Dissertation Report on Banned FDC drugs in India on 10th March

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<p>Overnight ban on Fixed Dose Combination Drugs by Government of India: Impacts &amp; Analysis on Indian Pharmaceutical Industry Dissertation ReportMarch-April, 2016</p> <p>Submitted By:Akshay SaxenaMBA (Pharmaceutical Management)Faculty of Management &amp; Information TechnologyJamia Hamdard Session: 2014-2016</p> <p>Submitted to:College Mentor:Dr. Shibu JohnHead of DepartmentJamia Hamdard</p> <p>Declaration</p> <p>I, Akshay Saxena hereby declare that the project entitled Overnight ban on Fixed Dose Combination Drugs by Government of India: Impacts &amp; Analysis on Indian Pharmaceutical Industry is my original and exclusively my own work. I further declare that the work is my own authentic piece of work and has not been submitted at my organization/institute/university for personal/academics gains and benefits or award of any degree/diploma/certificate.</p> <p>Akshay SaxenaMBA (Pharma Management)Enrolment No.: 2014-542-001Jamia HamdardNew Delhi</p> <p>Acknowledgement</p> <p>I wish to express my gratitude to the almighty God for giving me the strength to perform my responsibilities as an intern and complete the report within the stipulated time.I was given the opportunity to prepare a report for my dissertation work under supervision of our honourable supervisor of internship. It was great opportunity for me to augment my knowledge about analysing critical data and information. This report would have been incomplete without the help of certain people. The purpose this part of the report is to pay a tribute to all of those cooperative people who gave their precious time to help me and without whose assistance it would have been impossible to finish the report.I would also like to thank and express my gratitude to Dr. Shibu John, Head of Department, Jamia Hamdard for his invaluable feedback and support.I am also grateful to my parents, Harsh Shah and my other friends without their valuable input, this report and research could not have been successful.In the end, it is necessary to mention that this report is the result of days of hard work. I am thankful to the people who have contributed greatly behind the completion of the report. Without their help, this report would have not been even completed within the deadline.</p> <p>Executive Summary</p> <p>On 10 March 2016, the Union Health Ministry banned 344 fixed drug combinations by issuing a gazette notification. Fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines will have an impact of 3.1 per cent or Rs. 3,049 crore of the country's pharma retail market currently valued at 98,042 crores, according to a market based study.The list is inclusive of a number of commonly used cough syrup solutions, as well as antibiotic combinations and analgesics. Majority of the combinations banned are sold over the counter. The government had recently constituted an expert committee in order to gauge how effective were the various drug combinations found in India. It was on the basis of the recommendations made by the said committee that the ban was imposed. However, it is expected that the industry will not take this lying down; in fact, some of the companies affected by the ruling may even seek judicial redress.A lot of these medicines, thus developed, happen to have antibiotics in their make. They are also sold in an over-the-counter manner, thus, making it hard for authorities to carry out drug resistance measures properly. Recently, the Health Ministry had started a programme to reduce the casual and irresponsible manner in which antibiotics are consumed in India. As a result of that initiative, the government has now come up with a special schedule that requires chemists to check prescriptions before they sell medicines and also have records of the same. If they dont observe these measures, they may face actions initiated by the government against them.Even as the Union health ministry's ban on 344 fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines has made a sales impact of over Rs.10,000 crore, category of FDCs most impacted includes antibiotics, antihistaminic, caffeine and codeine combinations and NSAID.Government has banned common household medicines Crocin Cold and Flu, D-Cold Total, Sumo, Oflox, Gastrogyl, Chericof, Nimulid, Kofnil, Dolo Cold, Decoff, O2, paediatric syrup T-98 and TedyKoff, as part of its decision to stop the manufacture and sale of FDCs.Delhi High Court extends stay on ban ofsomedrugs till 28 MarchTheDelhi High Court put on hold a ban that has been imposed on the sale and manufacture of more than 300 fixed dose combinations (FDC) medicines like DCold, Vicks Action 500 Extra and Benadryl. After resuming a hearing on pleas by 30+ pharmaceutical companies, the court decided to hold the ban till 28 March 2016. Previously, Delhi High Court had offered an interim relief on 14 March to Pfizers cough syrup Corex.</p> <p>Content1.0 Introduction1.1 The Indian pharmaceutical industry71.2 The Ban91.3 List of banned FDC drugs11</p> <p>2.0 Literature Review20</p> <p>3.0 Justification/Rational254.0 Objectives26</p> <p>5.0 Research Methodology274.1 Research Design4.2 Research Tools4.3 Data Collection</p> <p>6.0 Study Findings6.1 Reason for the ban of FDC drugs296.2 Financial loss endured by the pharmaceutical companies356.3 Measures taken by the pharma companies after the ban426.4 Impact on consumers44</p> <p>7.0 Conclusion45</p> <p>8.0 Bibliography50</p> <p>1.0 Introduction</p> <p>The Indian Pharmaceutical IndustryThe Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on from a turnover of approx. US $1 billion in 1990 to over US $30 billion in 2015 of which the export turnover is approximately US $ 15 billion. The country now ranks 3rd world wide by volume of production and 14th by value, thereby accounting for around 10% of worlds production by volume and 1.5% by value. Globally, it ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms. Indian exports are destined to more than 200 countries around the globe including highly regulated markets of US, West Europe, Japan and Australia. It has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products. It has established its presence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies. Formulations in various dosage forms are being produced in GMP (Good Manufacturing Practices) compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible.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 pharmaceuticals market is expected to expand at a CAGR of 23.9 percent to reach US$ 55 billion by 2020. 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.The Indian pharmaceutical industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years. 