Saturday, 16 June 2018

Biotechnology

Biotechnology is the use of living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use" (UN Convention on Biological Diversity, Art. 2).[1] Depending on the tools and applications, it often overlaps with the (related) fields of bioengineeringbiomedical engineeringbiomanufacturingmolecular engineering, etc.
For thousands of years, humankind has used biotechnology in agriculturefood production, and medicine.[2] The term is largely believed to have been coined in 1919 by Hungarian engineer Károly Ereky. In the late 20th and early 21st centuries, biotechnology has expanded to include new and diverse sciences such as genomicsrecombinant gene techniques, applied immunology, and development of pharmaceutical therapies and diagnostic test

Definitions[edit]

The wide concept of "biotech" or "biotechnology" encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domesticationof animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials and organisms such as pharmaceuticals, crops, and livestock.[3] As per European Federation of Biotechnology, biotechnology is the integration of natural science and organisms, cells, parts thereof, and molecular analogues for products and services.[4]Biotechnology also writes on[clarification needed] the pure biological sciences (animal cell culturebiochemistrycell biologyembryologygeneticsmicrobiology, and molecular biology). In many instances, it is also dependent on knowledge and methods from outside the sphere of biology including:
Conversely, modern biological sciences (including even concepts such as molecular ecology) are intimately entwined and heavily dependent on the methods developed through biotechnology and what is commonly thought of as the life sciences industry. Biotechnology is the research and development in the laboratory using bioinformatics for exploration, extraction, exploitation and production from any living organisms and any source of biomass by means of biochemical engineering where high value-added products could be planned (reproduced by biosynthesis, for example), forecasted, formulated, developed, manufactured, and marketed for the purpose of sustainable operations (for the return from bottomless initial investment on R & D) and gaining durable patents rights (for exclusives rights for sales, and prior to this to receive national and international approval from the results on animal experiment and human experiment, especially on the pharmaceutical branch of biotechnology to prevent any undetected side-effects or safety concerns by using the products).[5][6][7]
By contrast, bioengineering is generally thought of as a related field that more heavily emphasizes higher systems approaches (not necessarily the altering or using of biological materials directly) for interfacing with and utilizing living things. Bioengineering is the application of the principles of engineering and natural sciences to tissues, cells and molecules. This can be considered as the use of knowledge from working with and manipulating biology to achieve a result that can improve functions in plants and animals.[8] Relatedly, biomedical engineering is an overlapping field that often draws upon and applies biotechnology (by various definitions), especially in certain sub-fields of biomedical or chemical engineering such as tissue engineering, biopharmaceutical engineering, and genetic engineering.

History[edit]


