Venom of Spurious Drugs: Lexicon, Magnitude, Detection and Control

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Spurious medicines not only adverse impact upon the health and well-being of patients but kill them too. They pose a serious threat to the healthcare system as well national economy. This article dwells upon the various terminologies used to express the problem; magnitude of the menace at global, national and state level; innovative technologies being developed for their detection and the measures required for their prevention and control.

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Venom of Spurious Drugs: Lexicon, Magnitude, Detection and Control

  1. 1. Dr Geer Mohammad Ishaq Senior Assistant Professor Dept. of Pharm. Sciences University of Kashmir UGC-Academic Staff College, University of Kashmir July 4th, 2013
  2. 2. Healthcare as a basic right  Access to health care is well recognized as a basic right of the people.  The right to protection of life and personal liberty is enshrined in Article 21 of the Constitution of India which includes the right to live with human dignity and all that goes along with it, namely, the bare necessities of life.  The Supreme Court of India has held that it (Article 21) must include the protection of health.  Section 24 of the Constitution of Jammu & Kashmir state casts a duty upon the State to improve public health.
  3. 3. Quality Control of Medicines  The Quality of a product has been defined as its “fitness for a purpose”.  “Quality Control” could be defined as any process, or a series of processes, which guarantee the fitness of a product for a given purpose.  The concepts of “Total Quality Control” and “Quality Assurance” refer to the perpetual process of striving to produce a perfect product by a series of testing and surveillance measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production.
  4. 4. A mix of terminologies and definitions used to describe spurious medicines
  5. 5. Definition of “Spurious Drug”  The term ‘Spurious Drug’ has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940, as amended by the Drugs and Cosmetics (Amendment) Act, 1982.  A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer.
  6. 6. Definition of Counterfeit Drugs  Counterfeit in relation to medicinal products means the deliberate and fraudulent mislabeling with respect to the identity, authenticity, effectiveness, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product.  The Sixty-fifth World Health Assembly in May, 2013 adopted resolution WHA65.19 establishing a Member State mechanism on substandard/spurious/falsely- labelled/falsified/counterfeit (SSFFC) medical products.
  7. 7. Counterfeit products may include: i) Products with correct ingredients, but containing insufficient or erroneous quantities of active ingredients, or expired active ingredients either to save cost or owing to poor quality control factors; ii) Wrong ingredients with possibly toxic elements and impurities and therefore directly harmful to patients; iii) Without active ingredients or using similar class of cheaper ingredients to escape detection; iv) Produced by unhygienic manufacture, or lack of rigorous cleaning between production batches; or v) Products with false or misleading packaging vi) Counterfeiting can apply to both branded and generic products, prescription and OTC medicines as well as traditional remedies.
  8. 8.  The Good: Promote the availability of good- quality medicines (supply focus)  The Bad: Target substandard and counterfeit medicines (supply focus)  The Ugly: Raise awareness about the negative health impact of SCMs (demand focus) [Source : Outterson, Kevin and Smith, Ryan, Counterfeit Drugs: The Good, the Bad and the Ugly. Albany Law Journal of Science and Technology, Vol. 15, 2006.] The Good, The Bad, and The Ugly of Counterfeit Medicines
  9. 9. “Good” of Counterfeit Drugs  Counterfeit in relation to medicinal products means the deliberate and fraudulent mislabeling with respect to the identity, authenticity, effectiveness, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product.  Counterfeit medical product describes a product with a false representation of its identity and/or source. This applies to the product, its container or other packaging or labeling information.
  10. 10. Definition for “Counterfeit", proposed by IMPACT in a meeting held in Hammamet, Tunisia on 3-5 Dec., 2008  Public health experts argue that IMPACT’s definition was too broad, and went beyond drugs—it includes medical devices, diagnostics, accessories and active pharmaceutical ingredients—and could brand even genuine generics as counterfeit that are similar either in look or colour.  This means that a product also may be classified as counterfeit for example when the shape or color schemes of a product is similar to the competing product irrespective of correct labeling information and contents.  This is particularly problematic since presently the scope of trademark protection covers not only traditional trademark like words, signs or combination of both but also non-traditional trademark taste, shape, color, touch and feel, smell, etc.
