Beruflich Dokumente
Kultur Dokumente
Hardik V. Patel
MBA (PHARMA)
MY ENTIRE WORK OF PROJECT HAS BEEN DEDICATED TO GOD, MY LOVING PARENTS, & WHO MY MY ELDER FRIENDS BROTHER
ALWAYS
SUPPORTED ME.
DECLARATION
I, Mr. Hardik V. Patel, student of the MBA (Pharma) affiliated to Kadi Sarva Vishwavidyalaya, Gandhinagar hereby declare that this project is a result of culmination of my sincere efforts.
I declare that this submitted work is done solely by me and to the best of my knowledge. I have tried at my level best to collect precise detail to provide useful information to the company.
I also declare that all the information collected from various sources has been duly acknowledged in this project report.
ACKNOWLEDGEMENT
Here, I take this opportunity to humbly express my gratitude to all those concerned with my project entitled Prelaunch survey of Ramipril and Ramipril Hydrochlorothiazide Combination. I would like to share the success of my project amongst the person who has directly and indirectly helped me to complete this project. In providing concrete shape of my project, there are numerous people who have taken part. I take this opportunity to express my deep sense of gratitude and hearty thanks to my Professor Mrs. Mallika Babu for her efforts to get training in the company. I am hearty thankful to her for providing me her valuable suggestions and remarks to complete this project. Her extensive knowledge of subject and the way, she imparted the same to me has enabled me to develop the project cohesive manner. We are highly obliged to Mr. Maulesh Shah . For allocating such an interesting project. In spite of being very busy, they were ready to help me whenever required. The whole staff of Kamron Laboratories Ltd. was co-operative and I am thankful for all the support they extended to me. A special thanks to my friends Mr. Sumit Tiwari and Mr. Yashrajsinh Rathod for his continuous support and guidance made my work very easy. I would like to express my heartiest thanks to my family, parents and brother to extend their help as and when required. I would like to thank my friends- Arshad, Gunjan and Ronak. Without their support this would not be possible. My guide at the institute shared his expertise knowledge, so I sincerely thank to Principal Dr. G.B.Shah and Dr. Srikalp Deshpande.
Hardik V. Patel
PREFACE
Summer training is an essential part of curriculum of MBA, affiliated to Kadi Sarva Vishwavidyalaya, and it is compulsory for every student. Management colleges provide their students theoretical knowledge but it remains incomplete without practical knowledge. Moreover students of MBA are required to gather maximum practical exposure towards corporate world. This experience provides the best of knowledge for any MBA students which cant be attained in class-room teaching. Through this project report work I can better understand the different aspects like research design, measurement and scaling techniques, questionnaire and its design, data collection, analysis and interpretation. Through this report I can understand business research methodology in practical term. The major emphasize of my work was to analyze the current market scenario of Ramipril and Ramipril hydrochlorothiazide. The working experience with Kamrom laboratories ltd., Kalol, Gandhinagar, was very exciting and it has created a long lasting impression in my mind. This project gave me immense opportunities to upgrade my knowledge related to marketing field and also gave me a chance to learn and understand the strategies to be kept in mind while launching a new product.
EXECUTIVE SUMMERY
Kamron Laboratories Ltd., has been set up in 1990 for manufacture of pharmaceutical formulations in dosage forms like Tablets, Capsules, Liquid Orals, Dry Syrups, Eye Drops and Injections. They have divided their products in three different groups as follows.1) Panchratna Brands 2) Platinum Blue Group: Platinum Green 3) Titanium Brands. I had done my summer project under titanium brands. The objective of my project was to do a survey of molecules Ramipril and Ramipril Hydrochlorothiazide combination in various areas of Ahmedabad to find out the market potential of given molecules. In first section of my report I had given brief information about pharmaceutical industry and in second section I had given brief information of Kamron laboratories ltd. In the main part of my project, I analyzed various parameters based on the survey conducted of 150 chemists of mentioned areas. The main potential seller of Ramipril and Ramipril Hydrochlorothiazide are Sanofi Aventis (Cardace), Micro Cardicare (Hopace), Alkem (Race), Cipla (Ramipres), Lupin (Ramistar), Macleods (Macpril) etc. At the end of the project, I had given my own findings and few of suggestions to guide the launch of these two molecules.
TABLE OF CONTENT
Sr no.
1
Content
Introduction of Indian pharmaceutical industry Advantage India The growth scenario Cardiovascular drug market Major players in Indian market
Page no
Company profile About Kamron Core values of Kamron laboratories ltd Vision statement of Kamron Mission statement Kamron Facilities Research & development Quality assurance International certifications Brand management team Product list
Data analysis Objectives Research methodology: Working area: Research design: Plan of work: About the molecules Data interpretation Findings Suggestions Limitation of survey References Appendix
LIST OF GRAPH
Sr no.
1
2 3
Graph Content
Sale of number of strips per week of different companies Percentage of total sale Sale Of Strip Of Ramipril And Ramipril Hydrochlorothiazide (Strength wise)
Page no
5 6
LIST OF TABLE
Sr no.