Brewing was an early application of biotechnology
Although not normally what first comes to mind, many forms of human-derived agriculture clearly fit the broad definition of "'utilizing a biotechnological system to make products". Indeed, the cultivation of plants may be viewed as the earliest biotechnological enterprise.
Agriculture has been theorized to have become the dominant way of producing food since the Neolithic Revolution. Through early biotechnology, the earliest farmers selected and bred the best suited crops, having the highest yields, to produce enough food to support a growing population. As crops and fields became increasingly large and difficult to maintain, it was discovered that specific organisms and their by-products could effectively fertilizerestore nitrogen, and control pests. Throughout the history of agriculture, farmers have inadvertently altered the genetics of their crops through introducing them to new environments and breeding them with other plants — one of the first forms of biotechnology.
These processes also were included in early fermentation of beer.[9] These processes were introduced in early MesopotamiaEgyptChinaand India, and still use the same basic biological methods. In brewing, malted grains (containing enzymes) convert starch from grains into sugar and then adding specific yeasts to produce beer. In this process, carbohydrates in the grains broke down into alcohols, such as ethanol. Later, other cultures produced the process of lactic acid fermentation, which produced other preserved foods, such as soy sauce. Fermentation was also used in this time period to produce leavened bread. Although the process of fermentation was not fully understood until Louis Pasteur's work in 1857, it is still the first use of biotechnology to convert a food source into another form.
Before the time of Charles Darwin's work and life, animal and plant scientists had already used selective breeding. Darwin added to that body of work with his scientific observations about the ability of science to change species. These accounts contributed to Darwin's theory of natural selection.[10]
For thousands of years, humans have used selective breeding to improve production of crops and livestock to use them for food. In selective breeding, organisms with desirable characteristics are mated to produce offspring with the same characteristics. For example, this technique was used with corn to produce the largest and sweetest crops.[11]
In the early twentieth century scientists gained a greater understanding of microbiology and explored ways of manufacturing specific products. In 1917, Chaim Weizmann first used a pure microbiological culture in an industrial process, that of manufacturing corn starch using Clostridium acetobutylicum, to produce acetone, which the United Kingdom desperately needed to manufacture explosives during World War I.[12]
Biotechnology has also led to the development of antibiotics. In 1928, Alexander Fleming discovered the mold Penicillium. His work led to the purification of the antibiotic compound formed by the mold by Howard Florey, Ernst Boris Chain and Norman Heatley – to form what we today know as penicillin. In 1940, penicillin became available for medicinal use to treat bacterial infections in humans.[11]
The field of modern biotechnology is generally thought of as having been born in 1971 when Paul Berg's (Stanford) experiments in gene splicing had early success. Herbert W. Boyer (Univ. Calif. at San Francisco) and Stanley N. Cohen (Stanford) significantly advanced the new technology in 1972 by transferring genetic material into a bacterium, such that the imported material would be reproduced. The commercial viability of a biotechnology industry was significantly expanded on June 16, 1980, when the United States Supreme Courtruled that a genetically modified microorganism could be patented in the case of Diamond v. Chakrabarty.[13] Indian-born Ananda Chakrabarty, working for General Electric, had modified a bacterium (of the genus Pseudomonas) capable of breaking down crude oil, which he proposed to use in treating oil spills. (Chakrabarty's work did not involve gene manipulation but rather the transfer of entire organelles between strains of the Pseudomonas bacterium.
Revenue in the industry is expected to grow by 12.9% in 2008. Another factor influencing the biotechnology sector's success is improved intellectual property rights legislation—and enforcement—worldwide, as well as strengthened demand for medical and pharmaceutical products to cope with an ageing, and ailing, U.S. population.[14]
Rising demand for biofuels is expected to be good news for the biotechnology sector, with the Department of Energy estimating ethanol usage could reduce U.S. petroleum-derived fuel consumption by up to 30% by 2030. The biotechnology sector has allowed the U.S. farming industry to rapidly increase its supply of corn and soybeans—the main inputs into biofuels—by developing genetically modified seeds that resist pests and drought. By increasing farm productivity, biotechnology boosts biofuel production.[15]

Examples[edit]


rose plant that began as cells grown in a tissue culture
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 plasticsvegetable oilbiofuels), and environmental uses.
For example, one application of biotechnology is the directed use of organisms for the manufacture of organic products (examples include beer and milk products). Another example is using naturally present bacteria by the mining industry in bioleaching. Biotechnology is also used to recycle, treat waste, clean up sites contaminated by industrial activities (bioremediation), and also to produce biological weapons.
A series of derived terms have been coined to identify several branches of biotechnology; for example:
  • Bioinformatics is an interdisciplinary field that addresses biological problems using computational techniques, and makes the rapid organization as well as analysis of biological data possible. The field may also be referred to as computational biology, and can be defined as, "conceptualizing biology in terms of molecules and then applying informatics techniques to understand and organize the information associated with these molecules, on a large scale."[16] Bioinformatics plays a key role in various areas, such as functional genomicsstructural genomics, and proteomics, and forms a key component in the biotechnology and pharmaceutical sector.
  • Blue biotechnology is a term that has been used to describe the marine and aquatic applications of biotechnology, but its use is relatively rare.
  • Green biotechnology is biotechnology applied to agricultural processes. An example would be the selection and domestication of plants via micropropagation. Another example is the designing of transgenic plants to grow under specific environments in the presence (or absence) of chemicals. One hope is that green biotechnology might produce more environmentally friendly solutions than traditional industrial agriculture. An example of this is the engineering of a plant to express a pesticide, thereby ending the need of external application of pesticides. An example of this would be Bt corn. Whether or not green biotechnology products such as this are ultimately more environmentally friendly is a topic of considerable debate.
  • Red biotechnology is applied to medical processes. Some examples are the designing of organisms to produce antibiotics, and the engineering of genetic cures through genetic manipulation.
  • White biotechnology, also known as industrial biotechnology, is biotechnology applied to industrial processes. An example is the designing of an organism to produce a useful chemical. Another example is the using of enzymes as industrial catalysts to either produce valuable chemicals or destroy hazardous/polluting chemicals. White biotechnology tends to consume less in resources than traditional processes used to produce industrial goods.[17]
The investment and economic output of all of these types of applied biotechnologies is termed as "bioeconomy".