  11. 11. at global level
  12. 12. Counterfeit Drugs: A Global Problem  The counterfeit drug problem is a worldwide problem! Globally, one of the fastest growing grey economies – after prostitution, narcotics, insurgency & arms trade.  Over 109 countries have reported counterfeit medications in 2008.  19 out of top selling 25 drugs have been found to be counterfeited across the globe.  Brands commonly faked in US include Lipitor, Botox, Viagra, Tamiflu, Procrit, Serostim etc .  WHO has estimated that 200,000 deaths per annum would be preventable if drugs used were not fakes.  In another survey by IPN it has been estimated that Malaria and TB deaths caused by fakes, combined together equal at least 450,000 + 250,000 = 700,000.
  13. 13. Global market of counterfeit drugs  World Health Organization (WHO) estimates that counterfeit drugs comprise 1% to 10% of the world market.  For developed countries, WHO estimates are < 1%.  For developing countries (African, parts of Asia, and Latin America) counterfeit drugs comprise 30 - 40% of the market.  WHO has estimated that fake drugs are $75 billion market.  However, in June, 2010, the World Customs Organization has estimated it was $200 billion market and from 2007 it has increased by 597%.  In 2012, a study showed that one-third of antimalarial medications in Southeast Asia and Sub-Saharan Africa failed chemical analysis, packaging analysis, or were falsified. [Source: WHO, IMPACT, 2006, Counterfeit drug report, World Customs Organization]
  14. 14. Countries most affected by Counterfeit Drug Problem  China  India—it is estimated at 15 to 20%  Brazil  Mexico (10% to 12%)  Pakistan  Indonesia (25%)  Russia up to 20% depending on republic  Cambodia (13%)  Columbia (5%)  Nigeria (70%)  Southeast Asia Countries (10 to 40%) [Source: WHO, IMPACT, November 15, 2006, Counterfeit drug update report, PSI Counterfeit Situation Report, 2010]
  15. 15. Formulation Categories & Type Counterfeit Drugs reported by dosage forms:  Tablets and Capsules – 87%  Injectables – 10%  Other dosage forms – 3 % Type of Counterfeit Drugs reported:  No active ingredients – 60%  Inaccurate dosage of correct ingredients – 17%  Incorrect ingredients – 16%
  16. 16. Counterfeit Trade Route
  17. 17. SPOT THE DIFFERENCE
  18. 18. "There are several instances of companies not being able to identify the counterfeit of their own products because of the labeling and packaging."
  19. 19. Ranbaxy’s $500mn Dirty Medicine
  20. 20. Implications of Spurious Drugs  Health Impact: increased morbidity and mortality (treatment failure; adverse reaction; antimicrobial resistance)  Financial Impact: waste of scarce financial resources; burden to national health care; risk of undermining past and current health investments  System Impact: loss of confidence in conventional medicines, health care system “Better to have lack of access, than to have access to counterfeits and substandard medicines” Dr. D. Akunyili
  21. 21. Implications (contd.)  Counterfeiting certainly damages legitimate commerce.  It undermines margins of legitimate drug companies, reducing profit for reinvestment in new drugs and for low cost, high quality generics.  It reduces the tax revenues of the country, which could be ploughed back in health infrastructure.  It also damages reputation of drug companies, demolishes public confidence in medicines, and hence companies are reluctant to publicize incidents of counterfeiting of their products.
