OVERVIEW OF pharma industry

OVERVIEW OF pharma industry
India is today recognized as one of the leading global players in pharmaceuticals. Globally the Indian pharmaceutical industry ranks 4th in terms of volume (with an 8 per cent share in global sales), 13th in terms of value (with a share of 1 per cent in global sales) and produces per cent of the world's generic drugs (in terms of value). Internationally recognized as amongst the lowest-cost- producers of drugs. Indian Pharma Industry is around Rs Cr. & 17% per annum*. It is estimated that by the year 2012, the Indian pharmaceutical industry has the potential to achieve over Rs.1,00,000 crore production of formulations and bulk drugs. *Source: ORG-IMS> ORG IMS is a leading market research agency, providing business intelligence about the pharmaceutical market. ORG IMS track and assess billions of transactions, from more than 1 million drug products and measure 75% of ethical drug sales which supports more than 3,000 pharma manufacturers through 29,000 data suppliers and 225,000 chemists.

TOP 10 PHARMA COMPANIES GLOBALLY. RANK CO. SALES($ Billion) % GR 1) PFIZER 2) NOVARTIS 3) SANOFI-AVENTIS 4) GSK (3.4) 5) ASTRAZENECA 6) ROCHE 7) J & J (6.6) 8) MERCK & CO (4.1) 9) Eli Lilly 10) ABBOTT Source: IMS Health, MAT Sept.2009

TOP 5 PHARMA BRANDS IN INDIAN PHARMA INDUSTRY VALUE(Rs.Cr.) GR% COREX (Pfizer) VOVERAN (Avantis) PHENSEDYL (Piramal HC) HUMAN MIXTARD (Novo nordisk) LIV (Himalaya) (Source: ORG-IMS,MAT JAN.09)

The Indian Pharmaceutical industry has been witnessing phenomenal growth in recent years, driven by rising consumption levels in the country and strong demand from export markets. This segment of Industry has shown tremendous progress in terms of infrastructure development, technology base and wide range of products. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes and has also developed excellent GMP (Good Manufacturing Practices) compliant facilities for the production of different dosage forms.

Rising disposable income, improving health infrastructure such as the government’s incentives to set up 100-bed hospitals in non-metro towns, and the general increase in health awareness due to deep penetration of the electronic media are the corner stones of sales expansion. While India’s metros and class I cities drive the growth, tier II cities and rural market add to the growth momentum. As far as MNCs in India are concerned most of the sales are generated in urban or semi-urban areas. However, multinationals like GSK, Sanofi-Aventis, MSD India (Merck) etc., have started tapping the rural sector too, of late, realizing their growing potential. Thursday, 12 November Cipla (Chemical, Industrial & Pharmaceutical Laboratories) launches generic drug to treat H1N1 (Business Standard Reporter/Mumbai ) Indian drug major Cipla has launched generic versions of anti-flu drugs oseltamivir and zanamivir in the local market to treat the H1N1 influenza, which is spreading across the globe and in India. Cipla will brand oseltamivir in the local market as Antiflu and zanamivir as Virenza. Antiflu will cost Rs 475 for 10 capsules, in line with the price of competing products in the market. Virenza — an inhaled drug — will cost Rs 800, which includes the price for an inhalation device.

The Domestic Pharma 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 maintain highest standards in Purity, Stability and International Safety, Health and Environmental (SHE) protection in production and supply of bulk drugs even to some innovator companies. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Anti- infectives, Cardiovascular, CNS group. Along with Brazil & China, India has carved a niche for itself by being a top generic Pharma player.

The Domestic Pharma Industry Increasing number of Indian pharmaceutical companies have been getting international regulatory approvals for their plants from agencies like USFDA, MHRA(Medicines and Healthcare products Regulatory Agency,UK), TGA(Therapeutic Goods Administration, Australia), MCC (Medicines Control Council of South-Africa), Health Canada etc. India has the largest number of USFDA - approved plants for generic manufacture. Major share of Indian Pharma exports going to highly developed western countries bears testimony to not only the excellent quality of Indian pharmaceuticals but also its price competitiveness. More than 50% share of exports is by way of dosage forms. Indian companies are now seeking more Abbreviated New Drug Approvals (ANDAs) in USA in specialized segments like anti-infective, cardio vascular and central nervous system groups.

Recent Initiatives in Pharma sector Government has taken various policy initiatives for the Pharma sector- 1. has offered fiscal incentives to R&D units in Pharma sector 2. Steps have been taken to streamline procedures covering development of new drug molecules, clinical research etc. 3. Government has also come up with two new schemes specially targeted at drugs & pharmaceutical research. These are: 'The New Millennium Indian Technology Leadership Initiative' (NMITLI) and the 'Drugs and Pharmaceuticals Research Programme' (DPRP).

Key Strengths- Strong manufacturing base Cost competitiveness Network of laboratories and R&D infrastructure Highly trained pool of scientists and professionals World-class quality products Strong marketing and distribution network Strong process development skills Potential ground for clinical trials Fast growing health care industry Rich biodiversity Growing biotechnology industry Highest Quality approvals from USFDA, EDQM(European Directorate for the Quality of Medicines & HealthCare), MHRA etc. Ranks 4th in the world, accounts 8% by volume and 2% by value. Very strong in Indian medicine systems of Ayurvedic, Homeopathy, Unani, Siddha and Herbal medicines. An excellent center for clinical trials.

Research and Development: In no other Industry segment, innovative R&D is as critical as in Pharma industry. Here, the New Drug Discovery Research (NDDR) has to keep pace with the emerging pattern of diseases as well as responses in managing existing diseases where target organisms are becoming resistant to existing drugs. The NDDR is also an expensive activity. It is encouraging to observe that at least 10 Indian companies are into new drug discovery in the areas of infections, metabolic disorders like diabetes, inflammation, respiratory, obesity & cancer. Most of these companies have increased their R&D spending to over 5% of their respective sales turnovers.

Research and Development: Introduction of Product Patent for Pharmaceuticals is an important feature for Indian Pharma R&D scenario. This has boosted the confidence of MNC Pharma companies in India where a number of western Pharma companies have already R&D collaborations with Indian Pharma companies in the field of NDDR. Western Pharma companies have recognized the attractiveness of India as a R&D outsourcing destination due to low cost scientific manpower, excellent infrastructure, top quality with capability to conduct modern research under GLP(Good Laboratory Practice), GCP(Good Clinical Practice) guidelines. Many of them have set up independent R&D centers in India. Clinical Trials to establish safety and efficacy of drugs constitute nearly 70% of R&D costs. Considering the low cost of Research and Development in India, several MNC Pharma companies as well as global Clinical Research Organizations are increasingly making India a clinical research hub. New drug discovery in India has made a promising start wherein at least five to six potential candidates in the areas of Malaria, Obesity, Cancer, Diabetes and Infections are likely to reach Phase II clinical trials.

Public Sector Undertakings Hindustan Organic Chemicals Ltd. (HOCL), Rasayani,Maharashtra. Hindustan Insecticides Ltd, New Delhi. Indian Drugs & Pharmaceuticals Ltd (IDPL),Dundahera Industrial Complex, Gurgaon, Haryana. Hindustan Antibiotics Ltd (HAL),Pimpri, Pune, Maharashtra. Smith Stanistreet Pharmaceuticals Ltd. (SSPL) ,Kolkata. Bengal Chemicals & Pharmaceuticals Ltd (BCPL), Kolkata, West Bengal. Bengal Immunity Limited (BIL) ,Kolkata, West Bengal. Joint Sector Undertakings Rajasthan Drugs & Pharmaceuticals Limited (RDPL) Orissa Drugs & Chemicals Limited (ODCL) Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) Maharashtra Antibiotics & Pharmaceuticals Ltd. (MAPL) Manipur State Drugs & Pharmaceuticals Limited (MSDPL) Wholly Owned Subsidiaries IDPL (Tamil Nadu) Limited, Chennai Bihar Drugs & Organic chemicals Limited, Muzaffarpur

HISTORY OF PHARMACEUTICAL INDUSTRY
The first Indian pharmaceutical company, Bengal Chemicals and Pharmaceutical Works, which still exists today as one of 5 government-owned drug manufacturers, appeared in Calcutta in 1930. For the next 60 years, most of the drugs in India were imported by multinationals either in fully-formulated or bulk form. The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970, enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out, Indian companies started to take their places. They carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.

future OF PHARMACEUTICAL INDUSTRY
INDIA IS PROJECTED TO BE THE 10th LARGEST MARKET BY 2015 Top 14 pharmaceuticals Top 14 pharmaceuticals markets, markets, 2015 1 US US 2 Japan Japan 3 France France 46 4 Germany Germany 38 5 Italy China 6 UK UK 7 Spain Spain 8 Canada Italy 9 China Canada 25 10 Mexico India 11 Brazil Brazil South Korea Mexico 19 13 Turkey South Korea 15 14 India Turkey 15 (US$ billion) Source: IMS World Review

Swot Analysis of INDIAN PHARMA INDUSTRY
Strengths: 1. Indian manufacturers are one of the lowest cost producers of drugs in the world. With a scalable labor force, Indian manufactures can produce drugs at 40% to 50% of the cost to the rest of the world. In some cases, this cost is as low as 90%. 2. Fast changing lifestyles in urban and to some extent rural centers, opens a huge market for lifestyle drugs, which has low contribution in the Indian markets, as of now. 3. Indian pharmaceutical industry possesses excellent chemistry and process reengineering skills. This adds to the competitive advantage of the Indian companies. The strength in chemistry skill helps Indian companies to develop processes, which are cost effective. 4. With the introduction of VAT, medicine prices have been standardized and price discrimination, in which different states pay different prices for the same products, has reduced. VAT has also helped reduce the illegal interstate transfer of goods and the unethical interstate trade for higher margins. 5. Large pool of skilled technical manpower. 6. Increasing liberalization of government policies.