1 2 3 4 5 6
Table Content
Indias domestic pharmaceutical market Brand classification of Kamron Available brands in the market Sale of number of strips per week of different companies Percentage of total sale Sale of strip of Ramipril and Ramipril hydrochlorothiazide(strength wise)
Page no
8 9
PROJECT REPORT
-Richard Gerster
The future depends on what we do in the present India is the worlds fourth largest producer of pharmaceuticals by volume, accounting for around 8% of global production. In value terms, production accounts for around 1.5% of the world total. The Indian pharmaceutical industry directly employs around 500,000 people and is highly fragmented having more then 20000 companies. While there are around 270 large R&D based pharmaceutical companies in India, including multinationals, government-owned and private companies, there are also around 5,600 smaller licensed generics manufacturers. The Indian Pharmaceutical industry currently tops the chart amongst India's science-based 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. Indian Pharmaceutical Industry ranks fourth in the world, pertaining to the volume of sales. The estimated worth of the Indian Pharmaceutical Industry is Rs.55,454 Crores. The growth rate of the industry is about 13% per year. Almost most 70% of the domestic demand for bulk drugs is catered by the Indian Pharma Industry. The Pharma Industry in India produces around 20% to 24% of the global Generic drugs. The Indian Pharmaceutical Industry is one of the biggest producers of the Active Pharmaceutical Ingredients (API) in the international arena. The Indian Pharma sector leads the science-based industries in the country. Around 40% of the
total pharmaceutical produce is exported. 55% of the total exports constitute of formulations and the other 45%comprises of bulk drugs. The Indian Pharma Industry includes small scaled, medium scaled, large scaled players, which totals nearly 300 different companies. As per the present growth rate, the Indian Pharma Industry is expected to be a US$ 20 billion industry by the year 2015. The Indian Pharmaceutical sector is also expected to be among the Top Ten Pharma based markets in the world in the next ten years. The sales of the Indian Pharma Industry would worth US$ 43 billion within the next decade. The multinational companies, investing in research and development in India may save up to 30% to 50% of the expenses incurred. The top revenue-generating therapeutic groups in the Rs 55,454 crore domestic markets are Anti-infective, Gaestro, Cardiac, Respiratory, Pain management and Vitamins. Incidentally, the vitamins, minerals and nutrients segment is the only area (among the ones tracked by ORG-IMS) where five of the top 10 players are foreign multinational firms.While the market leader is the Indian subsidiary of Germanys Merck Ltd, the other foreign MNCs among the top 10 are GlaxoSmithKline (GSK), Pfizer, Novartis and Abbott. Indian companies among the top 10 are Cipla, Ranbaxy, Wockhardt, Piramal Healthcare and Zydus Cadila.
Bussiness Standard
The domestic market of Indian pharmaceutical industry is likely to register 12%-13% growth in 2009, only marginally lower than the earlier projections of 15% as an impact of macroeconomic conditions, according to ORG IMS Research. The impact of macroeconomic factors is much less on the Indian companies compared to the global peers. In the next 4-5 years, this industry is expected to continue to grow at more than 10% to touch the $30 billion mark by 2020. In the long term, the domestic consumption is expected to keep growing at a healthy pace, because currently Indias healthcare spending is only 5.6% of the countrys gross domestic product (GDP), which is among the lowest globally.
ADVANTAGE INDIA
Competent workforce: India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available.
Cost-effective chemical synthesis: its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs. Legal & Financial Framework: India has a 60 year old democracy and hence has a solid legal framework and strong financial markets. There is already an established international industry and business community. Globalization: The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing.
Consolidation: For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India. THE GROWTH SCENARIO Indian contract research industry growing at 40-50 per cent The Indian contract research Industry has grown tremendously over the past few years. It has witnessed the emergence of several CROs in the area of drug discovery & development over the last decade. India to capture US$ 250-300 million or 10 per cent of global clinical trials by 2010. India is emerging as a favored global destination for global drug development companies. Recent changes in Indias healthcare policies and a maturing regulatory
environment have significantly brought down the risk of shifting more clinical research from the developed countries to India. The clinical research industry in India is presently estimated at over US$ 100 million. New product launches underlie market growth The market has been growing between 6-8 per cent over the last two years, primarily driven by new launches and to some extent by volumes. In the last two years, more than 3,900 new products (largely branded generics) have been launched in India, contributing about US$ 355.6 million (million) worth of market value. While the Indian pharma majors launched more than ten products per year, global MNCs averaged one or two annually.
COMPANY PROFILE...
We shall be known as a company that meets the needs of our customers by listening, communicating, cooperating and collaborating with our partners our customers. We remain focused on the customer, committed to exceeding regulatory and quality requirements through motivated, empowered and dedicated employees.
We observe laws and ethics, and strive to grow in harmony with society and
Facilities
Kamron has got facilities to manufacture Solid Dosage Forms. Liquid Orals and Small Volume Parenterals. Manufacture is carried out as per current good manufacturing practices using state of art automatic machines. Detailed validation is carried out for each machine. The manufacturing process is also validated so as to ensure consistent quality.
Quality Assurance
Kamron Laboratories Ltd. is committed. To provide best quality of medicine & service to our patient for better quality of life so as to ensure customers satisfaction. To improve quality of our products in our pharmaceutical business by use of latest technologies automated process & properly trained & qualified man power. To follow national & international standard for continual improvement in quality management system.
International Certifications
Kamron has got several international certifications which are a testimony to the above policy. Kamron has got: World Health Organization Good manufacturing practice certificate obtained in Decemeber-2004
ISO-9001-2000 Certification from BVQI obtained in October 2005.