  22. 22. Global Anti-Counterfeiting initiatives  Anti-Counterfeiting Trade Agreement (ACTA) (a pluri- lateral initiative of the European Union, Japan, United States and Switzerland),  World Customs Organisation on "Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE)",  G-8 Countries' Initiative on Counterfeits; WIPO's Advisory Committee on Enforcement (ACE),  Security and Prosperity Partnership (SPP) (between Canada, Mexico and US);  Interpol's initiatives on IP crime and other initiatives in US as well as in the EU, all geared towards strong protection and enforcement of IP.
  23. 23. at national level
  24. 24. Independent estimates of spurious medicines in India  WHO: 10-12% of global market, $32 billion, causing $46 billion annual loss to the global drug industry  USFDA: 25% of medicines consumed in poor countries are counterfeit or substandard.  Estimates ranging from as low as 0.25%, as per govt. claims to a whopping 35% (as per industry claims).  Industry Claims: 30 per cent of the Rs 22,000 crore (in 2001) pharma market in India. One in every five drugs is spurious.  ASSOCHAM: Spurious drug market is growing at 25% p.a.  Organization for Economic Cooperation and Development: 75% of fake drugs supplied worldwide have their origins in India.  Nimulid (Nimesulide) manufactured by Panacea Biotech had more than 35 counterfeits in the market at one time.
  25. 25. Independent estimates of spurious medicines in India  European Commission: India, United Arab Emirates, China and Switzerland together are responsible for more than 80% of all counterfeit medicines in the world; Egypt (7%) & China (6%).  Confederation of Indian Industries (CII):In 2001, out of a total production of Rs. 22, 887 crores, 18 % was spurious amounting to Rs. 4112 crores.  About 40% of fake drugs detected in Nigeria were manufactured in India.  A study in six African cities showed over one-third of anti- malarial drugs to be sub-standard. Of the drugs from Asia (principally India and China), 32% were sub-standard.  The average figure over studies is 15–20%, with the annual rate of growth at 25%, and manufacturing concentrated in northern states of India.
  26. 26. Govt. estimates of spurious medicines within India  MoH, GoI says 5 % of drugs in India are substandard while only 0.3 % are spurious.  Based on samples tested by the state drug testing authorities in India, for the period 1995-2008, extent of substandard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24% to 0.47%.  SEARPharm Forum in Association with SEARO, WHO estimated the extent of spurious medicines to be 3.1% in 2006. Based on domestic sales of Rs. 31,500 the magnitude of spurious drug trade was estimated to be Rs. 1000 crores.
  27. 27. Year Samples Spurious Percentage of Substandard Tested Drugs Spurious Drugs Drugs 2007-2008 34,725 46 0.13 6.3 2006-2007 35,189 51 0.14 6.4 2005-2006 38,704 124 0.32 7.3 2004-2005 49,287 144 0.29 7.5 2003-2004 40,862 118 0.28 6.3 2002-2003 43,138 129 0.29 9.34 2001-2002 38,824 96 0.25 8.96 2000-2001 36,947 125 0.34 8.36 1999-2000 35,570 115 0.32 10.31 1998-1999 38,936 94 0.24 8.19 1997-1998 32,939 157 0.47 9.04 Year-wise Percentage of Spurious Drugs reported by the state Drug Controllers in India
  28. 28. National/Regional Surveys on Spurious Medicines  Two pilot exercises have evaluated the extent of counterfeit drugs in India, one by the office of deputy drugs controller (DDC), Western Zone, and the other by an independent forum known as SEARPharm.  A total of 3,246 samples were drawn in the combined exercise. The results of the samples tested revealed only five drugs as counterfeit and two samples not complying to the standards.  The drive undertaken in two months by the western zone office of the Central Drug Standard Control Organisation (CDSCO) which tested 800 samples from various parts of the region, could find only one counterfeit drug, while it detected no spurious ones. Samples in this study were collected from rural areas in Madhya Pradesh and Orissa.  According to the Maharashtra Food and Drug Admin., spurious drug trade is only one per cent of the total marketed formulations in the state.
