DAVA. Drugs Authentication and Verification Application. A portal for Indian Drugs authentication, track and trace

Transcription

1 DAVA Drugs Authentication and Verification Application A portal for Indian Drugs authentication, track and trace Avinash Pedgaonkar

2 Objectives To ensure the genuineness and authenticity of the drugs with track and trace movement in its complete supply- chain. To provide simpler means for drug authentication to the consumer through Central Portal and Mobile app etc.

3 Stake Holders: Government of India Department of Commerce Pharmaceutical Export Promotion Council (Pharmexcil) GS1-India Directorate General of Foreign Trade (DGFT) Customs Ministry of Health and Family Welfare Drug Controller General of India Manufacturers/ Exporters/ Wholesalers/ Distributors/ Retailers Consumer/ Citizen / Importing country

4 Challenges Diversity of Indian Pharmaceutical Industry Implementation of method for unique identification of the product Data Management to maintain Parent-child Relationship among the various level of packaging by the manufacturer General awareness and readiness of the Indian Pharma industry Financial Implications and overheads for the manufacturers

5 The available technologies and methods for identification Parameters Fingerprint Barcodes RFID Holograms Scratch Labels Tamperproof Packaging Packaging Special identifier Bar Code printed Special identifier External Feature External Feature External Feature Technology Requirement Proprietary Device General Device Proprietary Device Cost High Low High Low Low Low Security High Medium High Low Low Low Parameters Fingerprint Barcodes RFID Holograms Scratch Labels Tamperproof Packaging Scalability Low High Low Medium Medium Medium Data Type Location, Origin, other details Location Origin, other details Location, Origin, other details Main Application Security Information embedded Security Information embedded Security Information embedded Overt Security Overt Security Overt Security Regular Verification Manufacturer Implementation Feasibility (Timeline for adoption & cost) Possible Possible Possible Low Low Low High High High Track and Trace Yes Yes Yes - - -

6 Packaging Levels covered:

7 Bar Code Labelling as per Global Standards: Labeling procedure (as per GS1 global standards) Level of packaging Data Elements Unique Identification Key Combination Primary (strip/blister/vial etc.) GTIN14, Unique Serial Number GTIN14+ Unique Serial Number Labelling 2D Bar Code Secondary GTIN14, Batch Number, Expiry Date, Unique Serial Number GTIN14 + Unique Serial Number 1D or 2D Bar Code The public noticegtin14, also indicates Batch Number, the implementation Serial Shipping dates for the Tertiary Expiry Date and Unique Serial Number i.e.sscc Container Code (SSCC) 1D Bar Code

8 Tertiary Level Labeling (Two 1D Barcodes) (05) (17)130616(10) Pack Level Identifier Digit Product Identification code (GTIN) (Manufacturer Code + Product Code + Check Digit) Expiry Date Batch Number Serial Shipping Container Code (SSCC) SSCC would uniquely identify Tertiary pack.

9 Secondary Level Labeling Pack Level Identifier Digit Product Identification code (GTIN) (Manufacturer Code + Product Code + Check Digit) Expiry Date Batch Number Serial Number The GTIN + Unique Serial Number would uniquely identify a secondary pack.

10 Primary Level Labeling ( Barcoding Optional) (2D Bar code) Product identification code (GTIN), Batch Number, Expiry date and Unique Serial Number of the Primary pack. These are also printed in human readable form along with Batch Number, Expiry Date, price etc. GTIN + Unique Serial Number would uniquely identify a primary pack GTIN: S.No.: Batch No.: bcd1234 EXP: Dec 15, 2017 GTIN + Unique Serial Number would uniquely identify a Primary pack

11 The available technologies and methods for identification Parameters Fingerprint Barcodes RFID Holograms Scratch Labels Tamperproof Packaging Packaging Special identifier Bar Code printed Special identifier External Feature External Feature External Feature Technology Requirement Proprietary Device General Device Proprietary Device Cost High Low High Low Low Low Security High Medium High Low Low Low Parameters Fingerprint Barcodes RFID Holograms Scratch Labels Tamperproof Packaging Scalability Low High Low Medium Medium Medium Data Type Location, Origin, other details Location Origin, other details Location, Origin, other details Main Application Security Information embedded Security Information embedded Security Information embedded Overt Security Overt Security Overt Security Regular Verification Manufacturer Implementation Feasibility (Timeline for adoption & cost) Possible Possible Possible Low Low Low High High High Track and Trace Yes Yes Yes - - -

