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Indian Pharmaceutical Industry

Indian Pharmaceutical Industry



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Published by: ramchandboop6703 on Dec 31, 2008
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Pharmaceutical company develops, produces, and marketsmedicinal drugs.Thesecompanies can deal ingenericor brandmedications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.Generic drug (generic drugs, short: generics) is adrugwhich is produced and distributedwithout patentprotection. The generic drug may still have a patenton the formulation but not on the active ingredient.Pharmaceutical formulation, in pharmaceutics,is the process in which different chemicalsubstances are combined to a puredrugsubstance to produce a finalmedicinal product.
A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 5 - 10 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, interms of technology, quality and range of medicines manufactured. From simpleheadache pills to sophisticated antibiotics and complex cardiac compounds, almost everytype of medicine is now made indigenously.It’s playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK.The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registeredunits. It has expanded drastically in the last two decades. The leading 250 pharmaceuticalcompanies control 70% of the market with market leader holding nearly 7% of the marketshare. It is an extremely fragmented market with severe price competition andgovernment price control.The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules,orals and injectibles. There are about 250 large units and about 8000 Small Scale Units,which form the core of the pharmaceutical industry in India (including 5 Central PublicSector Units). These units produce the complete range of pharmaceutical formulations,i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e.,chemicals having therapeutic value and used for production of pharmaceuticalformulations.
1. Competent workforce:
India has a pool of personnel with high managerial andtechnical competence as also skilled workforce. It has an educated work force andEnglish is commonly used. Professional services are easily available.
2. Cost-effective chemical synthesis:
Its track record of development, particularly in thearea of improved cost-beneficial chemical synthesis for various drug molecules isexcellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.
3. Legal & Financial Framework:
India has a 53 year old democracy and hence has asolid legal framework and strong financial markets. There is already an establishedinternational industry and business community.
4. Information & Technology:
It has a good network of world-class educationalinstitutions and established strengths in Information Technology.
5. Globalization:
The country is committed to a free market economy and globalization.Above all, it has a 70 million middle class market, which is continuously growing.
6. Consolidation:
For the first time in many years, the international pharmaceuticalindustry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has startedtaking place in India.
1.Ranbaxy2.Wockhardt3.Glaxo4.Novartis5.Cipla6.Cadila Healthcare7.Aurobindo Pharma8.Dr Reddy’s Laboratories9.Aventis Pharma10.Nicholas Piramal11.Sun Pharma12.Glenmark Pharma
1.Research and Development2.Regulators3.Production4.Quality5.Marketing
 Research and Development:
1.Drug Discovery2.Drug Development
Drug Discovery
: It is the process by which potentialdrugsare discovered or designed. Inthe past most drugs have been discovered either by isolating the active ingredient fromtraditional remedies or byserendipitousdiscovery. Modernbiotechnologyoften focuses on understanding themetabolic pathwaysrelated to adiseasestate or  pathogen,and manipulating these pathways usingmolecular biologyor Biochemistry. A great deal of  early-stage drug discovery has traditionally been carried out by universities and researchinstitutions.
Drug development:
It refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drugdevelopment are to determine appropriate f ormulationas well as to establishsafety.
This department is responsible for getting approval or license for the particular drugsmanufactured by their company. Every drug has to be approved by the central body before it is marketed to the customers. Regulators are doing the following activities in a pharma company1.Keeping in touch with doctors in the government hospitals regularly2.Introducing the newly developed drugs to the doctors, then drugs will be given tothe patients by doctors’ prescription.3.Doctors will analyze the patients normalcy, after they have the drugs4.As per the patients improvements, a separate report will be prepared for the drugand will be given to the regulatory department.5.These report will be submitted before the DCD (Drug Control Department) byregulatory department6.As per the doctor’s report drug will be licensed by the DCD.

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