VAT, as the name indicates, is a tax on Value Addition and thereby is applicable on all the stages of sales and services involved in the transfer of property in goods, till it reaches the consumer. VAT can be called a multi-point tax system. Under VAT there are only four rate structures, that is: zero per cent, one per cent, four per cent and 12.5 per cent, with no additional tax or surcharge, as was applicable under sales tax. It is a simplified form of tax allowing full input tax credit on the procurements and capital goods, except for a few restrictions, which differs from state-to-state. 20 of India’s 34 states and union territories have decided to adopt VAT. At present, VAT has replaced only Local Intra State taxes levied at state level like Local (basic) Sales Tax, Turnover Tax (TOT), Additional Taxes and Surcharges including taxes levied on deemed sales namely Work Contract (WC) and Leasing Transactions. It is important to note that Central Sales Tax (CST) governing interstate transactions continue to be operational as it is, though there has been a proposal to phase it out in 2 to 3 years.

Weakness: Indian pharma market is less penetrated in the world. However, growth has been slow to come by. As a result, Indian majors are relying on exports for growth. To put things in to perspective, India accounts for almost 16% of the world population while the total size of industry is just 1% of the global pharma industry. Due to very low barriers to entry, Indian pharma industry is highly fragmented with about 300 large manufacturing units and about 20,000 small units spread across the country. This makes Indian pharma market increasingly competitive. The industry witnesses price competition, which reduces the growth of the industry in value term. For eg.as per Sept.09 ORG-IMS,IPI has grown by 9.6%. A large proportion of the rural population still does not have access to proper medication and the situation may take long to improve. The Indian pharma companies are marred by the price regulation. Over a period of time, this regulation has reduced the pricing ability of companies. The NPPA (National Pharma Pricing Authority), which is the authority to decide the various pricing parameters, sets prices of different drugs, which leads to lower profitability for the companies. The companies, which are lowest cost producers, are at advantage while those who cannot produce have either to stop production or bear losses. Opportunities : The migration into a product patent based regime from Jan.2005, is likely to transform industry fortunes in the long term. The new patent product regime will bring with it new innovative drugs. This will increase the profitability of MNC pharma companies and will force domestic pharma companies to focus more on R&D. Large number of drugs going off-patent in Europe and in the US between 2005 to 2009 offers a big opportunity for the Indian companies to capture this market. Since generic drugs are commodities by nature, Indian producers have the competitive advantage, as they are the lowest cost producers of drugs in the world.

Opportunities (contd.): Opening up of health insurance sector and the expected growth in per capita income are key growth drivers from a long-term perspective. This leads to the expansion of healthcare industry of which pharma industry is an integral part. Being the lowest cost producer combined with FDA approved plants, Indian companies can become a global outsourcing hub for pharmaceutical products. Growing attention for health & Growing incomes. Globalization & Easier international trading. Threats: Threats from other low cost countries like China and Israel exist. High Cost of discovering new products and fewer discoveries.

Significant implications for Indian players
Indian companies will need to pursue differentiated strategies, sustain product access, drive market creation and strengthen sales and marketing capabilities. 1. Shift focus from market share capture to market creation Traditional product markets today are well covered and growth opportunities are medium or low. Need to create new markets thru new molecule launches, complete product basket. 2. Adopt new and differentiated business models With the ongoing changes in market opportunities, competitive scenario and disease profiles, a homogenous business model is unlikely to work. Domestic companies will do well to vary their approach in terms of products, pricing, physician coverage, selling approach and infrastructure, and financial expectations. 3. Sustain product access For local players , pre-1995 products will be the primary source of product access. In addition, incremental innovation through fixed-dose combinations will be important. Finally, in-licensing will provide a meaningful opportunity and the basket could include as much as one-third of all globally launched products. Companies with high quality sales coverage, strong marketing capabilities and a reputation for fair selling practices will emerge as the preferred partners for product in-licensing. 4. Strengthen sales and marketing capabilities To withstand competition and create genuine differentiation in the market place, domestic companies will need to upgrade their sales and marketing capabilities. These capabilities will need to encompass new product development and launch, brand lifecycle management, marketing spend effectiveness and sales force effectiveness. As companies attempt to create newer markets and adopt different business models, these capabilities will become more specialized.

NATURE OF PHARMA BUSINESS
The drug industry, the medical profession and the patient have a unique relationship. The industry makes products which it cannot sell to the patient (consumer) directly & on the other hand, the medical profession cannot treat the patient without drugs produced by the industry, thus the industry and medical profession are interdependent with a common aim of to alleviate pain and suffering. The pharma business has to work on two lines- a) Ethics of the business and b) sales promotion of the business organization.

Impact of Pharmaceutical Industry on INDIAN Economy
Among all the major industries in India, pharmaceuticals are surely one of the leaders. The Indian government has listed the pharmaceutical industry as an intellectual industry and investment in research and development has been enhanced. More than 9,000 companies are publicly listed. The Indian pharmaceutical industry is a net exporter of bulk drugs and generics and ranks 17th in the world in terms of bulk drug and formulation exports. More recently, a growing number of MNCs have entered into more collaborative ventures with Indian pharmaceutical companies and contract research organizations, extending well beyond task-driven outsourcing. These transactions involve more complex intellectual property considerations. The pharmaceutical industry in India is expected to grow to $75 billion USD by the year 2020. It has also started making global footprints and over $ 2.5 billion worth of acquisitions were made overseas in past couple of years.

What is MERGERS & ACQUISITIONS? One plus one makes three: this equation is the special alchemy of a merger or an acquisition. The key principle behind buying a company is to create shareholder value over and above that of the sum of the two companies. Two companies together are more valuable than two separate companies - at least, that's the reasoning behind M&A. This rationale is particularly alluring to companies when times are tough. Strong companies will act to buy other companies to create a more competitive, cost-efficient company. The companies will come together hoping to gain a greater market share or to achieve greater efficiency. Because of these potential benefits, target companies will often agree to be purchased when they know they cannot survive alone.

What is MERGERS & ACQUISITIONS? Distinction between Mergers and Acquisitions Although they are often uttered in the same breath and used as though they were synonymous, the terms merger and acquisition mean slightly different things. When one company takes over another and clearly established itself as the new owner, the purchase is called an acquisition. From a legal point of view, the target company ceases to exist, the buyer "swallows" the business and the buyer's stock continues to be traded. In the pure sense of the term, a merger happens when two firms, often of about the same size, agree to go forward as a single new company rather than remain separately owned and operated. This kind of action is more precisely referred to as a "merger of equals." Both companies' stocks are surrendered and new company stock is issued in its place.

What is MERGERS & ACQUISITIONS? In practice, however, actual mergers of equals don't happen very often. Usually, one company will buy another and, as part of the deal's terms, simply allow the acquired firm to proclaim that the action is a merger of equals, even if it's technically an acquisition. A purchase deal will also be called a merger when both CEOs agree that joining together is in the best interest of both of their companies. But when the deal is unfriendly - that is, when the target company does not want to be purchased - it is always regarded as an acquisition Whether a purchase is considered a merger or an acquisition really depends on whether the purchase is friendly or hostile and how it is announced. In other words, the real difference lies in how the purchase is communicated to and received by the target company's board of directors, employees and shareholders.

MERGERS & ACQUISITIONS: During the period July 2003 to February 2006,26 acquisitions made by the Indian pharmaceutical companies The major pharmaceutical mergers and acquisitions in 2007 can be enlisted as Wockhardt's acquisition of the French company Negma Laboratories for $265 million and the US-based Morton Grove Pharmaceutical s for $38 million. Jubilant Organosys' acquisition of Hollister-Stier Laboratories of the US for $122.5 million Alembic’s buyout of the entire domestic non-oncology formulation business of Dabur Pharmaceutical for Rs 159 crore. The largest Japanese pharmaceutical innovator company, Daiichi Sankyo acquired Ranbaxy Laboratories in June 2008 in a $4.6 billion deal. US-pharmaceutical major Abbott announced on to acquire Piramal Healthcare for USD 3.72 bn (about Rs 18,000 crore) to become the largest drug manufacturer in India. NeutraHealth, a UK-based supplier of vitamins and supplements, agreed to be acquired by India’s Elder Pharmaceutical for about £12.2 million ($19.1 million)

Many of the MNCs are collaborating with Indian companies, which often offer as much as 30% to 50% savings in total drug discovery and development costs. In 2005, India amended its patent laws to comply with the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international treaty mandating minimum standards for trade and intellectual property protection. Companies in India offer two types of opportunities for drug discovery and development: outsourcing and true collaborations. The outsourcing model entails an union between one or more entities to perform discrete tasks or specific operations and processes previously done in-house. In this model, the company soliciting the research typically maintains control over the technology and related assets, including intellectual property.

Global pharma scenario
The global pharmaceutical market is forecast to grow to $929 billion in 2012, an equivalent compound annual growth rate (CAGR) of 5.5% over. The leading therapy areas by sales were CNS with 16.5% share and cardiovascular with 15.4%. The US retail pharmaceutical market grew to $206 billion but growth rates fell due to loss of patent protection on some blockbusters. France, Germany and the UK together accounted for almost 50% of all European pharmaceutical sales in 2007. The top 100 blockbuster drugs generated sales of $252.5 billion, accounting for 35.5% of the total pharmaceutical market. The leading blockbuster by increased sales revenues in 2007 was the blood agent product Plavix (clopidogrel bisulfate), marketed by Sanofi-Aventis and Bristol-Myers Squibb. There were a total of 61 companies generating pharmaceutical sales in excess of $1 billion in 2007.

