Highlights of Some of the Articles from the Print Edition

In this issue..

CLINICAL TRIALS

DRUG DEVELOPMENT PROCESS

Currently, a new drug is estimated to cost about $800 million by the time it reaches the market. Clinical trials are the most time consuming and expensive part of the development process.

The clinical trial company bridges science to the market place by performing, assisting and managing pharmaceutical, biotechnology product and medical device development through preclinical and clinical (Phase I to Phase IV) studies.

INDIA'S ADVANTAGES

Overseas drug companies have shown increasing interest in carrying out trials in India because it is cheaper, 50 percent to 75 percent lower than the costs of a similar study in the US.

India's advantage in clinical development are clearly the speed of patient enrollment and shorter time for clinical trials.

The cost of clinical trials in the US and Europe have skyrocketed and recruiting qualified therapy-naive patients, who have not received any prior treatment, can be extremely time consuming and can cause delay in the completion of these trials for months or even years.

Completing clinical drug trials and product development in India could be up to 75% faster.

As per Rabo India Finance, although the average costs of doing Phase I/II/III drug trials in US are $20/50/100 million respectively, in India they are 50% to 60% of the same.

In recent years, India has created a favourable environment for clinical trials.

India signed the WTO agreement (fully effective in 2005) to alleviate issues related to protection of Intellectual Property. Regulatory laws have been updated to conform to the global GCP guidelines. All medical facilities have been mandated to meet the GCP procedures and training support of medical personnel necessary to achieve this goal provided. India has provided exemptions for import duties on clinical trials products and eliminated the procedural hurdles that were prevalent in the past.

India has a very large pool of highly trained physicians, nurses, and technical personnel and numerous world-class medical facilities that meet the global requirements for clinical testing.

Many major pharmaceutical companies have already successfully used clinical trials data from India for US FDA NDA (Federal Drug Authority New Drug Application) submissions.

The broadly developed information technology infrastructure in India provides added advantage to ensure speedy conduct of studies and flow of information data from the sites to the sponsors databases.

As a result, India is seeing a rapid growth of clinical trials. The setting of a large, diverse, and therapy-naive population, low cost for technical services, and use of English as the primary business and medical language is ideal for completing trials rapidly and cost efficiently.

There is need to leverage the India advantage with its value proposition to deliver world-class clinical research services to global pharmaceutical, biotechnology, medical device and nutraceutical organisations.

Clinical Research in India
Cost of research - US vis-C -vis India

Source: Rabo India Finance

US FDA submission / registration
Clinical trials performed in India since 1996

Source: Reliance Research

APOLLO HOSPITALS

Apollo Hospitals plans to tie-up with a contract research organisation (CRO) to tap the potential offered by the clinical trials business.

As the sensitive nature of clinical trials make it necessary for procedures to be strictly followed and volunteers to be adequately informed, Apollo uses another agency to keep an eye on the trials.

Spectra, a site management organisation that is largely owned by Apollo, monitors the trials carried out by the hospital. Spectra has an "arm's length" association with Apollo.

Apollo's large volume of patients provide opportunities to recruit volunteers. CRO that carried out the trials would have to pay the hospital a fee.

Apollo had carried out about 65 trials so far and the revenue was about Rs.40 million to Rs.50 million

At the moment, an ethics committee that is made up of members of its medical staff, a lawyer and a representative from the site management organisation supervises Apollo's trials.

RELIANCE CLINICAL RESEARCH SERVICES (RCRS)

RCRS is part of the Reliance Group of Companies and a component of the life science initiative of Reliance.

The company has made a foray into the clinical research services market in USA and Europe.

RCRS is currently conducting several studies for clients based in the US,UK and Middle-East. It is working for indications in oncology, burn wounds, cardiovascular, endocrinology, nephrology, gastroenterology, infectious diseases and vaccines.

Reliance Clinical Research Services (RCRS) is now addressing the clinical research services market in USA and Europe. RCRS is mandated to emerge as an India-based, world-class contract clinical research services organisation.