  29. 29. Pan India Survey in 2008  GOI launched a pan-India survey in 2008 in which 24780 samples were collected from across India and sent to drug makers (who have procured the license to produce the packs) for verification/authentication.  Survey report revealed that the extent of spurious drugs in retail pharmacy is only 0.046 %. Only 11 samples out of a total of 24,136 samples tested were found to be spurious [Bihar(5), West Bengal(3) U.P(2) & Gujarat (1)] and the extent of substandard drugs among the branded items was found to be only 0.1 %.  In this nationwide survey 5665 samples were collected from the entire North Zone including the state of J&K in which a Jammu-based NGO named Swasthya Sansar under the headship of Sh. Nigham Gupta assisted in collection of samples from the J&K state.
  30. 30. Testing by Central Laboratories  During the year 2010-11, a total of 10,055 samples were tested by various Central Drug Testing Laboratories, out of which 713 (7.09%) were found not-of-standard quality and 28 (0.27%) were found to be spurious/adulterated.  Four prosecutions were launched by CDSCO and in the remaining cases the concerned state licensing authorities were yet to take action.  During the year 2011-12, a total of 9,685 samples were tested, out of which 525 (5.42%) were found not-of- standard quality and 09 (0.09%) were found to be spurious/adulterated.
  31. 31. Dismal and Disheartening
  32. 32. Testing by J&K State Laboratories YEAR No. of Samples Lifted No. of Test Reports Received Found Sub- Standard No. of Prosecut ions Launche d No. of cases convicted by courts No. of cases acquitted by courts 2010- 2011 1080 920 23 (2.5%) 37 07 02 2011- 2012 1910 1517 78 (5.14%) 36 04 01 2012- 2013 2061 1994 85 (4.26%) 90 10 19
  33. 33. J&K Scenario  Medicines worth Rs. 1000 crore are being consumed in the Jammu & Kashmir of which Rs. 800 crore are consumed in the Kashmir valley only.  A total of 5646 retailer, 3148 wholesalers operate in Kashmir division and a total of 4990 retailers and 1646 wholesalers operate in Jammu division (Total 10636 retailers & 4794 WS) as on February 2013.  J&K has one Drug Controller, two Deputy Controller, seven Asstt. Controllers and around 90 Drug Inspectors besides two Drug Analysts and a few Govt. Analysts.
  34. 34. Drug Legislations in India Name of Legislation Enforcement Agency Drugs and Cosmetics Act, 1940 Drugs and Cosmetics Rules, 1945 (central Act) Drug and Food Control Organization, (Has around 90 DIs, 12 ADCs, 2DC, 2 DAs and one Controller) Drug Prices Control Order, 1995 (Recently replaced by) Drug Prices Control Order, 2013 Drug and Food Control Organization, (Drug Inspectors of Gazetted Cadre) Pharmacy Act, 1948 (Central Act) Pharmacy Council of India Narcotics Drugs & Psychotropic Substances Act, 1985 (Central Act) Excise Department & Narcotics Control Bureau Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 Drug and Food Control Organization
  35. 35. Dr Naresh Trehan/Dr Surinder Bazaz – Prophetic Revelations  “Many deaths in J&K are caused by fake, substandard or expired drugs resold in new packages, and it is known to druggists and medicos that many pharma agencies have been doing so with impunity,”  “I have been practicing in Kashmir since 1997, and have come across drugs which you can find nowhere else in the country. It seems as if this state has turned into a safe bastion for the trade in spurious and substandard drugs,” said another famous cardiologist, Dr Surinder Bazaz, in an interview. “Perhaps, the highest number of fake drugs worldwide, is sold here,” he added. (Ref: Kashmir Monitor dt. December 9th, 2011)
  36. 36. Deputy Drug Controller Kashmir  “We have conducted 8549 inspections since April this year. We collected 545 samples and in all those samples we didn’t find any spurious drug after test,” said Deputy Drug Controller. “Out of 545, only 31 were declared sub- standard. In these cases either administrative action has been taken against the culprits or prosecution has been initiated against them before the competent courts,” DDC said. “We didn’t find any spurious drug among 31 cases”. DDC defined spurious medicine as a drug in which active ingredient is zero percent, and said that any such drug was not found anywhere in the Valley. (Ref: Greater Kashmir, “ dated November 20th, 2011)
  37. 37. Drugs Controller, J&K  Confirming the use of spurious and sub-standard drugs in whole of Jammu and Kashmir, particularly in the valley, on a large scale, the state’s Drug Control Organization blamed doctors for pushing the nefarious business but expressed its helplessness to take any action against them.  Drug Controller, J&K confirmed to KNS that doctors were playing the key role in the clandestine operations of unrecognized and unlicensed pharmaceutical companies. “However, we don’t have the powers to tighten the noose around such elements,” he said, adding that the doctors involved in it were driven by an uncontrollable lust for money for which they were playing with people’s lives. (Ref: Kashmir Observer dt. November 24th, 2011)