Medicine[edit]

In medicine, modern biotechnology finds many applications in areas such as pharmaceutical drug discoveries and production, pharmacogenomics, and genetic testing (or genetic screening).

DNA microarray chip – some can do as many as a million blood tests at once
Pharmacogenomics (a combination of pharmacology and genomics) is the technology that analyses how genetic makeup affects an individual's response to drugs.[18] It deals with the influence of genetic variation on drug responses in patients by correlating gene expressionor single-nucleotide polymorphisms with a drug's efficacy or toxicity.[19] By doing so, pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects.[20] Such approaches promise the advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.[21][22]

Computer-generated image of insulin hexamers highlighting the threefold symmetry, the zinc ions holding it together, and the histidineresidues involved in zinc binding.
Biotechnology has contributed to the discovery and manufacturing of traditional small molecule pharmaceutical drugs as well as drugs that are the product of biotechnology – biopharmaceutics. Modern biotechnology can be used to manufacture existing medicines relatively easily and cheaply. The first genetically engineered products were medicines designed to treat human diseases. To cite one example, in 1978 Genentech developed synthetic humanized insulin by joining its gene with a plasmid vector inserted into the bacterium Escherichia coli. Insulin, widely used for the treatment of diabetes, was previously extracted from the pancreas of abattoir animals (cattle or pigs). The resulting genetically engineered bacterium enabled the production of vast quantities of synthetic human insulin at relatively low cost.[23][24]Biotechnology has also enabled emerging therapeutics like gene therapy. The application of biotechnology to basic science (for example through the Human Genome Project) has also dramatically improved our understanding of biology and as our scientific knowledge of normal and disease biology has increased, our ability to develop new medicines to treat previously untreatable diseases has increased as well.[24]
Genetic testing allows the genetic diagnosis of vulnerabilities to inherited diseases, and can also be used to determine a child's parentage (genetic mother and father) or in general a person's ancestry. In addition to studying chromosomes to the level of individual genes, genetic testing in a broader sense includes biochemical tests for the possible presence of genetic diseases, or mutant forms of genes associated with increased risk of developing genetic disorders. Genetic testing identifies changes in chromosomes, genes, or proteins.[25] Most of the time, testing is used to find changes that are associated with inherited disorders. The results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person's chance of developing or passing on a genetic disorder. As of 2011 several hundred genetic tests were in use.[26][27] Since genetic testing may open up ethical or psychological problems, genetic testing is often accompanied by genetic counseling.

Agriculture[edit]

