DAVA- Drugs Authentication and Verification Application. Executive Summary

Transcription

1 Executive Summary Indian Pharmaceutical Industry has one of the largest industries having about ten percent of world total production of pharmaceutical production. India has leadership position in generic drugs and vaccines. Indian exports go to more than 200 countries around the globe. Indian Pharmaceutical industry has approximately 250 large units and more than 8,000 small and medium scale units, which form the core of the Pharmaceutical industry in India. After the few cases of fake drugs exported in the name of Made in India discovered by the Indian regulatory agencies, the Government of India decided to be incorporated features of Trace, Track & Authentication need on all medicinal products being manufactured and exported from India. The agencies/ department/ Ministries of Government of India like Department of Commerce, Directorate General of Foreign Trade (DGFT), Indian Customs, Ministry of Health and Family Welfare, Drug Controller General of India, Pharmaceutical Export Promotion Council (Pharmexcil) and GS1-India are the stake holders of the project apart from Manufacturers/ Exporters/ Whole Sellers/ Distributers/ Retailers and Consumer/ Citizen / Importing country The Drug authentication, trace and track project is an initiative of Government of India, covering all the drugs manufactured in India. The basic objective of the project is to provide simpler means to the consumer and regulatory agencies for establishing drug authentication and protect the India s Brand image in international trade. After lot of deliberation and discussion with various stake holders and the representatives of Pharmaceutical Industry in India, Government of India decided to incorporate serialization mechanism using 1D and 2D bar code as per GS1 global standards for labelling at various level of packaging of drugs in its supply chain. The design and development of the application was entrusted to National Informatics Centre, a primer IT organisation of Government of India under Department of Electronics and Information Technology (DeitY). The application is named as DAVA which is synonym for Medicine in Indian language and abbreviated as Drugs Authentication and Verification Application DoC-NIC Page 1

2 The application is web based and has been designed and developed to create a database for all the drugs manufactured in India for Exports as well as domestic supply for drug authentication and its movement in its complete supply chain. This application would be used both by the Pharmaceutical companies (Manufacturers)/Exporters as well as the Citizens. The serialization of the product using GS1 Standards and its 1D or 2D bar code labelling at various level of packaging are the basic entities of the process of identification for the product and track its movement. The 14 digit Product Identification code (GTIN) (which is the combination of Manufacturer Code, Product Code and Check Digit) and the unique serial number uniquely identifies the Primary and Secondary package. The unique Serial Shipping Container Code (SSCC) is used to identify a Tertiary package. The data in the Parent-Child relationship between Tertiary Secondary and Secondary-Primary are being maintained and uploaded on the Central Portal by the manufacturer so that at any point of time it is known that how many and which are the secondary packages in a Tertiary Package and primaries in a secondary package. The designing and development has been done keeping in view the following important parameters: Availability, Performance and Scalability; Data Security & Integrity using Digital Signature and, Errors and Exception handling. The project has major objective to protect the country s brand image internationally specially with respect to exports of Indian Pharmaceutical Products and faith of consumer in Indian drug. Though the cases of fake or spurious drugs in India are less than 1% but it may still brings bad name to the Indian Industry. With the implementation of this project, the export of fake or spurious drug from the country, will not be possible and in case it happens it would be easily traceable. The application has value-added features like availability of stocks for a drug in an area/wholesalers/retailers at a point of time; whenever required drugs can easily be identified and recalled due to traceability of stocks, prevention of black marketing which especially arises during epidemics. DoC-NIC Page 2