Panchratna Brands Serra Group Lycofeast Group Marin Group Racifree / Rito Group
Platinum Blue Allorgic Group Azikam group Feast Ambrokam T Arthigo G Sylron TX
Platinum Green Zidon Group Apin PM Feprovit Syrup QXL group Onkam group TNN group
Product list
PROTEOLYTIC ANTI EMETIC
Serra-5/10/20 Serratiopeptidase Serra-D Serratiopeptidase Diclofenac Potassium Serra-N Serratiopeptidase Nimesulide Serra-DP Serratiopeptidase Diclofenac Sodium Paracetamol Serra-A Serratiopeptidase Aceclofenac
10 mg. Onkam-4/8 50 mg. Ondansetron Onkam-2/4 Tab. Ondansetron 15 mg. ml. 100 mg. Onkam
30 ml. Syp. 2 mg. / 5 ml. Tab. 10 mg. 10 mg. Tab. 10 mg. 10 mg. 2.5 mg. Tab. 20 mg. 20 mg.
50 mg. Doxylamine Succinate 500 mg. Pyridoxine HCL Tab. Vomsafe Plus 15 mg. Doxylamine Succinate 100 mg. Pyridoxine HCL Folic Acid Vomsafe OD Doxylamine Succinate Pyridoxine HCL
GASTRO INTENSTINAL
ANTIBIOTICS
Tab. Amiron-100/250/500
Inj.
150 mg. Amikacin 100 mg./250 mg./500 mg./2 ml. Cap. inj. Tab. 250/500 mg.
Domperidone Omeprazole Zidon-RD Domperidone Omeprazole Zidon-P Pantoprazole Domperidone Zidon-PZ Pantoprazole Domperidone Zidon Plus Domperidone Paracetamol
10 mg. Linkam
Inj.
10 mg. Lincomycin 300 mg./ml Inj. 1 ml./2 ml. Cap. Linkam-500 10 mg. Lincomycin 20 mg. Live-OD Cap. 500 mg. Tab. 200 mg. Tab. 200 mg. Tab. 200 mg. 600 mg. Tab. 250 mg./500 mg. Tab. 500 mg. 600 mg. Tab. 50 mg. Kid Tab. 150 mg. Inj. 1 gm. 1 gm./2 ml. Vial Cap. 250 mg. 250 mg. 60 Million Spores
Tab. Levofloxacin 20 mg. QXL-200 10 mg. Ofloxacin Tab. QXL-TZ 40 mg. Ofloxacin 10 mg. Tinidazole Tab Q-Bid-250/500 10 mg. 500 mg. Ciprofloxacin Q-Bid-TZ Ciprofloxacin Tinidazole
100 ml. Syp. Roxilide-Kid Roxithromycin Tebrutaline Sulphate 2.5 mg. + Brokam Bromhexine HCL 8 mg. + Guaiphenesin 100 mg. + Menthol 5 mg./10 ml. Ambrokam Dispersible Roxilide-150 Roxithromycin
100 ml. Syp. Sulcef Ambroxol HCI 30 mg. + Salbutamol 2 Cefoperazone mg. + Guaiphenesin 50 mg. /5 ml. Ambrokam-P Sulbactum
60 ml. Xyclox-LB Ambroxol HCI 15 mg. + Salbutamol Amoxycillin 1mg. + Guaiphenesin 50 mg. + Menthol Cloxacillin 1 mg./5 ml. Lactic Acid Bacillus Ekocet-DT Tab.
Cetirizine Dihydrochloride Disp. Kamolate Phenylephrine HCL 5 mg. + CP Maleate 2 mg. + Caffeine 15 mg. + Paracetamol 500 mg. Colstat Paracetamol 125 mg. + Pseudoephedrine 15 mg. + Chlorpheniramine Maleate 2 mg./5 ml. Voltriz-5 Levocetirizine Tab. 5 mg. 60 ml. Syp. Tab. 10 mg.
DIGESTIVE ENZYME
Kamozyme Fungal Diastase (1:1200) Pepsine (1:3000) Kamozyme Fungal Diastase (1:1200) Pepsine (1:3000) Kamozyme-EP Pancreatin Bile Constituents Activated Dimethicone
15 ml. Drops 33.3 mg. 5 mg./1 ml. 200 ml. Syp. 50 mg. 10 mg./5 ml. Tab. 192 mg. 25 mg. 40 mg.
ANTI - MALARIAL
NUTRITIONALS
Kay-Mal - Arteether
Feast
Vit. A (As acetate) 5000 i.u. + Vit. E (As acetate) 25 i.u. + Vit. C 100 mg. + Vit. B1 10 mg. + Vit B2 10 mg. + Vit. B6 3 mg. + Vit B12 5 mcg. + Folic Acid 1 mg. + Niacinamide 50 mg. + Calcium Pantothenate 12.5 mg. + Zinc Oxide 15 mg. + Cupric Oxide 2.5 mg. + Sodium Selenate 60 mcg. + Mag. Chloride 1.4 mg. + Chromium Chloride 65 mcg. Feprovit 200 ml. Syp.
ANTI-GOUT
Allgoric Allopurinol
Tramace
Riboflavin 2.5 mg. + Phridoxine HCL 1 Tramadol HCL 50 mg./1 ml. 100 mg./2 ml mg. + Cyanocobalamine 2.5 mcg. + Folic Acid 0.5 mg. + Niacinamide 25 mg. + D-Panthenol 2.5 mg. + Ferros Tramace-50 DT Tramadol HCL Tab. 50 mg.
