the concept paper

 Digital Seal
Concept Paper One Step Solutions. 107-­‐G, Commercial Phase 1, DHA Lahore. 54792, Pakistan Phone: +92-­‐42-­‐35691083 E-­‐mail: [email protected] Web: www.onestepsolutions.biz © 2013 One Step Solutions. DEFINITION OF TERMS, ACRONYMS AND ABBREVIATIONS The definitions of all terms, acronyms, and abbreviations used in this document are mentioned below: Term Description SMS Short Messaging Service PIN Personal Identification Number FDA Food and Drug Administration PIC Punjab Institute of Cardiology RS Requirement Specifications WHO World Health Organization SDLC Software Development Lifecycle UV Ultra Violet RFID Radio Frequency Identifier IEC International Electro-­‐technical Commission ISO International Organization for Standardization VAS Value Added Service ARPU Average Revenue per User Table of Contents DEFINITION OF TERMS, ACRONYMS AND ABBREVIATIONS .............................................................................................. i 1. INTRODUCTION ......................................................................................................................... 1 2. PROJECT OVERVIEW .................................................................................................................. 2 2.1. CURRENT SITUATION ....................................................................................................................... 3 2.2. CURRENT PROBLEM ........................................................................................................................ 3 2.2.1. Impact on Public Health ..................................................................................................... 4 2.2.2. Situation in Pakistan ........................................................................................................... 4 2.2.3. Scale of the problem ........................................................................................................... 6 2.2.4. Anti-­‐Counterfeiting ............................................................................................................. 6 2.2.5. Anti-­‐Counterfeit Platforms ................................................................................................. 7 3. PROPOSED SOLUTION ............................................................................................................... 8 3.1. TECHNOLOGY ................................................................................................................................ 8 3.1.1. How it works ....................................................................................................................... 9 3.1.2. How will seller identify the genuine being returned? ......................................................... 9 3.1.3. Asymmetric PIN Codes ...................................................................................................... 10 3.1.4. Asymmetric PIN Code Printing .......................................................................................... 10 3.1.5. Asymmetric PIN Code authentication Medium ................................................................ 10 3.1.6. Responses ......................................................................................................................... 10 3.1.7. Global Product Coverage .................................................................................................. 11 4. SYSTEM FLOW ......................................................................................................................... 12 4.1. SYSTEM COMPONENTS .................................................................................................................. 12 4.2. CASCADING AUTHENTICATION ........................................................................................................ 13 5. RETURN ON INVESTMENT ....................................................................................................... 14 5.1. 5.2. 5.3. 5.4. BENEFITS OF THE SOLUTION ........................................................................................................... 14 MANUFACTURERS ........................................................................................................................ 14 TELECOM NETWORKS .................................................................................................................... 15 GOVERNMENT AND LAW ENFORCEMENT .......................................................................................... 15 1.
Introduction The production of substandard and fake drugs is a vast and underreported problem, particularly affecting poorer countries. It is an important cause of unnecessary morbidity, mortality, and loss of public confidence in medicines and health structures. The prevalence of counterfeit drugs appears to be rising and has not been opposed by close cooperation between drug companies, governments, or international organizations concerned with trade, health, customs and excise, and counterfeiting. The purpose of this document is to define project requirements in order to obtain signoff of the customer and the software developer. The developers use this document while working through the different phases of the SDLC. This Document will be the basis of the FS Document. Documenting and controlling the customer requirements (RS) is a prerequisite for using them as the basis for planning, performing and tracking the software project’s activities throughout the software life cycle. The purpose of this document is to serve as an outline of requirements and a set of One Step Solutions guiding principles in the design and development of One Step Solutions applications. It is hoped that the general flavor of the design will be apparent after reading this document. Following the above and to confirm our understanding of the requirements, for each module we have included with flowcharts signifies our confirmation of the Functional Features and Requirements stated by the client. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 1 2.