3 Project Content Introduction The Indian pharmaceutical industry is 3rd largest in the world in terms of volume accounting for 10 percent of world s production and stands 10th in terms of value. India has leadership position in generic drugs and vaccines. India s total export of Pharmaceutical Products Industry in year is US$15.4 billion with growth of 2.6% over previous year. Indian exports go to more than 200 countries around the globe including the highly regulated markets of US, Europe, Japan and Australia. Every third dose of vaccine administered anywhere in the world comes from Indian manufacturing facility. The domestic Indian Pharmaceutical market is expected to reach US$ 55 billion in 2020 at a Compound Annual Growth Rate (CAGR) of around 15 percent. Other Other america European 0% Countries 1% Oceania 2% North America 29% Middle east 6% Others 0% LAC 7% South Asia 4% Africa 20% EU 16% Asean 7% Asia (Excluding Middle East) 3% CIS 5% (Fig. 1 : Distribution of India s Export of pharmaceutical product) Indian Pharma industry with more than 20,000 registered units is highly fragmented with severe price competition and government price control. There are approximately 250 large units and more than 8,000 small and medium scale units, which form the core of the Pharmaceutical industry in India. DoC-NIC Page 3

4 India is increasingly getting recognised as pharmacy of the world. Increasing competence of Indian pharma in the global market place and need for the protection of brand image of the country have lead to responsibility for supply of authentic, quality, safe and affordable drugs. After extensive consultations with the industry, the Government of India decided to be incorporated features of Trace, Track & Authentication need on all medicinal products being manufactured and exported from India. This was primarily to address the threat of fake medicinal products being supplied from outside India under Made in India label. The agencies/ department/ Ministries of Government of India like Department of Commerce, Directorate General of Foreign Trade (DGFT), Indian Customs, Ministry of Health and Family Welfare, Drug Controller General of India, Pharmaceutical Export Promotion Council (Pharmexcil) and GS1-India are the stake holders of the project apart from Manufacturers/ Exporters/ Whole Sellers/ Distributers/ Retailers and Consumer/ Citizen / Importing country Project Scope The Drug authentication, trace and track project is an initiative of Government of India to ensure the genuineness and authenticity of the drugs exported from India and for citizens in the domestic market. The project covers all the drugs manufactured in India. Goals and objectives The basic objective of the project is to provide simpler means to the consumer and regulatory agencies for establishing drug authentication and protect the India s Brand image in international trade. In achieving the objective, following goals have been set: DoC-NIC Page 4

5 Web based portal / SMS based system / Mobile App enabling the citizens to check the authenticity of the drugs online, Tracking and tracing of the drug movement for export as well as domestic consumption to ensure the reliable supply of drugs to consumers for patient safety and brand protection of manufacturer as well as nation, The information like Name of Drug, Name of Manufacturer, Batch number, Date of manufacturing, Date of expiry, Usage of drug (optional) and Composition of drug (optional), to be provided online to the consumer, Provide necessary support to the regulatory agencies in prevention of counterfeiting, fraud and illegal sale of drugs. Challenges a) Diversity of Indian Pharmaceutical Industry Indian Pharma industry has more than 20,000 registered units which are highly fragmented with severe price competition and government price control. There are approximately 250 large units and more than 8,000 small and medium scale units, which form the core of the Pharmaceutical industry in India. The large units are highly qualified technically as well as professionally. On the other hand, the medium and small manufacturers have limited resources for infrastructure and skilled professional. The pharmaceutical industry as such needs a lot of facilities and experts. As these facilities and experts are available only in the urban areas, Indian market comprises predominantly of urban areas (70 percent of the total market) and hardly 30 percent in rural areas. b) Implementation of method for unique identification of the product There are various active and passive technologies available like RFID, 1D or 2D Bar Codes, Hologram, Forensic taggants - Optical taggants, Microparticle taggants (nano taggants) etc. To implement a robust and effective DoC-NIC Page 5

6 solution to achieve both objectives Drug Authentication and Track & Trace, there was a need of globally accepted solution for uniquely identification of the product which is easily accessible, less space consuming for printing and cost effective for its all three levels of packaging namely Primary, Secondary and Tertiary. Primary is the package which is in direct physical contact with the active ingredient, Secondary is the carton containing one or more primary packs including a mono carton containing one primary pack and Tertiary means a shipper containing one or more secondary packs. c) Data Management to maintain Parent-child Relationship among the various level of packaging by the manufacturer For authentication, track and trace of the drugs, manufacturer need to maintain the Parent Child relationship data for all three levels of packaging so that at any point of time one would be able to identify the secondary packs of a tertiary and primary pack of a secondary. It may require investment in Information Technology to automate the data capturing from the production lines and data repository maintenance at an enterprise level. d) General awareness and readiness of the Indian Pharma industry The awareness about the necessity and benefits of the authentication, track and trace of the drugs was required to mobilise the manufacturer in Pharma industry. e) Financial Implications and over heads for the manufacturers The financial implications and investment for the implementation of the system was major concern of the Pharma Industry specially for small and medium scale manufacturers in the country. DoC-NIC Page 6