Tab. 50 mg. 325 mg. 250 mg. 3 ml. Inj. 25 mg./ml. Tab. 100 mg. Tab. 100 mg
B2 5 mg. + Vit B6 1.5 mg. + Vit. B12 5 Dicron mcg. + Niacinamide 25 mg. + Cal. Pantothenate 7.5 mb. Marin Diclofenac Sodium Docron- SR 100 ml. Susp. Diclofenac Sodium Nikam Nmesulide
Silymarin 35 mg. + Thiamine HCI 1.5 mg. + Riboflavin 1.5 mg. + Phridoxine HCI 1.5 mg. + Niacinamide 20 mg. + D-Panthenol 5 mg. + Vitamin B12 1 mcg Marin Forte Silymarin 140 mg. + Thiamine
ANTI - PYRETIC
Tab. 100 mg. 500 mg. 60 ml. Susp. 10 mg. 125 mg. / 5 ml
Mononitrate 5 mg. + Riboflavin 5 mg. + paracetamol Pyridoxine HCI 1.5 mg. + Niacinamide 25 mg. + Calcium Pantothenate 7.5 mg. + Vitamin B12 5 mcg. Mekam Tab. TNN Nimesulide paracetamol
Mecobalamin 500 mcg. + Thiamine Mononitrate 10 mg. + Pyridoxine HCI 3 mg. + Niacinamide 45 mg.+ Calcium Panthothenate 50 mg. Mekam Inj.
CALCIUM SUPPLEMENTS
Tab.
HCI 100 mg. + Pyridoxine HCI 100 mg. Tufcal + Niacinamide 100 mg. + D-Panthenol 50 mg./2 ml. Mekam-DM Tab.
MCHC eq. to Calcium 99 mg. + Phosphorous 45 mg. + Zinc Sulphat 20 mg. + Lysine Mono HCL 150 mg./10 ml. Tufcal -M Tab.
Acid 100 mg. + Folic Acid 1.5 mg. + Vit. B6 6 mg. + Vit. B1 10 mg. + Vit. E 25 i.u. MV-12 Part-I : Vitamin C 150 mg. Part-II : Vitamin B12 2500 mcg. + Folic Acid 0.7 mg. + Niacinamide 12 mg. Inj.
Ele. Calcium 500 mg. + vit. D3 250 I.U. + Magnesium (Elemental) 40 mg. + Manganese (Elemental) 1.8 mg. + Zince Sulphate 7.5 mg. + Copper Sulphate 1 mg. Boron 250 mcg.
HAEMOSTATIC
ANTI - SPASMODIC
Sylron-250/500 Etamsylate
Kamspas -250/500 Mefenamic Acid Dicyclomine Kamspas-T Mefenamic Tranexamic Acid Draw Drotaverine
Tab. Tranexamic Acid 250 mg + Etamsylate 250 mg. 250 mg 500 mg. Inj. 40 mg./2 ml Kool Calcium Dobesilate OTHERS Cap. 500 mg.
HAEMATINIC
Facicap-CI
Cap.
Tab. 0.25/0.50 mg. Tab. 10 mg. Inj. 50 mg./1 ml. 200 mg./4 ml. Cap.
Carbonil Iron (Eq. to ele. Iron) 100 mg. + Folic Acid 1.5 mg. + Vit. B12 15 mcg. + Vit. C 75 mg. + Zinc Sulphate 61.8 mg. Facicap Each 15 ml. Contains:
200 ml. Liq. Utegest Natural Micronized Progesterone Utegest 20/100/200 mg.
Ferrous Gulconate 300mg. + Vit. B12 15 mcg. + Niacinamide 45 mg. + Riboflavin 5 mg.+ Vit. B1 5 mg. + Vit. B6 1.5 mg. Facicap-Z
Cap. Deca-Kamolin
Inj.
Ferrous Fumarate 152 mg. + Zinc Sulphate 15 mg. + Vit. B12 mcg. + Folic Acid 1.5 mg.
DATA ANALYSIS
(A) OBJECTIVES
As a student my objective was to acquire practical knowledge of marketing field and to know the relation between theoretical and practical concepts. Moreover to be familiar with corporate world. From the companys point of view my objectives were: 1. Perform a market research to determine market share of given Molecule- Ramipril and Ramipril Hydrochlorothiazide
2. To seek the major prescribers of these molecules for the given molecule.
3. To know the market value of the given molecule before the launching of this new molecule. 4. To know what are the regular sale and new prescription wise sale.
The research began with the distribution of the allotted area into small parts. Then the survey of 150 chemists was conducted. In that survey it was tried to seek out maximum information from chemists related to molecule and to get information related to status the different brands. At the same time, prescribers of these molecules were known from the chemists and their medical specialties were known, so that the detailed and in depth analysis could be carried out. During the study it was also taken care to find out market share of different brands, their pricing strategy and tried to understand their marketing strategies, so as to implement them to increase our market share.
WORKING AREA:
I had been given the following area for the survey of all the chemists underlying in these areas. 1. Specific areai. Chandkheda ii. Sabarmati iii. Vadaj iv. Ranip 2. Common areai. VS Hospital ii. Doctor house iii. Stadium area
RESEARCH DESIGN:
The tool used for conducting survey is questionnaire which shown in appendix. The questionnaire is simple and contains open ended question. It is designed such that it can be easily understood by the respondent.
