biologic ale e chapter 1

8/9/2019 Biologic Ale e Chapter 1

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1. INTRODUCTION

1.1INDUSTRY PROFILE

The evolution of the pharmaceutical industry in India has been largely driven byregulated forces the DPOC (drugs prices control order), which regulated the prices of bulk drugsand formulations, and the Indian patent act, which granted process patent to bulk drugs. Theseregulations have resulted in the growth of the indigenous pharmaceutical industry, increasedavailability of bulk drugs at prices lower than those prevailing in other market, and theemergences of the India as a key exporter of bulk drugs in the world market during the period1970-1990, the Indian government as a member of the WTO agreed to adhere to the product patent regime by 2005. As part of TRIPS (trade related intellectuals property rights) thepharmaceutical industry will have the right to patent products as well as processes throughout theworld including India.

Being a member of GATT/TRIPS, India will also have a process patents that will beconsistent with the patent laws prevailing in the most developed countries with the expectation ofa product regime, the parent companies of a number of multinationals have begun the process ofincreasing their stake in Indian operations, multinationals started increasing the pace of newproduct launch and aggressively building market share by expanding their field force. Similarly,in order to increase their presence in domestic and international markets , Indian companies alsostarted following a number of strategies , such as , setting up manufacturing and marketing jointventures overseas, building world class facilities for bulk drugs , and conducting clinical trials inIndia to enable multinationals to reduce development costs for new drugs. `

India is one among the top manufacturers of bulk drugs in the world and is among thetop 20 pharmaceutical exporter in the world. The industry manufactures almost the entire rangeof therapeutic products and is capable of producing raw materials for manufacturing a widerange of bulk drugs from the basic stage. The government has taken measures to give impetus todomestic production drugs and formulations, creating an environment conductive for channelingnew investments in to pharmaceutical sector. However the industry and experts feel that time hascome for the government to announce new policy initiatives, particularly relating to the researchand development and pricing relating, in order to propel the industry in to a new growth orbit, aswell as, to face the challenges of the WTO led trading system and TRIPS driven product patentenvironment. Bulk drugs are medically effective chemicals. They are derived from 4 typeintermediate (raw materials) namely animal derivatives e.g., insulin extracted from bovinepancreas, synthetic chemicals and Biogenetic (human) derivatives e.g., human insulin.


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The Indian Pharmaceutical Industry today is in the front rank of Indias science-based industrieswith wide ranging capabilities in the complex field of drug manufacture and technology. Ahighly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5 billion,growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of

technology, quality and range of medicines manufactured. From simple headache pills tosophisticated antibiotics and complex cardiac compounds, almost every type of medicine is nowmade indigenously.Playing a key role in promoting and sustaining development in the vital fieldof medicines, Indian Pharma Industry boasts of quality producers and many units approved byregulatory authorities in USA and UK. International companies associated with this sector havestimulated, assisted and spearheaded this dynamic development in the past 53 years and helpedto put India on the pharmaceutical map of the world. The Indian Pharmaceutical sector is highlyfragmented with more than 20,000 registered units. It has expanded drastically in the last twodecades. The leading 250 pharmaceutical companies control 70% of the market with marketleader holding nearly 7% of the market share. It is an extremely fragmented market with severeprice competition and government control.

The pharmaceutical industry in India meets around 70% of the country's demand forbulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, oralsand injectibles. There are about 250 large units and about 8000 Small Scale Units, which formthe core of the pharmaceutical industry in India (including 5 Central Public Sector Units). Theseunits produce the complete range of pharmaceutical formulations, i.e., medicines ready forconsumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value andused for production of pharmaceuticals formulations. Following the de-licensing of thepharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical productshas been done away with. Manufacturers are free to produce any drug duly approved by the DrugControl Authority. Technologically strong and totally self-reliant, the pharmaceutical industry inIndia has low costs of production, low R&D costs, innovative scientific manpower, strength of

national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with itsrich scientific talents and research capabilities, supported by Intellectual Property Protectionregime is well set to take on the international market.

