A SURVEY BASED STUDY OF GENERIC AND BRANDED MEDICINES MARKET Dissertation work submitted to JNTUK In the partial fulfilment for the award of degree of BACHELOR OF PHARMACY BY CHITRAM AKHILA(17AB1R0020) ILLA DINESH(17AB1R0027) MADALA SURESH (17AB1R0038) POPURI PRAVALLIKA (17AB1R0063) S PAVAN KALYAN ADITYA (17AB1R0066) Under the esteemed guidance of Dr. CH. V. PRASADA RAO M.S(Pharma),(Ph.D) Professor & HOD Pharmacy Practice VIGNAN PHARMACY COLLEGE (Affiliated to JNTUK, KAKINADA, Approved by AICTE& PCI, New Delhi) VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522213 2021 Department of Pharmacy Practice, Vignan Pharmacy College 1 VIGNAN PHARMACY COLLEGE Approved by AICTE, PCI & Affiliated to JNTU KAKINADA) VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522 213 URL:www.vignanpharmacycollege.in Contact: 0863-2347768, 69, 34 DECLARATION BY THE CANDIDATES We, Chitram Akhila (17AB1R0020),Illa Dinesh (17AB1R0027), Madala Suresh (17AB1R0038), Popuri Pravallika (17AB1R0063), S Pavan Kalyan Aditya (17AB1R0066)students of B. Pharmacy, Vignan Pharmacy College, Jawaharlal Nehru Technological University, Kakinada, do here by declare that the evaluation embodied in the dissertation entitled“A SURVEY BASED STUDY OF GENERIC DRUGS AND BRANDED MEDICINES MARKET”is the genuinework carried out by us under the guidance of Dr.Ch. V. Prasada Rao,Professor& HOD Department of Pharmacy Practice, Vignan Pharmacy College. We declare that the work embodied in this thesis has not been submitted for the award of degree or diploma of this or any other University. Date: Place: Vadlamudi Chitram Akhila (17AB1R0020) Illa Dinesh (17AB1R0027) Madala Suresh (17AB1R0038) Popuri Pravallika (17AB1R0063) S Pavan Kalyan Aditya (17AB1R0066 ) Department of Pharmacy Practice, Vignan Pharmacy College 2 VIGNAN PHARMACY COLLEGE Approved by AICTE, PCI & Affiliated to JNTU KAKINADA) VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522 213 URL:www.vignanpharmacycollege.in Contact: 0863-2347768, 69, 34 CERTIFICATE This is to certify that Chitram Akhila (17AB1R0020),Illa Dinesh (17AB1R0027), Madala Suresh (17AB1R0038), Popuri Pravallika (17AB1R0063), S Pavan Kalyan Aditya (17AB1R0066)are bonafide students of this institution and have submitted the main project entitled“A SURVEY BASED STUDY OF GENERIC DRUGS AND BRANDED MEDICINES MARKET ”in the partial fulfilment for the award of the degree of “BACHELOR OF PHARMACY”prescribed by the Jawaharlal Nehru Technological University, Kakinada. Project guide External Examiner Dr.Ch. V. Prasada Rao,MS(pharm), Ph.D Principal Dr. P. SrinivasaBabuM.Pharm, Ph.D Department of Pharmacy Practice, Vignan Pharmacy College 3 In Dedication to Our Parents, Guide, Teachers and Our Beloved Principal Sir. Department of Pharmacy Practice, Vignan Pharmacy College 4 ACKNOWLEDGEMENT On the occasion of presenting this dissertation, we would like to thank the Almighty for providing strength and power by his enormous blessings to overcome all the hurdles and hindrances during this project work. We are thankful to my parents, who have struggled their present days for the wealth of my tomorrow, who showed their blessings, love and encouragement in every activity of mine. We also thank chairman Dr.L. RATHAIAH, Vignan Pharmacy College for providing necessary facilities to carry out this research work. We are grateful to my guide Dr. Ch.V. Prasada Rao, MS(Pharma), Ph.D., Professor& HOD of Pharmacy Practice, Vignan Pharmacy College for providing necessary facilities to carry out this research work. We owe our deep sense of gratitude, great pleasure and sincere whole hearted thanks to Dr. P. SRINIVASA BABU Principal, Vignan Pharmacy College for his guidance support, encouragement and valuable suggestions. We also thank to all Staff Members of Vignan Pharmacy College for their help during our project work. We thank our friends for their cheerful support and cooperation during my course of work and extremely thankful to Lab Technicians for their help during the course of work. Department of Pharmacy Practice, Vignan Pharmacy College 5 Table of Contents CHAPTER TITLE PAGE NO LIST OF ABBREVATIONS LIST OF TABLES LIST OF FIGURES ABSTRACT 1 INTRODUCTION 1.1 Introduction to pharmaceutical industry 1.2 Introduction to project 1.3 Generic drugs 1.4 Global generic drug industry 1.5 Indian generic drug industry 1.6 Indian generic drugs 2 LITERATURE REVIEW 3 AIM AND OBJECTIVES 4 PLAN OF THE WORK 5 MATERIALS & METHODS 5.1 Online feedback forms 5.2Cross sectional survey method among three target groups. 6 RESEARCH ANALYSIS 6.1Analysis of professionally qualified (science background) individuals 6.2 Analysis of professionally qualified (non-science background) individuals 6.3Analysis of pharmacist working in medical store (pharmacy 7 RESULTS AND DISCUSSION 8 CONCLUSION 9 BIBLIOGRAPHY Department of Pharmacy Practice, Vignan Pharmacy College 6 LIST OF ABBREVATIONS SYMBOL ABBREVATIONS CAGR Compound annual growth rate FY Fiscal year API`S Active pharmaceutical ingredient R&D Research and development M&A Merger and Acquisitions GDP Gross Domestic Price DGCIS Directorate general of commercial intelligence and statistics HS codes Harmonized System codes ODS Ozone depleting substance IMS Institute for management studies USFDA United states food and drug administration ANDA Abbreviated New Drug Administration CL Compulsory License PwC Price water house cooper report. Department of Pharmacy Practice, Vignan Pharmacy College 7 LIST OF TABLES TABLE NO LIST OF TABLES 1 Top 10 Global players 2 Leading Indian players by sales (INR Billion) 3 list of Indian generic drugs 4 Awareness among individuals about generic medicine law passed by Indian government. 5 Comparative analysis on the effect of generic medicines vs branded medicines. 6 Count of responses regarding FDA guidelines of generic medicines. 7 Total count of responses regarding current use of generic medicines. 8 Total count of responses regarding cost variation among branded and generic medicines. 9 Total count of responses regarding knowledge about generic medicine availability. 10 Total count of responses regarding knowledge about generic medical stores. 11 Total number of responses regarding questioning medical stores for generic medicines. 12 Total no of responses regarding seeking patient opinion on cost of medicine before prescribing. 13 Total no of responses regarding substitution of branded with generic alternative. 14 Total number of responses regarding the reason behind high cost of branded drugs. 15 Total number of responses regarding the reason behind low cost of generic drugs 16 Total number of responses regarding the savings per month using generic medicines. 17 Total no of responses regarding public opinion for generic drug laws. 18 Total number of responses regarding knowledge about generic medicines. Department of Pharmacy Practice, Vignan Pharmacy College 8 19 20 Total number of responses regarding knowledge about cost of generic medicines. Total number of responses regarding doctor preference to medicine. 21 Total number of responses regarding patient concern related to cost of medicine. 22 Total number of responses regarding effect of medicines with different costs. 23 Total number of responses regarding safety of generic drugs. 24 Total number of responses regarding patient’s preference. 25 Total number of responses regarding knowledge about cheap alternative of medicine. 26 Total no of responses regarding substitution of branded with generic alternative. 27 Total number of responses regarding any new /advertisements encouraging generic drugs. 28 Total number of responses regarding generic medicines advertisement. 29 Total number of responses regarding choice of medication. 30 Total number of responses regarding storage of generic medicines. 31 Total number of responses regarding reasons for not storing generic medicines. 32 Total number of responses regarding patient’s choice of cheaper alternative medicine. 33 Total number of responses regarding generic medicine suggestions. 34 Total number of responses regarding availability issue of generic medicines. 35 Total number of responses regarding usage of generic medicine. 36 Total number of responses regarding quality variation. 37 Total number of responses regarding affect of business due to low cost of generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 9 LIST OF FIGURES FIGURE NO LIST OF FIGURES 1 Import of medicinal and pharmaceutical products. 2 Export of medicinal and pharmaceutical products. 3 Growth in Indian pharmaceutical industry. 4 Guntur district map. 5 Leading Companies in the Generic Industry. 6 Savings by year ($ in billions) 7 Graphical view of responses regarding generic medicines law passed by Indian government. 8 Graphical view of responses regarding the effect of generic medicines.. 9 Graphical view of responses regarding FDA guidelines of generic medicines.. 10 Graphical view of responses regarding current usage of generic medicine. 11 Graphical representation of responses regarding cost variation among branded and generics 12 Graphical view of responses regarding knowledge about generic medicine availability. 13 Graphical view of responses regarding knowledge about generic medical stores 14 Graphical view of responses regarding questioning medical stores for generic medicines. 