[3]
Ramipril is a potent and long-acting inhibitor of the angiotensin convertingenzyme (ACE). It is a prodrug, which is hydrolyzed in the liver after absorption from the gastro-intestinal tract to form the active angiotensin converting enzyme inhibitor, ramiprilat. Hydrochlorothiazide (HCTZ) is a thiazide diuretic and an antihypertensive. The components have quite different but complementary antihypertensive mechanisms, and the improved efficacy is not due simply to additive antihypertensive effects. Ramipril blocks the counterregulatory rise in angiotensin II triggered by diuretic therapy. Diuretics appear to enhance the antihypertensive action of ACE inhibitors particularly when the renin-angiotensin system is inactive. As a result, patients who do not respond to monotherapy often do respond to combination therapy. A further benefit is that the dosages of components in a combination can be lowered for some patients, thus reducing the risk of adverse effects. Ramipril as well as its metabolite ramiprilat has been shown to be pharmacokinetically compatible with hydrochlorothiazide, they both require once daily dosage and achieve maximum hypotensive effect approximately 4 hours after administration.
CLINICAL PHARMACOLOGY
Ramipril Following oral administration of Ramipril, peak plasma concentrations of Ramipril are reached within one hour. The extent of absorption is at least 50-60% and is not significantly influenced by the presence of food in the GI tract, although the rate of absorption is reduced. Cleavage of the ester group (primarily in the liver) converts Ramipril to its active diacid metabolite, ramiprilat. Peak plasma concentrations of ramiprilat are reached 2-4 hours after drug intake. The serum protein binding of Ramipril is about 73% and that of ramiprilat about 56%. Ramipril is almost completely metabolized to ramiprilat, which has about 6 times the ACE inhibitory activity of Ramipril. After oral administration of Ramipril, about 60% of the parent drug and its metabolites are eliminated in the urine, and about 40% is found in the faeces. Less than 2% of the administered dose is recovered in urine as unchanged Ramipril. Blood concentrations of Ramipril and ramiprilat increase with increased dose, but are not strictly dose-proportional. The 24-hour AUC for ramiprilat, however, is dose-proportional over the 2.5-20 mg dose range. The absolute bioavailabilities of Ramipril and ramiprilat were 28% and 44%, respectively, when 5 mg of oral Ramipril was compared with the same dose of Ramipril given intravenously. The initial rapid decline of Ramipril due to tissue distribution has a half-life of 2-4 hours. The apparent elimination phase has a half-life of 9-18 hours. The terminal elimination phase has a prolonged half-life (>50 hours). It does not contribute to the accumulation of the drug. After multiple daily doses of Ramipril 510 mg, the half-life of ramiprilat concentrations within the therapeutic range was 1317 hours. After once-daily dosing, steady-state plasma concentrations of ramiprilat are reached by the fourth dose. Steady-state concentrations of ramiprilat are somewhat higher than those seen after the first dose of Ramipril, especially at low doses (2.5 mg), but the difference is clinically insignificant. In patients with creatinine clearance less than 40 ml/min/1.73m2, peak levels of ramiprilat are approximately doubled, and trough levels may be as much as quintupled. In multiple-dose regimens, the total exposure to ramiprilat (AUC) in these patients is 3-4 times as large as it is in patients with normal renal function who receive similar doses. The urinary excretion of Ramipril, ramiprilat, and their metabolites is reduced in patients with impaired renal
function. Compared to normal subjects, patients with creatinine clearance less than 40 ml/min/1.73m2 had higher peak and trough ramiprilat levels and slightly longer times to peak concentrations. In patients with impaired liver function, the metabolism of Ramipril to ramiprilat appears to be slowed, and plasma Ramipril levels in these patients are increased about 3-fold. Peak concentrations of ramiprilat in these patients, however, are not different from those seen in subjects with normal hepatic function, and the effect of a given dose of plasma ACE activity does not vary with hepatic function. Hydrochlorothiazide Thiazides affect the renal tubular mechanism of electrolyte reabsorption. Thiazides increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium. The mechanism of the antihypertensive effect of thiazides is unknown. Thiazides do not affect normal blood pressure. The onset of action of thiazides occurs in 2 hours and the peak effect at about 4 hours. The action persists for approximately 6-12 hours. Hydrochlorothiazide is rapidly absorbed, as indicated by peak plasma concentrations 1-2.5 hours after oral administration. Plasma levels of the drug are proportional to dose; the concentration in whole blood is 1.6-1.8 times higher than in plasma. Thiazides are eliminated rapidly by the kidney. After oral administration of 12.5 to 100mg doses, 72-97% of the dose is excreted in the urine, indicating dose independent absorption. Hydrochlorothiazide is eliminated from plasma in a biphasic fashion with a terminal half-life of 10-17 hours. Plasma protein binding is 67.9%. Plasma clearance is 15.930.0 L/hr; volume of distribution is 3.6-7.8 L/kg. Gastrointestinal absorption of hydrochlorothiazide is enhanced when administered with food. Absorption is decreased in patients with congestive heart failure, and the pharmacokinetics are considerably different in these patients.
INDICATION
Indicated for the treatment of mild to moderate hypertension in patients (in whom combination therapy is appropriate) who have been stabilised on the individual components given in the same proportion.
