Combating Counterfeit Medicines Challenges & Solutions
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1 Combating Counterfeit Medicines Challenges & Solutions XXXIII ALL INDIA STEEL MEDICAL OFFICERS CONFERENCE Presented by M & M Technologies P. Ltd. Meenaxee Padhy
2 A Boon for Manufacturers. A relief for the Society. A challenge for the public health. A determination for the Government. An empowerment to the Regulatory Authority. An enhancement to ethical growth. A fierce battle against the criminalism to survive with dignity. M & M Technologies Pvt. Ltd. 1 to 52
3 Objective Definition of Counterfeit Medicine Public Health challenges Threat and Consequence Impact on Stakeholders Global Scenario The Grim situation in India Smart Solution by M&M Overview of Technology Q & A M & M Technologies Pvt. Ltd. 2 to 52
4 Today s presentation aim at very clear and distinctive objectives Raise the awareness level among the Stakeholders on How grave is the counterfeit trade of medicine It s challenges and Solutions Highlighting on the Technology for solution. Identifying the role of Each Stakeholder in support and help to mitigate the problem. M & M Technologies Pvt. Ltd. 3 to 52
5 No Unified definition of counterfeit. Empirical, Reliable and Transparent statistic about drug counterfeiting virtually non-existent. In absence of the universally accepted definition; it makes difficulty in Exchanging information between the countries To gauge the magnitude of the problem globally. M & M Technologies Pvt. Ltd. 4 to 52
6 WHO was categorised the counterfeit Drugs as under: 1. Products without active ingredients (API) 2. Products with incorrect quantities of active ingredients (API) 3. Products with wrong ingredients. 4. Products with correct quantities of active ingredients but with fake packaging. 5. Copies of an original product. 6. Products with high levels of impurities & contaminants. M & M Technologies Pvt. Ltd. 5 to 52
7 FDA Government Manufacturer Pharmacy Patient Key Challenges Doctors M & M Technologies Pvt. Ltd. 6 to 52
8 Violets copyright of IP (Intellectual Property). Constitute Crime against Humanity. Dismantle Public Healthcare System. Paralyses Cross Border Legal System. Jeopardize Regulatory System. Betrays the vulnerability of Pharmaceutical Supply Chain System. Loss of confidence in Drug Control & Enforcement of Drug Law. Failure in Therapeutic efficacy. Worst Case Scenario FATAL M & M Technologies Pvt. Ltd. 7 to 52
9 Impact of Counterfeit Medicine Consumer Manufacturer Government & Regulatory Authority Economy as a whole Damage to health and safety Increase in Treatment Cost Lost Sale & Revenue, Loss of Brand Values Damage to Public Image Decreased incentive to Invest on R&D, Loss of Tax Revenue, Cost of IP Enforcement Risks of Infiltration by illegal trade Civilian safety & National Security at stake Lower Economy Growth Lost Revenue from declining legitimate Trade M & M Technologies Pvt. Ltd. 8 to 52
10 M & M Technologies Pvt. Ltd. 9 to 52
11 Source : Counterfeit Metakelfin: Uganda FAKE AUTHENTIC Source: Caribbean Poison Information Network FAKE AUTHENTIC Source : Pfizer Inc. Contd.. M & M Technologies Pvt. Ltd. 10 to 52
12 Can you make out the difference? Source: Caribbean Poison Information Network Genuine Counterfeit Source : IPI-USPTO-EAC Conference on Anti-Counterfeiting 2010 Source: Pharmaceutical Research Manufacturers Association in Taiwan M & M Technologies Pvt. Ltd. 11 to 52
13 Easy Money Illegal Internet Trade Inadequate Legislation, Regulation and Enforcement. Ineffective cooperation among Stakeholders. Corruption and conflict of interest Lack of Awareness High cost of medicines Demand exceed supply Lack of political will Weak law Enforcement M & M Technologies Pvt. Ltd. 13 to 52
14 Filthy environment, even garages.. Clandestine setup No quality check No FDA approval No safety measures No GMP (Good Manufacturing practice) All imitation : Look Alike M & M Technologies Pvt. Ltd. 12 to 52
15 Counterfeit Manufacturing Facilities Source: Pharmaceutical Research Manufacturers Association Source: Caribbean Poison Information Network M & M Technologies Pvt. Ltd. 14 to 52