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 pharma market to grow at 10-12 per cent in FY15 as compared to 9 per cent in FY14.Recognizing the potential for growth, the Government of India took up the initiative of developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008. The Department is entrusted with the responsibility of policy, planning, development and regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical Industry's strength reveals the following key features: Strong export market- India exported drugs worth US$ 15 billion to more than 200 countries including highly regulated markets in the US, Europe, Japan and Australia. Large Indian pharma companies have emerged as among the most competitive in the evolving generic space in North America and have created an unmatched platform in this space. Indian companies are also making their presence felt in the emerging markets around the world, particularly with a strong portfolio in anti-infective and antiretroviral. Large domestic pharma companies have continued to grow, assuming leadership position in many therapies and segments in the Indian market as well as creating a strong international exports back-bone. Competitive market with the emergence of a number of second tier Indian companies with new and innovative business modules. Indian players have also developed expertise in significant biologics capabilities. Biologic portfolios while still nascent in India are being built with an eye on the future. Multinational companies have continued to invest significantly in India and are making their presence felt across most segments of the Indian pharma market. Companies have also begun to invest in increasing their presence in tier II cities and rural areas and making medical care more accessible to a large section of the Indian population. Low cost of production. Low R&amp;D costs. Innovative Scientific manpower. Excellent and world-class national laboratories specializing in process development and development of cost effective technologies. Increasing balance of trade in Pharma sector. An efficient and cost effective source for procuring generic drugs, especially the drugs going off patent in the next few years. An excellent centre for clinical trials in view of the diversity in population.</p> <p>Indian pharmaceutical market segments by valueAnti-infective drugs command the largest share (16%) in the Indian pharma market. </p> <p>THE BANSince 1961, Indias drug controller has approved more than 1,200 combination drugs or FDCs (Fixed Dose Combinations), according to a list published on the website of the Health Ministrys Central Drugs Standard Control Organization (CDSCO), the national drug regulatory body. But many have also been licensed on the state level without the approval of the central government.It wasnt until 1988 that the definition of a new drug under Indian law was amended to expressly include the combination of two or more already approved drugs.What is a fixed-dose combination?The term fixed-dose combination product is synonymous with fixed-ratio combination product. Both terms refer to a product that contains two or more active ingredients. Because the product is of a defined composition, the two (or more) ingredients are present in a fixed ratio. Hence the term fixed dose or fixed ratio combination.Such a product may be available in more than one strength, each of which may itself be a fixed dose combination and may contain different ratios of active ingredients. For example, Augmentin Duo Forte tablets contain 850 mg of amoxicillin and 125 mg of clavulanic acid (a ratio of 6.8:1) whereas Augmentin Forte tablets contain 500 mg of amoxicillin and 125 mg of clavulanic acid (a ratio of 4:1). Different ratios can be rational in particular circumstances.Advantages of fixed-dose combinationsThe presumed advantages of FDCs include: Drugs that are normally given in combination are more conveniently prescribed and consumed as an FDC. Better patient compliance is claimed. It is cheaper to purchase an FDC product than to purchase the products separately. The logistics of procurement and distribution are simpler (which can be especially important in remote areas).</p> <p>Disadvantages of fixed-dose combinationsCritics of FDCs suggest that: FDCs discourage separate titration of each active ingredient. This is a particular problem when both of the active ingredients require dose titration. Indeed, it can be argued that the very existence of an FDC discourages adjustment of doses to the patients needs (if that is appropriate for the combination in question). When the active ingredients in question have different pharmacokinetics and/or pharmacodynamics, an FDC may not be appropriate. Unless both of the active ingredients are available as separate entities, FDCs encourage polypharmacy irrespective of whether it is appropriate for a particular patient.</p> <p>In 2007, the government tried and failed to get close to 300 state-licensed combination drugs withdrawn. In 2012, the government undertook another attempt to exert control over the FDC market. That followed a parliamentary report critical of the functioning of the CDSCO. The report also underlined the health risks posed by unapproved combinations.For a long time in India, patients have been consuming drugs which are banned in various countries like the USA, Canada, Europe, Australia etc. The most common are like Nimesulide, Furazolidone, Phenylpropanolamine and other over the counter preparation are banned by USFDA due to their side effect on kidney, liver and nervous system. Unfortunately analgesic, antidiarrheal and cough preparations which are banned in other countries and are blindly used in India as over the counter drugs because of unawareness, lack of law enforcement and corruption. All the formulations are meant for prevention or treatment of ailments and diseases, out of which only a few drugs are lifesaving and essential, rest of the drugs are substitutes of each other.Banned drugs are drugs which are prohibited to intake as they artificially improve the performance but show various adverse effects more than therapeutic effects. Their production or use is prohibited or strictly controlled via prescription.Drug Controller general of India is the highest authority in India to expand the approval of any drug or to ban a drug. Some of the dangerous drugs have been globally discarded but are available in India. The most common are like Nimesulide, Furazolidone and Phenylpropanolamine On 10 March 2016, an expert committee, CDSCO (Central Drugs Standard Control Organization) found about over 300 of medicinal products to be irrational in nature which means that they could potentially harm patients who consumed them. Commentators pegged fixed dose combination or FDCs to constitute nearly 50% of the $15 billion domestic Indian pharma market. It is impossible to believe that such a larg...</p>