7 Strategies a) Detailed Feasibility Study a. Selection of Technology and Method for Uniquely identifications, b. Status of similar systems worldwide, c. Required Business Process re-engineering, d. Functional and System Requirement Specification, b) Establishment of Regulatory and Statutory Framework, c) Formulation of Expert Group participated by all major stake holders to deliberate and resolve the implementation issues, d) Design and Development of the Web based Application, e) Data Preparation Support to manufacturers, f) Testing of Application, g) Launching of the System on separate URL, h) Outreach programmes for manufacturer. Methodology a) Detailed Feasibility Study The Feasibility Study was initiated by Ministry of Health and Family Welfare (MoH&FW), Government of India. The core objective was to find out technology solution for distribution and consumption of safe and secure drugs and recommend a drug authentication mechanism using simpler means for the use of common man. Since it has to be followed by all manufactures / exporters for the drugs manufactured in India, it was very important to conduct a holistic study to understand the current scenario of drug distribution in India and technological solutions attempted world wise with similar objectives. DoC-NIC Page 7

8 (Fig.2 :World wide implementation of application for identification of product) The available technologies and methods for identification were compared specially with respect to its robustness, scalability, global acceptance, easy of implementation and cost effectiveness. DoC-NIC Page 8

9 Parameters Fingerprint Barcodes RFID Holograms Scratch Labels Tamperproof Packaging Packaging Special identifier Bar Code printed Special identifier External Feature External Feature External Feature Technology Proprietary General Device Proprietary Requirement Device 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 Regular Verification Manufacturer Implementatio n Feasibility (Timeline for adoption & cost) Track and Trace Security Information embedded Security Information embedded Security Information embedded Overt Security Overt Security Possible Possible Possible Low Low Low High High High Yes Yes Yes (Table 1 :Comparison of various technologies for identification) Overt Security The report suggested the feasible solution based on unique item level serialization. Serialization is the process of uniquely identifying an object wherein information regarding product type, expiration date, best-before date, lot number, etc. associated with the item can be retrieved, but also any one item can also be distinguished from other items of the same type from the same batch/lot. There are various solutions available for Serialization based on randomized series of unique numbers. In view of using globally standards of serialization and non-proprietary solution, the serialization based on based on GS1 standards are recommended for implementation at three level of packaging namely Primary, Secondary and Tertiary. Primary packaging means the package which is in direct physical contact with the active ingredient. Secondary packaging means a carton containing one or more primary packs and includes a mono carton containing one primary pack and the tertiary packaging means a shipper containing one or more secondary packs. DoC-NIC Page 9

10 It further recommended for the creation of Central Portal having the database of pharmaceutical products manufactured in India with the details of their movement in their complete supply chain and which would be updated by the manufacturer. The central portal is to provide the query based system for trace, track and authentication of the pharmaceutical products. MOH&FW approved the Functional Requirement Specification (FRS) and System Requirement Specification (SRS) in Jan, 2014 and the National Informatics Centre (NIC), Government of India are assigned with the project design, development and implementation of the project. b) Establishment of Regulatory Framework In order to eliminate the cases related to exports of counterfeit and spurious drugs from India, Directorate General of Foreign Trade, Department of Commerce vide its notification (Public Notice No.59 (RE-2010)/ dated 30th June 11) decided to implement the 2D bar coding using GS1 global standards on export consignment of pharmaceuticals and drugs at all three level of packaging i.e. Primary, Secondary and Tertiary level by the Exporters for tracing and tracking purpose through Central portal setup by the Government. As per the DGFT s Public Notice No. 4/ dated 1 st April, 2015, the manufacturer of Indian drug formulations will print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products. The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. Primary, Secondary and Tertiary and their movement in its supply chain. The data shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution. The responsibility of the correctness, completeness and DoC-NIC Page 10