Formulations:

Doctors, post- diagnosis to cure a disease or disorder in the patient primarily prescribesformulation. To prevent misuse/incorrect administration, most formulations are disbursed bypharmacies only under medical prescription and these are called ethical products. However usercan also purchase tonics etc directly. These are called over-the-counter (OTC) products.Formulations can be categorized as per three route of administration to patient, like

Oral: Tablets, syrups, capsules, powders etc., taken internally.Topical: Ointment, creams, liquids, aerosols that are applied on the skin.Potentials: Sterile solutions injected in an intravenous or intramuscular fashion.Others: Eye-drops, peccaries, surgical dressings.


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1.2 COMPANY PROFILE

Biological E Limited was established over 50 years ago. It is the first privatesector biological products company in India and the first pharmaceuticals company in South

India. BE is also the pioneer in preventive medicine. Originally incorporated as BiologicalProducts Private Limited in 1953, and launched by Dr. D.V.K. Raju, Biological E today, is aleader in Vaccinology in India and a significant player in the world vaccine market. We arefurther expanding and enhancing the facilities and product lines for vaccines through theestablishment of a new plant and R&D centre in Andhra Pradesh.

Early on, Biological E Limited partnered with Evans Medical of UK to develop pharmaceutical formulations. Later it teamed with Glaxo, India to focus on building thepharmaceutical business in India. They have also collaborated with Pasteur Meriux Connaught ofFrance and Solvay & Cie of Belgium. Every tie-up they entered into has sought to strengthen andadvance their over all strategy of being innovative, expanding and developing product lines and

building infrastructure with an eye to the future. Biological E Limited supplies most of theessential and life saving drugs to Central and State Government Hospitals, Public SectorUndertakings, the Indian Armed Forces and the domestic retail market. Its International divisionprovides global-access to high quality innovative products and caters to the health and well beingof people worldwide.

Biological E Limited is now a serious participant in the exciting new face ofmedical science - Gene Therapy. With the dynamic Dr. Vijay Kumar Datla, Chairman &Managing Director as its head and inspiration, BE is offering hope to people who can't be helpedby standard treatments From being one of the first endeavours to promoters of the indigenous pharmaceutical industry to a formidable presence in the preventive spheres of vaccines;producers of bulk drugs to cutting edge genetic and cell-based technologies to treat disease,Biological E Limited has always displayed the vigour, energy to surmount ever higher peaks andthe vision to constantly expand it's horizons. Biological E Limited has a long and richly texturedhistory but the future promises to be even more exciting and successful.

Mission Statement: Biological E.Limited is a dedicated health Care Company, OfferingInnovative for Disease Prevention & Management, through superior, value added products thatsatisfy current and future needs, not only for its customers but also for the health and wellbeingof people worldwide

Vision Statement: A Leading Healthcare Company

Objectives: BE marshals its talents to explore new therapeutic approaches that address two keyobjectives: Meeting the medical needs of patients and their families and Improving theirQuality of life-Through high quality products, which strengthen the prescribing hand.


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manufacturing and development capabilities BE is focused on becoming a major world player inthe vaccines business. Biological E Limiteds dedicated manufacturing facilities have beenawarded with the WHO GMP certification. The new facilities at Biotech Park Phase II, AndhraPradesh are aimed at acquiring WHO prequalification for all the products.

(ii) Pharma: From 1977 Biological E Limited has focused on building its pharmaceutical business in India. Our core competencies are development, manufacturing and marketing ofpharmaceuticals. Biological E Limited is the 57th ORG ranking company in India in terms of itsprescription market share.

