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Extracts from Nandini Chemical Journal, Feb 2006

Vitamin-C|Polyvinylpyrrolidone|Indian Pharma|Indian Biotech

Highlights of Some of the Articles
NATIONAL MISSION ON BIODIESEL IN INDIA: THE LOOPHOLES IN THE PLANS The National Mission on Bio-diesel has got the in-principle nod of the Planning Commission. The Rural Development Ministry will be the nodal ministry for implementing the programme, which is expected to start in 2006-07. The subject was first discussed in the Planning Commission and an inter-ministerial committee was set up by the Commission in 2002 to explore and advise on the prospects of use of bio-fuels for commercial utilisation. The National Mission on Bio-diesel is proposed to be implemented in two phases. The first phase will involve a demonstration stage for plantation of jatropha on four lakh hectares and associated research activities for establishing the commercial viability of the fuel. Phase two will involve self-sustaining expansion on the bio-diesel programme. The overall objective of the National Mission is to promote the creation of national infrastructure for production of bio-diesel through cultivation of jatropha plant and processing of its oil. With the skyrocketing crude oil price and the general perception that the price of crude oil would remain nearly at the present level for all time to come, biodiesel is justifiably being viewed as the alternative source of energy for India. Obviously, jatropha based biodiesel have multiple advantages and high level of relevance in the present national context. Responding to the national euphoria in favour of bio diesel, the Government of India has now announced “National Mission on bio diesel” that would be implemented in two phases and that has received the approval of the Planning Commission. One significant shift in recent times by Government of India was to entrust the responsibility for promoting the biodiesel concept and project to Rural Development Ministry, instead of Petroleum Ministry. By this, the Government of India has recognized the biodiesel project for its potential to rapidly improve the rural economy and the employment generation opportunities in the agro forestry projects in rural areas. While this is an acceptable approach, nevertheless, the importance of biodiesel as a substitute for crude oil should also be given high level of importance. By shifting it to the Rural Development Ministry, an impression should not be given that the biodiesel project is a low technology area ,which it is not. Another significant initiative in recent times by the Government of India was to have fixed the price of biodiesel at Rs.25/- per litre. However, this price fixing decision make one suspect that Government of India has not realized the various problems and constraints in establishing the economics of the biodiesel project. There are a number of flaws that can be readily pointed out and it is amazing that the Government of India have overlooked these aspects. 1. The price of Rs.25/- per litre is not for biodiesel but it is for trans esterified vegetable oil. The trans esterified vegetable oil is the one that would be mixed with petroleum diesel in different proportions to produce biodiesel. Internationally, diesel mixed with the trans esterified vegetable oil is only known as bio diesel and this terminology should be followed in India also to avoid confusion. 2. The Government has not given any explanation as to how it has arrived at the price of Rs.25/- per litre inspite of objections and protests for such price fixation from various agencies. Given the fact that the farmer has to get at least Rs.4/- per kilogramme of jatropha seed to ensure reasonable income for his efforts, the price of bye product Glycerine is rapidly coming down in the international market due to over production and the jatropha cake cannot be used as cattle feed due to its toxicity, the price should be much higher than Rs.25/- per litre If Indian Oil Corporation would pay only Rs.25/- per litre, then substantial subsidy has to be extended by Government of India to protect the economics of the upcoming jatropha industry. The Government appears to be ignoring this aspect, which amounts to postponing the problem with possible serious adverse consequences later on. 3. While the National Mission on biodiesel speaks about rapidly enlarging the area of jatropha cultivation in India and stepping up the production of jatropha seeds , it has not revealed any plans about utilization of Glycerine that would be produced as bye product during the production of trans esterified vegetable oil. For every 1000 Kilograms of trans esterified vegetable oil produced , around 250 kgs of Glycerine would be produced. If India were to produce one million tonnes of transesterified vegetable oil, there would be production of 2.5 lakh tonnes of Glycerine. Indian demand for Glycerine is only around less than 50,000 tonnes per annum and there is no big scope for export of Glycerine in the global market. Unless there would be production of trans esterified oil at the level of one million tonnes per annum and more , there would be no significant impact of jatropha industry on the petroleum diesel scenario in India. 4. There is an immediate and urgent need for focused research and development efforts on utilization of Glycerine by developing new application areas and utilization of jatropha cake by either detoxifying it to be used as cattle feed or use the cake as biomass for power generation. Little thought has been given to this aspect at the national level by the Government of India or national R&D laboratories. 5. There are exciting possibilities of utilizing Glycerine for the production of very valuable products such as Propylene, Acrolein etc. which are highly sought after petro chemicals and which are presently produced from Natural gas or Crude oil. The creation of facilities for the production of Propylene / Acrolein from Glycerine would make the jatropha bio diesel project scheme very well balanced and highly viable. But, this calls for very urgent research and development initiatives in India. The National Mission on Bio diesel should address this Glycerine problem in a professional manner and take immediate initiatives to organize time bound plans on national level, by involving the leading scientific and technological institutions in India. The bio diesel project is of utmost importance for India and to realize its true potential, the Government of India should move with greater pragmatism and speed.