15 Graphical responses regarding seeking patient opinion on cost of medicine before prescribing 16 Graphical responses regarding substitution of branded with generic alternative 17 Graphical responses regarding the reason behind high cost of branded Department of Pharmacy Practice, Vignan Pharmacy College 10 drugs. 18 Graphical responses regarding the reason behind low cost of generic drugs. 19 Graphical responses regarding the savings per month using generic medicines. 20 21 22 23 24 25 Graphical view of responses regarding public opinion for generic drug laws. Graphical view of responses regarding knowledge about generic medicines. Graphical view of responses regarding knowledge about cost of generic medicines. Graphical view of responses regarding doctor preference to medicine. Graphical view of responses regarding patient concern related to cost of medicine. Graphical view of responses regarding effect of medicines with different costs. 26 Graphical view of responses regarding safety of generic drugs. 27 Graphical view of responses regarding patient’s preference. 28 Graphical view of responses regarding knowledge about cheap alternative of medicine. Graphical responses regarding substitution of branded with generic alternative. Graphical view of responses regarding any new/advertisements encouraging generic drugs. 29 30 31 Graphical responses regarding generic medicines advertisement. 32 Graphical view of responses regarding choice of medication. 33 Graphical view of response regarding storage of generic medicines. 34 Graphical view of responses regarding reasons for not storing generic medicines. Graphical view of responses regarding patient’s choice of cheaper alternative medicine. Graphical view of responses regarding generic medicine suggestions. 35 36 37 38 Graphical view of responses regarding availability issue of generic medicines. Graphical view of responses regarding usage of generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 11 39 Graphical view of responses regarding quality variation. 40 Graphical view of response regarding affect of business due to low cost of generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 12 ABSTRACT ABSTRACT The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as non-availability and distrust on the product quality. Cost of the medicines is a concern for the patients. Within India cost of medicines varies, the basic reason behind this is the brand price quoted by the pharmaceutical industries. Survey was undertaken to review and analyze various facts about branded and generic medicines of the same drugs. Method: The survey was conducted for following target groups and individuals. The groups are Literate population (science background), Common public (educated but non science background) and Practicing Pharmacists. The different sets of questionnaires were prepared for each group and survey was conducted (online feedback form). The questions were designed as to check awareness, knowledge and preference of medication. Results: The highlighting results of this survey-based project are that a greater number of consumers want economic alternative to the brand medicines which includes persons with or without science background, a remarkable number of consumers does not have knowledge about generic medicines, most of the physicians do not prefer generic medicines and most of the practicing pharmacists have very less business through generic medicines. Conclusion: Even if generic medicines are going to be made available free of cost at the government hospitals the war of prices between branded and generic may not stop. More stringent rules and regulation are required for making the drugs available at reasonable cost for the masses. For the benefit of the patients, if pharmacist needs to change a brand for generic medicine, should be permitted by law. Keywords: Survey, Questionnaire, Branded medicine, Generics, Regulations. 1 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY 1.1 INTRODUCTION TO PHARMACEUTICAL INDUSTRY Global Pharmaceutical Industry: The Global Pharmaceutical Industry is one of the multinational industries which gained a high cycle of growth especially in 1960s and the industry is in high risk, regulated and driven by lengthy R&D expenditures. The industry can be different in medicinal chemical, biological, ethical, proprietary product and private formula manufactures by their backgrounds and operation sectors and does not cover consumer or animal healthcare. In 2008 total revenue of global pharmaceutical industry was $615.1 billion and expected to reach $734 billion at the end of 2013. United States, Europe and Japan are the largest pharmaceutical market. [1] The report critically analyse the Global Pharmaceutical Industry, importance and growth with the expect of internal and external environment analysis, plausible views of industry in the future and moral values. Table No.1:- Top 10 Global players Sr. No. Company 2013 ($m) 2012 ($m) Growth ($m) Growth (%) 1 Pfizer 47878 51214 -3336 -7 2 Novartis 47468 46732 736 2 3 Roche 39163 38006 1156 3 4 Merck & Co. 37437 40601 -3164 -8 5 Sanofi 37124 39511 -2387 -6 6 GlaxoSmithKline 33330 33335 -5 0 7 Johnson & Johnson 28125 25351 2774 10 8 AstraZeneca 25711 27925 -2214 -9 9 Lilly 20962 20567 395 2 10 AbbVie 18790 18380 410 2 2 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY Indian pharmaceutical industry The Indian pharmaceutical industry currently tops the chart amongst India's sciencebased industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high amongst all the third world countries, in terms of technology, quality and the vast range of medicines that are manufactured. It ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds; almost every type of medicine is now made in the Indian pharmaceutical industry. Indian pharmaceutical industry has been witnessing significant growth over past few years. The size of the Indian pharmaceutical market increased from USD 6 Billion in 2005 to USD 18 Billion in 2012 by 2020, India ‘s pharmaceuticals market is expected to reach US$45 billion and become the sixth largest pharmaceutical market in the world [2] The Indian pharmaceutical sector is highly fragmented with more than the 20,000 registered units. It has expanded drastically in the last two decades. The Pharmaceutical and Chemical industry in India is an extremely fragmented market with severe price competition and government price control. The Pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals, and injectibles.[3] There are approximately 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). ―They (sales) are expected to rise to $23.6 billion in 2013 and reach $27.0 billion in 2016. As a percentage of health care expenditures, pharmaceutical sales were 22.6 per cent in 2012; they are expected to reach 23.6 per cent in 2013 and 27 per cent by 2016[4]. India is among the top five emerging Pharma markets and has grown at an estimated compound annual growth rate (CAGR) of 13 per cent during the period FY 2009–2013. The Indian pharmaceutical market is poised to grow to US$ 55 billion by 2020 from the 2009 levels of US$12.6 billion,[5] according to the report titled India Pharma2020‘byMcKinsey&Co. 3 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY India is among the top five emerging Pharma markets and has grown at an estimated compound annual growth rate (CAGR) of 13 per cent during the period FY 2009–2013. The Indian pharmaceutical market is poised to grow to US$ 55 billion by 2020 from the 2009 levels ofUS$12.6billion,[5] according to the report titled India Pharma2020‘byMcKinsey&Co. The country ‘s Pharma industry accounts for about 1.4 per cent of the global Pharma industry in value terms and 10 per cent in volume terms. Both domestic and export-led demand contributed towards the robust performance of the sector. An increase in insurance coverage, an ageing population, rising income, greater awareness of personal health and hygiene, easy access to high-quality healthcare facilities and favorable government initiatives are some of the important factors expected to drive the Pharma industry in India. The Government of India has unveiled Pharma Vision 2020‘aimed at making India a global leader in end-to-end drug manufacturing [6]. Current Scenario Indian pharmaceutical industry is expected to grow at 19% in 2013. India is now among the top five pharmaceutical emerging markets. There will be new drug launches, new drug filings, and Phase II clinic trials throughout the year. On back of increasing sales of generic medicines, continued growth in chronic therapies and a greater penetration in rural markets, the domestic pharmaceutical market is expected to register a strong double-digit growth of 1314 per cent in2013. Moreover, the increasing population of the higher-income group in the country will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015. Besides, the domestic Pharma market is estimated to touch US$ 20 billion by 2015, making India a lucrative destination for clinical trials for global giants [7]. The Indian pharmaceutical industry accounts for over 8 percent of global pharmaceutical production [8] . The industry has over 60,000 generic brands across 60 therapeutic categories and manufactures more than 400 different active pharmaceutical ingredients (APIs). The Indian Pharma industry has been growing at compounded annual growth rate (CAGR) of more than 15 % over the last five years and has significant growth opportunities 4 