Genetically modified crops ("GM crops", or "biotech crops") are plants used in agriculture, the DNA of which has been modified with genetic engineering techniques. In most cases, the main aim is to introduce a new trait that does not occur naturally in the species.
Examples in food crops include resistance to certain pests,[28] diseases,[29] stressful environmental conditions,[30] resistance to chemical treatments (e.g. resistance to a herbicide[31]), reduction of spoilage,[32] or improving the nutrient profile of the crop.[33] Examples in non-food crops include production of pharmaceutical agents,[34] biofuels,[35] and other industrially useful goods,[36] as well as for bioremediation.[37][38]
Farmers have widely adopted GM technology. Between 1996 and 2011, the total surface area of land cultivated with GM crops had increased by a factor of 94, from 17,000 square kilometers (4,200,000 acres) to 1,600,000 km2 (395 million acres).[39] 10% of the world's crop lands were planted with GM crops in 2010.[39] As of 2011, 11 different transgenic crops were grown commercially on 395 million acres (160 million hectares) in 29 countries such as the USA, Brazil, Argentina, India, Canada, China, Paraguay, Pakistan, South Africa, Uruguay, Bolivia, Australia, Philippines, Myanmar, Burkina Faso, Mexico and Spain.[39]
Genetically modified foods are foods produced from organisms that have had specific changes introduced into their DNA with the methods of genetic engineering. These techniques have allowed for the introduction of new crop traits as well as a far greater control over a food's genetic structure than previously afforded by methods such as selective breeding and mutation breeding.[40] Commercial sale of genetically modified foods began in 1994, when Calgene first marketed its Flavr Savr delayed ripening tomato.[41] To date most genetic modification of foods have primarily focused on cash crops in high demand by farmers such as soybeancorncanola, and cotton seed oil. These have been engineered for resistance to pathogens and herbicides and better nutrient profiles. GM livestock have also been experimentally developed, although as of November 2013 none are currently on the market.[42]
There is a scientific consensus[43][44][45][46] that currently available food derived from GM crops poses no greater risk to human health than conventional food,[47][48][49][50][51] but that each GM food must be tested on a case-by-case basis before introduction.[52][53][54] Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe.[55][56][57][58] The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.[59][60][61][62]
GM crops also provide a number of ecological benefits, if not used in excess.[63] However, opponents have objected to GM crops per se on several grounds, including environmental concerns, whether food produced from GM crops is safe, whether GM crops are needed to address the world's food needs, and economic concerns raised by the fact these organisms are subject to intellectual property law.

Industrial[edit]

Industrial biotechnology (known mainly in Europe as white biotechnology) is the application of biotechnology for industrial purposes, including industrial fermentation. It includes the practice of using cells such as micro-organisms, or components of cells like enzymes, to generate industrially useful products in sectors such as chemicals, food and feed, detergents, paper and pulp, textiles and biofuels.[64] In doing so, biotechnology uses renewable raw materials and may contribute to lowering greenhouse gas emissions and moving away from a petrochemical-based economy.[65]

Environmental[edit]

The environment can be affected by biotechnologies, both positively and adversely. Vallero and others have argued that the difference between beneficial biotechnology (e.g.bioremediation is to clean up an oil spill or hazard chemical leak) versus the adverse effects stemming from biotechnological enterprises (e.g. flow of genetic material from transgenic organisms into wild strains) can be seen as applications and implications, respectively.[66] Cleaning up environmental wastes is an example of an application of environmental biotechnology; whereas loss of biodiversity or loss of containment of a harmful microbe are examples of environmental implications of biotechnology.

Regulation[edit]

The regulation of genetic engineering concerns approaches taken by governments to assess and manage the risks associated with the use of genetic engineering technology, and the development and release of genetically modified organisms (GMO), including genetically modified crops and genetically modified fish. There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe.[67] Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.[68] The European Union differentiates between approval for cultivation within the EU and approval for import and processing. While only a few GMOs have been approved for cultivation in the EU a number of GMOs have been approved for import and processing.[69] The cultivation of GMOs has triggered a debate about coexistence of GM and non GM crops. Depending on the coexistence regulations incentives for cultivation of GM crops differ.[70]

Learning[edit]

In 1988, after prompting from the United States Congress, the National Institute of General Medical Sciences (National Institutes of Health) (NIGMS) instituted a funding mechanism for biotechnology training. Universities nationwide compete for these funds to establish Biotechnology Training Programs (BTPs). Each successful application is generally funded for five years then must be competitively renewed. Graduate students in turn compete for acceptance into a BTP; if accepted, then stipend, tuition and health insurance support is provided for two or three years during the course of their Ph.D. thesis work. Nineteen institutions offer NIGMS supported BTPs.[71] Biotechnology training is also offered at the undergraduate level and in community colleges.

List of Government Manufacturing Companies in Drugs and Pharmaceuticals Sector

This particular industry contributes much to the economic development of India. The sector is a major source for various medicines, drugs and other related pharmaceutical formulations. The main aim of these public sector companies is to manufacture quality products and to distribute to all at affordable prices. There are mainly five government owned pharmaceutical companies in the country.

