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CHAPTER ONE

1.0     Introduction

This project is on Design and implementation of drug verification system using GSM. Products are created by brand owners and handed to third parties (contract manufacturer, shipping company, distributor…) for delivery to merchants for later sale to consumers. These products can range from commodity items (e.g., flour) to limited quantity “luxury” items (e.g., designer handbags) to one-of-a-kind items (e.g., original artwork). Counterfeit products are often created and sold as the “real thing.” Counterfeits leverage the original brand but generally have less overhead due to some combination of lower quality, reduced marketing expenses, reduced support costs and/or reduced corporate expenses (ranging from lower labor costs to failure to pay tariffs).

The three main parties (brand owner, merchant and consumer) are affected differently by the distribution of counterfeits. Consumers either willingly purchase counterfeits at a lower cost or are tricked into buying a counterfeit thinking they are getting authentic merchandise. In the former case they are generally happy, at least initially. The latter case, in some instances, may have little effect, i.e., the consumer may have overpaid for an item. However, more damaging effects may be realized if the product malfunctions. These effects can range from lack of recourse (since the product is not covered by the warranty of the brand owner or manufacturer) to physical harm in the case of food, prescription drugs, mechanical equipment, etc. Merchants and third parties may unknowingly or willingly participate in the distribution of counterfeit products. Brand owners suffer both hard (decreased profit) and soft (brand erosion) losses from counterfeit products.

This research work describes a system that enables brand owners, merchants and consumers to verify the authenticity of a product. It analyzes the different avenues of attack and presents three potential implementations of the system based upon the motivation of the participants and the cost of implementation. The research assumes the reader is acquainted with the production and distribution of counterfeit products.

1.1 Background of the Study

With the majority of the world‟s population seeking required medications for various illnesses and medical conditions day-in-day-out, there is a need for appropriate pharmaceutical drugs. The agencies responsible for regulating and approving these pharmaceutical drugs are doing their best to provide the general population with at least a yearly update of all registered drugs approved for various distributions at local drug stores, hospital pharmacies, private pharmacies and licensed chemical sellers. However, due to challenging factors such as cost of production, middlemen distribution, research and legal issues, accessibility and reliable source of sale, there have been more issues arising from the illegal and unregistered pharmaceutical drugs. There is also no guarantee of an individual seeking medical help through the use of prescription drugs. Records gained after each annual registration will be made available and it will provide the various stakeholders with information regarding pharmaceutical drugs allowed for regulation on the local drug markets and the also the manufacturers responsible for each drug distribution. The stakeholders to make use of the information available include manufacturers, medical institutions, pharmacies and pharmaceutical drug importers, distributors and the general public. The provision or availability of the system will help the public to be aware of the pharmaceutical drugs that have being approved by the authority in charge. Also, to improve the quality of life by the healthcare community and life in general, and awareness of unregistered and/or fake pharmaceutical drugs to the public and stakeholders. This information of registered pharmaceutical drugs needs to be integrated and made accessible to the majority of population to enable them to view for themselves [Gostin, Lawrence O]. Over the years, a number of hybrid solutions have been applied to this problem. In general, they can be classified as employing a combination of stepped-up regulatory enforcement and technological innovation. Being pioneers in technology, industrialized nations have typically enjoyed a good balance between these two key ingredients [Home, W. H. O].

Developing nations, however, are comparatively less-endowed and generally not in the position to invest vast amounts in the research and development needed to yield effective anti-counterfeit technologies. Thus, where such countries have chosen to tackle the unregistered pharmaceutical drug problem, stepped up regulatory enforcement (syndicated raids and legal proceedings) is the only deployable tool. Fortunately, the need for technological assistance to the enforcement-only approach has been identified, and innovators in the first world have developed a number of products. Technologies like Nano-particle taggant, RFID tags and UV-sensitive labels, all require new training and expensive readers currently not present on the developing nation market. Holograms are the leading anti-counterfeit measure, but the mature technology is currently subject to routine counterfeiting due to low cost reproduction equipment. All these solutions will not give the consumer control in checking the validity of the drugs at the point of sale, but a system that can be with them, such as an online system for checking registered pharmaceutical drugs, will aid to an extent [Gillian J. Buckley]. As users of pharmaceutical drugs, being able to identify these unregistered and fake drugs has become very challenging in recent times. What baffles many is why and how some of these fake pharmaceutical drugs find their way on to the market without the knowledge and approval of the FDA. Some even believe that to cover their incompetence, the FDA, once in a while, picks on one of the local companies simply to give the impression that it is working. “In a statement issued on October 8, 2013, Imani Ghana said the FDA could not absolve itself from the apparent retrogressing in quality terms of products by the pharmaceutical companies as it has failed to ramp up its own internal capacity to lift up Ghanaian pharmaceutical companies.”[http://www.ghanaweb.com/] There is also the belief that the regulators have to “review the processes involved in the registration of pharmaceutical drugs in the country including, but not limited to, evaluation of documents/dossiers, average throughput time for registration, risk/analytical assessment reports of pharmaceutical drugs, the entry and clearance of pharmaceutical product at the various points of entry.” The Food and Drugs Authority occasionally publishes list of registered drugs but by then the harm of these unregistered pharmaceutical drugs will/have already crippled our healthcare system and markets. Interestingly, most of these companies have advertisements of the apparently fake drugs running on radio, television and in newspapers on daily basis. As a result, there are so many ways of ascertaining the availability of particular pharmaceutical drugs at any drug outlet. This leads to situations where majority of the population seeking healthcare solutions to variety of health problems not being able to cure themselves efficiently and effectively. There is currently no centralized system of checking list of registered and unregistered pharmaceutical drugs when needed. Depending on the locality of the user, he/she can research for himself/herself if a drug being purchased is registered and has fulfilled all necessities needed to distribute and sell to the Ghanaian population