  38. 38. Pathogenesis of Spurious Drug Disease in J&K state  Most of the spurious drugs find their way into the government institutions like civil hospitals and dispensaries, who bulk purchase drugs through the tender system and settle for the lowest bids.  The presence of corrupt purchase officials in these deals, the absence of any appropriate system of monitoring the quality of drug, aids spurious and sub-standard drugs finding their way into these places.  These spurious drugs unfortunately find their way into the health care system flooded by the poor and illiterate who unfortunately do not have the wherewithal to probe and identify spurious drugs and meekly accept whatever is prescribed or dispensed.  The ultimate loser is the patient who fails to improve; a notch below is the doctor, whose reputation would be compromised.
  39. 39. a highly challenging task
  40. 40. WHO - IMPACT  Responding to the growing public health crisis of counterfeit drugs, in February 2006, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).  At its core, IMPACT aims to build coordinated networks across and between countries in 0rder to halt the production, trading and selling of fake medicines around the globe.  IMPACT comprises all 193 WHO Member States on a voluntary basis and includes international organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non- governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients' groups.
  41. 41. KEY AREAS OF WHO-IMPACT To Assess technologies to prevent, deter or help to detect counterfeit medicinal products taking into account: a) cost; b) scalability; c) specific country needs and situations; d) feasibility; e) regulatory implications., IMPACT will focus on the following five key areas: i) Legislative and regulatory infrastructure, ii) Regulatory implementation, iii) Enforcement, iv) Technology, and v) Risk communication.
  42. 42. s
  43. 43. WHO-IMPACT TECHNOLOGIES  Overt verification tools –Can be seen with a human eye, meant for consumers, polychromatic, color shifting security inks, holograms, raised printing, 2D bar codes; widely used, but may be copied  Covert tools: cannot be seen with the eye, usually require a special instrument or scanner. Examples include micro wires, magnetic threads, invisible inks, hidden computer chips, nanoencryption, digital watermarks, etc.; also widely used, meant for professionals, dependent on security protection of the device; Expensive and/or not consumer-oriented  Forensic technology: chemical/biological tags; more secure against copying; more costly; limits across borders; invisible to providers and customers; often require lab analysis  Serialization + Track/trace: authentication through supply chain; trace history; bar codes; RFID; very expensive; different national standards; may be “hacked”
  44. 44. Anti-Counterfeiting Technologies  WHO has established a Rapid Alert System (RAS), the world's first web-based system for tracking the activities of drug cheats.  Global Trade Identification Number - GTIN, that makes use of a Unique pack numbering, or mass serialization option. By incorporating a unique serial number along with a product identifier plus lot and expiry data, one can facilitate both identification and authentication functions within one code.  End user verification (patient, doctor) via mobile phones, the Internet, etc; focus on the point of dispensing, with the pharmacist playing a vital role;  Security inks; Invisible digital graphics and  Dots: Surface fingerprinting and Infrared invisible codes etc. (http://www.who.int/impact/activities/impact_meetppt/en/index.html)
  45. 45. WHO-IMPACT TECHNOLOGIES  Radio-frequency identification (RFID) technique uses electronic devices to track and identify items, such as pharmaceutical products, by assigning individual serial numbers to the containers holding each product. It has demerits e.g. cost, privacy concerns, complex logistics throughout the distribution chain (For more info on RFID visit http://epic.org/privacy/rfid/)  Work is on for developing an electronic pedigree (E-Pedigree) system to track drugs from factory to pharmacy, thereby preventing the diversion of drugs or counterfeiting by allowing wholesalers and pharmacists to determine the identity and dosage of individual products.  A new technique, Raman spectroscopy, can be used to uncover counterfeit drugs while they are still inside their packaging.  A novel low-tech device to test and detect counterfeit drugs, by use of a handheld refractometer, which measures specific gravity of certain dissolved drugs, makes it possible to determine the amount of the active ingredient in a tablet. This device could be used as a first line of defense against counterfeits.
