India is increasingly becoming an attractive destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs for western countries

India is increasingly becoming an attractive destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs for western countries, United Nations Conference on Trade and Development said on Thursday.

It has been estimated that firms can reduce costs by 20-30 per cent by moving their R&D activities to India, UNCTAD's World Investment Report 2005, said.

However, the new patent regime in the country has eroded the power of domestic pharma companies to absorb knowledge spillover through reverse engineering, Nagesh Kumar director-general of Research and Information System for Developing Countries said while releasing the report.

So while the patent regime has reduced the power of domestic companies for absorption of knowledge dissemination on the other hand it has made India an attractive country for clinical trials, said Kumar.

The UNCTAD report said savings for firms going for clinical trials in India come from hiring researchers, nurses and IT staff at less than a third of wages in the West, in addition to differences in the costs associated with the patients.

However, there are some factors holding back the development of clinical research in India such as relatively slow approval process, the report said.

"Another one is India's reverence for animals, which makes it difficult to use certain animals (like monkeys)," the report added.

India, which is well-endowed with skilled R&D personnel, also has a substantial number of people with diseases that exist in developed countries, making it a favoured destination for clinical trials, according to the report.

India has up to 30 million people with heart disease, 25 million people with type-II diabetes and 10 million with psychiatric disorders, the report said.

The country also has a large pool of "treatment naive" patients who have not yet been exposed to other drugs in the market, UNCTAD said.

"In addition, Indian recruits are more likely to comply fully with the trial process, unlike in developed countries where a significant proportion of subjects drop out in order to seek second opinions," the report said.

It is estimated that the number of clinical research organisations based in India increased fourfold between 2001 and 2003, UNCTAD said adding Indian firms, too, are participating in this new industrial activity.

One factor apparently underpinning the shift has been India's newly adopted guidelines on good clinical practices, including the issue of consent by the patients in line with global norms, the report said.

However, other commentators have questioned what consent can mean in a drug trial when patients are illiterate and might not adequately understand the experiment's true risks.

"By definition, the drugs being tested have unknown beneficial effects on the patient's illness or disease, and negative side effects are also unknown," the report pointed out.

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Pharmceutical Errors

Pharmceutical Errors are different from Medic ok p6 y yal Errors.

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Manufacturing Errors
Compounding Errors 

Dispensing Error

Storage Errors

Clerical errors
Inventory errors
computer entry

Data entry in sheet errors
Pharmceutical Calculation Errors

Pharmaceutical Formulation Errors (Research & Development Errors)

Pharmaceutical Analysis Errors

Method of administration Errors

Drug Dose Titration Errors

Adverse Drug Reaction Reporting Errors (Pharmacovigilance Errors)

Drug Drug Interaction Reporting Errors

Ward Round Errors

NUTRACEUTICALS

Chia is grown commercially for its seeds rich in α-linolenic acid.

A Nutraceutical is a pharmaceutical-grade and standardized nutrient.^[1] In the US, "nutraceuticals" do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.

Regulation[edit]

Nutraceuticals are treated differently in different jurisdictions.

Canada[edit]

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction,^[3] referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States[edit]

The term "nutraceutical" is not defined by US law.^[4] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.^[5][6]

International sources[edit]

In the global market, there are significant product quality issues.^[7] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

Market[edit]

A market research report produced in 2012 projected that the worldwide nutraceuticals market would reach US$250 billion by 2018,^[8] defining that market as "Dietary Supplements (Vitamins, Minerals, Herbals, Non-Herbals, & Others), and Functional Foods & Beverages"^[9]

Classification of nutraceuticals[edit]

Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.^[10]

Dietary supplements[edit]

Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”^[11]

Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.

Functional foods[edit]

Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiologicalbenefit, other than a purely nutritional effect.”^[12] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.^[13]

History[edit]

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", was coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine.^[14] Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine.^[15] “Let food be thy medicine.” is a common misquotation ^[16] attributed to Hippocrates, who is considered by some to be the father of Western medicine.

The modern nutraceutical market began to develop in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry has grown alongside the expansion and exploration of modern technology.^[

What is pharmaceutical biotechnology definition?

Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. A majority of therapeutic drugs in the current market are bioformulations, such as antibodies, nucleic acid products and vaccines

Biotechnology & Pharmaceutical Companies

While biotechnology and pharmaceutical companies both produce medicine,biotechnology companies' drugs have a biological basis, while those of pharmaceutical companies have a chemical basis. Biotechnology companiesuse live organisms or their products, such as bacteria or enzymes, to manufacture their medicines.

A biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources.

The primary difference between biopharmaceuticals and traditionalpharmaceuticals is the method by which the drugs are produced: The former are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas the latter are manufactured through a series of chemical synthesis.

Relation between pharma and biotech

Relation between pharma and biotech

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

Government support[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]

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

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