16 Counterfeit Manufacturing Facilities Source: A Safe Medicines Chest for the World The methods of storage and production (cement mixer) discovered during a raid on a counterfeit drugs manufacturer in Haryana State, India, 2008 M & M Technologies Pvt. Ltd. 15 to 52
17 Route Source Vector Destination China & India Sea & Air South East Asia & Africa M & M Technologies Pvt. Ltd. 16 to 52
18 Source: A Safe Medicines Chest for the World M & M Technologies Pvt. Ltd. 17 to 52
19 Sources : Interpol M & M Technologies Pvt. Ltd. 18 to 52
20 Counterfeit Trade is no more a closed door practice. The Lucrative criminal activities spread over Globally in varied percentage. Difficult to ascertain the Accurate, Empirical Statistics. WHO has been spearheading the movement against this deplorable Practice. Contd.. M & M Technologies Pvt. Ltd. 19 to 52
21 USD in Billion The Center of Medicines in the Public Interest in United States estimate the Global Counterfeit Drug sale up to US$75 Billion in An Increase 90% from Years 2010 Source : WHO (Report 2006) (INCB Report : Press Release) Contd.. M & M Technologies Pvt. Ltd. 20 to 52
22 In developed countries it is most frequently new & expensive lifestyle medicine. In developing countries the counterfeit of medicine mainly attributed to life saving drugs like Anti malarial, Tuberculosis and HIV/AIDS including children Cough Syrups. The condition is worse in poor countries where regulatory and Legal oversight are the weakest. Contd.. M & M Technologies Pvt. Ltd. 21 to 52
23 Year 2010 Online Pharmacy Host Location 2009 Total No. of Incidents by Year Y 2002 Y 2010 Source: Confederation of Indian Industry (CII) Source: Pharmaceutical Security Institute (PSI) M & M Technologies Pvt. Ltd. 22 to 52
24 The European Commission EC 2006 On Counterfeit Seizure The report states in the medicines sector, India is the number one source, followed by the United Arab Emirates and China M & M Technologies Pvt. Ltd. 23 to 52
25 M & M Technologies Pvt. Ltd. 23 to 52
26 VERY GRIM. Blooming export market share of $ 8.5 Billion. A Hub of Illicit Trade of medicine and narcotics: INCB World s largest manufacturer of generic drugs, has become the Center for Counterfeit and Substandard Medicines- The Washington Post Contd.. M & M Technologies Pvt. Ltd. 24 to 52
27 Fake medicines are being paddled to different countries with an Indian Tag. In 2010 a huge fake drug racket was being exposed in Chennai selling expired medicines. Various state Drug Control authorities reveal the circulation of counterfeit drug 0.3%. Independent estimation goes up to 20% - 25%, WHO reports 35%. M & M Technologies Pvt. Ltd. 25 to 52
28 The Drug and Cosmetic Act 1940 been amended to Drug & Cosmetics (Amendment) Act, Stringent penalties and punishment for those found guilty. DGFT implemented Traceability for All Stage of pharma packaging. At par with Global Requirement. Industries focus on Newer Technologies to Control Counterfeit. M & M Technologies Pvt. Ltd. 26 to 52
29 ILLEGITIMATE LEGITIMATE UNWITTING CUSTOMER C&F Agent Distributer Stockiest Sub Stockiest Pvt. & Public Hospitals Warehouse Internet Trade Pharmacy Manufacturer Counterfeit Manufacturer Intermediary Trade Counterfeit Distributer Legitimate Illegitimate Counterfeit & Genuine M & M Technologies Pvt. Ltd. 27 to 52
30 Nuts & Bolts M & M Technologies Pvt. Ltd. 28 to 52
31 The Manufacturers The regulatory Authorities All Intermediaries in Supply Chain Network The Pharmacies The Doctors Hospitals WE Contd.. M & M Technologies Pvt. Ltd. 29 to 52
32 Each stakeholder holds the KEY to the solution in different magnitude!! Role of Each Stakeholder is Remarkable significant. M & M Technologies Pvt. Ltd. 30 to 52
33 Monitoring & Evaluation Appropriate legislation Empowering the Judiciary Strengthening Political Will & Commitment Enforcing Drug Control Laws At all International, National, Regional and Sub Regional Level. Contd.. M & M Technologies Pvt. Ltd. 31 to 52
34 Fostering Partnership. Sharing Responsibilities. Mobilizing the Community Importer, Custom Officers Intermediary. Health Professionals Consumers. M & M Technologies Pvt. Ltd. 32 to 52