  46. 46. How to Identify Spurious Medicines  If the packing of the medicine changes  If the colour of the medicine changes  If the consistency of the medicine changes  If the flavour or odour of the liquid prep changes  If the medicines are available at a very low price than the normal price  If the seller refuses to give the bill for the medicines purchased.  If the labelling or packaging of routinely used medicines like iodex, ointments is different.  If the expected result is not obtained from the medicines  If the medicine deteriorates or decomposes in a short span of time
  47. 47. BE AWARE: Tool for visual inspection of medicines  A tool developed by The World Health Professions Alliance (WHPA) for WHO.  This tool is designed to help health professionals carry out a visual inspection of medicines for signs of counterfeiting such as improper packaging, labelling, description of dosage, etc.  All suspicious drugs with incorrect labels, missing information about the strength, dosage, or expiration date should be reported to the appropriate authority.
  48. 48. Container and Closure  Do the container and closure protect the drug from the outside environment e.g. properly sealed?  Do they assure that the drug will meet the proper specifications throughout its shelf life?  Are the container and the closure appropriate for the drug inside?  Is the container safely sealed?
  49. 49. Label  The information written on the label is very important.  The information can be printed on a label adhered to the container, or printed directly onto the container itself, but all information must be legible and indelible.  If there is a carton protecting the container, does the label on the carton match the label on the container?  Is all information on the label legible and indelible?
  50. 50. The Trade Name  Is the trade name spelled correctly?  Is the drug (trade name) registered in the country by the DRA (drug regulatory authority)?  Is the drug legally sold in the country?  Does the symbol ® follow the trade name?
  51. 51. The Active Ingredient Name (Scientific Name)  Is the active ingredient name spelled correctly?  Do the trade name and the active ingredient name correspond to the registered drug? The Manufacturer’s Name and Logo  Are the manufacturer’s name and logo legible and correct?  Does the logo or hologram (if applicable) look authentic?  Does it change colour when viewed from different angles?
  52. 52. Manufacturer’s Full Address  Is the manufacturer’s full address legible and correct?  Has the company or its agent registered the drug in the country? The drug strength (mg/unit)  Is the strength - the amount of active ingredient per unit - clearly stated on the label? The dosage form (e.g., tablet/capsule)  Is the dosage clearly indicated?  Is the indicated drug under this dosage form registered and authorized for sale in the country? The number of units per container  Does the number of tablets listed on the label match the number of tablets stated on the container?
  53. 53. The Batch or Lot No.  Does the numbering system on the package correspond to that of the producing company? The date of manufacture and the expiry date  Are the manufacture and expiry dates clearly indicated on the label? Leaflet or package insert  Is the package insert printed on the same coloured or same quality paper as the original?  Is the ink on the package insert or packaging smudge- proof?