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY Market Size On improved utilization of manufacturing facilities, the domestic pharmaceutical market is likely to see high revenue growth and profit margins. Pharmaceutical sales in India are expected to grow by 14.4 % to US$ 27 billion in 2016 from US$ 22.6 billion in 2012, according to a report 2014 Global Life Sciences Outlook‘. India‘s pharmaceutical exports stood at US$[9] 14.84 billion in FY 2013–14. The United States (US) is the country‘s biggest market for Pharma exports accounting for about 25 %, followed by the United Kingdom (UK). ―India has been able to make its name as a quality supplier of affordable medicines across the globe [10] . Pharma exports from India will be more than the size of the domestic sales by FY 2015, according to a report by India Ratings & Research. The country provides generic medicines to almost 200 countries. It is responsible for about 40 per cent of the generic and over the-counter drugs consumed in the US. Indian generics market is expected to grow to US$ 26.1 billion by 2016 from US$ 11.3 billion in 2011 [11]. Table No. 2 Leading Indian players by sales (INR Billion) Company name Sales in INR billion Ranbaxy Lab 76.86 Cipla 69.77 Dr Reddy's Labs 66.86 Lupin Ltd. 53.64 Aurobindo Pharma 42.84 Sun Pharma 40.15 Cadila Health 31.52 Wockhardt 26.50 Jubilant Life 26.41 Ipca Labs 23.52 5 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY Challenges: Over the past decade, pharmaceutical companies have entered a difficult period where shareholders, the market, and regulators have created significant pressures for change within the industry [12]. The core issues for most of drug companies are declining productivity of inhouse R & D, patent expiration of number of block buster drugs, increasing legal and regulatory concern, and pricing issue. As a result larger pharmaceutical companies are shifting to new business model with greater outsourcing of discovery services, clinical research and manufacturing. Future Growth: India will see the largest number of merger and acquisitions (M&A) in the pharmaceutical and healthcare sector. A survey conducted across 100 companies has revealed that one- fourth of the respondents were optimistic about acquisitions in the pharmaceutical sector [13]. Government policies: The Indian government has been making efforts to improve nationwide provision of healthcare. It has launched policies that are aimed at: • building more hospitals, • boosting local access to health care, • improving the quality of medical training, • increasing public expenditure on healthcare to 2-3% of GDP, up from a current low of 1% [14] . Some of the significant government allocations on healthcare spend include a five-year tax break for opening hospitals anywhere in India, with an added focus on tier II and tier III markets, both in the 2008-09 Union Budget [15] . Some of the significant government allocations on healthcare spend include a five-year tax break for opening hospitals anywhere in India, with an added focus on tier II and tier III markets, both in the 2008-09 Union Budget. 6 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY Growth of Import-Export a) IMPORTS: As per the Directorate General of Commercial Intelligence and Statistics (D.G.C.I.S.) Kolkata, the value of imports of ―Medicinal and Pharmaceuticals Products for the latest period 2007-08 to 2010-11 is as under: In the year 2010-11 the import as shown declined in growth compared to previous year [16] . The country is almost self-sufficient in production of most of formulations / pharmaceuticals products. FIGURE: 1: Import of medicinal and pharmaceutical products. It may be observed that the imports have shown a growth of 29.43% in the year 2011-12 compared to previous year. The country is almost self-sufficient in production of most of formulations/ pharmaceuticals products. As such imports are being resorted to on quality & economic considerations and not necessarily due to non-availability from domestic sources. Manufacturers of Drugs & Pharmaceuticals are free to produce any drugs approved by the Drug control authorities [17]. Import of Drugs & Pharmaceuticals is regulated as per the Foreign Trade Policy of Government of India. Import of some drugs and drug intermediates are restricted under current Foreign Trade Policy. These restrictions are basically due to common HS codes assigned to some narcotic substances or similarity to some Ozone Depleting Substances (ODS) with pharmaceutical products. 7 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION TO PHARMACEUTICAL INDUSTRY b) EXPORTS:As Per DGCIS, Kolkata Exports of―Drugs and pharmaceuticals and Fine Chemicals for the period 2007-08 to 2010-11 are below: - FIGURE: 2: Export of medicinal and pharmaceutical products. Growth in Indian Pharmaceutical Industry: The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs ‘manufacturer of AIDS medicines. Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine [17] FIGURE: 3: Growth in Indian pharmaceutical industry. 8 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT 1.2 INTRODUCTION OF THE PROJECT Project location: GUNTUR, it is one of the districts in coastal Andhra region.it is bounded on the south by prakasam district and on the west by the state of Telangana. Andhra Pradesh bounded by west Godavari on the east, Bay of Bengal on the south, Guntur and suryapet districts in the west and a portion of it also borders with the state of Telangana. Demographics: Guntur district is one of the nine districts in the Andhra region of the Indentation Andhra Pradesh. The administrative seat of the district is located at Guntur, the largest city of the district in terms of area and with a population of 670,073. [3]It has a coastline of approximately 100 km (62 mi) on the right bank of Krishna River, that separates it from Krishna district and extends till it empties into the Bay of Bengal. It is bounded on the south by Prakasam district and on the west by the state of Telangana.[4]It has an area of 11,391 km2(4,398 sq mi) and is the 2nd most populous district in the state, with a population of 4,889,230 as per 2011census of India. Guntur District Map:- FIGURE: 4: Guntur district map. Health Service: - [18] . The following major national and state health programs are implemented by health dept. General Health Services Epidemic Control Measures & Reproductive and Child health programs - This includes family welfare programs, health services for children, health for 40 plus, Aids control. 9 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT 1.3 GENERIC DRUGS A generic drug is identical - or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. The determination of drug approval is made according to whether it is pharmaceutically equivalent, bio-available, and bioequivalent. World Health Organization (WHO) provided a definition for counterfeit drugs. After the patent is over, the same drug can be copied by anybody and the costs reduce drastically. Many of the anti-diabetic, antihypertensive and antibiotic drugs are available now as Generic formulations. After the expiry of patent of the patented drug, generic drugs are marketed. Generic drugs are available at affordable prices with maintaining quality [19] . These Generic formulations balance public interest as critical disease like cancer, AIDS etc. Brand name and generic versions of medicines like high blood pressure, diabetes, etc. Today about 50% of all prescriptions are filled with generic drugs. The FDA has established standards for generic drugs that might seem complicated but are really simple. The most important advantage with generic drugs is less expensive than the branded versions. They are cheaper as no R & D investments are involved as in the case of branded or new drug. Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices. So, generics can cost between 20 and 80 percent less.[20] According to the FDA, to substitute a generic for brand name drug must follow following criteria - It must contain the same active ingredients (the chemical substance that makes the drug work), the same dosage strength (the amount of active ingredients, for example 20 mg or 40 mg), the same dosage form (that it, it needs to be available in the same form as the original – for example as liquid, pill, etc.), have same route of administration (the way the medication is introduced into the body) 10 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT The generic market reached 100 billion dollars in 2010. The generic growth is three times higher than the overall growth of drugs. According to expectation of pharmaceutical industry, percentage of generic drugs in the US market will rise from 14 to 21.