Project Overview Counterfeited drugs are drugs that are not authentic and have been manufactured using incorrect quantities, or incorrect ingredients, to either reduce the potency, or nullify the potency of drugs. Addition of harmful ingredients could also lead to counterfeiting, and may cause serious health effects amongst the patient population. As counterfeiters have started working cross borders, the counterfeited drugs have become difficult to identify, and have become a public health risk for people living across communities and borders. Drug counterfeiting has become an economic and social problem for decades since they affect human beings directly due to the unavoidable importance of food and drug to live. The World Health Organization (WHO) has discovered a terrific growth rate in drug faking especially in the developing nations which has caused alarming rate of ill-­‐health and eventually deaths amongst all level of human development. Most countries have developed strategies to fight the growth of food and drug counterfeiting. The objective of this project is to study and propose the anti-­‐
counterfeit technology solutions to include all drugs and foods counterfeit to ensure a long lasting and effective preventive measure to reduce and eventually stop food and drug counterfeiting especially in the developing nations. This is a research and development project on counterfeit medicine spread over a long period resulted into something that would eventually change the dynamics of consumer industry. As a result of this innovative technology, suddenly all slogans of consumer awareness, stringent legislations, criminal proceeding threats, product authenticity checks at laboratories, scanning, labeling etc. will became irrelevant. Global approach towards this shady business had always been proactive, aggressive and cautionary; however with this state of the art technology, it will all became a simple three seconds exercise even before leaving the sales counter. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 2 2.1. Current Situation Counterfeit pharmaceutical drugs are fraudulently produced or mislabeled medicines purchased by consumers who believe them to be legitimate. These drugs can cause a range of serious health concerns. Fake pills may look nearly identical to their genuine counterparts, but may be incorrectly formulated and produced in substandard conditions. They are, by definition, not subject to the same regulatory scrutiny as legitimate medications. The drugs often have incorrect amounts of active ingredients, if those ingredients are present at all, and are illegal in developed countries. Pharmaceuticals are also considered counterfeit if the genuine products are stolen or repurposed and “up-­‐labeled” — a process in which pills of one dosage is placed in bottles listing higher dosages. For example, counterfeiters may use legitimate capsules with 10mg of active ingredient and sell them in bottles with labeled dosages of 40mg. Even individual components of pharmaceuticals can be counterfeit, requiring both companies and regulators to scrutinize suppliers to avoid illicit compounds entering legitimate facilities. 2.2. Current Problem Counterfeit prescription pharmaceuticals are a growing trend, widely recognized as a public health risk and a serious concern to public health officials, private companies, and consumers. These products pose a serious threat to brand owners and public safety worldwide. According to the World Health Organization, up to 30% of drugs sold in developing nations are counterfeit and could lead to the significant healthcare crises that fake drugs often unleash in resource-­‐
deprived areas. Legitimate manufacturers lose close to $500 billion due to counterfeit products -­‐ $75 billion of that loss is caused by fake drugs. In most of the world’s developed countries, however, effective regulatory systems and market controls cause an extremely low proportion of counterfeit drugs, usually below 1 percent. Even so, patients in developed countries can be affected by counterfeit drugs, and deaths linked to them occur every year in the U.S. and Western Europe—and even more often in South America, Asia, and Africa. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 3 Both brand-­‐name and generic pharmaceuticals are susceptible to counterfeiting; posing problems for any corporation producing legitimate drugs. According to a report by the WHO, in addition to pharmaceuticals, medical devices and medical-­‐related products have also been counterfeited, including blood glucose test strips, contact lenses, surgical instruments etc. 2.2.1. Impact on Public Health In most cases, counterfeit drugs are not equivalent in quality, safety and efficacy to their genuine counterparts. Even if they are of the correct quality or contain the correct amount of active substance, their production and distribution are not within the purview of the drug regulatory authority (DRA) of the country concerned. This means that any associated defects and adverse reactions will not be easily recognized or monitored and, if needed, an effective product recall would not be possible. So far the counterfeit drugs which have been discovered have rarely been efficacious. In many cases, they have been positively dangerous and detrimental to public health in terms of human suffering and burden on the health services. Patients may not respond as quickly as they should and, in some instances, may not respond at all. Treatment with ineffective counterfeit drugs such as antibiotics or vaccines may have a deleterious effect on a wide section of the population. In extreme cases, counterfeit drugs may cause serious harm to health or exacerbate the conditions being treated because of the harmful ingredients they may contain. As a consequence of such damaging effects, counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national DRAs. Incorrect labeling as to source can also be detrimental to the reputation and financial standing of the original and/or current manufacturer whose name is being fraudulently used. 2.2.2. Situation in Pakistan During late January 2012, a fake medicine crisis at the Punjab Institute of Cardiology (PIC) hospital in the Lahore region of Punjab, Pakistan, claimed the lives of over 100 heart patients. According to various reports, the incident involved patients who had been receiving treatment at the hospital and had been prescribed with counterfeit antihypertensive medicines. The Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 4 spurious medicine triggered a serious adverse reaction by depositing itself in the bone marrow and ending the body's resistance. The generation of white blood cells stopped in the body. Among the symptoms of the disease were a severe chest infection, change in skin color pigmentation, low platelet count and blood vomiting. Suspect drugs include isotab (isosorbide nitrate), lipitor (atorvastatin calcium), cardiovestin (simvastatin), alfagril (clopidogrel), concort (amlodipine), and soloprin (aspirin). The medicines were being distributed by the hospital free of charge mainly to poor people. The total number of people who may be at risk after taking medicine from the hospital may be as high as 46,000 according to one report. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 5 2.2.3. Scale of the problem As discussed earlier in the document around 30% of all the drugs sold in the developing
countries are fake, to give it a perspective FDA conducted a survey on the number of cases
registered per year in the office of criminal investigations to get a clearer picture of where
we stand. The results are displayed in figure 1
Figure 1 Counterfeit drug cases opened by FDA per fiscal year
2.2.4. Anti-­‐Counterfeiting Anti-­‐counterfeiting refers to the measures taken to prevent counterfeiting of drugs. According to FDA report in 2009, comprehensive measures need to be taken to prevent counterfeiting of drugs. Some of the measures recommended by the report are: 1.
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Implementation of new technologies to protect drug supply chain. Adoption and enforcement of anti-­‐counterfeiting laws and regulations. Increase in criminal penalties to deter counterfeiting Adoption of secure business practices by all participants in the drug supply chain Education of consumers, patients and health professionals. Collaboration with global stakeholders to prevent global counterfeiting of drugs. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 6 2.2.5. Anti-­‐Counterfeit Platforms Counterfeit or fake food crime has been around for decades. The practice of marketing fraudulent drugs is getting more attention recently because attacking a group, organization, or country, by producing counterfeit drugs become a more serious potential terrorist threat. Despite the outbreak of sicknesses such as kidney problems, diabetes, cancer, liver failure, heart failure, typhoid fever and so many others in the societies especially among the young people, suspected to be as a result of consumption of drugs the anti-­‐counterfeit measures do not include all drugs and non for food especially in the developing nations. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 7 3.