  54. 54. Uniformity of shape Are the tablets/capsules uniform in shape? Uniformity of size Are the tablets/capsules uniform in size? Uniformity of colour Are the tablets/capsules uniform in colour? Uniformity of texture Tablets can be film- coated, sugar-coated or enteric-coated. Do the tablets have a uniform coating? Is the base of the tablets fully covered? Are the tablets uniformly polished, free of powder, and non-sticking?
  55. 55. Markings (scoring, letters, etc) Are markings uniform and identical? Breaks, Cracks and Splits Are the tablets/capsules free of breaks, cracks, splits or pinholes? Embedded surface spots or contamination Are the tablets/capsules free of embedded surface spots and foreign particle contamination? Presence of empty capsules in the case of a sample of capsules Is the sample examined free of empty capsules? Smell Does the medicine smell the same as the original?
  56. 56. Drug Testing Cells in Hospitals  Quality control cells will have to be constituted in every major hospital as part of in-house Quality Assurance system.  Bare minimum equipment including UV- Spectrophotometer, HPLC, Disintegration and Dissolution test apparatus, friability and weight variation test apparatus, viscometer etc.
  57. 57. of the menace of spurious drugs
  58. 58. Dismal Scenario-Underlying Factors Social Factors Administrative Factors Legal Factors Economic Factors Political Factors
  59. 59. Facilitators of Counterfeit Drugs  Price differentials create drug diversion within and between distribution channels.  Weak regulatory control and enforcement.  Scarcity and/or erratic supply of medications.  Extended and unregulated markets and distribution channels in both developed and under-developed countries.  Lack of effective intellectual property protection.  Many countries do not have the people nor the legal processes which companies can use for remedial action against counterfeiters.  Weak penalties for convicted counterfeiters.
  60. 60. Drivers of Counterfeit Drugs
  61. 61. Etiology: Causes of the menace  Lack of adequate laboratory and testing facilities,  Lack of facilities for speedy communication and mobility,  Lack of adequate funds,  Lack of adequate training in investigational skills, which are hurdling to check the menace.  Lack of summoning or fining powers to the inspectors, and  Absence of special courts for speedy trials, which are needed to be constituted with co-ordination with other law enforcing agencies in order to maximize the fear of law.  The reason why it is easy to produce and sell fake drugs in India is that laws are lax, judicial system ineffective, the infrastructure for checks woefully inadequate, this is compounded by lack of personnel involved in supervision and widespread corruption.
  62. 62. Ethical Drug Promotion Policy  Authorities of government hospitals, particularly teaching hospitals, should ensure that medical and pharmaceutical sales representatives’ activities and conduct are in conformitywith standard ethical norms and do not, in any way, hamper routine patient care. All sales representatives should be allotted a specified time and venue inside the hospital for detailing their products.  All drug promotional practices of pharmaceutical companies have to be in accordance with 2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics) Regulations, 2002 and the prescribers have to adhere to these guidelines in letter and spirit.  Drug Policy must ensure rational prescribing practices by doctors, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner.
  63. 63. Spurious Drugs Control  Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution respectively.  Discouraging proliferation of drug distribution outlets. A distance of at least 500 meters to be maintained between two successive shops.  Necessary changes in law shall be made to provide enhanced penalties, making the offences cognizableand non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.  Special courts shall be designated to try the cases of spurious drugs.  Severeand deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs.  Preparation of dossiers of suspected dealers and manufactures shall be a perpetual exercise.  Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, must be developed.
  64. 64. Spurious Drugs Control  Provision of secret funds and incentives to informers giving information about spurious drugs shall be endeavoured.  Effective networking system between neighbouring states shall be fostered.  Manufacturers shall be encouraged to have their own anti- counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.  Trade associations shall be impressed to have better surveillance on defaulting members and to take strict action against them.  Creation of better awareness amongst consumers shall be given priority.  A statewide survey shall be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner.