[21] This growth will enhance the export of pharmaceutical products from India will double every year. In future contribution from the Indian pharmaceutical companies will increase due to low cost of worker, innovation, recent success in track record in design operation of high-tech manufacturing, testing, quality control, research, clinical testing and biotechnology. Availability of Generic drugs in the Indian Market is very low. It is only supplied to the Government and other hospitals or to the physician ‘s dispensary. For more profit, generally branded drugs are promoted to doctors while branded generics are sold at the Maximum Retail Price (MRP). But distributor ‘s buys branded generic from companies at the discount of 1015% of the MRP. In present situation, consumer patients are not benefited and retail chemists earn huge profit [22]. Generic Drugs are available all over the world at affordable prices with maintaining quality. These Generic formulations balance public interest like critical disease like cancer, AIDS etc. Most nations require generic drug manufacturers to prove their formulation exhibits bioequivalence to the innovator product. A number of developing countries have made use of compulsory licensing or government use orders to enable the supply of more affordable generic drugs in recent years. India today has the distinction of producing high quality generic medicines that are sold around the world. India tops in the world in exporting generic medicines and currently, the Indian pharmaceutical industry is one of the world's largest and most developed industry. Scope of generic drugs In today ‘s era, the scope of generic drugs is increasing day by day specially in several ill health conditions such as diabetes, cardiovascular and in microbial diseases etc. When any patent expires, new generics are introduced into the market [23] . The scope is also increased due to Para IV filings and Bolar provisions. Recently, Para IV filing strategy has been adopted by leading Indian pharmaceutical companies to introduce generic drug of its own taking advantage of shortcoming in patent application of patent holders. 11 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT According to this, a generic manufacturer challenges the original patented drug and claims that the generic version proposed to be launched by the manufacturer does not infringe the patent holder ‘s version. In case a patent challenge is won, it entitles the first to file Para IV generic manufacturer a 180 days exclusivity, if company come up with an equivalent of the innovator ‘s branded formulation [24]. Bolar provision ‘allows generic manufacturers to prepare and develop regulatory procedures before patent expires, so that, products are ready for market as soon as the patent ends. With these provisions, in India, the scope of generic drug manufacturing has also increased. Basic Generic Drugs Requirement: Same active ingredient(s) Same route of administration Same dosage form Same strength Same condition of use Inactive ingredient already approved in similar NDA GENERIC INDUSTRY The generic drug industry covers the marketing and sale of medication containing the same active ingredients (API's) and dosages as brand-name drugs manufactured by the pharmaceutical industry. Generic drugs are under the same governance as brand-name drugs and must adhere to the same standards. When brand-name drugs come off patent, the market is opened up to generic versions. Patent protection generally protects a drug's intellectual property rights for about 20 years, but because the patent is effective from the clinical trial stage [25]. Since the late 1970‘s the substitution of generic drugs for brand name drugs has become a relatively common physician practice. At the same time, several studies reported a connection between physicians ‘sources of drug information, their attitudes toward generics and their prescribing. 12 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT By 2003 generic drug prescriptions represented 43 percent of all prescriptions written and 47 percent of new (non-refill) prescriptions Generic drugs were also one of the fastest growing sectors of the pharmaceutical industry to Given the rise in direct-to-consumer advertising, the use of formularies to control costs, and continued concern about drug safety, it is time to revisit physicians ‘opinions and practices regarding generic drug substitution. FIGURE NO: 5: Leading Companies in the Generic Industry. 1.4 GLOBAL GENERIC INDUSTRY: The availability of generic drugs will drive demand in developing countries. Growing middle classes in Asia, the Middle East, and Latin America will seek affordable versions of the best-selling drugs. Central and South American governments are stepping up healthcare efforts and with a growing 65-and-older population, the use of generic drugs in the region is growing exponentially. Chinese and Indian drug manufacturers already produce more than 80% of API's used in medication worldwide. With patent expirations, the production and demand for generic drugs and APIs in China, India, Latin America, and Central & Eastern Europe is expected to climb. 13 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT Teva is the world's biggest generic company and is continuing to climb. During the course of 2010, Teva launched 18 generics that targeted drugs with 12.2 billion in U.S. Sales. Teva reported that it accounts for 21.8% of total U.S. Generic prescriptions. [26] Teva manufactures 71 billion tablets a year in 77 pharmaceutical and API facilities around the world. Sandoz is the number two generic company worldwide. It is Novartis' generic unit, located in Germany with a 7.8 % market share. The company has strong results from the U.S., Canada, Russia, Italy, Japan, and biosimilars. Sandoz has three strategic priorities: 1. To be first-to-market as originators' substance patents expire of become unenforceable 2. To be cost competitive by leveraging economics of sale in development and production 3. To differentiate Sandoz based on its extensive global reach and advanced technical expertise in the development An Economic Analysis of Generic Drug Usage: -This independent analysis, conducted by the IMS Institute. The use of generic prescription drugs in place of their brand name Counterparts saved the health care system more than $931 billion over the past decade [27]. In 2010 alone, generic use generated more than $157 billion in savings. Savings from newer generic medicines—those that have entered the marketsince2001— continue to increase exponentially and account for more than one-third of the total savings. FIGURE NO: 6: - Savings by year ($ in billions) 14 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT 1.5 INDIAN GENERIC DRUGS INDUSTRY: India supplies 20% of generic drugs worldwide Posted 01/03/2013. Every fifth tablet, capsule and injectables generic drug being used in the world is manufactured in India, according to India ‘s Health Minister Ghulam Nabi Azad [29]. ―Being a world leader in generics, India already has a huge presence in the highly regulated markets in terms of Pharma exports. Almost two thirds of Indian generic exports are to the highly regulated markets (e.g., the US and Europe), which speaks volumes about the quality of Indian medicines. Already this year, India ‘s Dr. Reddy ‘s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla have invested over $ 500 million in R&D, which is allowing increased innovation in manufacturing processes and will ultimately help to lower the cost of medicines production.[29] Growth of Generic Drug Industry: In future contribution from the Indian pharmaceutical companies will increase due to low cost of worker, innovation, recent success in track record in design operation of high-tech manufacturing, testing, quality control, research, clinical testing and biotechnology. Most of the Indian companies have United States Food and Drug Administration (USFDA) approved plants, about 20% of all Abbreviated New Drug Applications (ANDA) to the USFDA are field by Indian companies. Now India ‘s share of the generic market is about to 35% [30]. Hence the contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high. Over the next few years, an abnormally large number of blockbuster drugs are scheduled to lose their patent protection, opening the doors to cheaper generic drugs. These drugs are Blockbuster-brand products and offer tremendous scope to generic manufactures. Growth in the use of generics in India is being encouraged by instructions being issued to governmental hospitals and doctors to prescribe and to pharmacies to dispense generics to the maximum extent possible ‘. 15 Department of Pharmacy Practice, Vignan Pharmacy College LITERATURE SURVEY Availability of Generic drugs in the Indian Market: Availability of Generic drugs in the Indian Market is very low. It is only supplied to the Government and other hospitals or to the physician ‘s dispensary. For more profit, generally branded drugs are promoted to doctors while branded generics are sold at the Maximum Retail Price (MRP). But distributor ‘s buys branded generic from companies at the discount of 10-15% of the MRP [31] . In present situation, consumer patients are not benefited and retail chemists earn huge profit. Exports of generic drugs by Indian Pharma companies: India's pharmaceutical industry is gaining its position as a global leader. The Pharma market in India is expected to touch US$ 74 billion in sales by 2020 from the current US$ 11 billion, according to a Price water house Cooper (PwC) report [32]. India has world renowned capacity in producing low cost, high quality bulk and generic drugs. The share of Indian Pharma companies in the total pie of approvals for generic drugs (called abbreviated new drug applications (ANDA) approvals in the US) has risen steadily. In 2011 itself, more than a third of the ANDA approvals were by Indian firms. As a consequence, formulation exports from India, essentially generic drugs, have grown at 21 per cent compounded annual growth rate (CAGR) between 2005-06 and 2010-11. With patents of about US$ 150 billion worth of drugs set to expire between 2010 and 2015, it is expected that the growth momentum in exports would continue over the next five years, with exports growing at 14-16 percent CAGR [34]. Department of Pharmacy Practice, Vignan Pharmacy College 16 INTRODUCTION OF THE PROJECT 1.6 INDIAN GENERIC DRUGS Table No. –3 list of Indian generic drugs 17 Department of Pharmacy Practice, Vignan Pharmacy College INTRODUCTION OF THE PROJECT 18 Department of Pharmacy Practice, Vignan Pharmacy College LITERATURE SURVEY 2.LITERATURE SURVEY 1. Philip mathewet.al 2015 reported in the article Generic drugs: Review and experiences from South India: The cost of pharmaceuticals, as a percentage of total health care spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation. 