Source: http://entrance-exam.net/list-of-government-companies-in-drugs-and-pharmaceuticals-sector/#ixzz5Iecswz5e


Major Government Companies in Drugs and Pharmaceuticals Sector
Indian Drugs and Pharmaceuticals Ltd. (IDPL) – IDPL is the central pharmaceutical sector that is fully under the control of government of India. It was founded in the year 1961. The tremendous growth of the company has made a change in the development of economy of the country. It has become a role model in healthcare to various other pharmaceutical firms.
List of Drugs and Pharmaceutical Companies in Western part of India
Hindustan Antibiotics Limited (HAL) – HAL located in Pune was established during the year 1955-1956. It has also four joint sectors in the country. The company manufactures various drugs like Penicillin, Streptomycin and a number of formulations.
List of Drugs and Pharmaceutical Companies in Eastern part of India
Bengal Chemicals and Pharmaceuticals Limited (BCPL) – BPCL was formerly known as the Bengal Chemical & Pharmaceutical Works Limited. The company was known in this name from the year 1901. It started working in its present name from 1981. The company is said to be the heritage firm of Indian industries.
Bengal Immunity Limited (BIL) – The Company was formerly a sick company in the private sector with the name Bengal Immunity Company Limited. It was taken over by the Indian government in the year 1984. It has two manufacturing units in the country, one at Calcutta and other at Dehradun. The company manufactures various drugs like  Sera, Vaccines and Toxiodes.
Smith Stanisteet Pharmaceuticals Ltd (SSPL) – The Company was formerly known in the name Smith Stanistreet Company Limited. This was also a financially weak company in the private sector and was taken over by Central Government in the year 1972. But it was nationalized in the year 1977. It manufactures various drugs in the form of Tablets, Capsules, Parenterals and liquid orals.


Source: http://entrance-exam.net/list-of-government-companies-in-drugs-and-pharmaceuticals-sector/#ixzz5Ied9Aizm


Are there medicines/pills for each and every health/mental conditions?


Are there any Indian Government Pharmaceutical Manufacturing Industries?

Why there are no any Indian Government Pharmaceutical Manufacturing Industries?

OVERVIEW
The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labor in India at low cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market.Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.
Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise.
In terms of the global market, India currently holds a modest 1–2% share, but it has been growing at approximately 10% per year. India gained its foothold on the global scene with its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 US FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies. Growth in other fields notwithstanding, generics are still a large part of the picture. London research company Global Insight estimates that India’s share of the global generics market will have risen from 4% to 33% by 2007.The Indian pharmaceutical industry has become the third largest producer in the world and is poised to grow into an industry of $20 billion in 2015 from the current turnover of $12 billion.

Quality[edit]

The Quality of drugs and APIs (Active Pharmaceutical Ingredients) made by Indian pharmaceutical companies is often poor. In the past three years 2015 - 2017, there were 31 FDA warning letters to Indian pharmaceutical companies citing serious Data Integrity issues, including data deletion, manipulation or fabrication of test results, see “An Analysis Of 2017 FDA Warning Letters On Data Integrity” By Barbara Unger, Unger Consulting Inc. https://www.pharmaceuticalonline.com/doc/an-analysis-of-fda-warning letters-on-data-integrity-0003
See the very long list of Indian pharmaceutical companies which have been placed on Import Alert by the FDA due to serious noncompliance with Good Manufacturing Procedures http://www.accessdata.fda.gov/cms_ia/importalert_189.html
See the European Medicines Agency EudraGMDP Noncompliance Reports based on Inspections of companies that revealed serious noncompliance with Good Manufacturing Procedures: http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do
See FDA Warning Letters detailing serious noncompliance with Good Manufacturing Procedures: http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm

Exports[edit]

Exports of pharmaceuticals products from India increased from US$6.23 billion in 2006-07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%.[2] Some of the major pharmaceutical firms include Sun PharmaceuticalCadila Healthcare and Piramal Enterprises.[2]
India exported $11.7 billion worth of pharmaceuticals in 2014. The 10 countries below imported 56.5% of that total:[12]
RankCountryValue (US$)Share
1United States$3.8 billion32.9%
2South Africa$461.1 million3.9%
3Russia$447.9 million3.8%
4United Kingdom$444.9 million3.8%
5Nigeria$385.4 million3.3%
6Kenya$233.9 million2%
7Tanzania$225.2 million1.9%
8Brazil$212.7 million1.8%
9Australia$182.1 million1.6%
10Germany$178.8 million1.5%