WORLD PHARMA MARKET- YEAR VALUE (in USD) bn bn COUNTRY Pharma Mkt. Growth in 2008 (%) US JAPAN ASIA,AFRICA & AUSTRALIA LATIN AMERICA EUROPE

GLOBAL PHARMA MARKET SEGMENTATION (% Share by Value): Geography % AMERICAS EUROPE ASIA-PACIFIC TOP 5 BRANDS IN THE WORLD: BRANDS CO Value (USD bn) LIPITOR(Atorvastatin) Pfizer ,66 PLAVIX (Clopidogrel) Aventis NEXIUM(Esomeprazole) Astra SERETIDE(Fluticasone/Salmeterol) GSK ENBREL (Etanercept) Wyeth

EXPANDING GLOBAL PRESENCE
alliances: Indian Firm International Firm Market DRL Par,Pharmascience US/Canada Cipla Ivax,Watson,Morton Grove,Eon US Cadila Mayne,Mallinckrodt Global JB Chemicals Pharm-a-Care Australia Lupin Watson,Baxter US Wockhardt Pharma Dynamics S.Africa Glenmark KV , Apotex US

EXPANDING GLOBAL PRESENCE
Acquisitions: Indian Firm International Firm Market RANBAXY Ohm Laboratories US RANBAXY RPG Aventis France RANBAXY Basics Germany WOCKHARDT Wallis, CP Pharma UK WOCKHARDT Esparma Germany CADILA Alpharma France SUN PHARMA Caraco US

CHALLENGES AND OPPORTUNITIES FOR THE INDIAN PHARMA INDUSTRY
With the implementation of product patent from the year 2005, there will be a tough competition for the global marketshare. Pharma companies will have to focus more intensively on R&D activity to survive the competition. Table 2: Global Health Expenditures % Share of GDP Spent on Health United States Germany United Kingdom China India Brazil Pakistan Mexico South Africa Sri Lanka

Challenges and opportunities in today’s global Pharmaceutical scenario
The pharmaceutical industry is facing an unprecedented number of challenges. However, these challenges also present unparalleled opportunities for pharmaceutical companies to redefine themselves and remain profitable and competitive moving forward. Following are some of the industry’s most pressing issues, as well as potential responses to increase future success- 1.Managing Expiring Patents And The Competition From Generics: There are a large number of drugs coming off patent in the next two to four years. Analysts estimate that the pharmaceutical industry could lose $35 billion to $50 billion in product sales to generics during this timeframe – a huge loss of dollars that drive research & development and earnings results. The existing product pipeline is estimated to only account for annual sales growth of about 5.5 percent, even after adjustments for an aging population and expansion into new markets. This leaves an anticipated gap between market expectations and reality. What can the industry do to maximize the value of its pipelines? -First, companies need to embrace R&D in areas such as specialty products - Second, pharmaceutical companies need to look to additional partnering, licensing, mergers and acquisitions as a way to fill their product pipelines and to minimize capacity challenges created by the industry’s recent low productivity.

What are the Generic Drugs: A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use[1]. The FDA's use of the word identical is very much a legal interpretation, and is not literal.

What are the Generic Drugs: In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

Organizations must also be open to creating flexible and innovative deal structures, particularly when partnering with smaller biotech companies or organizations. Evolving Drug Development From Blockbusters To Specialty Products: Large pharmaceutical companies that continue to rely on a 30-year-old investment and commercialization model that hinges on blockbuster brands will face considerable challenges in the coming years. Companies that can diversify, yet focus, their opportunities by developing and marketing specialty products will be better positioned for price, regulatory and marketplace dynamics. Redefining the Role Of The Sales Representative : An ongoing issue is the ROI of the pharmaceutical industry’s costly “saturation” sales force and promotion model. The industry’s challenge is to find a more efficient way to target and to increase time with physicians, particularly in an education mode. One solution that ties closely to the evolution of specialty products is to establish more specialty care sales forces, which focus on one target market and are usually smaller in size. Additional cost-effective sales and promotional alternatives are seminars, peer-to-peer education and patient-centered education.

Maximizing the Potential of Emerging Global Markets By the year 2020, it’s projected that the greatest mass of individuals needing health care will be in Eastern Europe, the Pacific Rim and Africa. Conducting business in emerging economies, particularly India and China, offers tremendous opportunities and benefits including less expensive clinical trials, easier access to drug- naïve (Drug-naïve is the term used to describe patients or animals who are not under the influence of any psychotropic substances (drugs). This term usually refers to patients or animals undergoing drug-related testing, such as the effect of a certain drug on behaviour or cognitive ability). patients, potential for in-country drug discovery and development, a cost-effective population to staff drug manufacturing facilities, and a huge consumer/patient population. Companies Must Respond To Survive Those that can leverage technology and adapt their discovery, development and sales processes to support a diverse product portfolio and emerging global markets will realize financial gains and continued growth. Perhaps the biggest challenge for the pharmaceutical industry is its ability to transform the culture of its workforce.

Scope of Pharmacy: Pharmacy (from the Greek 'pharmakon' = drug) is the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of Pharmaceutical drugs. The mortar and pestle, an internationally recognized symbol to represent the pharmacy profession. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to health care, including clinical services, reviewing medications for safety and efficacy, and providing drug information.

Scope of Pharmacy: Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes. Pharmacy is also the term for an establishment where pharmacy (in the first sense) is practiced (synonym: drugstore). The word pharmacy is derived from its root word pharma which was a term used since the 1400– 1600s. Disciplines: The field of Pharmacy can generally be divided into three primary disciplines: Pharmaceutics Medicinal chemistry and Pharmacognosy Pharmacy practice

Development of Pharmacy profession:
Symbols: The two symbols most commonly associated with pharmacy are the mortar and pestle and the ℞ (recipere) character, which is often written as "rx" in typed text. Bowl of Hygeia The green Greek Cross used in Spain, Argentina, France, Poland, the United Kingdom and other countries Recipere symbol The red stylized "A" used in Germany Caduceus (used erroneously) Rod of Asclepius Hanging Show Globe

Pharmacists: Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Many pharmacists are also small- business owners, owning the pharmacy in which they practice. Pharmacists are represented internationally by the International Pharmaceutical Federation (FIP). They are represented at the national level by professional organisations such as the Royal Pharmaceutical Society of Great Britain (RPSGB), the Pharmacy Guild of Australia (PGA), the Indian Pharmaceutical Association(IPA) and the American Pharmacists Association (APhA).

Types of pharmacy practice areas: Pharmacists practice in a variety of areas including retail, hospitals, clinics, nursing homes, drug industry, and regulatory agencies. Pharmacists can specialize in various areas of practice including but not limited to: hematology/oncology, infectious diseases, ambulatory care, nutrition support, drug information, critical care, pediatrics, etc.

1)Community pharmacy: A pharmacy (commonly the chemist in Australia, New Zealand and the UK; or drugstore in North America; retail pharmacy in industry terminology) is the place where most pharmacists practice the profession of pharmacy. It is the community pharmacy where the dichotomy of the profession exists—health professionals who are also retailers. Community pharmacies usually consist of a retail storefront with a dispensary where medications are stored and dispensed. The dispensary is subject to pharmacy legislation; with requirements for storage conditions, compulsory texts, equipment, etc., specified in legislation. All pharmacies are required to have a pharmacist on-duty at all times when open. In many jurisdictions, it is also a requirement that the owner of a pharmacy must be a registered pharmacist (R.Ph.). In addition to medicines and prescriptions, many now sell a diverse arrangement of additional household items such as cosmetics, shampoo, office supplies, confectionary, and snack foods.

2)Hospital pharmacy: Pharmacies within hospitals differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues. Hospital pharmacies can usually be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications given intravenously. This is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities.

3)Clinical pharmacy: Clinical pharmacists provide direct patient care services that optimizes the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside hospitals and clinics. Clinical pharmacists often collaborate with physicians and other healthcare professionals to improve pharmaceutical care. They work collaboratively with physicians, nurses and other healthcare personnel in various medical and surgical areas.

4) Compounding pharmacy: Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead. Another form of compounding is by mixing different strengths,(g,mg,mcg)of capsules or tables to yield the desire therapy indicated by the doctor. This form of compounding is found at community or hospital pharmacies or in-home administration therapy. Compounding pharmacies specialize in compounding, although many also dispense the same non-compounded drugs that patients can obtain from community pharmacies.

5.Consultant pharmacy: Consultant pharmacy practice focuses more on medication regimen review (i.e. "cognitive services") than on actual dispensing of drugs. Consultant pharmacists most typically work in nursing homes, but are increasingly branching into other institutions and non-institutional settings.

6) Internet pharmacy: Since about the year 2000, a growing number of internet pharmacies have been established worldwide. Many of these pharmacies are similar to community pharmacies, and in fact, many of them are actually operated by brick-and-mortar community pharmacies that serve consumers online and those that walk in their door. The primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient and private method rather than traveling to a community drugstore where another customer might overhear about the drugs that they take. Internet pharmacies (also known as Online Pharmacies) are also recommended to some patients by their physicians if they are homebound. Canada is home to dozens of licensed internet pharmacies, many of which sell their lower-cost prescription drugs to U.S. consumers, who pay one of the world's highest drug prices. In recent years, many consumers in the US and in other countries with high drug costs, have turned to licensed internet pharmacies in India, Israel and the UK, which often have even lower prices than in Canada.

7) Veterinary pharmacy: Veterinary pharmacies, sometimes called animal pharmacies may fall in the category of hospital pharmacy, retail pharmacy. Veterinary pharmacies stock different varieties and different strengths of medications to fulfill the pharmaceutical needs of animals. 8) Nuclear pharmacy: Nuclear pharmacy focuses on preparing radioactive materials for diagnostic tests and for treating certain diseases. 9) Military pharmacy: Military pharmacy is an entirely different working environment due to the fact that technicians perform most duties that in a civilian sector would be illegal. State laws of Technician patient counseling and medication checking by a pharmacist do not apply.

Introduction to various dosage forms
Basic information on pharmaceutical dosage forms: From drug substance to pharmaceutical preparation – a). Active drug substance (active pharmaceutical ingredient - API) b). Excipients (inactive pharmaceutical ingredients) Technological, biopharmaceutical and/or stability reasons Diluents/fillers, binders, lubricants, desintegrants, coatings, preservants and stabilizers, colorants and flavorings Should always be stated in Label (important in the case of allergies) Pharmaceutical dosage form determines the physical form of the final pharmaceutical preparation is a drug delivery system which is formed by technological processing (drug formulation) must reflect therapeutic intentions, route of administrations, dosing etc.