CONTRAINDICATIONS
Ramipril or Ramipril + Hydrochlorothiazide must not be used in patients with hypersensitivity to Ramipril, hydrochlorothiazide or other thiazide diuretics, sulphonamides or any of the excepients and allergy to starch. History of hereditary angioneurotic oedema.Severe impairment of renal function with a creatinine clearance below 30ml/min/1.73m2 body surface area and in dialysis patients
(hydrochlorothiazide ineffective). Haemodynamically relevant unilateral or bilateral renal artery stenosis, mitral stenosis, aortic stenosis, and in patients with low blood pressure (hypotensive patients) or in patients with an unstable circulatory situation (haemodynamically unstable patients) where there might be a risk of life threatening fall in blood pressure and renal failure. Clinically relevant electrolyte disturbances e.g. hypokalemia, hyponatremia or hypercalcemia which may worsen following treatment. Severe impairment of liver function (risk of fluid and salt imbalance).Rapid onset allergy (anaphylactoid) like hypersensitivity reactions sometimes progressing to shock have been described in the course of dialysis with certain high flux membrane (polycrilonitril membranes) during therapy with ACE inhibitors such as Ramipril.
PRECAUTIONS
Treatment with Ramipril or Ramipril + Hydrochlorothiazide requires regular medical supervision. Generally dehydration, reduced blood volume (hypovolumia) or salt depletion should be corrected before initiating the treatment (in patients with concomitant heart failure, however, this must be carefully weighed against the risk of volume overload). Special caution is necessary during the treatment of:
Patients with severe and particularly with malignant hypertension. Patients with concomitant and particularly with severe heart failure. Patients in whom fluid or salt deficiency exists or may develop (as a result of inadequate fluid or salt intake) or as a result of diarrhoea, vomiting or excessive sweating in cases where salt and fluid replacement is inadequate. Patients with haemodynamically relevant renal artery stenosis. Close medical supervision is also necessary in patients with
haemodynamically relevant stenosis of coronary arteries or of the blood vessels supplying the brain.In patients with pre-existing impairment of renal function or in kidney transplant patients. Serum sodium, potassium, calcium, uric acid, and blood sugar should be monitored regularly. More frequent monitoring of potassium is necessary in patients with impaired renal function. White blood cell count should be monitored (more frequent in the initial phase of the treatment) so that leucopenia can be detected.
ADVERSE REACTIONS
The following adverse effects can be observed during therapy with Cardiovascular Symptomatic hypotension characterised by light-headedness sometimes accompanied by concentration disturbances as well as impaired reactions, fatigue, dizziness, weakness may occur as a result of vasodilatation after the initial dose of Ramipril or Ramipril or Ramipril + Hydrochlorothiazide. Other symptoms may include tachycardia, palpitation, orthostatic hypotension, nausea, headache, tiredness or tinnitus after excessive reduction of blood pressure. This occurrence may be more likely in patients with: Severe and malignant hypertension Concomitant and particularly severe heart failure Previous diuretic therapy Fluid or salt deficiency Haemodynamically relevant renal artery stenosis. Pre-existing coronary artery disease or cerebrovascular disease, a sudden fall in blood pressure may cause perfusion disturbances to the heart (angina
pectoris or myocardial infarction) or the brain (transient ischemic attacks or stroke). Renal During treatment with Ramipril or Ramipril + Hydrochlorothiazide there may be deterioration in renal function under certain circumstances progressing to lifethreatening acute renal failure. This applies particularly in patients with renovascular diseases (haemodynamically relevant renal artery stenosis, in renal transplant patients and in patients of cardiac failure). In isolated cases, interstitial nephritis may develop during therapy with hydrochlorothiazide. Preexisting pronounced urinary protein excretion might increase under treatment with Ramipril or Ramipril +
Hydrochlorothiazide however renal protein excretion may also be reduced in patients of diabetic nephropathy. Ramipril or Ramipril + Hydrochlorothiazide may lead to a decline in serum sodium concentration particularly in conjunction with restricted salt intake. Hydrochlorothiazide may contribute to the development of hypochloremia, hypomagnesemia as well as hypercalcemia. In addition Ramipril or Ramipril + Hydrochlorothiazide may contribute to development or aggravation of a metabolic alkalosis. Ramipril may contribute to an increase in concentration of serum potassium while hydrochlorothiazide may contribute to a decrease in serum potassium. Thus during the therapy with Ramipril or Ramipril + Hydrochlorothiazide both a decline and increase in serum potassium are possible, the latter effect being mainly encountered in patients with impaired renal function (e.g. diabetic nephropathy) or those receiving potassium sparing diuretics or potassium salts concomitantly. Warning signs of electrolyte disturbances (e.g. changes in serum levels of sodium, potassium, calcium and magnesium) include thirst, headache, confusion, muscle cramps, tetany, muscle weakness and gastrointestinal symptoms. Gastrointestinal Reactions in digestive tract may develop e.g. dryness of mouth, irritation or inflammation of oral mucosa, constipation, diaorrhea, nausea and vomiting, gastritis like abdominal pain, pancreatitis, increase in hepatic enzymes and/or bilirubin, cholestatic jaundice and other forms of impaired liver function and in some instances life threatening hepatitis.