Patents[edit]

A significant change in intellectual property protection in India was the 1 January 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after 1 January 1995.[13] Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders.[needs update]
In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patents who make up only 12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations.[citation needed]

Product development[edit]


Small and medium enterprises
[edit]Indian companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, companies are lured by the promise of hefty profit margins and thus a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.[14]
As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed[when?] so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies cut back on outsourcing and what business is left shifted to companies with facilities in the four tax-free states – Himachal PradeshJammu and KashmirUttarakhand, and Jharkhand. Consequently, a large number of pharmaceutical manufacturers shifted their plant to these states, as it became almost impossible to continue operating in non-tax free zones. But in a matter of a couple of years the excise duty was revised on two occasions,[when?] first it was reduced to 8% and then to 4%. As a result, the benefits of shifting to a tax free zone was negated. This resulted in, factories in the tax free zones, to start up third party manufacturing. Under this these factories produced goods under the brand names of other parties on job work basis.
As SMEs wrestled with the tax structure, they were also scrambling to meet the 1 July deadline[when?] for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax. Swas Medicare is one of the small scale leading pharmaceutical company of India , which is owned and founded by a Physician.

Largest companies[edit]

Sales, marketing, and business[edit]

Multinational Pharmaceutical Companies ranked as per active presence of sales, marketing and business in India[15]

Publicly traded pharmaceuticals[edit]

Top 9 Publicly Listed pharmaceutical companies in India by Market Capitalization as of 2017.[16]
RankCompanyMarket Capitalization 2017 (INR crores)
1Sun PharmaceuticalRs 1,55,716 Crore
2Lupin LtdRs 68,031 Crore
3Dr. Reddy's LaboratoriesRs 49,293 Crore
4CiplaRs 47,319 Crore
5Aurobindo PharmaRs 41,283 Crore
6Zydus Cadila HealthcareRs 31,631 Crore
7Piramal EnterpriseRs 30,975 Crore
8Glenmark Pharmaceuticals25,302 Crore
9Torrent PharmaceuticalsRs 22,742 Crore

Biotech[edit]

Top 20 Biotechnology companies in India, as of 2013.[17]
RankCompany
1Serum Institute of India
2Biocon
3Nuziveedu Seeds Private Limited
4Novo Nordisk
5Syngene International
6Reliance Life Sciences
7Eli Lilly and Company
8Bharat Serums
9Biological E. Limited
10Fortis Clinical Research
11Novozymes South Asia
12Ankur Seeds
14Indian Immunologicals Limited
15GlaxoSmithKline Pharmaceuticals Ltd
13Bharat Biotech International
16Tulip Group
17Hafkine Biopharmaceutical
18Mahyco
19Advanced Enzymes
20Raasi Seeds
Top 20 Biotechnology companies in India, as of 2016.
RankCompany
1Serum Institute of India[18]
2Biocon[19]
3Jubilant Life Sciences[20]
4Syngene International[21]
5Biological E[22]
6Nuziveedu Seeds[23]
7AstraZeneca Pharma India[24]
8Mahyco[25]
9Bharat Biotech International[26]
10GSK India[27]
11Anthem Biosciences[28]
12Metahelix Life Sciences[29]
13Advanced Enzyme Technologies
14Concord Biotech
15Panacea Biotec
16Ankur Seeds
17Ecron Acunova
18Zytex
19Accurex Biomedical
20Bhat Bio-Tech India

Relation between pharma and biotech[edit]

Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India, with biotech a much smaller part of the economy. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 13th in the world in number of biotech. In 2004-5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion. The Indian biotech market is dominated by bio pharmaceuticals; 76% of 2004–5 revenues came from bio-pharmaceuticals, which saw 30% growth last year. Of the revenues from bio-pharmaceuticals, vaccines led the way, comprising 47% of sales. Biologics and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in bio-generics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities.[30]
Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 92% of which were incorporated in the last five years. The newness of the companies explains the industry’s high consolidation in both physical and financial terms. Almost 30% of all biotech are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 72% of the bio-pharma sector and 52% of the industry as a whole.[4,46] The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CII) seem to suggest that it is possible.[31]