Pharmaceutical preparation (PP) particular pharmaceutical product containing active and inactive pharmaceutical ingredients formulated into the particular dosage form. Packed and labeled appropriately Two major types of PP according the origin: Manufactured in large scales by pharmaceutical industry (original and generic preparations) Compounded individually in compounding pharmacies Pharmaceutical preparations manufactured by pharmaceutical industry Currently certainly the most frequent and favorable approach MUST be approved by national authority (FDA) Rigorous quality control (QC) and quality assurance (QA) during manufacturing - with surveillance of national authorities to ensure the safety and effectiveness

Original pharmaceutical preparations undergo full and very extensive pharmacological/toxicological and pharmaceutical pre-clinical and clinical development and evaluation particularly important is the proof of effectiveness and safety Generic pharmaceutical preparations (authorized copies of original preparations) Can be released after the expiration of the patent protection of the original preparation The approval for clinical use is easier due to the prior experience with the original preparation Must be pharmaceutically equivalent: same API, dose, pharmaceutical dosage form and the same route of administration as in original preparation Must be clinically bioequivalent: i.e. it must be of very close PK profile as original preparation. PK parameters (Cmax, tmax, AUC) are within % range as compared with the original preparation. The proof of therapeutic equivalence (comparing directly the clinical effectiveness) is not commonly required (due to the technical, financial and ethical issues). Hence, it can be only assumed from the bioequivalence.

Pharmaceutical preparations compounded individually These PP are compounded individually for a particular patient according to the physician's prescription in a pharmacy licensed for compounding In contrast to the past, they are used rather rarely and mostly in specific situations It is highly advisable that whenever the particular suitable PP is approved and commercially available it should be preferred over the compounding The main advantage of compounded PP is the opportunity to individualize the pharmacotherapy Hence, the individually compounded PP can be a justified choice when: The drug in a particular dosage form is not commercially available on the market The extraordinary low or high dose is needed (young children, elderly people, special situations – e.g., intoxications). In this case right dosage strength need not be readily commercially available for every patient The patient suffers from the allergy on a specific excipients (e.g., lactose – a filler, some colorizing/flavouring or antimicrobial agents - parabens) or another drug appearing in the PP Patient is unable to use a PP in its commercially available dosage form (e.g., children, elderly)

The major disadvantage of Pharmaceutical preparations compounded individually ,is the lack of standardization (it is always a single-patient batch), unavailability of rigorous QC testing and the appropriate clinical evaluation. Classification of pharmaceutical dosage forms according to its physical properties Dosage forms Homogenous systems Dispersion systems – one phase (dispersed phase) is distributed throughout another one (continuous phase, dispersion medium) According to the size of dispersed particles (1 nm- 0,5 mm) a molecular, colloidal and coarse dispersions can be distinguished May require shaking before administration According to the overall physical properties of dosage forms (both homogenous and dispersion systems) one can distinguish Gaseous dosage forms Liquid dosage forms Semisolid dosage forms Solid dosage forms

Classification of pharmaceutical dosage forms according to its physical properties: Gases Gases – medicinal gases, inhalation/volatile anesthetics (vaporized before administration by inhalation) Aero dispersions of solid particles (e.g., inhalation antiasthmatics) or liquid particles (inhalation antiasthmatics or sprays) Liquids (SES) Solutions – one homogenous phase, prepared by dissolving one or more solutes in a solvent Emulsions a dispersion system consisting of two immiscible liquids o/w or w/o cloudy appearance Suspensions A dispersion system where solid particles are dispersed in liquid phase Not intended for systemic administration of drugs with high potency

Semisolid dosage forms Unshaped (without specific physical shape) (GCOP) Gels -A semisolid systems in which a liquid phase is constrained within a 3D cross-linked matrix. Creams – semisolid emulsion systems (o/w, w/o) containing more than 10% of water. o/w creams - more comfortable and cosmetically acceptable as they are less greasy and more easily water washable w/o creams – accommodate and release better lipophilic API, moisturizing, Cold creams Ointments – semisolid dosage forms with the oleaginous (hydrocarbon), water-soluble or emulsifying base Oleaginous (hydrocarbon) base: Petrolatum (Vaseline – white, yellow) Water-soluble base: Polyethylenglycol (PEG)- ointment – syn. macrogol ointments Pastes – semisolid dispersion system, where a solid particles (> 25%, e.g. ZnO) are dispersed in ointments – mostly oleaginous (Petrolatum)

Shaped Suppositories (for rectal administration) different shapes Melting/dissolving at body temperature Oleaginous (cacao butter) or aqueous (PEGs, glycerinated gelatin) Pessaries (vaginal suppositories) Similar as above, PEGs or glycerinated gelatin are often used as base. Solid dosage forms Unshaped (without specific shape) - powders for external/internal use Tablets Capsules Implants Transdermal patches…

Classification of pharmaceutical dosage forms according to its physical properties Dosage forms for systemic administration p.o. (per Oral) s.l.(sub-lingual) and buc.(buccal cavity) rectal parenteral transdermal inhalation for local administration Topical (on the skin or mucosa) Into/onto - the eye, nose, ear - the oral cavity - the vagina, rectum - the bronchi - the skin Local parenteral (viz Parenteral above) Done

Dosage forms for Systemic administration – ORAL (p.o.) solid dosage forms Tablets - Compressed product (API+ excipients – e.g., fillers, disintegrates) Conventional – Disintegration/Desagregation/Dissolution, can be divided (half/quarters) Coated (not to be divided) To mask unpleasant taste or smell of API To avoid of adhesion in esophagus (to facilitate swallowing and/or avoid release of API and local adverse reactions) To ensure drug stability To provide enter solvent coating To overcome – possible degradation of API in the stomach and possible local irritation/adverse reactions in the stomach Effervescent tablets – not a final dosage form (drug is administered as the solution), CO2 produced by chemical reaction of acid and NaHCO3. Hygroscopic!!! Rapid absorption  rapid on-set of action Avoids potential tablet adhesion to mucosa and local irritation Besides tablets for p.o. there are also special tablets for s.l. a bucc.; however, these are different and presents different route of administration!!!

Capsules (not to be divided, can also be compounded individually) - API + excipients - enclosed in the hard/soft water soluble container made of gelatin. - Consist of cap and body – filled with powders, pellets, granules (paste, oil) - In the GIT gelatin shell softens, swells and dissolve – particles are dispersed  disintegration  API dissolution  absorption - Hygroscopic - Enteric coating available CR (SR) tablets and capsules Reservoir type (not to be divided) Core consisting of API and excipients is encapsulated by wall/membrane determining the rate of release Mechanisms of release Dissolution of the outer/inner layer Diffusion (permeation) throughout membrane pores Osmosis (OROS system)

Matrix type (tablets) : Drug is dispersed within the polymer Polymer matrix can be biodegradable – drug is released continuously Polymer matrix can form pore – drug can gradually diffuse Dosage forms for systemic administration – ORAL (p.o.) liquid dosage forms Solutions (drops) – aqueous, oils Syrups – aqueous sol. with sugar (or sugar substitute) with/without flavoring agents Elixirs – sweetened hydro alcoholic sol., can accommodate less water sol. API Tinctures – alcoholic or hydro alcoholic sol. – herbal extracts… Emulsions Suspension – should not be used for drugs with high potency (dosing!) Advantages: easier for administration (children, elderly people), good compliance (can be flavored), rapid absorption, flexible dosing Disadvantages: stability (chemical, microbial… - a need for preservatives), accurate dosing???

Rectal suppositories Solid dosage form under r.t., which are melted at the body temperature Different size – children and adult supp. !!! Suppository basis (i.e., basic excipients) – oleum cacao, glycerogelatine – melting point, non-irritating, chem. stable and inert Different shape – mostly “torpedo”-like, formed by mould casting Advantages: offers an alternative to p.o. – especially useful when patient can not swallow the drug (unconsciousness, vomiting patents, serious GIT disturbances, Children) or when we need to avoid local adverse reactions (e.g., NSAIDs). Disadvantages: poor compliance, some API can cause local irritation of rectal mucosa, stability of the dosage form during high temp., the melted supp. matter may come out Storage: cool place! Other rectal dosage forms for systemic administration: rectal tablets, capsules Common API classes: opioid analgesics, NSAIDS, antipyretics (paracetamol), antiemetic

Rectal suppositories Rectal suppositories are commonly used for laxative purposes, with chemicals such as glycerin or bisacodyl treatment of hemorrhoids by delivering a moisturizer or vasoconstrictor delivery of many other systemically-acting medications, such as promethazine or aspirin general medical administration purposes: the substance crosses the rectal mucosa into the bloodstream; examples include paracetamol (acetaminophen), diclofenac, opiates, and eucalyptol suppositories. Alprostadil pellets are urethral suppositories used for the treatment of severe erectile dysfunction. Vaginal suppositories are commonly used to treat gynecological ailments, including vaginal infections such as candidiasis.

Dosage forms for systemic administration -Parenteral route dosage forms Injectables – dosage forms which are intended for administration using a hypodermic (hollow pointed) needle . Injections (available as ampoules, vials with rubber head) Solutions, emulsions or suspensions which MUST BE STERILE – free of microorganisms (microbiological tests) PYROGEN-FREE (test for pyrogens) ISOTONIC (NaCl usually as the additive) I.V. injections Must be PARTICLE-FREE (visual inspection prior administration!) Not intended for API inducing clotting or haemolysis Isoacidity is desirable – but different pH often needed to assure solubility of API or chemical stability (may cause local reaction – phlebitis or pain at the site of injection) Moderately irritating compounds can be administered (e.g., anticancer drugs) Vehicle – sterile water for injections, co-solvents may be added (ethanol, PEG 300/400, propylenglycol, Cremophor) to solubilize poorly soluble API I.M. and S.C. Isoacidity should be guaranteed (to avoid risk of inflammation/necrosis of the tissues) API and excipients should be non-irritating Suspension/emulsion injectables can be administered (depot forms), oil-based vehicles may be used The volume administered depends on site of administration (e.g., up to 5 ml i.m.)

