Providing proper care to the patient for most effective result of the medication.
[00128] Uses IOT to track deliveries and ensure safety. On demand supply can be done easily by mapping the exact location of delivery.
[00129] Dramatic reduction in out of stock issues. Best way to track upcoming expiry stocks and plan handling of it.
[00130] Protect drugs/medicines being counterfeit. Increases proper medication and saving precious lives.
[00131] Verified delivery of relief for reporting to funding organizations.
[00132] Cold chain monitoring, to ensure vaccines given are safe and effective.
[00133] Identify chronically failing fridges/cold rooms/storage. Monitoring and implementing GSDP.
[00134] Remotely diagnose certain common causes of fridge/freezer/AC failure using temperature data signatures. Monitoring and implementing GSDP.
[00135] Verify fixes conducted remotely or in person by following temperature data closely after a fridge/AC/freezer repair. Monitoring and Implementing GSDP.
[00136] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.
[00137] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims.

,CLAIMS:

WE CLAIM:
1. A system for electronically verified and verifiable, good storage and distribution practices (evv GSDP) of the pharmaceutical products in the supply chain, the system comprises:

a platform for creating a digital signature for each of the new drug produced, and wherein the said digital signatures are created by using drug manufacturer’s sku code and serialized sku code, batch code, expiry date and other internal data points as an encrypted and pass phrase protected unique QR code for a particular drug;

plurality of Internet of Things (IOT) devices for monitoring environmental conditions such as but not limited to temperature, humidity, lux and location co-ordinates of the particular device; and wherein the said Internet of Things (IOT) devices connects via BLE (Bluetooth Low Energy), GPRS, 2G/3G/4G sensor devices, customized Beacons and further connected to various types of sensor devices over Zigbee, and Wi-Fi communication or connectivity mechanisms to a Gateway (evv programmed gateway - smart phone/mobile application) for collecting/reading the monitored environmental conditions;

a central remote server hosted on cloud comprising a cloud software system and a storage; and wherein the said cloud software system further comprises rules engine comprising plurality of rules for data computation and retrieval;

a mobile application in a mobile computing device for real time monitoring of the data such as but not limited to environmental conditions, transit, warehouse, etc; and wherein the said mobile computing device is any of a electronic device selected from the group comprising a tablet, a Smartphone, PDA’s, desktop or personal computer, etc;

a Web Application for desktop or personal computer for real time monitoring of the data such as but not limited to environmental conditions, transit, warehouse, etc;

wherein the said evv GSDP platform uses batch production information to validate the drug counterfeit in combination with: digitally signed QR code, drugs supply chain movement/positioning statuses.

2. The system as claimed in claim 1, wherein the said data collected/read by the IOT devices along with mapped drug information then uploaded on to the cloud server where the said evv GSDP platform (cloud software system) analyzes all the data based on GSDP norms of specific drug monitoring, compliance tracking and reporting requirements, and wherein this is achieved via evv GSDP tracking and notification rule engine algorithms written as part of the cloud software system.

3. The system as claimed in claim 1, wherein once the norms are cross referenced/checked, plurality of alerts and notifications on the real-time basis for individual drug in-transit or store are generated for different stake holders of the supply chain eco-system at respective steps to bring it to the notice of concern team or person to take preventive or corrective course of action to protect the drug or its efficacy; and wherein the said data being in centralized cloud server database storage is always available for historical analysis, tracking, reporting and future referencing for in-depth analysis requirement.

4. The system as claimed in claim 1, wherein the said data collection mechanism along with the eVVGSDP rule engine is defined to build the logistic tracking framework; and wherein the said tracking includes the important factors and guideline of GSDP for pharmaceutical product such as but not limited to transportation, business case for operational efficiency and the mode of transport data along with the mapped product packet, SKUs inside the packet and environmental conditions (temperature and humidity) information to provide an in-depth tracing mechanism for the in-transit pharmaceuticals product.

5. The system as claimed in claim 1, wherein the said eVVGSDP in-transit tracing mechanism takes the input of packet, reference invoice no, start and destination location, path to follow to reach destination (point a to b via..), number of stop locations, each stop duration, packet delivery destinations, SKUs details inside the packet (quantity, expiry, batch, etc.), temperature check range for each packet, humidity check range for each packet, planned start timestamp, planned reached timestamp, data collection frequency and alerts and notifications hierarchy.