Comparison with the United States[edit]

The Indian biotech sector parallels that of the US in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries see growth potential in biotechnology and have either invested in existing start-ups or ventured into the field themselves.[3]

Government support[edit]

The Indian government established the Department of Biotechnology in 1986 under the Ministry of Science and Technology. Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India’s science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister’s initiative. States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities.[32]
The biotechnology sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.[33]
The government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that will work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government’s strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a "Bio-Edu-Grid" that will knit together the resources of the academic and scientific industrial communities, much as they are in the US.[33]

Foreign investment[edit]

An initiative passed earlier this year[when?] allowed 100% foreign direct investment in the biotech sector without compulsory licensing from the government.[citation needed]

Saturday, 10 February 2018

Pharmacists fume over neglect of Pharm D graduates as Clinical/Community Pharmacist in India*

Pharmacists fume over neglect of Pharm D graduates as Clinical/Community Pharmacist in India*
Pharm D courses were introduced to create a special cadre of clinical pharmacists to record adverse drug reaction.Pharmacists were unhappy with the Pharmacy Council of India stating that the Central and state governments must amend rules to recruit pharmacists, without specifying that a separate post had to be created for clinical pharmacists in hospitals. The Doctor of Pharmacy Association (DPA), which includes Pharm D graduates, said this was the same reply they got in 2015. DPA national president Dr Sai Kumar Katam said, “Pharm D courses were introduced to create a special cadre of clinical pharmacists to record adverse drug reaction, advise on drug dosage to patients on prescription from doctors and also carry out other works like immunisation in all hospitals with JCI/NABH/ISO accrediatation and as a Community Pharmacist in the Community healthcare centres.
There is a reason for creating these specialists.“But instead of recognising and placing them in the right sector, they are merely stating that they must be placed as pharmacists in Clinical Pharmacy. There are already B Pharm and M Pharm graduates working in the sector. But it must be understood that these two courses are not equivalent to Pharm D which is a grade higher.”
Pharm D graduates could work along with Physicians,Surgeons and Nurses along with other medical professionals, during bedside practice and be of great help in monitoring various drugs advised to patients and update the knowledge of entire medical team. Presently, the complete system depended on Physicians for the diagnosis, drug delivery and also observes & reports drug reaction. A Pharm D specialist can monitor drug delivery, dosage and drug reaction reducing the work of Physicians. Hence the course was not merely to dispense medicines but to also follow up, they said.
Senior pharmacist Dr Sanjay Reddy said, “It is high time the government gave due recognition to pharmacists as Clinical pharmacist in clinical pharmacy, Pharmacovigilancer, Community pharmacist in Community health centers, Industrial Pharmacist in Manufacturing companies, Researcher/ Pharma-Scientist, Clinical Preceptor in Pharmacy colleges and Dispensing pharmacist by involving them actively in the healthcare system. Health is a state subject and for that reason the policies of the Central governments have to be implemented by states and review the same routinely. The PCI has to actively follow not only with the Centre but also states.”
The issues of Clinical pharmacists now took centrestage again as PharmD students passing out of colleges did not get jobs and lack of proper salary scheme similar to other medical professionals, which was leading to frustration, and forcing them to opt for change in their profession which is taking advantage by MNC,. TS health minister Dr Laxma Reddy had been approached nearly four times in the last two months as Pharm D students were getting agitated over the government failure to make them part of the healthcare system

PHARM-D and Scope of Pharmacy

Doctor of Pharmacy (Pharm.D.New Latin Pharmaciae Doctor) is a professional doctorate in pharmacy. In some countries, it is a first professional degree, and a prerequisite for licensing to practice the profession of pharmacy or to become a Clinical pharmacist. In many countries they are allowed to practice independently and can prescribe the brand of drugs directly to the patients. Pharm.D program has significant experiential or clinical education components in introductory and advanced levels for the safe and effective use of drugs. Experiential education prepares graduates to be practice-ready as they already spent a significant amount of time training in areas of direct patient care and research. A Pharm D graduate can also use the prefix 'Dr' along with their name. [1]

