Strength And Weakness Of Drug Facts Economics Essay

Strength And Weakness Of medicine Facts Economics EssayIn otc drugs, there is variation in stigmatizeing nonprescription(a) drugs. Those otc drugs which be exported to foreign countries argon labeled in perfect partner, but that is in revise in Indian market. In India, nonprescription(a) drugs be distributed in pitiable manner and it exhibits the lack of regulations in labeling. It is required to improve the labeling of over-the-counter(a) drugs. For achieving proud- feature labeling, the following info should be acceptd in the labeling requirements of otc drugs.1. The suggest of the drug2. Detailed warning messages3. Inactive ingredients4. Dosage instructions5. Users Contact data, equipped to get information for their queriesThe Drug and Cosmetic Act was executed in 1945. At that time, the literacy rate, which depicts the literacy (who roll in the hay be read and write) business office of a population over the age 15, was very low. The prerequisites of labeling w ere depended on general public education and circumstances. after that, there was a great improvement in both literary rate and the usage of OTC drugs. Stated by the surveys, India is currently in eleventh position in the global OTC market, and it is believed to be in the 9th position in following five years. All these represents the need of modification which is required in the Drug and Cosmetic Act established in 1945, in order to improve the level of OTC drug labeling.History of OTC labelsThe manufacture, distribution, sale and substance of drugs and cosmetics in India atomic number 18 regulated by the following legislationsThe Drugs and Cosmetics Act, 1940 (DCA) and its subordinate legislationDrugs and Cosmetics Rules, 1945 (DCR)Drug (Prices Control) Order, 1995Drugs (Magic Remedies) Objectionable Advertisement Act, 1954Pharmacy Act, 1948The above-mentioned legislations ar regulated by the Central Government (Ministry of Health Family Welf be) and ar enforced through Food and Drug Administration (FDA) the State Government. Even though, OTC drugs do not birth separate labeling requirements in India, all drug products should have a minimal information present on the label of the innermost container of any drug and on both other layer in which the container is packed , as per rule 96 of the Drugs and Cosmetics Rules, 1945 (DCR), except homeopathic medicines. The following ar the minimum labeling requirements Name of the drug Proper (generic) name, immediately followed by Trade (brand) name Net content of drug in the container Content of active ingredients/single dose or venereal infection unit Name, address and license number of the manufacturer Distinctive Batch number or Lot number for the product Manufacturing and Expiry date supreme Retail Price (inclusive of all taxes)In India, Peoples habit of taking drugs differs from place to place. Around30%-45% of people prefer pharmacist and self treatment for their illness like cough, cold, pain, fever , injuries and digestive disorders. India is famous for Ayurveda and several(prenominal) other long-established systems of medicine. The aim of the evaluation conducted by Rama Krishna Chaitanya Aluri from Manipal College of Pharmaceutical Sciences, based on nearly 200 OTC drug labels, is to check the suitability of information on the labels for successful self-treatment by consumers.Recent changes in drug factsRecently, the FDA conducted extensive research on how consumers use OTC drug product labels, objet dart comparing to the drug facts labels on advanced countries. The clarity of the labels was one major problem, e fussyly for older Ameri clears, who purchase almost 30% of the OTC drugs, sold in The United States. To determine the best way to order this information on OTC drug labels, a recent research has been conducted. Vigilante and Wogalter (1997) pragmatically distinguishable an ordering of OTC label components based on users beliefs about what was (?)Strength and weakn ess of Drug FactsHaving nonprescription(a) practice of medicine will save you time from tour the doctor every time you have a little sniffle or an ache or pain. There are many safe drugs which can take care of most of your everyday illnesses like the followingcoldscoughsaches and painsupset stomachdiarrheaallergiesThese types of drugs are not the drugs themselves its the people A look at of horribly unobservant people do not take the time to read directions in order to know how to take the medicine properly. There are many types where people use over- the-counter medicines erroneously and poison themselves.Review in IndiaHistory of drug regulationsDrug regulation organizations in existence today, like Drug Laws, Drug Regulatory Agencies, Drug Evaluation Boards, QC Laboratories, Drug Information Centers, etc., have developed over time. Such usings began centuries ago in some countries, and in others, they are comparatively recent, some of them having started only in the 1990s. The restrictions nether the Drugs (Price