RCRS provides services in project management, clinical operations, site management, biometrics (data management and biostatistics), medical affairs (pharmacovigilance and medical writing), regulatory affairs, animal studies, quality assurance, molecular diagnostics, ICH-GCP training, archival facility and drug storage and supplies.

The vision of RCRS is to become a world-class full-service contract clinical research service provider, with quality delivery to ICH-GCP (International Conference on Harmonisation. Good Clinical Practice) standards and conduct of speedy clinical trials.

CONTROVERSIES

Indian clinical trials have also stirred controversies in the past primarily because it was found that procedures had not been followed.

A trial's sponsor was the best check for its integrity because a drug company had a lot to lose, if it would be later found that procedures were violated.

GVK Biosciences, a GVK group company, has strongly denied the allegations that it is undertaking illegal clinical trials. The company stated that it is taking up only bio equivalence (BE) studies on generic drugs, which does not require approvals from the Drug Controller General of India (DCGI).

The Hyderabad police had filed a case against the company on May 3rd,2004 based on the complaints received from four unemployed youths who alleged that they were paid just Rs.30 after taking blood samples, as part of the tests, though they were promised employment.

The police also arrested the labour contractors.

Meanwhile, the state government had ordered probe into the entire issue through the state drug controller.

The company claims that it has also formed an ethical committee, chaired by a retired High Court judge, to supervise every BE study before giving the clearance to go ahead with the project.

Meanwhile, the state's Drug Control Administration (DCA) formed a two member special investigation team to probe into the issue. The team has submitted a detailed report to the state government and is in the process of informing the central office.

STRATEGY

The value proposition is built around a strong knowledge base and network in the medical domain, full service project planning, conduct and management of trials throughout India, in-house molecular diagnostic support and in-house Phase I and pre-clinical toxicity ability.

Tetramethylammonium hydroxide is a colourless crystal (generally contains 3 or 5 crystal waters in each molecular). Easily deliquesces and absorbs carbon dioxide in air.

It decomposes into methanol and trimethylamine at 130 Deg.C. It is normally made 10% to 25% solution in water and crystalline.

It is a strong organo alkali, a supporting electrolyte in polarography, a developer for photoresists and no residue catalyst in organosilicon polymerization processes.

Further, this articles discusses the following aspects :

• Physical and chemical properties
• Product application
• Indian manufacturer
• Global scenario

Diesel engine dominates the field of commercial transportation and agricultural machinery on account of its superior fuel efficiency. The increasing cost of petroleum and the uncertainties of supply have accelerates the tendency to depend heavily on diesel engine. The consumption of diesel oil is several times higher than petrol consumption.

Due to limitation on the supply of diesel fuel as well as its increasing cost, an alternate source of fuel in place of diesel is essential. Biodiesel is a competent substitute for the diesel fuel.

Biodiesel is made through a chemical process called transesterification whereby the glycerin is separated from the fat or vegetable oil. The process leaves behind two products methyl esters (the chemical name for biodiesel) and glycerin.

It is nontoxic, biodegradable and it can be used in any diesel engine with few or nil modifications. Although biodiesel contains no petroleum, it can be blended with petroleum diesel at any level.

The most common blending ratio is 20% biodiesel mixed with 80 per cent diesel (B20) and B100 meaning that it contains 100% pure biodiesel.

The Cetane number of vegetable oil is comparable to diesel. If biodiesel is converted into methyl esters the viscosity becomes equal to that of diesel oil and the carbon deposition properties is also nearer to diesel. High flash point and very less amount of NOx, COx, and Sox emission are the salient features of Biodiesel.

The United Nations has come in favour of using biotechnology in food production, saying it holds clear promise to alleviate global hunger and help millions of people achieve better lives.

A new report by United Nations Food and Agriculture Organisation (FAO) released from its headquarters in rome and in Washington rejects as too extreme the position of many environmental and advocacy groups that have called for bans on genetic engineering of plants and animals.