2. Anita Kotwani et.al 2010 reported in the article Will generic drug stores improve access to essential medicines for the poor in India? Start with awareness and advocacy for generic equivalents of medicines for the public. Publicize evidence-based results about the quality of generic medicines available at generic drug stores. Stock the generic drug stores with all the essential medicines. Open stores in the private sector, not only in urban areas but also in villages and small towns. If quality medicines at affordable prices are accessible to the general public in the private sector, then access to essential medicines will improve. 3. Anil C Anand et.al 2017 reported in the article Using generic drugs in India: Some Thoughts: The price of pharmaceuticals has become an issue of great concern for people and governments around the world. Thus, governments across the globe must make efforts to correct the present distortions around the concept of generic drugs. Effective price competition remains the rule in generic markets for large-selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. 4. Puneeta Gupta, Mehvish Khan et.al 2019 reported in the articleGenerics and Biosimilars; A Step Towards Sustainable and Low-Cost Health Care: Millions of people across the globe go without essential medicines resulting in many avoidable deaths each year. It's no secret that the cost of prescription drugs, including the life-saving ones has been rising far faster than inflation over the last few years. If we take the example of diabetes and as India has the largest number of patients with the condition in the world; it has been shown that patients belonging to the low-income group in urban India were spending. 27% of their annual income and those in rural India 34% of their annual income on diabetes care; most of which was spent on purchase of medicines. 5. Richard G Frank, Thomas G McGuire, Ian Nasonet.al 2021 reported in the articleThe Evolution of Supply and Demand in Markets for Generic Drugs: Competition in generic drug markets varies widely by market size and product form. Recent changes in demand-side market structure imply more downward pressure on prices stemming from buy-side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply-side changes point to further market instabilities across all generic markets due to producers' changing economic position. 6. Pola B Gupta et.al 2008 reported in the articleSurvey of Pharmacists: Impact of the Generic Department of Pharmacy Practice, Vignan Pharmacy College 19 LITERATURE SURVEY Drug Scandal and Implications for Marketing Generic Drugs: The generic drug scandal that made headlines in 1989 shocked consumers, prescribers, pharmacists, insurers, the pharmaceutical industry, the FDA and Congress. Using data collected after the scandal was reported, this study investigates the impact of scandal on pharmacists' confidence in generics, and their attitudes, opinions and behavior toward generics. Based upon the findings, the author provides a set of recommendations for marketing generic drugs. 7. Proteesh Rana, Vandana Roy et.al 2015 reported in the articleGeneric medicines: issues and relevance for global health: Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in sterms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. 8. Pieter Dylst, Arnold Vulto and Steven Simoenset.al 2015 reported in the article Societal value of generic medicines beyond cost-saving through reduced prices: Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Conclusion: Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines. 9. Kate MacKrill, Maria Kleinstäuber & Keith J. Petrieet.al 2019 reported in the article The effect of rebranding generic medicines on drug efficacy and side effects: Branded medicines have a greater placebo effect, resulting in a heightened therapeutic response, whereas generics are associated with greater side effect reporting. These two studies investigated whether enhancing the appearance of a generic medicine could increase placebo and decrease nocebo responding. While the sample characteristics and familiarity of the medicines may have influenced the findings, we found no evidence that enhancing the branding of generic medicines improved response to the medication or reduced side effects. 10. Kevin A Schulman et.al 2020 reported in the article Challenges in Ensuring the Quality of Generic Medicines: A refill of a generic attention deficit hyperactivity disorder prescription leads to new side effects and raises questions about the quality of generic drugs. The studies have mixed results; some interventions in some settings were useful, while others were not. Not all interventions consistently improved the uptake of generic medicines. There was limited literature available and further work is required to develop a range of interventions. Department of Pharmacy Practice, Vignan Pharmacy College 20 AIM AND OBJECTIVES 3.AIM AND OBJECTIVES Aim: The aim is to make study and understand about generic drug market and branded drug market, role of sales representatives and chemists in this regard. To understand the promotional strategies used by the pharmaceutical companies to sell their products. Objectives: To study the awareness of generic drugs amongst doctors, chemists & distributors. To understand the perception of Chemists & Distributors towards Generic drugs. To know what promotional strategies are used by pharmaceutical companies to sell their products in the market. To carry out comparative analysis of generic drugs and branded drugs. 21 Department of Pharmacy Practice, Vignan Pharmacy College SAMPLE DESIGN 4.PLAN OF WORK 22 Department of Pharmacy Practice, Vignan Pharmacy College LITERATURE SURVEY 5. MATERIALS & METHODS Research Method: Survey Method Research Tool: Questionnaire containing open as well as close ended questions. Data Collection Method: Personal Interviews method (a structured questionnaire with open and closed ended questions) Research region: Guntur district Duration of research: 2months Duration of Data collection:6Weeks Respondents: Educated (science students) Educated(non-science) Pharmacists Chemists Distributors Sampling technique: Random sampling Department of Pharmacy Practice, Vignan Pharmacy College 23 RESEARCH METHODOLOGY RESEARCH METHODOLOGY WHAT IS RESEARCH? Research is a logical and systematic search for new and useful information on a particular topic. Research is done with the help of study, experiment, observation, analysis, comparison and reasoning. Research is in fact ubiquitous. For example, we know that cigarette smoking is injurious to health; heroine is addictive; cow dung is a useful source of biogas; malaria is due to the virus protozoan plasmodium; AIDS (Acquired Immuno Deficiency Syndrome) is due to the virus HIV (Human Immuno Deficiency Virus). How did we know all these? We became aware of all these information only through research. More precisely, it seeks predictions of events, explanations, relationships and theories forthem. As stated by Gerald Milburn Scientific research is a chaotic business, stumbling along amidst red herrings, errors and truly, creative insights. Great scientific breakthroughs are rarely the work of a single researchers plodding slowly by inexorably towards some final goal. The crucial idea behind the breakthrough may surface a number of times, in different places, only to sink again beneath the babble of an endless scientific discourse. WHAT ARE THE OBJECTIVES OF RESEARCH? The prime objectives of research are (1) To discover new facts (2) To verify and test important facts (3) To analyze an event or process or phenomenon to identify the cause (4) To develop new scientific tools, concepts and theories to solve and understand scientific and nonscientific problems (5) To find solutions to scientific, nonscientific and social problems. (6) To overcome or solve the problems occurring in our everyday life. 24 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH METHODOLOGY SOME IMPORTANT AVENUES OF RESEARCH ARE: (1) A research problem refers to a difficulty which a researcher or a scientific community or an industry or a government organization or a society experience. It may be a theoretical or a practical situation. It calls for a thorough understanding and possible solution. (2) Research on existing theories and concepts help us identify the range and applications of them. (3) It is the fountain of knowledge and provides guidelines for solving problems. (4) Research provides basis for many government policies. For example, research on the needs and desires of the people and on the availability of revenues to meet the needs helps a government to prepare a budget. IMPORTANCE OF RESEARCH METHODOLOGY IN RESEARCH STUDY: - It is necessary for a researcher to design a methodology for the problem chosen. One should note that even if the methods considered in two problems are same the methodology may be different. It is important for the researcher to know not only the research methods necessary for the research under taken but also the methodology. For example, a researcher not only needs to know how to calculate mean, variance and distribution function for a set of data, how to find a solution of a physical system described by mathematical model, how to determine the roots of algebraic equations and how to apply a particular method but also need to know (i) Which is a suitable method for the chosen problem? (ii) What is the order of accuracy of the result of a method? (iii) What is the efficiency of the method? And soon. 25 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH METHODOLOGY STEPS IN RESEARCH PROCESS:1. Formulating the Research Problem 2. Extensive Literature Review 3. Developing the objectives 4. Preparing the Research Design including Sample Design 5. Collecting the Data 6. Analysis of Data 7. Generalization and Interpretation 8. Preparation of the Report or Presentation of Results-Formal write ups of conclusion reached. 