1.2     Statement of Problem

The major and core issue that gave rise to this research work, is on the fact that most of the pharmaceutical drug users seek to use original product but because fake of counterfeit drugs now, do not let one differentiate from the original anymore, and the process of verifying a product currently is not encouraging because it will take much time and before then, the ill person is supposed to take his medication, which is to say that the verification process is slow and not reliable as sometimes you don’t get thee feedback at all. This issue is what the research seek to resolve by developing a secure and reliable system that can function better than the previous one.

1.3     Objective of the Study

The basic objective of the project is to provide simpler means to the consumer and regulatory agencies for establishing drug authentication and protect the consumers’ health and life safety. In achieving the objective, following goals have been set:

1. Web based portal / SMS based system / Mobile App enabling the citizens to check the authenticity of the drugs online,
2. Tracking and tracing of the drug where manufactured to ensure the reliable supply of drugs to consumers for patient safety and brand protection of manufacturer as well as nation,
3. 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,
4. Provide necessary support to the regulatory agencies in prevention of counterfeiting, fraud and illegal sale of drugs.

1.4     Significance of the Study

This thesis will present in a precise manner, the importance of drugs validity and authenticity to our health. It is believed that if this research wok in full implemented will help reduce the rate of counterfeit in drugs production and uses among individual. It is also expected that the study will benefit the manufacturers of this drugs that is the original company and industry because they will have more sales as the citizens will go for the original one and the fake will have no sales in the market anymore.

The software developed from this study will be useful to the end users or the customers in helping them to verify the drugs they buy for medication. It is expected that the findings will expose the fake drug sellers in the market and they production companies. By this exposure, the pharmaceutical industry will learn more and stand by manufacturing quality products. It is possible that by this outcome the fake pharmaceutical industries will realistically adjust to the standard of production approved by the world Health Organization (WHO).

Subsequently, it will go a long way to enhance the computer science students’ effectiveness in the society by being capable of carrying out what they have learned, thereby contributing to the building up of the society at the local, national and international levels.

The research will also be beneficial to the researcher. This is because the study will expose the researcher to so many related areas in the course of carrying out his research. This will enhance the researcher’s experience, knowledge and understanding on real live application and solution solving techniques.

1.5     Project Study Scope

The Drug verification system and authentication system project is an initiative of the researcher to ensure the genuineness and authenticity of the drugs used within the country imported from any part of the country to ours (Nigeria) basically imported from India and for citizens in the domestic market. The project covers all the drugs sold in our country Nigeria.

1.6     Limitation of the Study

The challenges of implementing this system and its cost are details below.

1. a) Diversity of Pharmaceutical Industry

Nigerian Pharmaceutical drugs comes mostly from the Indian Pharma industry, having 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 will not afford to implement this system a drug verification information system (DVI system). So this will be a core challenge to the implementation of this system.

1. 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 , Micro-particle taggants (nano taggants) etc. To implement a robust and effective solution to achieve both objectives ‘Drug Authentication’ and ‘Verification’, 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.

1. c) 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.

1.7     Definition of Terms

Database: A collection of logically related data to meet the information need of organization.

GSM: Global System for Mobile communication.

DBMS: Database  Management Software that enable the user to define, maintain Control the database.

MENU: This is a list of options presented on the screen with each option identified by short code followed by longer description of its purposes.

Drug: It is referred to as a medicine    or chemical substances that are administered to Patients          for curative measures.

Pharmacy: A placed in a hospital where medicine or chemical substances are kept, stored and prepared.