  65. 65. Other Remedial Measures  Monitoring of drugs through supply chain management,  Proper control on the allied supply industries and transporters,  Identifying and notifying nodal officers in state and central drug control organizations as well as manufacturers for effective and speedy communication,  Training manpower in investigational skills,  Creation of adequate infrastructure,  Limit the restricted licenses to rural areas,  Creating central registry for formulations under the brand names and their compositions,  Creation of advisory bodies at district level with NGOs and Consumer Associations,  Define exports and apply all the conditions applicable to local manufacturer for exports with proper exemptions in standards and labeling as per import requirements.
  66. 66. Collaborative and Coordinated efforts required for combating the menace of spurious medicines Drug/National Regulatory Authority Healthcare & medicine providers Civil societies Patient Interest Groups Patients / consumers Drug manufacturers importers & wholesalers medicines Ministries, police, customs, Prosecutors Government medicines
  67. 67. QA in Drug Procurement Cycle Drug Selection Choose Procurement Method Locate & Select Suppliers Fix Contract Terms Monitor Order Status Receipt & Inspection Warehouse Storage Distribution Consumption Information QUALITY ASSURANCE AT EVERY STEP OF THE CYCLE Quantification
  68. 68. Quality Assurance in the Drug Management System Selection of well documented quality products from reliable manufacturers. Certificate of Analysis of delivered products. Use of WHO pre-qualification certificates Quality assessment of drugs upon receipt. Pre and Post-shipment Inspections. Laboratory testing. Appropriate storage and distribution Appropriate dispensing and use Monitoring of product quality/reporting system
  69. 69. Quality Assurance of TNMSC  Every Batch of Drugs and Medicines supplied and kept under Quarantine is tested at initial supply stage through Empanelled Laboratories.  Random samples are drawn from every Warehouse where the Batch has been supplied. Batch wise Drug sample de-coding is done through strict confidential system.  De-coded samples are sent for quality checking randomly to any of the Empanelled Laboratories which are located throughout the Country.  On receipt of "Quality Passed" certificate from the Empanelled Laboratories that batch is "Released" for distribution of Drugs to Government Hospitals.  During the shelf life of Drugs, random samples are periodically drawn from Warehouse and quality is checked to ensure that Drug is of Standard Quality up till date of expiry.
  70. 70. Quality Assurance of TNMSC  Randomly picked control samples are sent to Government Laboratories as well as to Empanelled Laboratories for analysis to compare the accuracy and correctness of testing quality of the Empanelled Laboratories.  If any drug batch fails in quality on testing in the Empanelled Laboratories or in Govt Labs the remaining stock in Warehouse are frozen, the unused Hospital Stock of the Drug of failed batch is recalled to Warehouse and returned to the supplier.  If three batches of any drug failed during tender period either at the time of initial receipt or during the shelf life of drug the product is blacklisted for five years.  If the supplier supplied more than one item and 50% of such items during relevant tender period, fail, then the suppler is blacklisted for five years.  Information of failed batches and black listed companies put up on the Net.
  71. 71. Rational Use of Medicines  Rational Use of Medicines is defined as “Patients receiving medication appropriate to their clinical needs, in doses that meet their own individual requirement, for an adequate period of time and at the lowest cost to them and their community”.  It covers issues like Quality, Safety, Efficacy, Availability, Affordability, Equitable Access and Improved Use of Medicines.
  72. 72. Lessons learnt from the Spurious Drug Debacle in Kashmir Valley Streamlining supply chain and medicines management Legal and administrative reforms Drug testing facilities Quality control of drug supplies in government sector Interaction and collaboration between stake- holders Regulation of drug licensing and registration
  73. 73. What have we finally gained out of all the hue and cry over fake drugs?
  74. 74. Final Word It requires a worldwide, coordinated response. No one country can bring this hideous crime under control. It requires both private and international governmental efforts. It requires added resources, defining the roles of each fighting component, technical expertise, and coordinated strategies working with law and regulatory agencies worldwide.
  75. 75. Thank u all for your kind attention

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