Control) Order, 1995 are not directly related to the question of categorization of the drugs as OTC drugs or otherwise. entirely still, they are required to be considered, as restriction on pricing may influence the decision to launch a drug as OTC drug. It is mandatory to obtain price approval from the Central Government, if the drug is classified as scheduled formulation under the Drug (Prices Control) Order, 1995. Also, Central Government can fix a maximum price at which every manufacturer is required to sell his product. For Example, Aspirin and vitamin preparations are deliberated as OTC products for the purpose of marketing. However, under Drugs (Prices Control) Order, 1995, they are considered as scheduled formulations and are subject to price restrictions, unless these formulations are manufactured at SSI units.Difference between pharmacy in India and USOTC in pharmaceutical industry dialect stands for over-the-counter (mainly with reference to drugs). The purchase/sale of drugs across the counter without prescriptions is denoted by this. In fact, in India, every pharmaceutical product market is OTC. People can orally ask for any product and buy it across the counter. In US, there are prescription drugs and over-the-counter drugs. The prescription drugs are strictly sold only on showing the prescription (Rx). Once the products are dispensed as per Rx, a seal is administered, to evidence that the Rx has been filled. If the patient goes in for refill of the Rx, the pharmacist does it only if it is legally permissible. In such cases, a seal or stamp is put on the Rx again, to insinuate that the Rx has been filled once again. But in India, such procedures are not strictly followed. Hence, in a way, the Indian retail pharmaceutical market is OTC or rather it is better to be calledOTX(combination ofOTC and Rx).Strength and weakness of OTC drugs in Indian and USIn India, with the counter medication, there is no need to visit doctor every time for a little sniffle or pain or an ache, so drug facts are good. some(prenominal) safe drugs are available which cures normal illnesses such as aches, colds, pains and coughs, allergies, and diarrhea and stomach upset.These types of drugs are the people but not the drugs themselves. People are terribly unperceptive and dont even care to read the directions mentioned on the drugs before consuming. Several cases happened when people took the counter medicines improperly and resulted in poisoning.MethodologyFollowing methods are consideredTo know in depth of a particular aspect case study method alleviates the researchers in many cases it selects specific location with very down(p) portion as subject. Real time example is considered with limited number of conditions and events for case study investigation. According to Yin 1984, 23 case study definition a formula based calculations comparing with real world using many sources of evidence, relationship s in between them are not accurately explained.Investigation of some case study is do by using longitudinal structures of single event which helps to observe sequence of data, events, reports and results from a long time, for example child language development investigation.According to Zaidah, 2003 Firstly useful data is deeply investigated according to situation based upon particular activity. Case study is very effective example sagacious the interesting subject for authentic use. Students an opinion has to be revolve arounded during leisure hours the average number of particular subject is taken into the count. This kind of example determine slightly deviates when n number of variable are consider.The examination of data is conducted within its context and in addition within its situation wherein the activity takes place. A case study would always be interested when subject put forwards it as an authentic text. In order to investigate, the researcher must be able in disco ver subject environment such as reading in class room or else reading in leisure time. According to zaidah 2003 it mostly focuses on limited number of variables.Results and DiscussionThe research literature consists of few studies in relations concerning medications that can be bought without any kind of medical prescription as well as named or over the counter as cold/flu medications etc. in spite of the fact that they are widely used and also represents if it is been misused. As proposed by Ferguson, Dodds, and Flannigan, 1994 one such area in which they are been misused that which involves not only overdosing but also interaction with any other substance. For showcase some case studies have documented individuals who seek to relieve depression symptoms by inducing a state of euphoria with multi-symptom cold syrup which contains chlorphenhydramine, dextromethorphan, and phenylpropanolamine. These substances may induce behavioral and emotional reactions, especially in prone indiv iduals, leading to potentially serious health risks and consequences (Mendez, 1992).The Dangerous substance