Blood picture The following changes in blood picture may occur: a mild to severe reduction in red blood cell count and haemoglobin content, blood platelets and white blood cell count, impaired blood cell formation (bone marrow depression) and excessive reduction in number of all blood cells (pancytopenia) have been observed. Such changes in blood picture that are sometimes life-threatening are more likely to occur in patients of impaired renal function, in patients with concomitant connective tissue disorder or in patients treated with other drugs that may cause changes in blood picture. Others Disturbance of balance, visual disorders, headache, nervousness, restlessness, tremor, sleep disturbances, confusion, and loss of appetite, depressed mood, feeling of anxiety, abnormal sensations, taste change and muscle cramps. Erectile impotence and reduced sexual desire (decreased libido) may occur. Inflammation of blood vessels (vasculitis), muscle and joint pains (myalgia and arthralgia), fever, eosinophilia may occur. During treatment with hydrochlorothiazide and thus, with Ramipril or Ramipril + Hydrochlorothiazide increased blood concentrations of uric acid levels may occur. This may lead to gout attacks particularly in those patients whose uric acid levels are already elevated. Hydrochlorothiazide might lower the tolerance of glucose. In patients with diabetes mellitus this may lead to deterioration of metabolic control. A latent diabetes mellitus may become manifest for the first time. Hydrochlorothiazide may cause an increase in serum cholesterol and triglycerides. Raised titres of antinuclear antibodies have been seen with other ACE inhibitors. In temporal relationship with the use of hydrochlorothiazide, the development of lupus erythematosus has been described. Effects on the ability to drive and operate machinery: The antihypertensive effect in individual cases may be symptomatic. Treatment with Ramipril or Ramipril + Hydrochlorothiazide may therefore, affect the ability to drive, cross the road safely or operate machinery, especially at the start of treatment or when changing over from other preparations, or during concomitant use of alcohol.
INTERACTIONS Combination with diuretics or other antihypertensive agents or nitrates and tricyclic antidepressants may potentiate the antihypertensive response to Ramipril or Ramipril + Hydrochlorothiazide. Patients previously treated with diuretics may experience a marked drop in blood pressure. Potassium-sparing diuretics such as spironolactone, amiloride and triamterene or potassium supplements may increase the risk of hyperkalemia. Ramipril or Ramipril + Hydrochlorothiazide may weaken the effectiveness of blood sugar lowering medications (antidiabetic agents, e.g. insulin and sulphonylurea derivatives). A high intake of dietary salt may decrease the effects of antihypertensive medication. Leukopenia may be aggravated in patients undergoing treatment with
immunosuppressants, cytostatic agents, systemic corticosteroids or allopurinol. Concurrant administration of methyldopa may result in hemolysis. Since ACE inhibitors decrease the excretion of lithium salts, lithium concentrations in the blood should be monitored in patients undergoing such therapy. When Ramipril or Ramipril + Hydrochlorothiazide are administered simultaneously with nonsteroidal
antihypertensive drugs (e.g. acetyl salicylic acid or indomethacin) attenuation of antihypertensive effect and moreover acute renal failure may occur. Ramipril or Ramipril + Hydrochlorothiazide may potentiate the effects of alcohol. DOSAGE AND ADMINISTRATION Hypertension: The recommended initial dosage is 1 capsule/tablet of Ramipril or Ramipril + Hydrochlorothiazide once a day. It is started with Ramipril alone first then if required then with diuretics. The dose can be up titrated at intervals of 2-3 weeks to Ramipril 5mg and hydrochlorothiazide 12.5mg and then to a maximum of Ramipril 10 mg and hydrochlorothiazide 12.5 mg. If required another antihypertensive agent may be added. In patients pre-treated with a diuretic, consideration must be given to discontinuing the diuretic at least 2-3 days (depending on the duration of action of the diuretic) longer before initiating the treatment with Ramipril or Ramipril + Hydrochlorothiazide. If discontinuation is not possible the treatment should be
initiated with the smallest possible dose of Ramipril (1.25mg daily) in a free combination. Subsequently a changeover to an initial daily dose of Ramipril or Ramipril + Hydrochlorothiazide not exceeding one capsule should be made. Dosage in patients with impaired renal function: For patients with creatinine clearance between 60 and 30ml/min/1.73m2 body surface area, treatment is initiated with Ramipril alone 1.25mg. After gradually increasing the dose of Ramipril, medication with Ramipril or Ramipril + Hydrochlorothiazide is initiated at a daily dose of 1 capsule. The maximum permitted daily dose is 2 capsules of Ramipril or Ramipril + Hydrochlorothiazide in such patients. Administration Generally, the prescribed daily dose should be taken in the morning as a single dose. The capsules must be swallowed as a whole with sufficient amounts of liquid (approx glass). They may be taken before during or after a meal.