11 ensuring timely upload of data on the central portal shall be with the manufacturer. The above mentioned DGFT s Public Notice No. 4/ dated 1 st April, 2015, will not be applicable to those drug formulation manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the barcodes in their format with the permission of licensing authority appointed under rule 21. However, the tertiary level of packaging will have additional printing of barcode as per India regulatory requirements in addition to importing country requirements, if any. c) Formulation of Expert Group participated by all major stake holders The Expert Group has the composition of the representatives from following Department/ Ministry of the Government of India, Manufacturer Associations, Export Promotion Council : 1. Government of India a. Department of Commerce, b. Directorate General of Foreign Trade (DGFT) c. Ministry of Health and Family Welfare (MOH&FW), d. Drugs Controller General of India (DCGI), e. National Informatics Centre (NIC) 2. Pharmaceutical Export promotion Council (Pharmexil) 3. GS1 India 4. Pharmaceutical Companies / manufacturers in India Following are the Terms of Reference of the Export Group: 1. Identification of issues relating to the implementation of Trace, Track and authentication system and suggesting of possible solutions thereof., 2. Suggesting the Business Process Reengineering required at the firm and industry level, DoC-NIC Page 11

12 3. Evaluating the cost of acquiring/developing and adopting the technology for labelling and serialization, 4. Assessing the capability of the existing manufacturers to service the demand for the technology and hardware on the scale that would be required when the Track & Trace System is fully functional. d) Design and Development of the Web based Application The responsibility of designing, development and implementation of a system was entrusted to National Informatics Centre, a primer IT organisation of Government of India under Department of Electronics and Information Technology (DeitY). A web based application is designed and developed to create a database for all the drugs manufactured in India for Exports as well as domestic supply for drug authentication and its movement in its complete supply chain. This application would be used both by the Pharmaceutical companies (Manufacturers)/Exporters as well as the Citizens. The serialization of the product using GS1 Standards and its 1D or 2D bar code labelling at various level of packaging are the basic entities of the process of identification for the product and track its movement. The 14 digit Product Identification code (GTIN) (which is the combination of Manufacturer Code, Product Code and Check Digit) and the unique serial number uniquely identifies the Primary and Secondary package. The unique Serial Shipping Container Code (SSCC) is used to identify a Tertiary package. Application Identifiers (AI) are used as per Global Standards for bar coding while labeling by the manufacturers/ exporters. Following tables gives the various AIs used and their details: (00) SSCC No.(Serial Shipping Container Code (SSCC) : 18 digit unique identification Number for the Tertiary Level Package as Logistic unit including first digit as extension digit and last digit as check digit DoC-NIC Page 12

13 (01) GTIN14 (Global Trade Item Number) : 14 digit globally unique number comprising of first digit as Level of Packaging, next 12 digits manufacturer identification number + product identification number and last digit as check digit (17) Expiry date : YYMMDD format (10) Lot/batch number : maximum 20 characters (21) Unique serial number in a lot/batch : maximum 20 characters Primary Level Labeling has 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. (Fig.3. Sample Primary Package) Secondary Level Labeling (1D or 2D bar code) has Product identification code (GTIN), Batch Number, Expiry date and Unique Serial Number of the Primary pack.. ((Fig.4. Sample Secondary Package) DoC-NIC Page 13

14 Tertiary Level Labeling has two 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. ((Fig.4. Sample Tertiary Package) The data in the Parent-Child relationship between Tertiary Secondary and Secondary-Primary are being maintained and uploaded on the Central Portal by the manufacturer so that at any point of time it is known that how many and which are the secondary packages in a Tertiary Package and primaries in a secondary package. Following table shows the Unique Identification Key combination to identify various types of packaging and data elements for labelling: Level of packaging Labelling Data Elements for labelling Unique Identification Key Combination Primary (strip/blister/vial etc.) 2D Code Bar GTIN14, Unique Serial Number GTIN14+ Unique Serial Number Secondary 1D or 2D Bar Code GTIN14, Batch Number, Expiry Date, Unique GTIN14 + Unique Serial Number DoC-NIC Page 14