26 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH ANALYSIS 6. RESEARCH ANALYSIS For professionally qualified (science background) individuals: FIGURE NO: 7: Graphical view of responses regarding generic medicines law passed by Indian government. ROW LABELS Yes No Grand Total COUNT 45 15 60 TABLE NO :4: Awareness among individuals about generic medicine law passed by Indian government. INFERENCE: 75% of individuals replied, they do know that Government of India has passed a law about generic medicines. Whereas, 25% of individuals replied, they don’t know that Government of India has passed a law about generic medicines. 27 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH ANALYSIS FIGURE NO: 8: Graphical view of responses regarding the effect of generic medicines. ROW LABELS Yes No May be GRAND TOTAL COUNT 36 05 18 60 TABLE NO: 5: Comparative analysis on the effect of generic medicines vs branded medicines. INFERENCE: Above than 60% of individuals say that generic drugs are having same effect as that of the branded drugs. 10% of individuals feel that generic drugs are not having same effect as like that of the branded drugs. Whereas 30% of individuals feel may be generic drugs have same effect as like that of the branded drugs. 28 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH ANALYSIS FIGURE NO: 9: Graphical view of responses regarding FDA guidelines of generic medicines. ROW LABELS Yes, follow exactly Yes, certain parameters Can`t say No Grand Total COUNT 22 31 06 01 60 TABLE NO: 6: count of responses regarding FDA guidelines of generic medicines. INFERENCE: According to 36.7% of individuals, generic drugs follow the FDA guidelines as branded drugs. According to 51.7% of individuals, generic drugs follow certain parameters of FDA guidelines as branded drugs. According to 10% of individuals, generic drugs may or may not follow the FDA guidelines as branded drugs. 1.7% of individuals believe that, generic drugs do not follow the FDA guidelines as branded drugs. 29 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH ANALYSIS FIGURE NO: 10: Graphical view of responses regarding current usage of generic medicine. ROW LABELS Yes No Grand Total COUNT 13 47 60 TABLE NO: 7: Total count of responses regarding current use of generic medicines. INFERENCE: 21.7% of individuals said that, they are currently using generic medicine. Whereas, 78.3% of individuals said that, they are currently not using generic medicine. 30 Department of Pharmacy Practice, Vignan Pharmacy College RESEARCH ANALYSIS FIGURE NO: 11: Graphical representation of responses regarding cost variation among branded and generics. ROW LABELS Yes A huge difference Yes but little bit Don’t know COUNT 38 14 09 TABLE NO: 8: Total count of responses regarding cost variation among branded and generic medicines. INFERENCE 63.3% of individuals say that they found a huge cost difference between generic and branded medicines. 23.3% of individuals say that they found a little cost difference between generic and branded medicines. 15% of individuals say that they don’t know cost difference between generic and branded medicines. Department of Pharmacy Practice, Vignan Pharmacy College 31 RESEARCH ANALYSIS FIGURE NO: 12: Graphical view of responses regarding knowledge about generic medicine availability. ROW LABELS Yes No Grand Total COUNT 41 19 60 TABLE NO: 9: Total count of responses regarding knowledge about generic medicine availability. INFERENCE: More than 68.3% of individuals know medical shops where generic medicines are available. 19% of individuals don’t know medical shops where generic medicines are available. Department of Pharmacy Practice, Vignan Pharmacy College 32 RESEARCH ANALYSIS FIGURE NO: 13: Graphical view of responses regarding knowledge about generic medical stores. ROW LABELS Yes No Grand Total COUNT 41 19 60 TABLE NO: 10: Total count of responses regarding knowledge about generic medical stores. INFERENCE: 73.3% of individuals would like to know the medical stores where generic medicine is available. 26.7% of individuals don’t want to know such medical stores which sell generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 33 RESEARCH ANALYSIS FIGURE NO: 14: Graphical view of responses regarding questioning medical stores for generic medicines. ROW LABELS Always Never Often Grand Total COUNT 09 18 33 60 TABLE NO: 11: Total number of responses regarding questioning medical stores for generic medicines. INFERENCE: 15% of individuals always ask for generic medicine in medical store. 30% of individuals never ask for generic medicine in medical store. 55% of individuals often ask for generic medicine in medical store. Department of Pharmacy Practice, Vignan Pharmacy College 34 RESEARCH ANALYSIS FIGURE NO: 15: Graphical responses regarding seeking patient opinion on cost of medicine before prescribing ROW LABELS Always Never Often Grand Total COUNT 02 37 21 60 TABLE NO: 12: Total no of responses regarding seeking patient opinion on cost of medicine before prescribing INFERENCE: According to 3.3% of individuals, their doctors always ask whether the cost of medicine is concern before prescribing the medicine. 61.7% of individuals say that their doctor never ask them about cost concern before prescribing. 35% of individuals say that their doctor often ask them about cost preference before prescribing. Department of Pharmacy Practice, Vignan Pharmacy College 35 RESEARCH ANALYSIS FIGURE NO: 16: Graphical responses regarding substitution of branded with generic alternative ROW LABELS Yes No Grand Total COUNT 08 52 60 TABLE NO: 13: Total no of responses regarding substitution of branded with generic alternative. INFERENCE: According to 86.7% of individuals say that their doctor or pharmacist never asked them to switch from generic to branded alternative. According to 13.3% of individuals say that their doctor or pharmacist asked them to switch from generic to branded alternative. Department of Pharmacy Practice, Vignan Pharmacy College 36 RESEARCH ANALYSIS FIGURE NO: 17: Graphical responses regarding the reason behind high cost of branded drugs. ROW LABELS High quality Better therapeutic effect Company`s reputation Can`t say Any other COUNT 17 22 31 04 04 TABLE NO: 14: Total number of responses regarding the reason behind high cost of branded drugs. INFERENCE: 51.7% of individuals believe that company reputation is the reason for high cost of branded drugs. 36.7% of individuals believe that best therapeutic effect is the reason for high cost. 28.3% of individuals believe that high quality is the reason for high cost. Department of Pharmacy Practice, Vignan Pharmacy College 37 RESEARCH ANALYSIS FIGURE NO: 18: Graphical responses regarding the reason behind low cost of generic drugs. ROW LABELS low quality less therapeutic effect Company`s reputation Can`t say Any other COUNT 06 14 19 07 23 TABLE NO: 15: Total number of responses regarding the reason behind low cost of generic drugs. INFERENCE: More than 31.7% of individuals say that company`s reputation is reason for generic drug low cost. 23.3% of individuals say that less therapeutic effect is reason generic drug low cost. 10% of individuals say that low quality may be the reason. 38.3% of individuals say that there may be any other reasons for low cost. Department of Pharmacy Practice, Vignan Pharmacy College 38 RESEARCH ANALYSIS FIGURE NO: 19: Graphical responses regarding the savings per month using generic medicines. ROW LABELS Up to 25% Up to 50% Up to 75% Can`t say Grand Total COUNT 13 22 10 15 60 TABLE NO: 16: Total number of responses regarding the savings per month using generic medicines. INFERENCE Almost 36.7% of individuals think that they save 50% per month by using generic medicines. 21.7% of individuals think that they save 25% per month by using generic medicines. 10% of individuals think that they save 75% per month by using generic medicines. 