DATA INTERPRETATION
BRAND NAME
CARDACE HOPACE RAMIPRES RAMACE RAMISTAR RL RAMCOR RACE ODIPRIL MACPRIL ZIRAM ZOREM RAMIHEART
COMPANY NAME
Sanofi Aventis Micro Cardicare Cipla Astra Zeneca Lupin Sunij Pharma Epca Alkem Blue Cross Macleods Fdc Intas Mankind
AVAILABLE STRENGTH
2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg, 2.5H 2.5mg, 5mg, 2.5H 2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg, 2.5H 2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg, 2.5H 2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg, 2.5H, 5H 2.5mg, 5mg 2.5mg, 5mg 2.5mg, 5mg
[Table no-3]
Notes: Here,
2.5 mg= 2.5 mg of Ramipril 5 mg= 5 mg of Ramipril 2.5 H= 2.5 mg of Ramipril + 12.5 mg of Hydrochlorothiazide 5 H= 5 mg of Ramipril + 12.5 mg of Hydrochlorothiazide
Brand Name
Company Name
Cardace Hopace Ramipres Ramace Ramistar Rl Ramcor Race Odipril Macpril Ziram Zorem Ramiheart
Sanofi Aventis Micro Cardicare Cipla Astra Zeneca Lupin Sunij Pharma Epca Alkem Blue Cross Macleods Fdc Intas Mankind Total
400
391
350
300 275
250
131
62
50
70 32 9
22 0
Brand Name
[Graph 1]
Cardace
Hopace Ramipres Ramace 5.73 Ramistar Rl Ramcor Race Odipril
1.1
3.52 3.12 10.82 14.14 6.79
13.83
Macpril Ziram
[Graph 2]
0.30
22%
[Graph 3]
5 237 55
2.5H 102 8
5H 10 0
11.15
Tablet Capsule
88.85
[Graph 4]
Unit percentage value is the value which gives information about percentage of total revenue generated from sale of the brand. It is calculated from total unit sale of the product and price per unit.
Brand Name
2.5 Cardace Hopace Ramipres Ramace Ramistar Rl Ramcor 6.54 4.5 4.52 6.73 5.5 2.4 2.5
Price
Unit Sale
Value
Unit % Sale
5H 11.4
5H 50 29308.6 6169 14467.5 14916.75 17140 6220 1901 28.57 6.01 14.10 14.54 16.71 6.06 1.85
4.4 Race Odipril Macpril Ziram Zoram Total 5.4 2 1.1 1.78 5.21 6.5 3 2.2 3.49 8.66 5.5 2.5 1.75 530 150 1770 1020 270 140 50 530 290 50
40 50 20 200 4047 500 3486 2836.7 1581.2 102573.75 3.95 0.49 3.40 2.77 1.54 100
[Table no-8]
Unit % Value
30
25
20
Unit % Value
15
10
Brand Name
[Graph 5]
250
200
sale
150
100
50
[Graph 6]
FINDINGS
As per the survey conducted, the market share of different companies is quite different. Many companies are available in the market but few brands are running good. The market share of SANOFI AVENTIS under the brand name of CARDACE is around 20 %. Then other brands are also having good position like RAMISTAR (LUPIN) 14.14% RAMIPRES (CIPLA)- 13.83% MACPRIL (MACLOEDS)- 12.58% Most Prescribed strength in Ramipril is 2.5mg because the treatment is started with normal dose. Then the doctor moves to higher dose. Based on severity Ramipril hydrochlorothiazide is prescribed. I also came to know that doctors are also prescribing hypertensive drugs other than the Ramipril also. Price difference is more among the brands. MACPRIL 2.5 mg is available only at Rs.11 while CARDACE 2.5 mg is available at Rs. 65. 88.85 % brands are available in Tablet form while only 11.15 % brands are available in capsule form. All brands are available in 10 TAB/strip except RAMACE which is available in 15 TAB/strip.
Pharmaceutical market is most dynamic and continuously changing market so
nothing is permanent.
SUGGESTIONS
I would like to give following suggestions based on my market survey, 1. Market share of CARDACE is highest though its price is high than others because most doctors prefer more that. So company should think about this price factor and also how to conduct doctors that they prescribe more.
2. Company should think about field force penetration in different areas in which will help in capture the market.
3. For the help of field force I have specified name of major prescribers of each brand so company should give more attention on them.
4. Price range is around 10-30 Rs. for lower brands and for higher brand 40-60
hydrochlorothiazide is less preferred. So my suggestion is to concentrate on only Ramipril. 6. During my survey I came to know doctors are preferred Tablet form more than capsule so my suggestion is to keep the dosage form to Tablet form. 7. Promotional efforts are zero from the company. So we can include promotional efforts like leaflets, posters, banners etc.
LIMITATION OF SURVEY
This survey is conducted in limited area in Ahmedabad. So it is not total picture or reflection of the market of whole Ahmedabad. So it cannot be generalized. The findings in this study are purely dependent on the answers of the respondents. The information recorded is based on the opinion and reactions of the respondents as on the date of research.
References
1. http://www.themedica.com/drug/cardiovascular-drug/ 2. http://www.kamronlabs.in 3. http://www.drugs.com/ramipril.html 4. http://www.drugs.com/dosage/ramipril.html#ixzz0sRXmqiIk 5. http://www.drugs.com/ppa/ramipril.html#ixzz0sRWRpeFoF
APPENDIX Questionnaire
Name of the Chemist: Date: Area: 1) Which brands of Ramipril and Ramipril + Hydrochlorothiazide you are having: Brand name Company name Dosage forms Tablet Capsule
2) In which strength tablet and capsule are available? Tablet mg of Ramipril + mg of hydrochlorothiazid e Capsule mg of Ramipril + mg of hydrochlorothiazi de
Brand name
Company name
3) Which type of packaging available for tablet & capsule? Brand name Company name Tablet/strip or Capsule/strip
Company name
Rs./Tablet or Rs./Capsule
5) How much quantity of Ramipril you sell per day? 6) Approximately how much quantity of each brand you sell per day? Brand name Company name Tablet/day or Capsule/day
7) How many no of prescription are you handling during the day from Dr.? Prescription No of Brand name Doctors name strength Speciality prescriptions/ day