15 Serial Number Tertiary 1D Bar Code GTIN14, Batch Number, Expiry Date and Unique Serial Number i.e.sscc Serial Shipping Container Code (SSCC) (Table2. Unique Identification Key combination for various packages) The designing and development has been done keeping in view the following important parameters: Availability, Performance and Scalability High availability is about ensuring that a database system or other critical server functions remain operational both during planned or unplanned outages, such as maintenance operations, or hardware or network failures. The system has been designed in such a way w.r.t hardware and software that it supports ease in addition of services in future and scalability in provided services. It ensures easy scalability and extensibility through minimum effort. Reduced database down-time enables to meet strict Service Level Agreements (SLAs) with no loss of data during infrastructure failures. Data Security & Integrity The application is access control using role based systems with its defined category of the users viz. Manufacturer/ exporter (responsible for the data upload and allocation of role to its subsequent representative), Administrator (responsible for system and data management) and Guest. The data Access and functionality access of the system are driven by roles. Each user is granted with roles for Read/Write/Upload/Delete data. The security of data and its integrity have been ensured by integrating the Digital Signature for the functions of data upload and its management. DoC-NIC Page 15

16 Errors and Exception handling For handling the errors and exceptions occurring within a process, system logs are being maintained. Help for system handling The system provides guidelines for each functionality and FAQs to provide necessary help for the user. It also has contact details of Helpdesk team. Data Management and handling Master Tables (Directories) Login Master Registration Detail Master Country Master State Master District Master Distribution Type Master Upload Master File Information Master Error Master Transaction Tables Distribution Point Details Product Details Batch Detail Production Detail s Movement Details Data are captured in standard XML formats which are to be validated by defined XML schema. DoC-NIC Page 16

17 Mobile Phone GS1 India Manufacturer Details Central Portal GTIN14 + Serial No XML Format SMS Gateway 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 (Fig 4. System access diagram) e) Modules of the Web based Application The application has different modules for Manufacturers/Exporters, GS1India and Citizens. The modules are as follows: Registration: To register manufacturers/exporters and/or its designated agencies with web based application on Central Portal for their identification and enablement of data upload and maintenance. The manufacturers/exporters must have manufacturer code (User Id) registered with GS1 India, Class II or Class III Digital Certificate, issued by Certifying Authority (CA) in India, valid mobile number and address along with few more details. The process is highly secure so that only genuine/authentic users could be the part of application. DoC-NIC Page 17

18 Administrator s activities: To authorize/activate/de-authorise/deactivate the manufacturers/exporters and/or its designated agencies already registered on the portal for further activities. These activities ensures the secured environment in which the data upload takes place and all the administrator responsibilities. Data Upload: To provide facility to the Manufacturers/ Exporters to upload data in a prescribed format in the central database Online and/or through a Web Services in XML format. Manufacturer/exporter needs to upload data after the production of drugs and its first movement out of its manufacturing premises. The complete responsibility of updating the database with all the Points in Supply chain lies with the Manufacturer and needs to update the details of the shipment at each point of supply chain. The manufacturer would keep updating the data of the medicines until the medicines reach the Indian Customs or the final consumer for Exports and domestic supply chain respectively. The manufacturer/exporter would upload the data for the following details: Distribution Point Details Product Details Batch Details Production Details Movement Details Queries/Reports: To allow users (Manufacturers/exporters/GS1India, Citizens) to perform queries related to Manufacturers, Distribution points, Product, Batch etc. Online entry/editing by the authorised registered users is also allowed in this module. The system provides the facility for the user to access application online for query/verification of drugs using the barcodes its reading through barcode scanner/ online entry. DoC-NIC Page 18

19 Following is the homepage of the Central Portal DAVA- Drugs Authentication and Verification Application ( (Fig 5 Home Page of the Central Portal DAVA ) User may enter the unique identifcation key (GTIN14+Serial number) to authenticate. The screen would look like as follows: (Fig 6: Authentication of drug ) DoC-NIC Page 19