Infusions (available in plastic bags) I.V. and S.C. route Higher volumes over much larger times (from min to days) Advantages It can be a approach of choice in the case of Problems with oral absorption (poor/erratic) Problems with stability of API in GIT (pH, enzymes) Uncooperative patients (unconsciousness, vomiting…) Urgent need for rapid onset of action (emergencies) Disadvantages Non-compliance (phobias, children..) Pain/irritation at the site of injection Certain degree of heamolysis may occur Need for trained personnel using aseptic procedures Higher risk of adverse severe reactions (inc. hypersensitivity on excipients)

Dosage forms for systemic administration - Parenteral route dosage form Implants Controlled drug delivery for over a long time (months/years) Advantages – largely overcomes problems with individual compliance Disadvantages – mini-surgery is needed, uneasy to simply discontinue the therapy, local reactions Examples: hormones/contraception Dosage forms for systemic administration Transdermal drug delivery systems (TDDS) TDDS (transdermal patches) are designed for affixing on healthily and clean skin in order to assure controlled drug delivery into the systemic circulation

Transdermal drug delivery systems (TDDS) Advantages Elegant alternative to injectables Pain and stress-free No need for trained specialist Long-term drug delivery with minimal fluctuations of drug concentrations Good compliance Unlike other controlled drug delivery systems, the delivery of the API can be immediately discontinued (e.g., upon occurrence of adverse reactions…) Disadvantages Not feasible for all API ! High potency (high doses can not be accommodated and delivered) Climatic conditions

Dosage forms for local drug administration into the eye Eye liquid (Ophthalmic dosage forms) Drops (smaller volumes, ml) and Lotions (up to 100 ml) Can be both manufactured and compounded (however, higher tech. demands!) Must be Sterile (sterile ingredients/preparation) – proper handling, storage and administration to avoid contamination Often deserves to employ antimicrobial agent (may be a source of allergy) Isotonic with tears (to avoid eye irritation due to the hypotonic preparations) Vehicle – sterile water (oil) Advantages: high local concentration, lower systemic adverse reactions, minor effects on vision Disadvantages: local hypersensitivity, rapid tear wash-out!

Eye semisolid drug formulation Gels, Creams and Ointments MUST also be sterile and clear (particulate free) Direct application into the conjunctiva to avoid contamination (do not use fingers) Advantages: API exposure is longer! Disadvantages: can hinder vision (useful for overnight treatment), dosage accuracy Eye solid drug formulations Eye inserts (soluble, insoluble, biodegradable) – slow release of API Examples: antiglaucoma drugs (pilocarpin, timolol), antimicrobial agents, vasoconstriction agents and antihistamines.

Nasal/ear drops and sprays Usually isotonic Vehicles and API must be non-irritating Vehicle – isotonic aqueous solutions/oils Technique of (self)-administration May require special dropping device Nasal/ear semisolid dosage forms - gels, creams and ointments More complicated administration into the ear Ex. Nose – decongestants, antihistamines, anti-inflammatory, antiseptic agents Ear: anti-microbial

Dosage forms for local drug administration into the vagina/rectum Vaginal dosage forms Tablets Compressed products disintegrating in vagina Markedly different appearance to oral ones Application devices Capsules Pessaries (vaginal suppositories) – hydrophilic bases are more frequent (more comfortable) Both manufactured and compounded Vaginal foams Examples: namely antimicrobial agents (antibacterial, antimycotic, antiprotozoal) Rectal dosage forms Suppositories (as given previously for systemic administration) Gels and creams Enemas

link between pharmacy & Clinical science
Clinical science is the practical study of medical principles or investigations using controlled procedures to evaluate results. An example is Clinical pharmacology - the study of drugs in patients. Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world. It has a broad scope, from the discovery of new target molecules, to the effects of drug usage in whole populations. Clinical pharmacology connects the gap between medical practice and laboratory science. The main objective is to promote the safety of prescription, maximize the drug effects and minimize the side effects. It is important that there be association with pharmacists skilled in areas of drug information, medication safety and other aspects of pharmacy practice related to clinical pharmacology.

link between pharmacy & Drug Information services
The provision of accurate and timely drug information to health care professionals is an important mechanism to promote safe and effective drug therapy. Such service is lacking in India. The term 'drug information’ was coined in the early sixties and the first drug information center (DIC) was opened at the University of Kentucky Medical Center. Link between Pharmacy & Biotechnology: Biotechnology is technology based on biology, agriculture, food science, and medicine. Modern use of the term usually refers to genetic engineering as well as cell- and tissue culture technologies. Biotechnology has applications in four major industrial areas, including health care (medical), crop production and agriculture, non food (industrial) uses of crops and other products (e.g. biodegradable plastics, vegetable oil, biofuels), and environmental uses. Medicine In medicine, modern biotechnology finds promising applications in such areas as- drug production; pharmacogenomics; gene therapy; & genetic testing

The Legal and Regulatory Environment
The current legal and regulatory environment of the pharmaceutical industry in India is a result of several statutes enacted over a period of more than a hundred years. These statutes or enactments can broadly be categorized into two areas: Those pertaining to quality control of the pharmaceutical industry such as quality control, safety and standards of all the drugs manufactured and marketed in the country and those imported in the country. All these are under the purview of the Union Ministry of Health (Directorate General of Health Services). Those pertaining to other aspects of manufacture and marketing of drugs such as investment, foreign collaboration, licensing of production facilities, pricing, trademarks, patents, import of capital equipment, raw materials and technology. All these aspects come under the purview of different departments like the ministries of Petroleum, Chemicals and Fertilizers, Industry, Finance, Law, Commerce and labour of the Central Government.

Some of the more important legislations are listed hereunder
Some of the more important legislations are listed hereunder. Pharmaceutical marketer has to be aware of these and also should posses some insight into these statues and their implications. The Opium Act, 1878. The Poisons Act, 1919. The Dangerous Drugs Act, 1930. The Drugs and Cosmetics Act, 1940. The Industries (Development and Regulation) Act, (IRDA) The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The Trade and Merchandise Marks Act, 1958. The MRTP Act, 1969. The Drug Price Control Order (DPCO), 1995. The Patents Act, 1970. The Foreign Exchange Regulation (FERA) Act, 1973.

Drugs Price Control Order (DPCO):
Brief introduction to Laws and Acts governing the Pharmaceutical Industry Drugs Price Control Order (DPCO): The Drugs Price Control Order (DPCO), 1995 is an order issued by the Government of India under Section 3 of the Essential Commodities Act, to regulate the prices of drugs. Drugs and formulations have been subjected to price control for more than three decades now. The economic reforms initiated by the Government of India in July 1991, trickled down to the Pharmaceutical Industry only in 1994 and that too partially. The main objectives of the Drug Policy after the modifications in the Policy of 1986 announced in September 1994 are to ensure- a) availability, at reasonable prices of essential and life saving and prophylactic medicines of good quality; b)strengthening the system of quality control over drug production and promoting the rational use of drugs in the country; c)creating an environment conducive to channelizing new investment into the pharmaceutical industry to encourage cost-effective production with economic sizes and introducing new technologies and new drugs; and d) strengthening the indigenous capability for production of drugs.

Drugs Price Control Order (DPCO) & NPPA
Brief introduction to Laws and Acts governing the Pharmaceutical Industry Drugs Price Control Order (DPCO) & NPPA The Order provides – 1)The list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things. 2)For the purpose of implementing provisions of DPCO, powers of the Government have been vested in the National Pharmaceutical Pricing Authority (NPPA). Drugs are essential for health of the society. Drugs have been declared as essential and accordingly put under the Essential Commodities Act. 3) Only 74 out of 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under the price control category. However, the prices of other drugs can be regulated, if warranted in public interest. The NPPA was established on 29th August 1997 as an independent body of experts following the Cabinet Committee’s decision in September 1994 while reviewing the Drug Policy. The Authority, has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country.

Brief introduction to Laws and Acts governing the Pharmaceutical Industry
NPPA is vested with the powers for implementing provisions of DPCO. Only 74 (see the list of price-controlled drugs below) out of 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under the price control category. The price is fixed through after considering all possible costs in packaging, conversion and material costs, as well as the excise duty, by the NPPA. Costs involving packaging and conversion contribute about one-third of the price that consumers pay for medicines. NPPA carries out the price-fixing exercise as a step to bring in uniformity of cost among all the formulations containing price- controlled drugs across the country. NPPA give a free reign (control) for those drug which do not come under price-control, allowing them to increase the price by up to 10% annually.

33. VITAMIN B2 (RIBOFLAVIN) 34. THEOPHYLLINE 35. LEVODOPA
Brief introduction to Laws and Acts governing the Pharmaceutical Industry List of Price Controlled Drugs (DPCO 1995) BULK DRUGS 19. TRIMETHOPRIM 20. CLOXACILLIN 21. SULPHADIMIDINE 22. SALBUTAMOL 23. FAMOTIDINE 24. IBUPROFEN 25. METAMIZOL (ANALGIN) 26. DOXYCYCLINE 27. CIPROFLOXACIN 28. CEFOTAXIME 29. DEXAMETHASONE 30. EPHEDRINE 31. VITAMIN B1 (THIAMINE) 32. CARBAMAZEPINE 33. VITAMIN B2 (RIBOFLAVIN) 34. THEOPHYLLINE 35. LEVODOPA 36. TOLNAFTATE 1. SULPHAMETHOXAZOLE 2. PENICILLINS 3. TETRACYCLINE 4. RIFAMPICIN 5. STREPTOMYCIN 6. RANITIDINE 7. VITAMIN C 8. BETAMETHASONE 9. METRONIDAZOLE 10. CHLOROQUINE 11. INSULIN 12. ERYTHROMYCIN 13. VITAMIN A 14. OXYTETRACYCLINE 15. PREDNISOLONE 16. CEPHAZOLIN 17. METHYLDOPA 18. ASPIRIN

54. FRAMYCETIN 55. VERAPAMIL 37. VITAMIN E 38. NALIDIXIC ACID
Brief introduction to Laws and Acts governing the Pharmaceutical Industry List of Price Controlled Drugs (DPCO 1995) BULK DRUGS 37. VITAMIN E 38. NALIDIXIC ACID 39. GRISEOFULVIN 40. GENTAMICIN 41. DEXTROPROPOXYPHENE 42. HALOGENATED HYDROXYQUINOLINE 43. PENTAZOCINE 44. CAPTOPRIL 45. NAPROXEN 46. PYRENTAL 47. SULPHADOXINE 48. NORFLOXACIN 49. CEFADROXYL 50. PANTHONATES & PANTHENOLS 51. FURAZOLIDONE 52. PYRITHIOXINE 53. SULPHADIAZINE 54. FRAMYCETIN 55. VERAPAMIL 56. GLIPIZIDE 57. SPIRONOLACTONE 58. PENTOXYFYLLINE 59. AMODIAQUIN 60. SULPHAMOXOLE 61. FRUSEMIDE 62. PHENIRAMINE MALEATE 63. CHLOROXYLENOLS 64. BECAMPICILLIN 65. LINCOMYCIN 66. CHLORPROPAMIDE 67. MEBHYDROLINE 68. CHLORPROMAZINE 69. METHENDIENONE 70. PHENYL BUTAZONE 71. LYNESTRANOL 72. SALAZOSULPHAPYRINE 73. DIOSMINE 74. TRIMIPRAMINE

GENERIC DRUGS: A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

GENERIC DRUGS: When can a generic drug be produced?
When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where: 1. the patent has expired, 2. the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed 3. for drugs which have never held patents, or 4. in countries where a patent(s) is/are not in force. The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market. This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

GENERIC DRUGS: A prime example of how this works is simvastatin (Zocor), a popular drug created and manufactured by U.S. based pharmaceutical Merck & Co., which lost its US patent protection on June 23, India-based Ranbaxy Laboratories(at the 80 mg strength) and Israel-based Teva Pharmaceutical Industries (at all other strengths) received 180 day exclusivity periods for simvastatin; due to Zocor's popularity, both companies began marketing their products immediately after the patent expired. However, Dr. Reddy's Laboratories also markets an authorized generic version of simvastatin under license from Zocor's manufacturer, Merck & Co. Regulation of therapeutic goods: The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.