We have dedicated manufacturing facilities for Solid Dosage Forms, Liquid Oralsand Syrups, Parenterals and Active Pharmaceutical Ingredients and continue to invest in world-class facilities that will be in accordance with US FDA and EMEA standards. Biological ELimited has significant capabilities in pharmaceutical product development. We are looking atpartnering with innovators and academic institutions as well as licensing from other companies.Our strategy is to develop and launch innovative pharmaceuticals through a collaborative model.In the domestic market, we have sales offices at 23 locations and 25 depots. We cover around 1 ,00,000

doctors allover India and our products are sold by around 15,000 stockists in India.These facilitate the marketing efforts of our team throughout the country. Biological E Limited isalso expanding sales and marketing channels internationally. Currently, we export to Japan,Korea, Taiwan, Indonesia, Malaysia and the CIS countries.

(iii)Public Market: As the first private sector manufacturer of vaccines and pharmaceuticalproducts in India, Biological E Limited has built up a countrywide distribution network ofclients. We cover 72,000 doctors all over India .However, the Government of India, allinstitutions allied to it, semi-government organizations including Private and Public Institutionsare Biological E Limited's biggest clients. The Government of India as a single entity stands outas our largest customer. This is in keeping with its social objectives of providing affordablehealthcare and medicines to the masses. Among the most sought after products are Anti Snake

Venom, Anti-Tetanus Serum, Tetanus Toxoid, DPT, DT, Heparin and the Coscopin Range

d) Infrastructure

(i) Manufacturing:Biological E. Limited has several firsts to its credit. It was the first privatesector biological products company in India; the first pharmaceutical company to manufactureanti-TB drugs in India and the first private sector vaccine manufacturer in the country. However,Biological E Limited's standing and reputation lie not in merely being first but in its longstanding and firm commitment to maintaining the highest quality standards through constantinnovation, partnerships with reputed institutes and modernization of its manufacturing facilities.


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(ii) Sales and Distribution: Sales and Distribution is the backbone for any business. Thedistribution department plays a vital role in the success of the company. Sales and distribution

strategies are essential for taking a new product beyond its introduction phase, increasing marketshare and maximizing potential .BE's committed and hard working Distribution Departmentsupports the Marketing team by ensuring the timely availability of finished goods in the market.As we are leaders in the Vaccine Market, the Distribution Department makes that extra effort inspecially packing and forwarding goods to the highest standards.

Sales & Distribution operates as an extended arm of the Financedepartment and co-ordinates various services in support of the Marketing Department. TheMarketing Department in turn ensures the redistribution of finished goods to end users throughAuthorized Stockists spread across the nation, getting the most out of the distribution.

Marketing services plays a key role

The appointment of stockists and CFAs Timely settlement of customer claims

Optimum customer satisfaction

Attending to customer Quires

B.Es Network

The department has four Zonal Representatives with the objective of providingefficient services to internal and external customers and the CFA's. These representatives act asInternal Auditors, visiting all the CFA's periodically. This has led to improved CFAPerformance.The Company operates with

25 carrying and forwarding agents.

Approximately 15,000 authorized Distributors across the country.

(iii) Quality standards: Quality Policies are focused on the World Health Organization as wellas the Drug and Cosmetics Act 1940, India guidelines, laws and regulations governing themanufacture of Pharmaceutical products, Biological products, Herbal products and ActivePharmaceutical Ingredients as well as pharmaceutical requirements to achieve customers delight.

Quality Management is mandated and supported by executivemanagement and although co-ordinated by the Quality Management Department, it is monitored by departmental self-audits, internal facility audits and Quality Assurance complianceprograms. It is further enforced by regulatory agency inspections/investigations

Quality Standards are achieved through Quality principles and

relevant Standard Operational Procedures that ensure each product meets the requirements forsafety, identity, potency, strength, quality, purity, uniformity, reliability and stability. TheseQuality principles in conjunction with our internal procedures are used in the planning, designand construction of facilities and validation of processes, products, test methods and systems.Research and Development, Engineering, Maintenance, Materials Management, Production,Quality Assurance and Quality Control are always oriented with true Quality principles.