interactions have received some attention in the psychiatric disorders area. A questionnaire administered to 139 patients diagnosed with every depression or social phobia revealed that 40% of them used OTC cold/flu remedies which had minus interactions with their prescribed medications (Sweet et al., 1995). Another study examined the rate of consumption of TV advertised OTC medications by 471 college students. The results showed that, in addition to frequently using one or more such medications they did so without talking to their physicians about it or specifically determining the conditions under which they were taking such medications. These findings led the authors to emphasize the need to still study the effects of the media on the use of potentially risky OTC medications (Burak and Damico, 2000)The Indian OTC pharmaceuticals market generated total revenues of $2.5 bill ion in 2006,this representing a manifold annual growth rate of 8.3%for the five year layover spanning 2002- 2006. In comparison ,the US and Chinese OTC pharmaceuticals markets grew with CAGRs of 4.3% and 7% over the same period ,to reach respective values of $21.2billion and $11.9billion in 2006. Traditional medicines proved the most lucrative for the Indian OTC pharmaceuticals market in 2006, generating total revenues of $679.3 million. In comparison, gross revenue of cough and cold preparations generated revenues of $492.6 million in 2006.Category%ShareTraditional Medicine27Cough and cold preparations19.80Vitamins and Minerals11.60Medicinal skin plants2.60Others26.03Indian OTC pharmaceuticals market Share % share, by value, 2004**Company%sharePfizer Inc5.10Sanofi Aventis5.10Johnson Johnson2.0Other85.10Inorder to obtain a better way of getting work done and make companies focus on packaging a better pharmacist improvement through a better training sessions. By having, better ac cess through labellng and packaging of OTC drugs through government and other pharma companies ensuring a better management of ailments through OTC medication. By developing a better approach of companies launching a better way of public education campaign fulfilling needs of OTC drugs and educating them to empower better way of medication. With all leading pharma companies launching their public education campaigns to fill the knowledge gap in proper selection and use of OTC drugs, it can be a untarnished case of PPP where the ultimate winner will be the consumerSuggestions and improvements in OTC labeling in USBased on Institute of Medicine IOM, 2008 medication label standardization U.S pharmacopeia health literacy launched container label prescription for consumers advice. Gerald McEvoy and Schwartzberg were the chairmans of American Society of Health System Pharmacists. According to them labels should contain the following principle1. Easy, comprehendible prescription and dire ctions for consumers use.2. Worldwide medicines should contain prescription label based upon exported countrys standards and basic exporters are clinicians, health literacy experts, academic researchers, government health agency representatives and pharmists.According to IOM, 2008 every year millions of drugs are misused, even after mentioning source of information and safety precautions clearly on the label. Sometimes written and oral consultations information may or may not present on the panel, in case of Rx container label should strictly contain doctors prescription for consumers safety.As per U.S. Pharmacopeia Health Literacy Instruction Container Labeling informative Panel recommend the followingRecommendationsArrange the label prescription in such a way that it always stays as a snapper in comforting the users. The direction of a drug is given neatly and orderly in making the customer easily understand the prescription and to make use of them in a safe and also effective u se. usefull information is given on the label of drug and they are as followsUseful directions are present at the top of the panel.Medication details are present at bottom.Most important precautions like dosage.Administrative instructions are determined with specific style.The proposed labeling consists of various components and they study these components by making use of certain facts of drug. And labeling format is as follows1. Label to include the Active ingredient all on with its strengthResultsAll the 100 labels are examined and mentioned in the active ingredients along with their potency/strength.2. Label to include Therapeutic year/purposeIts 55% of labels are disclosed in therapeutic category.3. Label to include Uses /indications for which medicine can be utilizedEven though a significant percentage (75%) mentioned the indications think for the medicine, 25% of the labels failed to do so.4. Label to include Warnings related to common unpleasant effects, drug interaction s, contraindications, precautions, over dosage, when it is appropriate to seek medical advice and also in special conditions like pregnancy breast-feeding. This also includes