Many of these groups are opposed in principle to a technology in which genes are deliberately transferred from one species to another to confer new traits.

Prabhu Pingali, director of agricultural and development economics for the FAO, told reporters Washington on 17th May while releasing the report "the state of food and agriculture," it is not appropriate to be either for or against biotechnology.Biotechnology is a tool, nothing more and nothing less. The impact depends on how it is used."

The report says that at present, the promise of biotech is more theory than reality, largely because far too little money is being spent to use the new technologies in ways likely to benefit subsistence farmers.

"Barring a few initiatives here and there, there are no major public or private sector programmes to tackle the critical problems of the poor or targeting crops and animals that they rely on. Concerted international efforts are required to ensure that the technology needs of the poor are addressed and that barriers to access are overcome."

"Thus far in those countries where transgenic crops have been grown, there have been no verifiable reports of them causing any significant health or environmental harm. On the contrary, some important environmental and social benefits are emerging," the report says.

The report cites as an example the sharply reduced use of chemical pesticides to grow gene altered, pest resistant cotton and the rising income of small cotton farmers in countries such as China and South Africa, that have embraced the new technology.

It, however, cautions that technology is no panacea and it does not dismiss potential risks. While there is broad scientific consensus that current biotech crops are safe to eat, the report says, there is less consensus about their likely environmental effects over the long term and that issue will require careful monitoring.

The report points out that few poor countries have the technical ability to analyse biotech crops and that they are not getting much outside help.

It adds that "science can not declare any technology completely risk-free and that it is unrealistic to demand certainly about the effects of a technology before deciding whether to use it.

William Freese, an analyst at Friends of th Earth in Washington, criticised the report saying FAO is too eager to embrace a high tech solution to a low tech problem. Instead of advocating biotechnology , he said,the agency should push for more funds for conventional crop research.

Biotechnology for poor countries, he said, "would be like introducing an SUV (sport utility vehicles) to a country where people do not even have bicycles."

SOYABEAN - HIGHLIGHTS OF FAO STUDY

There has been little doubt about the growing importance of soyabean for nutrition at the global level, given the crop's abundant and rising availability, high nutritional value and varied uses as food and feed.

However, determining the crop's contribution to combating hunger in food-insecure,import-dependent developing countries is a complex task, which can lead to different results for different countries, according to the Food and Agriculture Organisation (FAO).

In a study on the role of soyabean in fighting world hunger, FAO found that the crop was well placed to meet the fast growing demand for vegetable oil and animal feed in developing countries. Being one of the world's major and fastest expanding crops, soyabean contributes significantly to overall human nutrition, in terms of both calorie and protein intake.

While the crop can be encouraged in small holder based production systems in the tropics and sub tropics to diversify production, generate income and capture positive rotation effects that improve productivity of other crops grown, the economic viability of growing soyabean depended on local marketing opportunities, the report pointed out.

Can small producers of soyabean compete successfully in the market? Global production, processing and marketing of this legume is characterised by a high level of concentration, specialisation, vertical integration and economies of scale. Thus, small producers in developing countries find it difficult to compete especially when confronted by fast expanding and highly efficient trade.

Referring to the general trend towards integration of developing countries into the international markets for food stuff and other agricultural commodities like vegetable oils and meals, the FAO report cautioned that increased dependence on imports --while not in conflict with food security objectives in terms of overall food availability -- might expose countries to a number of risks.

For food-insecure countries in Africa and pockets in Asia and Latin America, increasing food availability through domestic production or import of food like soyabean products is important.

However, in several countries, especially in Asia, hunger seems to be related more to inadequate access to food than insufficient supply.

"For this reason, it will be important to integrate supply oriented polices with access based strategies that focus on income generation and distribution, access to assets, markets and education and improvement in infrastructure," the report concluded.

FAO's current initiatives to fight poverty and hunger are increasingly adopting such an approach.