Quality Control laboratories are equipped with routinely calibratedinstruments that carry out chemical, biological and microbiological testing. These laboratories


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separated from the production areas are independent. Our controls are designed to ensure thatraw materials, package components, in-process materials, labeling, finished products conform toappropriate standards of safety, identity, strength, quality, purity, uniformity, reliability , andstability. Biological E Limited attaches high importance to maintaining a strict quality control, atevery stage of its processes, and over products and management practices across all its facilities

and throughout the organization. The safety of our products is checked, through extensivetesting, sampling and validation procedures, so as to be consistent with the final productspecifications.

e) Awards and Recognition:In 2005, based on the export performance of last three years, BEhas been awarded STAR EXPORT HOUSE status by Directorate General of Foreign Trade,Ministry of Commerce and Industry, Govt. of India. All India Congress of Obstetrics andGynecology (AICOG ) has recognized BE for the invaluable support and assistance rendered inthe area of Obstetrics and Gynecology in 2003. In 2001, Department of Biotechnology , Ministryof Science & Technology, Govt, of India has given recognition to BE for its outstandingcontribution towards technology development and Industry Partnership in Biotechnology.

f) Research and Development: R&D Cycle

(i) Discovery: Drug discovery is the process by which drugs are discovered, designed and thendeveloped. Despite advances in technology and understanding of biological systems, drugdiscovery is still a long process with low rate of new therapeutic discovery . Biological E Limitedhas always been conscious of the need to continuously discover and develop new products. Thisunderstanding has seen Biological E Limited enter into Partnerships with highly reputed researchinstitutions across the world in its efforts to develop and bring out remedies to ailments. We areconstantly in the process of developing and launching pharmaceutical products through thiscollaborative model. Biological E Limited is building partnerships with various companiesgiving it access to innovative products.

(ii)R&D: Biological E Limited has a dedicated development facility having a large pool ofexperienced scientists who are committed to development of various vaccines and recombinantproteins. Our R & D scientists are engaged in process development, process improvement,formulation and analytical development. Our product development pipeline includes various bacterial polysaccharide and conjugate vaccines, viral vaccines and recombinant proteintherapeutics. This facility is recognized by Department of Scientific and Industrial Research,Government of India.(iii)Clinical Research: Biological E Limited's Clinical research is that part of the continuum ofhealth research which is conducted in human beings. This discipline combines discoveries fromthe basic science laboratory with the observations and insights of clinicians. It then delineates themechanisms of human health and disease, develops potential preventive, diagnostic andtherapeutic measures and finally evaluates their effectiveness for improving health. It alsofocuses on making rigorous comparisons among current diagnostic, therapeutic and preventiveapproaches and developing new ones, to determine which are most effective and safe. Clinicalresearch merges with the closely related fields of health systems and population health research.Biological E Limited believes that the maximal benefits to the nation's health and its economy
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will be achieved by supporting a continuum from basic to clinical to health services topopulation health research.

g) Recent Developments:

The state of the art facility (100%EOU) set up at shamerpet, R.R District, spread over 72 acres ofland and WHOGMP compliant, was developed by Shapoorji Pallonji and jointly promoted bylatest WHO release, this is not showing any signs of weakening and there is an acute shortage ofvaccines, especially in the developing nations. The technology contracted for by the company isa revolutionary one capable of producing about 3000 to 5000 million doses in a 8 to10 week timeframe, which is several times of the capacity involving other technologies. Once proved, thecompany will be able to produce the vaccine in huge quantities, at a very affordable cost andwith good potency and safety.

h) Human resources and expertise:

BE has a large pool of experienced and dedicated scientist who are committed to development ofvarious vaccines and recombinant proteins. BE technical team has vast experience in processdevelopment and manufacturing ranging from handling Fermentor,Bioreactor vessels,Rollerbottles,cell factories for growth of bacteria and /or viruses, process improvement forimproving the yield, formulation and analytical development.

i)Manufacturing Locations: The company has the following manufacturing facilities:

Azmabad, Hyderabad(Registered office and plant)

Gaganpahad, RR district, Andhra Pradesh

Pattancheru ,Medak District ,Andhra Pradesh

Shameerpet, RR district, Andhra Pradesh

Dehradun, Uttarakhand.

biologic ale e chapter 1

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