Proposed Solution One Step Solutions proposes a robust anti-­‐counterfeiting and brand loyalty solutions to companies targeting cash-­‐based societies. Akin to the very popular scratch card method for replenishing cellular talk-­‐time, users reveal a one-­‐time-­‐use code on a product and text the code to a specified number for fake products which is identical on all cellular networks. This solution will be beneficial for all the key stake holders 1. Legitimate Manufacturers; can now avoid brand-­‐degrading lawsuits and costly anti-­‐fake media campaigns, while reclaiming critical market share and profitability lost to counterfeiters. Manufacturers will gain key consumer intelligence, knowing where, when, what and how often products are purchased. 2. Consumers can now avoid purchasing fake products, while anonymously and passively providing key intelligence to law enforcement agencies to help find fake products. Most of today’s solutions to counterfeiting are either technically acute or costly, making them a poor choice for educationally challenged and resource-­‐deprived environments – locales at the frontline of the fake drug onslaught. Technologies like nanoparticle tangents, RFID tags and UV-­‐
sensitive labels all require extensive staff and user training and expensive readers currently not present in the Pakistani market. We provide a solution that leverages the strengths of cash-­‐
based societies. 3.1. Technology We have designed a technology that is specifically for emerging markets. Using any cell phone your customers send a text message with an item / unique code and get an instant response confirming your brands genuineness. Our authentication scheme is based on Asymmetric encryption the same ethos behind the security infrastructure powering billions of e-­‐commerce and high level government communications daily. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 8 Developing nations supply chains can be quite fragmented, with several private distributors reaching out to your clients nationwide. How do you keep track of your goods to ensure they are not diverted are managed by our Cascading Authentication solution. Scratch off technology has been proven over and over again in the harshest of emerging markets. The booming Trillian dollar mobile operator market chose scratch offs instead of holograms for popular pay as you go subscription schemes. 3.1.1. How it works A particular manufacturer, for instance, has a production line of 50,000 pieces per month. They are allocated a stock of codes equivalent to pieces of production. These codes are covered with scratch able latex and are simply pasted on each product, either on its body, its container, bottle or main container packing. When a consumer purchases the product, they simply scratch the PIN and send it to a dedicated Cell number via an SMS. Within 3 seconds, the database, which have that particular PIN Code already allocated to the same product, returns an SMS with up to 140 character message, containing validation, brand, and any other information manufacturer desires to enter. Or, it simply informs the customer that, the said product is invalid, thus fake and counterfeit. Every single piece will have a unique code of its own, so that every single piece can be individually identified. For products with expiry dates, like food items, medicines and other perishable goods with
limited shelf life, it would also validate the expiry date and if already expired, would
instantly inform the customer. A code once used will never be accepted by the database,
thus rendering
it useless after product is opened. 3.1.2. How will seller identify the genuine being returned? With every latex covered PIN, there is visibly printed product identification code, which would be entered in store inventory before sale; thus even used code should match its distinct identification code as per store/factory/ warehouse record. No fakes can be returned against genuinely sold products So manufacturers may recall their sold products from the consumers, or a product may be returned to seller against any term of sales, like money back guarantee etc. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 9 3.1.3. Asymmetric PIN Codes All the PIN Codes are 100% secure and at no stage can be accessed by any individual or computer or other means. In accordance with ISO/IEC 27002, the integrity of whole data has been secured with multiple foolproof active as well as passive measures. Our database is stored under multi-­‐tire arrangement under highest security levels at strategic locations with back up available around the globe, so practically no down time. 3.1.4. Asymmetric PIN Code Printing PIN Codes in Pakistan, are being printed by the most secure printing press, where almost all mobile phone operator companies get their scratch able mobile fund charging cards and calling cards printed. It is an ISO Certified printing press with highest level of security and a human hand can only reach a card when it is printed, latex coated and packed in cellophane. 3.1.5. Asymmetric PIN Code authentication Medium In Pakistan, a four digit Access number has been provided by four major Telecom companies. PIN Codes are sent to this single point access number via SHORT TEXT MESSAGE (SMS). This number has direct access to our data bank, which instantly processes it, identifies it and sends a reply to sender either confirming the product authentication with various details or simply replies that the sent PIN was not a valid product. Example: To: XXXX Simply type PIN code “XXXXXXXXXXXXXXXX” and send 3.1.6. Responses If the code is correct a sample response could be (Manufacturer name) Thanks for buying our genuine (Product name) If the code is incorrect a sample response could be We are sorry we have no information about this product. If the code is already checked a sample response could be Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 10 The code for this product has already been checked on (Date) 3.1.7. Global Product Coverage Pakistan has one of the most advanced GSM based cell phone services with local consumer exceeding 124 million. There are 5 major service providers for GSM coverage beside one satellite based universal communication service provider. Manufacturers with global presence or presence of their products in other parts of the world are linked to our local telecom companies, which receive and forward SMS to our data bank. Alternatively they have the access through their local telecom companies, which are provided access to our Database via IP over broadband. There are multi-­‐level arrangements for convenience of consumers. In any case our system never fails to respond within stipulated time frame. All telecom companies in Pakistan are very anxious to reach out to such potential customers and make arrangements with the local telecom companies so that a customer purchasing a brand anywhere in the world at any given moment, is not deprived of his right to validate the product he has purchased. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 11 4.