cautions in keeping them away from children.Results90% of the labels failed to enumerate the adverse effects of the medicine.86% did not state what is to be done in case of overdose92% gave no Information regarding usage in pregnancy and Breastfeeding87% of the labels did not mention of the possible drug interactions, contraindications and precautions.73% labels did not even advise to seek medical guidance.Only 36% labels mentioned that the medicine is required to be kept out of the reach of children.5. Label to include Directions including how much to be take n, dosage interval, and maximum dose allowed per day and the dose for childrenAlmost half of the medicines (46%) did not mention the amount to be used, charm 34% did not mention the dosing interval. 85% of the medicines did not state the maximum dose al lowed. Out of the 15% which did state the maximum dose, 20% were ambiguous with the details. It was also observed that 70% of the medicines failed to specify the dose for children. Only 1 label includedInstructions for use in Devanagiri script.6. Label to include The products inactive ingredients help the consumers in avoiding ingredients that may cause an allergic reaction.None of the labels included the inactive ingredients.7. Label to include Storage conditions.Even though a large percentage (88%) of the labels provided the storage conditions, 64% of them were imprecise and difficult to understand. Nearly 85% of the labels were found without a specific temperature. Furthermore, storage conditions were often mentioned using terms which the common man are not familiar with. The exact temperature was rarely mentioned.Besides, we also assessed the label for 2 more criteria 1. Label to include Legibility to find out whether the label is easily readable, read with difficulty or with th e aid of a magnifying glass.40% of the medicine labels were clearly read only with the aid of a magnifying glass as the font size was too small. 22% of drug labels were read with difficulty leaving just around 38% whichcould be read easily. This suggests that 62% of the labels are read with much effort.1. Label to include Additional information through patient package inserts, information on secondary packages (wherever applicable) Patient package inserts are useful for providing additional information to the patient. Out of the 100 medicines examined, only 3 included a patient package insert. Many a times, secondary packagings of medicines are also given to the patient as additional protection for their medicines or as attractive packs. These secondary packages can also be used to get down valuable information to the patient. In 56% of the cases, a secondary package was found to be available to the patient, yet only 36% of them gave more information on its label than the primary p ackage.ConclusionThe OTC drug offering is incomplete with out empowering public on its rational use through soundly planed strategic marketing initiative revolving around the aliment, the knowledge to diagnose and manage the same. In this empowerment process which can be considered as CSR, the objective should be prevention and holistic awareness creation leading to health and well creation than just offering the minimum needed information to use ones products.Thus by educating public (consumer) on how to manage common ailments and finally how to prevent them, the pharma companies can achieve its real goal of health for all and improve the quality of peoples life In India, OTC products are marketed and advertised liberally, with a view of educating the maximum number of consumers, and promoting treatment of minor ailments at home using OTC products as first line of defense. It can be anticipated that, more Rx to OTC switch will increase number of drugs in OTC category in near futur e. Hence it may be valuable to conduct more research on group of Consumers, who consume OTC Products freely and either switch from the existing brand or continue to earlier brand. A study on marketing of OTC products, used by post office and postman, can also be a studied as a channel of marketing of OTC drugs at national area.Since, the Customer and Consumer are being the same in the OTC drug marketing, companies must instantly address the information needs more effectively and uninterruptedly. Once the awareness level is enhanced, the acceptableness of OTC drugs will improve. The knowledge about allopathic OTC drugs has to be disseminated by manufacturing companies, in order to ensure drastic reduction in the high information asymmetry existing now-a-days, especially when the knowledge of the traditional medicine is rooted in the culture.BibliographyAjith, P., (2007). OTC Drug Marketing -. Global Trends and Indian Experiences.etal, C.P.B.., 1998. Patients spatial relation to ove r the counter drugs possible professional response to self Medications. Oxford University Press, volume- 15, pp.44-50.Food and Drug Administration (FDA). 21 CFR Part 201, e.a., 1999. 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