20 For authenticated drug, screen similar to following appears showing the details of the authenticated drug: (Fig 7: Authentication of drug ) For NOT authenticated drug, screen similar to following appears showing the details of the authenticated drug: (Fig 8: Non-Authentication of drug ) DoC-NIC Page 20

21 Mobile Application : A Mobile Application for verification of authenticity of drug and its movement in the supply chain is also developed and available in google play-store to be downloaded and used. Presently it works on Android phone and is being extended for other operating systems also. f) Data Preparation Support to manufacturers, : A module for data preparation methodology and related guidelines is provided for manufacturer/exporter and its designated agency. Another guidelines related to registrations, signer utility, various schema files validate the concerned XML files etc. are provided in the Resource Centre Section of the web portal. g) Testing of Application : After designing and development of application, testing was done with few selected manufacturers. First, GS1 India got registered on the portal using their Digital Signature Certificate and uploaded the manufacturers list on the portal. It is required as any other manufacturer that would be registering need to be in listed in the database. Thereafter few manufacturers for registered on the web portal using their DSCs. They prepared the data in prescribed XML format required by the system, validated it against its XML schema and uploaded successfully through the web service provided. h) Launching of the System The system is launched after successful testing of application. The web portal is i) Outreach programmes for manufacturers/exporters The outreach programs/workshops/trainings etc. is being conducted at various locations to acquaint stakeholders to appreciate the new process and DoC-NIC Page 21

22 system proposed for Drug Authentication, Track and Trace project in order to : Motivate, train and capacitate employees/stakeholders to undertake the revised roles and responsibilities associated with their job responsibilities Streamline transition of all aspects of proposed service covered under the project in consideration of all associated stakeholders of the project Ensure successful implementation of the project and embed sustainability of the project Re-engineering Serialization and labelling of various level of packaging using GS1 global standard, Maintenance of data of packaging in Parent-Child relationship. Standards (especially developed by UN/CEFACT or other international standard organizations) UN/LOCODE Code List for Country codes GS1- Standard for barcoding and serialization Indian egovernance Standard for o State Codes, o District code, o Permanent Account Number (PAN), o Tax Deduction and Collection Account Number (TAN), o Importer Exporter Code(IEC) for Trading Community DoC-NIC Page 22

23 Economic benefits, achievements, and impacts The project has major objective to protect the country s brand image internationally specially with respect to exports of Indian Pharmaceutical Products and faith of consumer in Indian drug. This is obviously a precious activity which may not be quantified in monitory terms but certainly qualified in terms of the benefits in longer run for the country as well as citizen of the country. Though the cases of fake or spurious drugs in India are less than 1% but it may still brings bad name to the Indian Industry. As per the projection of various study conducted for the domestic 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. Other Benefits & Impact Benefits to the citizens Provision of a Safe and Secure mode of authentication of drugs. A simplified and user friendly method of drug authentication. Multiple channels to access services from drug control agency. Simplified process and channel for grievance registration. Improved relationship management for victims and witnesses. Faster and assured response from drug control agency to any emergency calls for assistance. Benefits for Government Agencies o Department of Commerce Prevention of fake drugs being exported, Protection of Brand India in international market, Growth in export of pharmaceutical products, DoC-NIC Page 23

24 o 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. o 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. Easy and low-cost scalability of drug tracking systems in the future. o 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. DoC-NIC Page 24

25 Next step on ward 1. The system is implemented for exports of drugs manufactured in India. 2. With the success of this project, Government of India has decided to extend the scope of the system to cover medical devices and equipments. 3. Government of India is contemplating leveraging this technological solution for other products like explosive and FMCG products etc. Resources (indicate the expense allocated on manpower, hardware, software, networking, etc.) The system was developed and implemented by the in-house NIC s technical team for 240 man months with total expenditure on infrastructure creation was 5.0 US $ million (approx.). It includes cost of Survey Study, Manpower, hardware, software, networking development and implementation, training and outreach programmes and other contingencies. ** ** ** DoC-NIC Page 25