31.7% of individuals can’t say what their savings per month using generic medicines. Department of Pharmacy Practice, Vignan Pharmacy College 39 RESEARCH ANALYSIS FIGURE NO: 20: Graphical view of responses regarding public opinion for generic drug laws. ROW LABELS Yes No Grand Total COUNT 53 07 60 TABLE NO: 17: Total no of responses regarding public opinion for generic drug laws. INFERENCE: Almost 88.3% of individuals think that government should come up with stringent laws regarding generic medicines. 11.7% of individuals think that there is no need of such laws for stringent laws. Department of Pharmacy Practice, Vignan Pharmacy College 40 RESEARCH ANALYSIS 15. What are the disadvantages of generic medicines according to you? Majority of the population said generics are less effective compared to its brand name medicine, many of them perceive generics to be of poor quality and few don’t know about disadvantages. Department of Pharmacy Practice, Vignan Pharmacy College 41 RESEARCH ANALYSIS FOR EDUCATED INDIVIDUALS (NON SCIENCE BACKGROUND): FIGURE NO: 21: Graphical view of responses regarding knowledge about generic medicines. ROW LABELS Yes No Grand Total COUNT 41 20 61 TABLE NO: 18: Total number of responses regarding knowledge about generic medicines. INFERENCE: More than 68.3% of individuals know about the generic drugs. 33.3% of individuals don’t know about the generic drugs. Department of Pharmacy Practice, Vignan Pharmacy College 42 RESEARCH ANALYSIS FIGURE NO: 22: Graphical view of responses regarding knowledge about cost of generic medicines. ROW LABELS Yes No Grand Total COUNT 33 28 61 TABLE NO: 19: Total number of responses regarding knowledge about cost of generic medicines. INFERENCE: More than 55% of individuals know that generic drugs are available at cheap price. 45% of individuals don’t know that generic drugs are available at cheap price. Department of Pharmacy Practice, Vignan Pharmacy College 43 RESEARCH ANALYSIS FIGURE NO: 23: Graphical view of responses regarding doctor preference to medicine. ROW LABELS Always Never Often Grand Total COUNT 11 22 30 63 TABLE NO: 20: Total number of responses regarding doctor preference to medicine. INFERENCE: 50% of individuals say that their doctor often gives preference to low cost medicine. 36.7% of individuals say that their doctor never gives preference to low cost medicine. 18.3% of individuals say that their doctor always gives preference to low cost medicine. Department of Pharmacy Practice, Vignan Pharmacy College 44 RESEARCH ANALYSIS FIGURE NO: 24: Graphical view of responses regarding patient concern related to cost of medicine. ROW LABELS Yes No Grand Total COUNT 25 35 60 TABLE NO: 21: Total number of responses regarding patient concern related to cost of medicine. INFERENCE: 41.7% of individuals replied that, they ask their doctor for medicine having low price. 58.3% of individuals replied that, they don’t ask their doctor for medicine having low price. Department of Pharmacy Practice, Vignan Pharmacy College 45 RESEARCH ANALYSIS FIGURE NO: 25: Graphical view of responses regarding effect of medicines with different costs. ROW LABELS Yes same effect Yes even better effect No give less effect Can`t say Grand total COUNT 23 05 04 28 60 TABLE NO: 22: Total number of responses regarding effect of medicines with different costs. INFERENCE: 46.7% of individuals can`t say whether generic drugs have same effect as branded drugs. 38.3%% of individuals believe that generic drugs have same effect as branded drugs. 8.3% of individuals believe that they are more effective than branded drugs. 6.7% of individuals believe that generic drugs are not effective as branded drugs. Department of Pharmacy Practice, Vignan Pharmacy College 46 RESEARCH ANALYSIS FIGURE NO: 26: Graphical view of responses regarding safety of generic drugs. ROW LABELS Yes No Grand Total COUNT 44 17 61 TABLE NO: 23: Total number of responses regarding safety of generic drugs. INFERENCE: More than 73.3% of individuals replied that, generic drugs are as safe as branded drugs. 26.7% of individuals replied that, generic drugs are not as safe as branded drugs. Department of Pharmacy Practice, Vignan Pharmacy College 47 RESEARCH ANALYSIS FIGURE NO: 27: Graphical view of responses regarding patient’s preference. ROW LABELS Yes in emergency Yes always No Grand Total COUNT 41 12 09 62 TABLE NO: 24: Total number of responses regarding patient’s preference. INFERENCE: 68.3% of individuals said that even they know that generic drugs are of low cost they still pay for branded drugs in emergency conditions. 20% of individuals said that even they know that generic drugs are of low cost they still pay for branded drugs always. 15% of individuals said that they wouldn’t pay more for branded drugs. Department of Pharmacy Practice, Vignan Pharmacy College 48 RESEARCH ANALYSIS FIGURE NO: 28: Graphical view of responses regarding knowledge about cheap alternative of medicine. ROW LABELS Yes No Grand Total COUNT 42 19 61 TABLE NO: 25: Total number of responses regarding knowledge about cheap alternative of medicine. INFERENCE: More than 70% of individuals replied that, they would like to know whether there is any cheap alternative for their medicines. 30% of individuals replied that, they wouldn’t like to know any alternative for their medicine. Department of Pharmacy Practice, Vignan Pharmacy College 49 RESEARCH ANALYSIS FIGURE NO: 29: Graphical responses regarding substitution of branded with generic alternative. ROW LABELS Yes if physician permits Yes if it reduces my bill No Can`t say COUNT 31 22 03 07 TABLE NO: 26 Total no of responses regarding substitution of branded with generic alternative. INFERENCE: 51.7% of individuals say that they would switch to generic medicine if physician permits. 36.7% of individuals say that they would switch to generic medicine if their bill reduces to half. 11.7% of individuals say that they couldn’t decide whether they switch to generic medicine or not. 5% of individuals say that they wouldn’t switch to generic medicine on any cost. Department of Pharmacy Practice, Vignan Pharmacy College 50 RESEARCH ANALYSIS FIGURE NO: 30: Graphical view of responses regarding any new/advertisements encouraging generic drugs. ROW LABELS Yes No Grand Total COUNT 22 38 60 TABLE NO: 27: Total number of responses regarding any new /advertisements encouraging generic drugs. INFERENCE 63.3% of individuals said that during the last three months they have not seen or heard advertisement, news or information encouraging people to use generic medicines. 36.7% of individuals said that during the last three months they have seen or heard advertisement, news or information encouraging people to use generic medicines. Department of Pharmacy Practice, Vignan Pharmacy College 51 RESEARCH ANALYSIS FIGURE NO: 31: Graphical responses regarding generic medicines advertisement. ROW LABELS News papers TV channels Online Medical stores COUNT 06 09 35 26 TABLE NO: 28: Total number of responses regarding generic medicines advertisement. INFERENCE 58.3% of individuals have seen or heard information regarding generic medicines through online. 43.3% of individuals have seen or heard information regarding generic medicines through pharmacy. 15% of individuals have seen or heard information regarding generic medicines through TV channels. 10% of individuals have seen or heard information regarding generic medicines through news papers. Department of Pharmacy Practice, Vignan Pharmacy College 52 RESEARCH ANALYSIS FIGURE NO: 32: Graphical view of responses regarding choice of medication. ROW LABELS Yes No Grand Total COUNT 10 50 60 TABLE NO: 29: Total number of responses regarding choice of medication. INFERENCE More than 83.3% of individuals don’t follow TV advertisements for selecting their medication. 16.7% of individuals follow TV advertisements for selecting their medication. Department of Pharmacy Practice, Vignan Pharmacy College 53 RESEARCH ANALYSIS FOR PHARMACISTS WORKING IN MEDICAL STORES, CHEMISTS, and DISTRIBUTORS. FIGURE NO: 33: Graphical view of response regarding storage of generic medicines. ROW LABELS Few All No Grand Total COUNT 16 10 5 31 TABLE NO: 30: Total number of responses regarding storage of generic medicines. INFERENCE: 53.3% of pharmacists replied that, they do keep few generic medicines in their pharmacy. 33.3% of pharmacists replied that, they do keep all generic medicines in their pharmacy. 16.7% of pharmacists replied that, they don`t keep generic medicines in their pharmacy. Department of Pharmacy Practice, Vignan Pharmacy College 54 RESEARCH ANALYSIS FIGURE NO: 34: Graphical view of responses regarding reasons for not storing generic medicines. ROW LABELS Less demand Less or no prescription Don’t know Grand Total COUNT 08 09 13 30 TABLE NO: 31: Total number of responses regarding reasons for not storing generic medicines. INFERENCE 43.3% of pharmacists can`t say why they don’t store generic medicine. 30% of pharmacists say that, they don’t store them because of less or no prescription. 