GENERIC DRUGS: Economics:
Generic drugs can save patients and insurance companies substantial costs. The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million

GENERIC DRUGS: Economics:(Contd.)
Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well- known to patients and providers. For as long as a drug patent lasts, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at a level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of new medicines which most generic companies cannot afford to do. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug.

Regulation of therapeutic goods:
Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair. Under Retail and Distribution:- Drugs classified under 5 heads 1. Schedule X drugs – Narcotics 2. Schedule H and L – Injectables, Antibiotics, Antibacterial 3. Schedule C and C1- Biological Products-example Serums and Vaccines Under Manufacturing Practice 1. Schedule M List of the equipment for the efficient running of manufacturing wing, Qualified personnel

Clinical trial: Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries. Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization. Phases involved in Clinical Trials: Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug- development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Clinical trial: Pre-clinical studies:
Pre-clinical studies involve in vitro (test tube) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug. Phase 0 Phase 0 is a recent designation for exploratory, first-in-human trials conducted in accordance with the United States Food and Drug Administration's(FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) studies. Phase 0 trials are also known as human micro dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics(how the body processes the drug) and pharmacodynamics(how the drug works in the body).

Clinical trial: Phase 0(contd.):
A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data. Phase I Phase I trials are the first stage of testing in human subjects. Normally, a small (20-50) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options.

Clinical trial: Phase II
Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)). Some trials combine Phase I and Phase II, and test both efficacy and toxicity. Phase III Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

Clinical trial: Phase III(contd.)-
Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.

Clinical trial: Phase IV
Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). Length of Clinical Trial: Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever undergoing clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial.

PHARMACOVIGILLANCE: Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs such as liver damage are often undetected because study populations are small. Post marketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.

Post marketing surveillance
Post marketing surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been "controlled" for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and post marketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Done.

At present the following Acts and Rules ,that govern the manufacture, sale, import, export and clinical research of drugs and cosmetics in India. 1. The Drugs and Cosmetics Act, 1940 2. The Pharmacy Act, 1948 3. The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 4. The Narcotic Drugs and Psychotropic Substances Act, 1985 5. The Medicinal and Toilet Preparations (Excise Duties) Act, 1956 6. The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act) (Source: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India ) SOME OTHER LAWS: There are some other laws which have a bearing on pharmaceutical manufacture, distribution and sale in India. The important ones being: The Industries (Development and Regulation) Act, 1951 The Trade and Merchandise Marks Act, 1958 The Indian Patent and Design Act, 1970 Factories Act

Drugs and Cosmetics Act,1940:
Brief introduction to Laws and Acts governing the Pharmaceutical Industry Drugs and Cosmetics Act,1940: INTRODUCTION: In 1937 ,a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. This Bill was referred to the Select Committee and the Committee expressed the opinion that a more comprehensive measure for the uniform control of manufacture and distribution of drugs as well as of imports was desirable. There upon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly. The Drugs and Cosmetics Act *The object of the Act is to regulate the import, manufacture, distribution and sale of drugs. *Under the provisions of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees for the consideration of a particular matter.

Drugs and Cosmetics Act,1940: ACT 23 OF 1940
Brief introduction to Laws and Acts governing the Pharmaceutical Industry Drugs and Cosmetics Act,1940: ACT 23 OF 1940 The Drugs and Cosmetics Bill was passed by the Central Legislative Assembly and it received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and Cosmetics Act, 1940 (23 of 1940). LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. The Repealing and Amending Act, 1949 (40 of 1949). 2. The Adoption of Laws Order, 1950 3. The part B States (Laws) Act, 1951 (3 of 1951). 4. The Drugs (Amendment) Act, 1955 (11 of 1955). 5. The Drugs (Amendment) Act, 1960 (35 of 1960). 6. The Drugs (Amendment) Act, 1962 (21 of 1962). 7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964). 8. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972). 9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982). 10. The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986).

The Pharmacy Act 1948: -The Pharmacy Act was passed in 1948 and was amended in 1959, 1976 and The aim of this law is to regulate the profession of Pharmacy in India. -Under the provisions of this act the Central Government constitutes a Central Pharmacy Council of India consisting of following members: a) Six members from the Teachers of pharmacy. b) Six members from practicing pharmacists or Pharmaceutical Chemists holding degree of diploma. c) One member elected by the Medical Council of India. d) The Director-General of Health Services. e) The Director of the Central Drugs Laboratory. f) The Chief Chemist, Central Revenues. g) One member to represent each state elected by members of State Councils who shall be a registered pharmacist. h) One member to represent each State Government who shall be either registered medical practitioner or a registered pharmacist.

The Pharmacy Act 1948: *The President and Vice-President of the Central Council of Pharmacy are elected by the members of the Council among themselves, hold office for five years and are eligible for re-election. *The conducting of courses of study for pharmacists, and the examinations in Pharmacy in the states are subject to the approval of the Central Council. Besides the Council has the responsibility to supervise the Education of Pharmacy in the States. Where it is found that the course of study is not in conformity with the Education Regulations, the Council may withdraw approval accorded to the course or the examination. The Central Council can approve qualifications granted by an outside authority for qualifying for registration under this Act.

The Pharmacy Act 1948: State Pharmacy Councils The Act makes upon the State Governments to constitute State Pharmacy Councils with the following members: a) Six members elected from amongst themselves by registered Pharmacists of the state. b) Five members of whom at least two shall be persons possessing a prescribed degree or diploma in Pharmacy or Pharmaceutical Chemistry or members of the Pharmaceutical profession nominated by the State Government. c) One member elected by the State Medical Council. d) The Chief Medical Officer of the State. e) The State Drug Controller. f) The Government Analyst. Registration of Pharmacists The State Government has under the provisions of the Pharmacy Act to get a register of the State Pharmacists prepared and it is the State Pharmacy Council which has to maintain the register. The register shall contain the name and residential address of Pharmacist, the date of his first admission to the register, qualifications for registration, his professional address, the name of his employer and prescribed particulars

The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954:
Brief introduction to Laws and Acts governing the Pharmaceutical Industry The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954: *This Act is meant to control the Advertisements regarding drugs; it prohibits the advertising of remedies assumed to possess magic qualities and to provide for matters connected therewith. *The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for: a) the procurement of miscarriage in women or prevention of conception in women; and b) the maintenance or improvement of the capacity of the human being for sexual pleasure; c) the correction of menstrual disorders in women; d) the diagnosis, cure, mitigation, treatment or prevention of any venereal disease. It is prohibited to directly or indirectly give a false impression regarding the true character of a drug or make false claim for it or to convey any false or misleading information in any material particular about it. No person shall import into or export from India any document containing advertisement of this nature.

The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954:
Brief introduction to Laws and Acts governing the Pharmaceutical Industry The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954: *Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine. In case of subsequent convictions the imprisonment can be extended to one year. The document, article or thing which contains the offending advertisement can be seized and confiscated. *If the person contravening any of the provisions of the Act is a company, every person who at the time the offence was committed was in charge of the business of the company shall be deemed guilty. *The prohibition under this Act does not apply to: a) any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease, b) any treaties or book dealing with any of the matters from a bonafide scientific standpoint, c) any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory, and d) Government advertisements.

The Narcotic Drugs and Psychotropic Substances Act, This is an Act to consolidate and amend the law relating to Narcotic Drugs(e term narcotic originally referred medically to any psychoactive compound with sleep-inducing properties. It has since become associated with opioids, commonly morphine and heroin), to make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewith. Psychotropic drug: Any drug capable of affecting the mind, emotions, and behavior. Some legal drugs such as lithium for depression are psychotropic. Many illicit drugs such as cocaine are also psychotropic. Also called a psychodynamic drug.

Patent Laws: A patent ,is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention. A patent is an intellectual property right relating to inventions & is the grant of exclusive right, for limited period, provided by the government to the patentee, in exchange of full disclosure of his invention,for excluding others, from making,using,selling,importing the patented product or process. Typically, however, a patent application must include one or more claims defining the invention which must be new, inventive, and useful or industrially applicable. Under the World Trade Organization's (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be the minimum twenty years. Different types of patents may have varying patent terms (i.e., durations).

Indian Patent Law - Some Reflections:
Brief introduction to Laws and Acts governing the Pharmaceutical Industry Indian Patent Law - Some Reflections: India is a signatory to the TRIPS agreement hence it modified its patents law in conformity with TRIPS agreement. The existence of IPRs(Intellectual Property Right) is very old. The basic aim of conferring an IPR upon the person owning the same is to give a social recognition to its holder. This social recognition can further bring economic benefits to its holders. It is just and reasonable to award a person an IPR in the form of 'limited monopolistic rights' for his/her labour and efforts. The TRIPS Agreement was formulated to bring basic level harmonization in IPRs laws all over the world. The provisions of TRIPS agreement are the most extensive and rigorous in nature. They protect all the forms of IPRs collectively. The protective umbrella of TRIPS covers the following IPRs: (1) Copyright and Related Rights, (2) Trademarks, (3) Geographical Indications, (4) Industrial Designs, (5) Patents, (6) Layout designs of Integrated Circuits, and (7) Protection of Undisclosed Information.