System Flow 4.1. System Components Our Scalable cloud computing back end provides on demand computing power, so you only pay for what you use. Figure 2 System Flow
Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 12 4.2. Cascading Authentication With cascading authentication we make sure only trusted agents handle your products, while each one of your supply chain agents can individually verify the authenticity of products as they disperse through the distribution network. Figure 3 Cascading Authentication
Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 13 5.
Return On Investment 5.1. Benefits of the Solution According to the World Health Organization (WHO), up to 30 percent of drugs sold in developing nations are counterfeit, with the counterfeit drug market estimated at $200 billion by the World Customs Organization (WCO). In addition, up to 50 percent of some medicines in specific developing countries, including Ghana and Pakistan, are substandard. These substandard drugs – which do not have the correct potency of the legitimate drug – have led to a significant healthcare crisis, both in terms of number of deaths (700,000 deaths from fake malaria and TB drugs alone) and increased drug resistance in treating which will become an issue in the longer term. With the counterfeit drug market on the rise in Africa and elsewhere, we developed a simple, efficient and cost-­‐effective way for customers to verify the authenticity of medication prior to purchasing them. Given the prevalence of mobile technology throughout the world, it made sense to use a technology that was already in every customer’s pocket. Through drug authentication, consumers can avoid purchasing counterfeit medication, while anonymously and passively providing key intelligence to law enforcement agencies regarding the location of fake drugs; anytime authentications fail repeatedly. This improves consumers’ overall health and quality of life. In most developing nations, government serves as the primary health care provider, and unknowingly pays for medication that could be counterfeit. Patients return to hospitals, incurring more costs for illnesses that should be cured once but are instead paid for over and over again. With just a text message, we have solved this problem. Our solution also provides specific benefits to manufacturers, telecom networks, government and law enforcement and foreign donors. 5.2. Manufacturers Legitimate manufacturers can now avoid brand-­‐degrading lawsuits and costly media campaigns, while reclaiming critical market share and profitability lost to counterfeiters. Customizable authentication responses also enable manufacturers to administer product recalls quickly and cheaply – currently a very challenging and costly activity in developing nations. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 14 Through a cost-­‐efficient, scalable electronic system for capturing consumer purchasing behaviors in cash based societies, we are able to generate advertising-­‐ready consumer profiles in developing nations on a scale never before seen. We will sell our analytics and data set to allow advertisers to capitalize on new markets. Clients use our secure One Step Solutions Visualization Portal to generate real-­‐time market intelligence based on our aggregate SMS authentication data. 5.3. Telecom Networks Mobile phone operators benefit from the increased SMS traffic from drug authentication requests. Our service fits well with their strategic focus on Value Added Services (VAS) as a means to draw consumers into using features that lead to a greater Average Revenue per User (ARPU). 5.4. Government and Law Enforcement Increased visibility to drug usage and movement data provided by large scale anonymous authentication statistics gives agencies new levels of oversight and metrics of accountability at a granular level. Law enforcers can now see where counterfeit “hot spots” are in real-­‐time by tracking the “fake product” text message responses sent in a geographic area over time. Such intelligence allows law enforcement to make targeted store inspections instead of the highly inefficient random sampling currently carried out with low success rates. Copyright © One Step Solutions. All rights reserved Unauthorized copy or use of this document is strictly prohibited 15