26.7% of pharmacists say that, they don’t store them because of less demand. Department of Pharmacy Practice, Vignan Pharmacy College 55 RESEARCH ANALYSIS FIGURE NO: 35: Graphical view of responses regarding patient’s choice of cheaper alternative medicine. ROW LABELS 5% 10% 15% 20% Grand total COUNT 06 08 09 07 30 TABLE NO: 32: Total number of responses regarding patient’s choice of cheaper alternative medicine. INFERENCE According to 30% of pharmacists, 15% patients ask them for generic medicine/cheaper alternative to brand. According to 26.7% of pharmacists, 10%patients ask them for generic medicine/cheaper alternative to brand. According to 23.3% of pharmacists, 20% patients ask them for generic medicine/cheaper alternative to brand. According to 20% of pharmacists, 5% patients ask them for generic medicine/cheaper alternative to brand. Department of Pharmacy Practice, Vignan Pharmacy College 56 RESEARCH ANALYSIS FIGURE NO: 36: Graphical view of responses regarding generic medicine suggestions. ROW LABELS Always Never often Grand Total COUNT 10 07 14 31 TABLE NO: 33: Total number of responses regarding generic medicine suggestions. INFERENCE 46.7% of pharmacists often suggest generic medicines to patients. 33.3% of pharmacists always suggest generic medicines to patients. 23.3% of pharmacists never suggest generic medicines to patients. Department of Pharmacy Practice, Vignan Pharmacy College 57 RESEARCH ANALYSIS FIGURE NO: 37: Graphical view of responses regarding availability issue of generic medicines. ROW LABELS Yes No Grand Total COUNT 09 21 60 TABLE NO: 34: Total number of responses regarding availability issue of generic medicines. INFERENCE: 70% of pharmacists replied that there is no availability issue of generic medicine. 30% of pharmacists replied that there is availability issue of generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 58 RESEARCH ANALYSIS 6. What kind of difficulties do you face about generic medicine availability or sale? According to pharmacists most of the patients strictly follow prescription which mostly has branded medicines and few of them said there is very less demand of generics. Some percentage said that there is no difficulty in keeping generic medicines. 7. Which pharmaceutical industries make generic medicines? Majority of the pharmacists were aware that large no. of companies deal in generics, they named a few prominent ones which included GSK, Cipla, Ranbaxy, Lupin, FDC,Alkem, Intas, Emcure etc. Department of Pharmacy Practice, Vignan Pharmacy College 59 RESEARCH ANALYSIS FIGURE NO: 38: Graphical view of responses regarding usage of generic medicine. ROW LABELS Yes No Grand Total COUNT 17 13 30 TABLE NO: 35: Total number of responses regarding usage of generic medicine. INFERENCE: 56.7% of pharmacists said that they personally use generic medicine instead of branded medicines. 43.4% of pharmacists said that they don’t use generic medicine. Department of Pharmacy Practice, Vignan Pharmacy College 60 RESEARCH ANALYSIS FIGURE NO: 39: Graphical view of responses regarding quality variation. ROW LABELS Yes No Grand Total COUNT 13 18 31 TABLE NO: 36: Total number of responses regarding quality variation. INFERENCE: 60% of pharmacists believe that there is no quality difference between generic and branded medicines. 43.3% of pharmacists believe that there is quality difference between the generic and branded drugs. Department of Pharmacy Practice, Vignan Pharmacy College 61 RESEARCH ANALYSIS 10. Why generic medicines have lesser price than branded? Pharmacists said that less price of generics could be because of low investment in marketing, company policies and reputation, quality difference and very few were aware about the patent expiration of parent molecule. 11. What are the disadvantages of generic medicines? More than 90 % of pharmacists responded saying none and few find poor quality is major disadvantage. Department of Pharmacy Practice, Vignan Pharmacy College 62 RESEARCH ANALYSIS FIGURE NO: 40: Graphical view of response regarding affect of business due to low cost of generic medicine. ROW LABELS COUNT Yes No Grand Total 09 21 30 TABLE NO: 37: Total number of responses regarding affect of business due to low cost of generic medicine. INFERENCE: 70% of pharmacists believe Government with new law, making generic medicines available free of cost at government hospitals, do not affect their business. 30% of pharmacists believeGovernment with new law, making generic medicines available free of cost at government hospitals, do affect their business. Department of Pharmacy Practice, Vignan Pharmacy College 63 RESULT AND DISCUSSION 7.RESULT AND DISCUSSION Survey conducted among different groups of population showed various opinions about generic drugs. The survey result of professionally qualified science background individuals showed that people were quite aware about various government policies about generic drugs. Nearly 60% of individuals said that the generics are as effective as branded medicines. More than 63.3% individuals found a huge cost difference between generic and branded medicines. More than 31.7% people didn’t know such stores where generic medicines are available but when they were asked if they would like to know such store near about 73.3% responded positively. Though professionally qualified 30% science background individuals never asked about generic medicines in medical stores and about 33% asked often, more than 37% said their doctor never asked about the cheaper alternatives or about generic version of branded medicines. More than 51.7% of people thought reason of high cost of the branded medicines is due to company’s reputation and 28.3% said it could be the high quality of branded medicines that make them costly. The survey results of pharmacist shows that many of them do not keep all kind of generic medicines. 53.3% of pharmacists said that they keep few regular generic medicines. The main reason behind not keeping generic medicines was less demand from the patients. As per the pharmacist in the survey 10-15% of patients asked about generic or cheaper alternatives to brand, more than 40% pharmacists never suggest generic medicines to patients, though they were well aware about all major generic manufacturing companies. Besides all above when they were asked about their business regarding new government policy of free drug distribution more than 70% pharmacist said that it may not affect their business. The survey result of educated but non-science background shows that a good number nearly 68.3% of population knew about the generic medicine, but more than 58.3 % of them never asked their physician about generic medicine or cheaper alternative to branded medicine. In a few instances when patient asked doctor about generic medicine physicians replied that branded medicines will act quickly and effectively compared to generic medicine. This shows the attitude of physicians about generic medicines. More than 46.7% of individuals were not aware about effects of generic medicines while nearly 6.7% said that generics are less effective than branded. Near about 49% individual thought generics are not as safe as branded, but 70% were ready to know the cheaper alternative to branded. The war of generics versus branded getting popular in country like India and electronic and print media is approaching to this issue significantly. More than 58.3% people in the survey got aware about OTC and generic medicines via these media and consulted with the physician about these generic medicines rather than blindly following the TV or other advertisements. Department of Pharmacy Practice, Vignan Pharmacy College 64 CONCLUSION 8.CONCLUSION Survey of 60 science background individuals, 60 educated but non-science background individual and 30 Pharmacist was carried out to throw light on generics versus branded medicine scenario in Andhra Pradesh state particularly in districts of Krishna and Guntur. It isobvious from survey that educated and non educated would like to have access to generic medicine and want to have more knowledge and information about generics from the doctors as most of them do not like to violet prescription. Thus it could be suggested that doctors can write generic alternative to branded medicines for the benefit of the patients as most of the individuals in survey have conclusively said that they would like to have cheaper alternative to branded medicines. There is strong belief amongst the educated individuals that if doctor has prescribed the branded medicines it cannot be changed and generic alternative may have less effect. This myth was revealed in survey of pharmacists as most of them know generic medicines are not compromised medicines and could be as efficacious as branded medicines. The main reason of less sell of generic medicines is due to lack of such prescriptions received from physicians. There is also willingness from pharmacist side to help the people by supplying generic alternative to branded medicines which the author belief should be supported by law. Food and drug administration has stringent rules and regulations in bringing out generic medicines in public use thus there is no reason to believe that generics are substandard than branded (though does not reflect from survey of educated people and therefore people need to be informed in this regard). India is a leading country in Pharma manufacturing sector and is serving humanity by producing cost effective but quality medicines in the entire world and also supplying these medicines to most of the countries, at the same time the poor population in India is still unable to get access to modern medicines. Thus, the new regulation of generic medicine and implementation steps should be taken by the government. Department of Pharmacy Practice, Vignan Pharmacy College 65 BIBLIOGRAPHY 9. BIBILOGRAPHY 1. 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