6. The system as claimed in claim 1, wherein the end consumers (hospitals/patients) uses a simple mobile application (android/ios) at their site and scan the QR code as mentioned on the packet or particular SKU package to verify the drugs/medicines source to destination travel details and avails the associated temperature and humidity information for establishing the fact that drugs/medicines being delivered through a proper channel, taking care of the important efficacy factors at each and every level.

7. The system as claimed in claim 1, wherein the said eVVGSDP system is a virtual GSDP (good storage and distribution practice) environment replicating the actual warehouse, cold store and deep freezer environment and storage capacity structures; and wherein the aid system allows defining the floors, rooms, racks and boxes for each type of store units where pharmaceutical products are placed under different storage environments; and wherein the said system associate a particular manufacturer or group of manufacturer and it’s one specific product or range of products to a floor, room, rack or even up to individual storage boxes (in a rack); and wherein the said storage units are mapped with dedicated wireless sensors or IOT (internet of things) devices such as but not limited to BLE, beacons, wi-fi and GPRS based devices, to collect temperature and humidity data from the particular spots and pass it on to the said eVVGSD; and wherein the said system attaches timestamp, location and other details such as but not limited to business location code, floor, room, rack and codes through a smart gateway to monitor a particular SKU storage conditions.

8. A method for electronically verified and verifiable, good storage and distribution practices (evv GSDP) for the pharmaceutical products in the supply chain, the method comprising the steps of:

creating a digital signature for each of the new drug produced, and wherein the said digital signatures are created by using drug manufacturer’s sku code and serialized sku code, batch code, expiry date and other internal data points as an encrypted and pass phrase protected unique QR code for a particular drug;

monitoring environmental condition of plurality of pharmaceutical products storage area through a plurality of Internet of Things (IOT) devices;

collecting/reading the monitored environmental conditions such as but not limited to temperature, humidity, lux and location co-ordinates of the particular drug;

uploading the said collected/read data along with drug information to a cloud server and wherein the said evv GSDP platform (cloud software system) analyzes all the data based on GSDP norms of specific drug monitoring, compliance tracking and reporting requirements;

validating the drug counterfeit in combination with: digitally signed QR code, drugs supply chain movement/positioning statuses using the batch production information; and

generating plurality of alerts and notifications on the real-time basis for individual drug in-transit or store, once the norms are cross referenced/checked for different stake holders of the supply chain eco-system at respective steps to bring it to the notice of concern team or person to take preventive or corrective course of action to protect the drug or its efficacy; and wherein the said data being in centralized cloud server database storage is always available for historical analysis, tracking, reporting and future referencing for in-depth analysis requirement.

9. A method for protecting counterfeiting of pharmaceutical products and managing pharmaceutical product efficacy in the supply chain cycle; the method comprising the steps of:

monitoring entire supply chain; and wherein the step of monitoring entire supple chain further comprises the steps of:
retrieving a particular drug/medicines batch production till distribution level information;
analyzing the complete set of data at any point of time;
monitoring any infiltration or unauthorized entry or unaccounted exit;
raising an alarm in a digital way (alerts/notifications via push notifications, SMS and email) to respective stake holders about the missing data links, SCM data mismatch and probable positions of counterfeits,

monitoring batch level information; and wherein step of monitoring batch level information further comprises the steps of:

retrieving data points of batch information comprising batch code, SKU code, expiry date, manufacture info, origin locations, total quantity produced in the particular batch;
retrieving documentation of stock-transfer memos, invoices or returned/expiry good receipts or way bills (in-transit) in each step of the product movement;
using batch number as the primary identifier between any successful transaction (forward/backward) along with the SKU Code and quantity of the products being moved;
tracing a specific batch number; and
validating the said batch number and SKU code associated with the batch number (from source) and quantity moved; and

tracking products at SKU level; and wherein step of tracking products at SKU level further comprises the steps of:

creating an encrypted QR with serialized SKU codes for each unit of production under any particular batch;
creating an unique identifier for each of the SKU/Pack/Vile at the smallest unit possible level;
clubbing each of the said encrypted QR serialized code moving in the supply chain (Block chain) as an individual unit/identity, with the batch code and other manufacturer data;
linking the location parameter to the above said information for tracking the intended receiver at supply chain level in an on-going transactional basis as the products starts moving from one layer and one location to multiple locations at the other layer;
verifying the entire traversal path of the particular SKU, since each SKU is uniquely encoded; and
raising alarms/alerts and notifications to concern stake holders in case of mismatch

Dated this 30th day of June, 2020

For VHS LOGITECH PVT LTD

BY THEIR AGENT
(DR. BABITHA THARAPPAN)
IN/PA-1614
ATV-LEGAL