Family: Iridaceae
Botanical name: Crocus Sativus Linn.
Botanical trait: A small bulbous perennial herb with tuberous roots

Saffron flower has long red style, which is divided into three threads with shorter, yellow stem.

Saffron is the triploid form of a species found in Eastern Greece, Crocus cartwrightianus; it probably appeared first in Crete.

Because of being triploid, saffron is necessarily sterile, and its beautiful flowers cannot produce any seeds.

Propagation is possible only via corms.

Common Name

Latin name: Saffron (Crocus sativus L.)

Crocus sativus: Saffron flower

Chemical Constituents

The intensive colour of saffron is caused by pigments of carotenoid type.

Although saffron contains some conventional carotinoids (&alpha- and &beta-carotene, lycopin and zeaxanthin), its staining capability is mostly caused by crocetine esters; crocetin is a dicarboxylic acid with a carotenoid-like C18 backbone which is formed from carotenoid precursors (diterpen carotenoid).

Crocin, a diester of crocin with gentobiose, is the single most important saffran pigment.

In the essential oil (max. 1%), several terpene aldehydes and ketones are found. The most abundant constituent is safranal, 2,6,6-trimethyl 1,3-cyclohexadiene-1-carboxaldehyd (50% and more); another important compound is 2-hydroxy-4,4,6-trimethyl 2,5-cyclohexadien-1-one.

Furthermore, terpene dervatives have been identified (pinene, cineol).

The bitter taste is attributed to picrocrocin, the glucosid of an alcohol structurally related to safranal (4-hydroxy-2,4,4-trimethyl 1-cyclohexene-1-carboxaldehyd). On de-glucosylation, picrocrocin yields safranal.

Safranal and its relatives, most typically C9 or C10 isoprenoids with a cyclohexane ring, are formed from carotenoid pigments as the result of enzymatic degradation.

This article also discusses the following aspects :

• Application sector
• Price
• Regions cultivated in India
• Countrywise Import/export details
• Selected Indian players
• Driving factors for demand
• Observations

POLYVINYL ALCOHOL-INVESTMENT OPPORTUNITY

In this article, following aspects are discussed ::

• Product characteristics and specification
• Product applications
• Broad outline of manufacturing process
• Process flow sheet
• Indian Manufacturers
• Import Details
• Assessment of Demand Supply Scenario – Period 2004
• Global scenario
• Global demand patter for PVA
• Major global producers
• Growth
• USA scenario
• USA Demand Period 2004
• Use Pattern
• US Growth rate
• Strength
• Weakness
• Outlook
• Global Trend
• Recommendations

ACCREDITATION FOR CARBON CREDIT

CO2 emission from developed countries are way beyond those from the developing countries. Added to this, the compulsion faced by developed countries to reduce emissions by 2008 to 2012 have created opportunities in carbon trading/

The catch however is the cost developed countries have to spend nearly $300 to $500 for every tonne reduction in CO2 emission. Contrast this with $10 to 24 to be spend by the developing countries.

OTHERS ARTICLES

• Quality of India’s Scientific Research
• Update on Nano Technology
• Certification issues
• Fertiliser Sector-Consultant’s Report
• Safety and Accident Page
• Process Flow – Cumene
• Herbal page
• Safety Data – Veratraldehyde
• World Copper Demand-Consultant’s Report
• Pesticide News
• Anti Dumping Page - International
• News Round Up-International/India
• Technology Development - International/India
• Agro chemical page- India
• Pharma Page – International
• Nutraceutical Page
• Price details – International/India
• Environmental Page - International/India
• Air Pollution-Highlights of recent developments in UK
• Energy Page
• Business Opportunities
• Directory of Chemical Industries in China-Manufacturers, Trading Houses and Promotional Organisations – Part XVII
• International Maritime Dangerous Goods Code – Part XXI
• Nandini Internet Index
• Chemicals Exported at Chennai Port During the Month of March 2004
• Chemicals Imported at Chennai Port During the Month of March 2004

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