12 Mobile Phone GS1 India Manufacturer Details Central Portal GTIN14 + Serial No XML Format Internet INTERNET Authentication Details Basic Details & Movement Detail XML Format Manufacturer Distribution Point Details Product Details Batch Detail Production Detail s Movement Details Central Data Base Master Directories Login Master Registration Detail Master Country Master State Master District Master Distribution Type Master Upload Master File Information Master Error Master INTERNET GTIN14 + Serial No Web/ Mobile App/ Barcode Scanner

13 Unique Features of application State of art Platform to Authenticate, trace and track Drug. International standards used GS-1 for Pack identification UN Country codes Indian egovernance Standard for State Codes, District codes Permanent Account Number (PAN), Tax Deduction and Collection Account Number (TAN), Importer Exporter Code(IEC) for Trading Community

14 Unique Technical Features of application Platform independent XML for data exchange Open source (Java) for application development Digital Signatures for Authentication and authorisation (2048 characters long SHA-II standard PKI technology approved by CCA) Secured, Scalable, industry neutral aggregation and tracking mechanism New stake holders can easily plug in with web services Accessibility via portal, barcode reader and Mobile App etc

15 Basic principals for maintaining and hosting of the data The responsibility of upload and maintenance of data is sole responsibility of the Manufacturer concerned; Manufacturer may extend the responsibility to next level i.e. Wholesalers/ Distributors/ Retailers etc. in its supply chain; Data is to be maintained ensuring the Parent-Child relationship between Tertiary-Secondary and Secondary- Primary level of packaging. Data movement at each hop i.e. every time the movement of drugs take place, wherever possible, is captured and uploaded by the manufacturer/authorised distribution point on the central portal.

16 About Software The current software developed by NIC provisions and envisages authentication, track and trace of drugs at strip/blister/vial level i.e. primary level, intermediate packing i.e. secondary level and shipment packing i.e. Tertiary level. Unique Serial Number is maintained by the manufacturers using their own algorithm or through third party at primary as well as secondary levels of packaging. Manufacturers are free to use any such method of serialization as per their convenience. In general, Bar code labeling as per GS1 Global Standards consists of Unique Identification Key and other mandatory fields. Contd

17 Features : 1. Web based portal / Mobile app based system enabling the citizens to check the authenticity of the drugs online or on mobile 2. Complete supply chain for drugs exported/ domestic supply to ensure the reliable supply of drugs to consumers for patient safety and brand protection of manufacturer as well as nation 3. Following information to be provided online or on mobile : Name of Drug Name of Manufacturer Batch number Date of manufacturing Date of expiry Usage of drug (optional) Composition of drug (optional) 4. Help in prevention of counterfeiting, fraud and illegal sale of drugs

18 Value-added Features : Availability of stocks for a drug in an area/wholesalers/retailers at a point of time o If required, drugs can easily be identified and recalled due to traceability of stocks Prevention of black marketing which especially arises during epidemics Regulatory agencies like DCGI can do sample picking from the market itself Availability of authentic and real-time information for policy makers

19 Process Flow Batch, Production and Movement details are Repetitive processes * One time # One time or when new product /Distribution Point is added.

20 Economic benefits, achievements, and impacts protect the country s brand image internationally specially with respect to exports of Indian Pharmaceutical Products and faith of consumer in Indian drug Indian Pharmaceutical market is expected to reach US$ 55 billion in 2020 at a Compound Annual Growth Rate (CAGR) of around 15 percent. This system is going to help the Indian Pharmaceutical Industry to protect its global image and enhance the global markets in the coming years

21 Benefits to Citizens A simplified and user friendly method of drug authentication. Multiple channels to access services from drug control agency. Improved relationship management for victims and witnesses. Faster and assured response from drug control agency to any emergency calls for assistance.

22 Benefits :Drug Control Agency Enhanced tools for investigation. Centralized drug information repository of all the drugs manufactured in India along with the serialization, batch number and other relevant details. Enhanced ability to analyze spurious drugs incidents and other related patterns. Faster turnaround time for the analysis results (spurious drugs) to reach the officers on the field. A collaborative knowledge-oriented environment where knowledge is shared across different regions and units. Better co-ordination and communication with external stakeholders through implementation of electronic information exchange systems.

23 Benefits :Customs Faster clearance of shipments of pharma products for export at ports. Availability of detail information of the Drug inside the box by only scanning the Tertiary level pack.

24 Benefits:Ministry of Health & Family Welfare Faster and easier access to drug authentication information across the country in a manner amenable for trend and pattern analysis. The ability to respond faster and with greater accuracy to inquiries from the parliament, citizens and citizens groups; and to RTI queries. Other external departments/ agencies Seamless integration with drug authentication systems for better citizen service delivery and improved law enforcement. Quick exchange of accurate information with the drug control department.

25 Authentication through DAVA Mobile App

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29 Authentication via DAVA Web portal

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31 THANK YOU.