Pharm D, a 6-year integrated course.
"Being a pharmacist is the most obvious choice.
THERE is tremendous scope for research and higher studies in pharmacy and job opportunities are vast. In the last few years, there has been a revolutionary growth in every area of the pharma field. With the increasing number of life-saving drugs and new methods and techniques of manufacturing and analysis of drugs, the responsibility of pharmacists has increased considerably.
Clinical Pharmacy,Hospital Pharmacy and Community Pharmacy are emerging in India, which involve planning, procuring, dispensing drugs apart from patient counselling. It is interesting to note that a considerable percentage of drug stores in the US are now owned by Indian pharmacy graduates.State and Central Governments appoint Drugs Inspectors to implement the Drugs and Cosmetics Act. A pharmacy graduate alone is eligible for this post and they are the only regulators in the field of Drugs Control Administration. A career in the field of pharmaceutical education combines teaching with research and sometimes, administrative activities. Though the posts require M.Phar/PhD degree, it is not difficult as the government and pharmaceutical industry support PG and research students through scholarships and fellowships. Research in drug development is another exciting area. In India many pharmaceutical industries like Dr. Reddy's, Ranbaxy, Cadilla, Glen-mark, Cipla, Aurobindo, Hetro have excellent divisions in R&D.
A degree in Pharmacy makes you eligible not only to seek employment in various drug, chemical, biotechnology and health care industries but also to start your own business. Pharmaceuticals is a fast growing industry. Government-sponsored industries are engaged in manufacture of live-saving drugs while manufacture of a major portion of bulk drugs and formulations is in the private sector. Here a young and enthusiastic pharmacist can make a mark with his entrepreneurial skills. There are opportunities for pharmacy graduates in marketing and pharmaceutical journalism also. They can serve as technical advisors or consultants for project-funding agencies to banks, financial institutions etc. By becoming a manufacturing chemist, a pharmacist can rise from the position of production supervisor to production manager and vice president.
Pharmacy education is set to undergo a sea-change in the next few years. The introduction of Pharm D., a six-year integrated postgraduate programme, is expected to take pharmacy education to international levels. Pharm D., is expected to provide plenty of opportunities to Indian students to practice pharmacy abroad. They can pursue careers in various fields, including institutional practice; community pharmacy practice;managed care; drug information and long-term care; consultant's role; clinical liaisons with pharmaceutical industry; patient education; and clinical trial research.
The 6-year course provides intensive training in pharmacy practice and clinical pharmacy services. It will include five years of clinical and community-based theory with ward rounds and one-year internship in hospitals. Students will work in coordination with doctors to treat patients. In the final year, the students will come out as clinical pharmacists, an essential component of health care, equal to doctors. Graduates will study in detail about drugs for different diseases. Pharmacists will advise patients about dose, action and side effects, while B.Pharm deals with different drug sources, synthesizing drugs,formulations, analysis, regulations, pharmacological actions, dosage and toxicology.
In a way, pharmacy is coming full circle, and we're seeing it lean more towards direct patient care. As the population grows and ages, people are taking more prescriptions, and there is more demand for pharmacists to have hands-on time with patients. More advanced-practice pharmacists are specialising and rounding with physicians and other health care providers in hospitals as part of a health care team. That's a win-win situation for patients.
The profession is changing and the opportunities are growing. There's more depth and breadth to what pharmacists are expected and asked to do. In a nutshell, pharmacy assures a bright and prosperous future.
Dr. Joel Thomas, Pharm D

M.PHAR

Sunday, 4 February 2018

PHARMACY PRACTICE RESEARCH (PPR)

The Pharmacy Practice Research Trust (PPRT) was an independent charity established in July 1999, by the Royal Pharmaceutical Society. It aims were support and promote the professional practice and development of pharmacists and develop the field of Pharmacy Practice Research. In January 2013 the PPRT was wound up and a new charity Pharmacy Research UK was launched in its place.

PHARMACY PRACTICE RESEARCH (PPR) is research that focuses on the practice of pharmacy in contrast to lab-based research and establishes a solid evidence for new pharmacy practices and services. This is how we can frame our own set of guidelines for management of all diseases rather than adopting them from western countries. 

Even after a decade of this clinical course; there were fewer research activities. Pharmacy Practice Research is equally important in India which can fetch 1000's of job opportunities in various Central and State Research Organizations.