Brief introduction to Laws and Acts governing the Pharmaceutical Industry Indian Patent Law - Some Reflections: Patents Act, 1970 and TRIPS Agreement The Indian Patents Act, 1970 provides patent protection in India. The same is in accordance with the provisions of the TRIPS Agreement. The recent conferment of 'product patent' along with the 'process patent' is an example of such compatibility. Salient features of Indian Patent law : The Patent law of India has the following salient features that decide whether a patent will be granted or not: (a) The object: The object of patent law is to encourage scientific research, new technology and industrial progress. The price of the grant of the monopoly is the disclosure of the invention at the Patent Office, which, after the expiry of the fixed period of the monopoly, passes into the public domain. (b) Inventive step: The fundamental principle of Patent law is that a patent is granted only for an invention which must have novelty and utility.

Brief introduction to Laws and Acts governing the Pharmaceutical Industry Indian Patent Law - Some Reflections: Salient features of Indian Patent law(contd.): (c) Useful: The previous Act, i.e. Act of 1911, does not specify the requirement of being, useful, in the definition of ‘invention’, but courts have always taken the view that a patentable invention, apart from being a new manufacture, must also be useful. (d) Improvement: In order to be patentable, an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement, and must independently satisfy the test of invention or an inventive step. It must produce a new result, or a new article or a better or cheaper article than before. The new subject matter must involve "invention" over what is old. (e) The guiding tests: In short the “invention” must involve an inventive step and the same must be capable of “industrial application”. It must be supplemented by the concept of “non-obviousness”.

Governmental control over the activities of Pharmaceutical Industry:
Drug safety and Post-marketing surveillance : Phamacovigilance Set of methods that aim at identifying and quantitatively assess the risks related to the use of drugs in the entire population, or in specific population subgroups. What is Pharmacovigilance? • Proactive monitoring and reporting on the quality, safety and efficacy of drugs • Assessment of the risks and benefits of marketed medicines • Monitoring the impact of any corrective actions taken • Providing information to consumers, practitioners and regulators on the effective use of drugs • Designing programs and procedures for collecting and analyzing reports from patients and clinicians

Governmental control over the activities of Pharmaceutical Industry:
Drug safety and Post-marketing surveillance : PSUR (Periodic Safety Update Report) A report containing information collected by marketing authorization holders through pharmacovigilance activities. It is usually required by regulatory authorities for drugs that have not been marketed for more than five years Side effect Any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the drug. Serious adverse event: a. life-threatening or fatal b. cause or prolong hospital admission c. cause persistent incapacity or disability; or d. concern misuse or dependence

Structure and Functions of Pharmaceutical industry
Marketing Dept: PRODUCT POSITIONING: In marketing, positioning has come to mean the process by which marketers try to create an image or identity in the minds of their target market for its product, brand, or organization. Re-positioning involves changing the identity of a product, relative to the identity of competing products, in the collective minds of the target market. Product positioning process: Generally, the product positioning process involves: Defining the market in which the product or brand will compete (who the relevant buyers are) Identifying the attributes (also called dimensions) that define the product 'space' Collecting information from a sample of customers about their perceptions of each product on the relevant attributes Determine each product's share of mind Determine each product's current location in the product space

Product positioning process(contd.): Determine the target market's preferred combination of attributes. Examine the fit between: The position of your product The position of the ideal vector Position. Challenges of product positioning: With a plethora of brands competing with each other for the attention of physician, the pharma companies should resort to strategic positioning of their products highlighting their unique selling points. When a plethora of brands compete with each other for the attention of the physician/ prescriber, the pharma companies should resort to ‘strategic positioning’ of their products i.e. the product should satisfy a need which is not satisfied by any other product and should have a ‘unique selling point’ (USP). The distinct advantages of the product should be clearly communicated to the physician by means of MRs/PSRs and promotional literature.

This can be done by researching the market, interviewing experienced physicians and surgeons etc. Most successful companies have recognized the importance of this concept and are putting it into actual practice. Once a physician recognizes and appreciates the ‘USP’ of a product, he would remember it for a long time, because it has been successful in catching his attention. Some of the strategies used in product positioning are discussed below: Pharmacokinetic properties: Positioning based on superior pharmacokinetic properties. Torrent’s Moxif 400 has been positioned as a drug having the highest AUC,MIC and Cmax,MIC ratio and therefore offers minimal potential for development of resistance, faster relief of symptoms and effective against resistant pathogens. Treatment by single-dose kit: Biochem’s ‘safkit’ is a kit consisting of secnidazole tablets, azithromycin tabs. and fluconazole tabs, treating all three kinds of infections of fungi, protozoa and bacteria in a single dose, when used as single kit. Low-price advantage: FDC’s Zoxan promotional line says ‘the most economical ciprofloxacin’

Drug combination with complementary action: When two drugs having complementary actions are combined in a single product, their effective action may be superior to that of individual action of any drug. For instance, Hoechst Marion Rousell’s Cardace H tablet mentions ‘superior BP reduction as compared to monotherapy’ in its promotional campaign. Drug in a novel galenical form: Cipla’s Predone syrup relies on the fact that prednisolone in syrup form is better tolerated by children than tablets of prednisolone. Hence it says ‘oral corticosteroid therapy made easier for children.

Pharmaceutical Marketing In India: Pharmaceutical marketing is a specialized field where medical representatives form the backbone of entire marketing effort. Pharmaceutical companies appoint medical representatives and assign them defined territories. Medical representatives meet doctors, chemists and stockiest as per company norms. Medical representatives try to influence prescription pattern of doctors in favor of their brands. The pharmaceutical distribution channel is indirect with usually three channel members i.e. depot/C&F, stockiest and chemist. Pharmaceutical companies appoints one company depot or C&F agent usually in each state and authorized stockiest in each district across the country.

Pharmaceutical Marketing In India: Company depot/C&F sends stocks to authorize stockiest as per the requirement. Retail chemists buy medicines on daily or weekly basis from authorized stockiest as per demand. Patients visit chemists for buying medicines either prescribed by a doctor or advertised in the media.

Pharmaceutical Marketing In India: Organogram of Marketing and Sales Department Managing Director Chief Executive Officer Director (Marketing and Sales) General Manager (Marketing and Sales) Sales Product Management National Sales Manager Group Product Managers Zonal Sales Managers Product Managers Area Managers Product Executives Medical Representatives

PROPER SALES MANAGEMENT STEPS TO SUCCED: 1.Do Market Audit :This activity analyses different marketing activities and suggest the bench mark for the company. This is a self supportive study as the marketing audit gives lot of avenues in streamlining the operations and cutting the cost. It also helps to remove unnecessary activities, which may be redundant for tomorrow. 2.Sales Management Audit and Preparation of New Sales Strategy: Medical Representative or Area Manager is the key person in improving the sales. Many people forget this basic approach and tend to develop “Marketing Arrogance” leading to not learning of the newer strategies, not changing to newer environment, developing of over confidence on hollow foundation and not on solid foundation. Span of Control: Managers expenses are more or less equivalent to 2 to 3 representatives’ cost. Therefore, managers should be optimally utilized. Manager has to control his people and proper discipline is a must in any organization. He is a counselor and give direction to the medical representatives so that MR achieves their target. Therefore, the second step in sales management related activity was to enforce certain discipline.

Improve Control Measures: Implementation of E-reporting which will lead to better communication, low cost of communication and quick communication. Better communication between the Company and field force Bring in sense of urgency Higher degree of commitment due to increased control measures This leads to better calls per day/better strike rate per call and increased no. of customer base for the company. Morale of the people goes down if the lethargy environment seeps in. The sales people should not get switched off. It is very difficult to keep the morale of the people very high unless there is innovative schemes or activities for their development.

VARIOUS SKILLS REQUIRED FOR A SUCCESSFUL MR : To build customer relationships and to promote marketed products of the pharma company Key Accountability's Sales and Expenses • Achieve sales objectives for marketed products. • Achieve market share objectives • Achieve specific objectives for pre-marketed products. • Develop and maintain expense budgets related to territory activities (Continuing Health Education [CHE] and travel). • Work within budget Territory Business Planning • Create and implement territory business plan • Plan and execute CHEs • Achieve reach and frequency objectives • Identify and follow-up on specific actions

Product and Therapeutic Knowledge •To obtain and maintain comprehensive product, therapeutic market and competitive knowledge • Provide market intelligence Selling/Communication Skills • Appropriate usage of selling material • Effectively and consistently use selling and communication skills to gain commitment from customers (internal and external) • Develop advocates in the medical community who are able and willing to discuss with their colleagues issues related to the adoption, or maintenance of companies products. • Bring customer issues to the attention of relevant internal business partners, and where appropriate, takes the lead in dealing with these issues. Administration • Ensure timely completion and accuracy of all administrative responsibilities including: reports, profiling, expenses, correspondence and other duties as required.

Key competencies required to be successful in this role: Organizational strategy • develop a network of influential customers • educate and influence customer thinking • listen to and understand the customer • represent customer concerns within organization • anticipate customer needs; give high priority to customer satisfaction Organizational Knowledge • have a clear understanding of companies business plan and strategic direction • understanding of and ability to apply knowledge about products for specified indication • keep abreast of current developments and trends in Critical Care • possess superior selling skills • possess computer skills (i.e. application and communication software) • plan and implement innovative cost-effective education programs that assist in achieving business goals

Interpersonal build effective working relationships with a variety of people • look for win-win solutions • respected both internally and externally as a team player and sales professional • work effectively with those outside formal line of authority • help generate consensus within the team or work group • volunteering to help in order to support team priorities Leadership • work with minimal supervision • think strategically/proactively • self-directed/managed • identify market opportunities • identify market threats and provides way to deal with them

Communication • communications are timely, clear, effective and appropriate for audience • express ideas and opinions openly and constructively • take the time to actively listen; obtain understanding of communication through feedback • maintain logic and clarity in pressure situations Risk taking and innovative thinking

TRAINING: Reorientation of the field force and manager is a must. Training plays a very important role in motivating representatives as well as managers. It helps them to sharpen their tools and develop confidence. A series of refresher course need to be organized in order to update them on the medical skills and the selling skills. The result has to come. Training gave them lot of confidence and the net benefits were : Confidence level of the medical representatives should be high. Increase in customer base with also regular visit to key customers will lead to improvement in output. Productivity will go up. Improvement in strike rate – Earlier medical representatives used to take about 7 to 12 calls to make a important doctor prescribe a product. This led to improvement in the productivity. 3.Training helped in accelerating productivity and overall growth in the Company.

