FORM-2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL
Specification
(See section 10 and rule 13)
DETECTION OF SPURIOUS/COUNTERFEIT MEDICINES
TATA CONSULTANCY SERVICES LTD.
an Indian Company
of Bombay House, 24, Sir Homi Mody Street, Mumbai 400 001,
Maharashtra, India
THE FOLLOWING SPEC IFICATION DESCRIBES THE INVENTION.

Field of Innovation
This invention relates to the field of pharmaceuticals.
In particular this invention relates to the field of detection of spurious/counterfeit medicines.
Background
Drugs play a crucial role in saving lives, restoring health, preventing diseases and epidemics. When drug itself is counterfeit, it poses addictive danger to patients. Counterfeit medicines are difficult to detect and most of the time fake drugs escape all controls and monitoring systems. Due to huge monies involved and the effect it has on the health of the common man, drug, counterfeiting has become a global problem. Even though the World Health Organization (WHO) has taken all possible initiatives to combat counterfeiting and laid various guidelines on this, India is fast becoming the capital for counterfeit drugs, accounting for one-third of the counterfeit drugs worldwide. According to WHO study, India accounts for nearly 35% of world's spurious drugs market. It is estimated that 40% of the pharmacy market in India, i.e. 8000 crores is under the grip of spurious and black marketed drugs. In this context a reliable and low-cost mechanism to authenticate drug or identify counterfeit drugs is a necessity which is not available today.
An object of this invention is to provide an anytime, easy to use system which will help people verify whether the purchased, prescribed or over the counter drug from a medical stockiest is counterfeit or not instantly at the time of purchase. The device in accordance with this invention is capable of verifying the validity of the drugs in terms of batch number (location based), expiry date and manufacturer's brands (logo based).


Objects of the invention
An object of this invention is to enable a person detect counterfeit medicines.
Another object of this invention is to facilitate identification of counterfeit drugs using multiple parameters.
One more object of the invention is to provide a portable (anytime, anywhere), easy to use system to identify the authenticity of drugs.
Still another object of the invention is to provide a drug authentication facility feasible in remote locations where computers and Internet are not readily available without any extra infrastructure cost.
Additionally, an object of the invention includes the provision of a multiple verification strategy using multiple technologies to robustly detect spurious drugs.
The system in accordance with this invention does not expect a user to type in any information, making it illiterate friendly.
The invention envisages a system for which includes identification of a spurious or counterfeit drug using a mobile phone, particularly a mobile phone equipped with a camera device for capturing and recording of images. The device in accordance with this invention has the following enabling features:
• Recognition and verification - of the expiry date and batch number from the images of the drug envelop captured by the mobile phone camera.
• Location identification - identify mismatch between the batch numbers of the drug with valid sale location.
• Logo validation - measuring the genuineness of the logo or trademark on the purchased drug.


• Manual backup - manually analyzing the input images and send a response if the system fails to recognize the expiry date and batch number due to the low quality input images.
Additional features of the invention includes the provision of voice/text guidance in native language to help common people to interact with the system without any difficulty.
The system in accordance with this invention includes a client-server architecture which makes it easy to setup and maintain and further the system has the provision of scalability.
The invention will now be described with reference to the accompanying
drawings, in which
Figure 1 illustrates the high-level architecture of the invention to enable detection
of spurious drug using a personal mobile device; and
Figure 2 shows the architecture of the invention in more detail.
Referring to Figure 1 there is shown a system which includes an application server having the ability to send and receive data in multitude format (images, text, speech). Additionally the application server has access to a dynamically updated database from multiple sources either residing on the application server or hosted on another server and accessed electronically using different protocols including WAP, HTTP and others.
The solution comprises a client residing on handset (Handset required: BREW/J2ME or similar) and a server residing on a computer. The client part consists of the following modules.