35 M & M Technologies Pvt. Ltd. 33 to 52
36 SMART SimpleMultipurposeAdaptable Reliable &Tested M & M Technologies Pvt. Ltd. 34 to 52
37 Features of I Key Unique Distinctive identification Code Key Features Secured, Coveted Taggant System Innovative, Proven & Commercialized Maintained in GAD System Contd.. M & M Technologies Pvt. Ltd. 35 to 52
38 Contd.. M & M Technologies Pvt. Ltd. 36 to 52
39 Contd.. M & M Technologies Pvt. Ltd. 37 to 52
40 GAD System by M & M GAD System is Inaccessible to everyone. Only Authorized Person in Plant have access. GAD records movement of products from plant to pharmacy outlet in Pre-determined manner. Provides market Intelligence Report. Contd.. M & M Technologies Pvt. Ltd. 38 to 52
41 Effective Tool for Supply Chain Systems. Unfold Real Time / Geographic Zone. GAD prohibits unofficial transport Route. GAD System identifies Wrong Location identity. Maintains Parent-child relation. M & M Technologies Pvt. Ltd. 39 to 52
42 GAD assist Stakeholders in Supply Chain Management Authentication Management Recall System Management Traceability Management Contd.. M & M Technologies Pvt. Ltd. 40 to 52
43 How does GAD Communicate with Stakeholders? Consumer INFO Camera Mobile Distributer Scanner Manufacturer Scanner Authority Scanner M & M Technologies Pvt. Ltd. 41 to 52
44 GAD System By M&M Manufacturer Code generation Request for a batch Database Server With all details CODE Generated are sent to the Code Printing System Application Server Code Printing System Packing and dispatch Notify to Server Firewall Web Server Distributer confirm receipt of package Confirm receipt of package Send Secret code to server for Validation / Verification / receiving return response Incase of investigation & verification Packager Distributer Pharmacy Consumer Regulator M & M Technologies Pvt. Ltd. 42 to 52
45 Government FDA Pharmacy Patients Manufacturer Hospital Doctors M & M Technologies Pvt. Ltd. 43 to 52
46 STANDARD QUESTIONS.. Will it Work? Will it Worth Investment? SIMPLE ANSWER : The Key Issue is not just adopting the technology, But the Right Technology. Contd.. M & M Technologies Pvt. Ltd. 44 to 52
47 The key to the solution Starts with the Manufacturer. Strong Business Code & Conduct. To adopt and implement the Right technology. To empower product level authentication. To provide clear asset in terms of Anti counterfeiting Impact. To portrait Brand Protection in terms of Brand Evolution. M & M Technologies Pvt. Ltd. 45 to 52
48 Play Proactively in their role to eliminate counterfeit drug. Doctors wield an awesome influence on patient s healthcare. Uphold ethical practice. Work for ultimate good of patients. Contd.. M & M Technologies Pvt. Ltd. 46 to 52
49 Ensure to source the medicine from Credible Source. Counsel the patient to check the authentication measure before buying. Educate them to report any deviation in case of falsified medicine intake. Encourages your patient to take up issue with FDA / Any Grievance Cell. M & M Technologies Pvt. Ltd. 47 to 52
50 Play important role at his Critical time. Ensure the supply source to be Genuine / Credible sources. Be aware of the problem of counterfeit medicine. Ensure the safety of medicines administered to the patients. Educate the patients / Staff / Pharmacies to use the anti counterfeiting Tools to ensure the Patients safety. M & M Technologies Pvt. Ltd. 48 to 52
51 Need to be alert for the act of miscreants. Play crucial role in control of counterfeit supply. Can insist on strictly following the Anti counterfeit Tools by the manufacturing source. M & M Technologies Pvt. Ltd. 49 to 52
52 Technology can not stand alone. It is a Big Task! Massive load on Government to Comprehend and Formulate. Drug Control Authority to Comply With Manufacturers to Adhere. The Consumers to be Alert. Respect to LIFE. M & M Technologies Pvt. Ltd. 50 to 52
53 Not Just adopting the Technology, Adopting The Right Technology M & M Technologies Pvt. Ltd. 51 to 52
54 M & M Technologies Pvt. Ltd. 52 to 52
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