The objective of pharmaceutical marketing is to make profits through satisfying customer needs and wants. Hence, the marketers have to understand the real needs, wants, belief and attitude of customers towards products and services. With Product patent being implemented in India, the operating dynamics of the Indian pharmaceutical industry are poised for significant changes. The pace at which Indian companies were able to introduce new formulations till now is likely to slow down considerably. Indian Pharmaceutical Marketing System Pharmaceutical marketing is a specialized field where medical representatives form the backbone of entire marketing effort. Pharmaceutical companies also appoint medical representatives and assign them defined territories. Medical representatives meet doctors, chemists and stockiest as per company norms. Medical representatives try to influence prescription pattern of doctors in favour of their brands.

The pharmaceutical distribution channel is indirect with usually three channel members i.e. depot/C&F, stockiest and chemist. Pharmaceutical companies appoints one company depot or C&F agent usually in each state and authorized stockiest in each district across the country. Company depot/C&F sends stocks to authorize stockiest as per the requirement. Retail chemists buy medicines on daily or weekly basis from authorized stockiest as per demand. Patients visit chemists for buying medicines either prescribed by a doctor or advertised in the media. Supply Chain of Indian Pharmaceutical Market

Supply Chain of Indian Pharmaceutical Market Most Important Factors Physicians are quality, price & availability conscious persons. Quality of medicines is most important for physicians, as it is not only helps curing the disease but also helps in building their reputation. Physicians on the basis of company image and consistent results with a product, judge the quality of products. So company image is also on high priority in their mind while prescribing medicines. Rank Factors Average 1. Product Quality 9.89 2. Price of Product 8.50 3. Availability 8.46 4. Company Image 8.37 5. Regular Visit of Medical Representative 8.20 6. Research Molecule 7.90 7. Literature/Updates/Journals 7.54

Most Important Factors 8. Personality of Medical Representative 7.40 9. Sponsorship for conferences 7.00 10. New Combinations 6.90 11. Medical Education Programmes 6.35 12. Packaging 6.20 13. Incentives 5.34 14. Personal Gifts 4.94 15. Samples 4.78 16. Free disease detection camps 4.70 17. Having Websites 4.66

Factors, which help in brand recalling Physicians have to remember many brands of different companies. After doing a pilot survey, the researcher short-listed five factors that help them in recalling brand names while prescribing. Physicians were asked to rank the factors in order of importance that help in brand recall. Table 2 Rank Factors 1. Name related to Molecule/organization/disease 2. Short Product Name 3. Constant reminder (Calls, mailers etc.) 4. Name easy to pronounce 5. Table top/in chamber reminders Table 2 clearly shows that physicians prefer short brand names related to molecule or organization or indication. The researcher is of the opinion that regular reminder through regular calls and mailers having brand name at regular interval is a better option than presenting a small gift (having brand name) to be placed in the chamber or on the table of the physician.

Brand Shifting Physicians were asked whether they shift from one brand to another brand in same therapeutic category Yes % No % Most of the physicians shift from one brand to another brand in same therapeutic category due to one or the other reason. Reason for shifting from one brand to another in same therapeutic category After doing a pilot survey, the researcher short-listed five reasons that lead to brand shifting. Physicians were asked to rank these reasons in order of importance. Rank Reasons 1. Price 2. Introduction of Newer Molecule 3. Persistence of the Medical Representative 4. Promotional effort of the company 5. Trial of a new brand.

Pharmaceutical Distribution in India: Rapid growth of Indian Pharma Industry has yet to translate into a modernization of the Indian distribution system. India is a geographically diverse country with extreme climates that make distribution a critical function. The long channel of distribution and high incidence of brand substitution makes it mandatory for a company to make all its stock keeping units (SKUs) available at all levels at all times. Drug distribution in India has witnessed a paradigm shift. Before 1990, pharmaceutical companies used a different distribution system, in which they established their own depots and warehouses that now have been replaced to certain extent by clearing and forwarding agents (CFAs). These organizations are part of the distribution chain, and are primarily responsible for maintaining storage (stock) of the company's products and forwarding SKUs to the stockiest on request. Most companies keep one to three CFAs in each Indian state. On an average, a company may work with a total of 25–35 CFAs.

Pharmaceutical Distribution in India: Unlike a CFA that can handle the stock of one company, a stockiest (a regional distributor) can simultaneously handle more than one company (usually, 5–15 depending on the city area), and may go up to even 30–50 different manufacturers. The stockiest, in turn, after 30–45 days (a typical credit or time limit) pays for the products directly in the name of the pharmaceutical company. The CFAs are paid by the company yearly, once or twice, on a basis of the percentage of total turnover of products. In 2006, the market size of India's pharmaceutical logistics segment (distribution) was valued at around $200 million and the logistics/distribution industry has been growing at an average annual growth rate of 4% since 2002. According to the Indian Retail Druggists and Chemists Association, in 1978, there were roughly 10,000 distributors and 125,000 retail pharmacies in India. Today, the total number of stockiest in India is around 65,000 and the number of pharmacies is about 550,000, an increase of around six- and four-fold, respectively.

Pharmaceutical Distribution in India: Despite the rapid increase in the number of stockiest and pharmacies, there has not been a proportional increase in the volume of prescriptions distributed. It is estimated that more than three-fifths of Indians still do not have access to modern medicines. This clearly shows that the rural market is largely unattended and untapped. PRICING AND MARGINS: The prices and the margins of drugs for the wholesaler and retailers are largely decided by the National Pharmaceutical Pricing Authority (NPPA), which varies depending on whether the active constituent of the product is a scheduled drug or a nonscheduled drug. Scheduled drugs are price-controlled whereas nonscheduled drugs are not. In addition to the above mentioned margins, wholesalers and retailers are also compensated with additional trade offers. Hospitals and large institutions sometimes directly negotiate with the manufacturing company and get the drugs in their pharmacy at lower costs. Generally, hospitals order large quantities and can negotiate with stockiest, who provide payment terms, credit periods, and margins.

Production Dept: Good manufacturing practice: Good manufacturing practice or "GMP" refers to the quality control of manufacturing for foods, pharmaceutical products, and medical devices. Basic principles of GMP: Manufacturing processes are clearly defined and controlled. Instructions and procedures are written in clear and unambiguous language. Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.

Research and development (R&D Dept.): Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen. Drug development refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate Formulation and Dosing, as well as to establish safety. Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials. Quality Control Dept.: The quality control department shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. They will review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control department shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

Role of QC dept: Evaluation of quality throughout process Raw materials and API Drug Product Packaging components QC Responsibilities Efficacy Safety Quality Compliance FDA, MHRA, ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) USP, BP, EP(European pharmacopoeia).

Quality Control (QC): Quality control is a process employed to ensure a certain level of quality in a product or service. It may include whatever actions a business deems necessary to provide for the control and verification of certain characteristics of a product or service. The basic goal of quality control is to ensure that the products, services, or processes provided meet specific requirements and are dependable, satisfactory. Quality assurance (QA) is the process of verifying or determining whether products or services meet or exceed customer expectations. Quality assurance is a process-driven approach with specific steps to help define and attain goals. This process considers design, development, production, and service..

Research and development in Indian Pharma Industry: Investment in R&D by industry as a whole in India has been low, only around 0.6% of the turnover. In the Indian pharmaceutical industry the average R&D expenditure is around 2% of the turnover contributed by around 150 companies. The low investment in R&D is due to the low levels of profitability and comparatively small size of the companies. However, the scenario is now changing. Some pharma companies now spend nearly 5% of their turnover on R&D. In addition to R&D in industry, substantial pharma related R&D is carried out in publicly funded research organizations, mainly by the laboratories of Council of Scientific & Industrial Research (CSIR), Indian Council of Medical Research (ICMR), around 25 universities and a few pharmacy colleges. Some of the new R&D units in industry and a few of the publicly funded laboratories are equipped with sophisticated laboratory equipment, instruments and pilot plant facilities. The R&D manpower is generally highly qualified and proficient in conventional techniques of pharmaceutical R&D.

Research and development (R&D Dept.): R&D was largely concentrated on process development for known bulk drugs albeit through novel and innovative process routes, invariably substituting for expensive imported raw materials enhancing the productivity and efficiency of the processes. India’s R&D forte has been in synthetic organic chemistry and process development. A few new drugs, using conventional screening techniques, have emerged from the Indian R&D, but none of them have been blockbusters. India acknowledged Intellectual property rights by embracing the patent regimen and then enforced it from January 1st, Since then, a new wave of progress has swept the country. Post 2005, pharmaceutical and medical biotechnology companies experienced some very critical changes, and since then, the only real differentiator has been innovation. Earlier they had thrived with little or no need to have a robust new product pipe lines, as only process patents were recognized in India. Besides price, there are many other hurdles that the Indian pharmaceutical companies face in their path to discovery. For instance, Dr.Reddy’s had to abandon development of drugs to treat diabetes and obesity after disappointing result in the early phase of clinical trials. Such inevitable bottlenecks often have a discouraging effect on market capitalization for the company.

Drug Regulatory Affairs(DRA)Dept.: DRA is a process of interaction of the company with- Drug Regulatory Authorities like CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION) Internal Dept.of the organization viz. Product Development,Clinical Research & Trials,Licensing,Manufacturing. through out the life cycle of a product i.e. from Synthesis of active moiety to marketing to post approval activities. DRA dept.provide assistance on- Licensing b.Registration c.Development d.Manufacturing e.Quality Guidance f.Pricing g.Marketing h.Pharmacovigilance i.GMP/GLP/GCP j.Patent k.Copyright l.Trademark Different applications filed by DRA Dept.- Abbreviated New Drug Applications(ANDA) For GMP certification For obtaining Patents, Copyright & Trademark Registration.

OVERVIEW OF pharma industry

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OVERVIEW OF pharma industry

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