Client Components
• Interface to the server
• a downloadable application, which can be installed on a client
mobile device over the air.
• a module which allows the client mobile device to capture and upload an image.
• module to determine if the uploaded image is error free.
• Expiry date and batch number recognition (client) module
• to recognize expiry date, batch number and logo at client
side and communicate to the server for validation.
• If not able to detect in the client side send to the server for further
process
• Location Identification module
• a module to identify the location of the mobile device (using
location based service or GPS). Location information can come
via client or server depending on the available technology.
Manual entry option will be provided if any of the location technology is not available
The modules designed for server include following facilities.
Server components
• Image Processing and OCR (server) module
• a variant of optical character recognition (OCR) to identify, extract
and recognize expiry date/batch number and the logo of the
manufacturer from the image uploaded by the client mobile device
• Logo (Image) Comparison Tool
• a module of several Image processing and pattern recognition
algorithms, to verify the logo with a reference logo


• Database Interface
• an interface to interact with multiple external database sources
(including information about the link between drug batch number and location it was supplied.
• Regional language interface
• facility to provide the user with an analysis of the genuineness of the
drug in multiple Indian languages, in the form of an image, text or
speech.
• Information Security and privacy module
• This module provides anonymity to the end users. Here the personal
information (mobile number etc.) will be stripped of after a certain
level of processing.
The invention also includes a Client Resident (downloadable) Application tool
The invention includes an over the air downloadable tool for multiple mobile devices, suitable to work on multiple OS and multiple carriers. The client tool includes a media interface, an application engine and prompts menu, in addition it has a facility to configure the language of the user. The client application requests the user (using either a text message or speech) to capture the image of the drug package where the batch number and expiry date is mentioned. Additionally the client software shows the analysis of the drug either by delivering a text or a speech message in the chosen language.
Whenever the client application fails to recognize the relevant information on the captured image like expiry date/batch number it sends the image to the server for further processing. It will also exchange the location of the mobile device identified by the location based service or GPS to the server if it is captured at client side.


The server works on the image uploaded by the client while maintaining a link between the images uploaded and the mobile device through a unique session number. The information security/privacy module takes care of the end users identity. This module will stripped off the personal information and will not allow sharing it to the outside world.
The server works on the image by first identifying the region of interest and then extracts the batch number and expiry date information using an optical character recognition technology. Additionally the server has the capability of identifying expiry dates in multiple different format (mm/yy, mmm/yy. mmm/yyyy. mmm yyyy etc) from the image corresponding to the image received from the package and also the logo of the manufacturer. The details are then compared with the information available in the database by making multiple requests to multiple databases either in parallel or in sequence.
If server is not able to accurately recognize the expiry date and batch number or logo, the system will send the images to a human agent for manual analysis and response. After that the client will get the expiry date information to the client as a speech file or a text message in the user selected language. In addition the server checks for the drug spuriousness by checking the database which links the drug batch number with the location to which it was sent and sends a message (voice or text) to the user in his language confirming the genuineness of the drug or otherwise.
The invention includes another server module having the capability of identifying the location of the mobile device using a location based engine if it is not done on the client side depending upon the technology used.
The advantages of the device in accordance with this invention include
• Very simple and convenient technique for determining authenticity of drugs.

• Uses commonly available mobile phones for information capture, processing and communication with a easy to use interface
• Provides a wide coverage of use (available to large population) even in remote areas where there is mobile phone coverage.
• Uses multiple strategies for information extraction - robustness.
• Driven by a set of text or voice prompts in the local language of the user
• A log will be collected from this application - will be useful to pharmacy manufactures to monitor their drug sales etc.
• Client server architecture is secure and easy to maintain, operate and upgrade.
• Information Security (anonymity) module is also integrated
In summary the stakeholders including end users, drug manufactures and chemists will be benefited in different ways as pointed.
End Users
• Easily downloadable tool.
• No additional investment is required other than a mobile phone having a camera.
• Text/speech interface in various regional languages ensures the ease of use to the common people.
• Anonymity is ensured to the users (information about the end users will be restricted to outside world).
Drug Manufactures
• Can supplement on brand enhancement.
• Can identify counterfeit medicines and initiate legal action against it.
• Able to monitor sales and other related activities based on the log collected from the end users through the application.

Chemists
• Chemists can show the authenticity of drugs based on the customers request at any point of sale.
• Can ensure increase in sale.