By introducing improved technology, China has now emerged as the dominant producer of Vitamin C in the World. As a result, several Vitamin C units in the advanced countries in Europe and North America have closed operations. Process technology The manufacture of Vitamin C is now carried out in two ways namely Reichstein and Two step Fermentation Process Forms of Vitamin C produced Many raw vitamins can be unstable if affected by temperature, light, acidity or alkalinity. To prevent degradation in use, these vitamins may be combined with other products or, alternatively, various chemical derivatives of the vitamins may be produced. Global Producers
  • BASF
  • Takeda
  • DSM
  • Merck
  • ADM
Chinese Producers
  • North East General Pharmaceutical Co. Ltd.,
  • Jiangsu Jiangshan Pharmaceutical Co. Ltd.,
  • Shijiazhuang Welcome (Weierkang)
  • Shijiazhuang No.1 (Weishang) Pharmaceutical Factory
  • Shanghai Sunve (Sanwei) Pharmaceutical Factory
This article contains the following details
  • Methods of producing Vitamin C
  • Reichstein Process
  • Two stage fermentation process
  • Forms of Vitamin C Produced
  • Global producers and production method adopted
  • Technology Development
  • Research into new processes
  • Technology development by Scottish Crop Research Institute (SCRI)
  • RRL, Jammu
  • Genetech, USA
  • University of Exeter
  • Economic capacity for new project
  • Global Production
  • Profile of major producers
  • Chinese Producers
  • Price trend
  • Competitive condition
  • Anti Dumping Measure in India
  • Indian Demand
This article discusses the application aspects and process technology as well as Indian import/export trends for polyvinylpyrrolidone Polyvinylpyrrolidone (PVP) is a hygroscopic, amorphous polymer. It is available in several molecular weight grades, each characterized by K-value. Synonyms Polvinylpolypyrrolidone; N-Vinylbutyrolactam polymer; poly[1-(2-oxo-1-pyrrolidynyl)ethylene] CAS No. 9003-39-8 Chemical Formula (C 6 H 9 NO) x Appearance Off-white to yellow powder. Odor Odorless Solubility Soluble in water Specific Gravity 1.1 to 1.3 Stability Stable under ordinary conditions of use and storage. Incompatibilities Strong oxidizers. Availability PVP is available in liquid or solid state under different forms, the most common being powder, aqueous and organic solutions. PVP is offered as homopolymer, cross-linked and over 30 cationic, anionic and non-ionic co-and ter-polymer products. Chemistry Polyvinylpyrrolidone can be plasticized with water and most common organic plasticizers. It is considered to be physiologically inert. Applications take advantage of one or more properties inherent in the polymer, typically due to the lactam ring Application Polyvinylpyrrolidone are water-soluble polymers with many uses that are determined by its co- and terpolymer, and ionic type, including as a binder, bodying or curl control agent, dispersant, fixative, film former, stabiliser, thickener and sustained release agent. Demand drivers Demand in recent years has been driven in particular by cationic PVP in cosmetic/personal care applications, PVP-iodine in anti-microbial and crosslinked PVP in beverages. In this article, following details are provided:
  • Producer’s Specification
  • Manufacturing Process
  • Growth rate in demand
  • Indian Scenario
  • Global Scenario
  • Global Capacity
  • Major Global Producers
  • Market Share of Major Players
  • All India countrywise Imports and individual import details
The year 2005 witnessed some major shifts for the Indian pharmaceuticals industry.These shifts, fundamentally changed the way the pharmaceuticals sector has been functioning since the early seventies, when the government brought in a process patent regime, doing away with the product patent regime. The third amendment to the Indian Patent Act of 1970 could not have come a day too soon for the Indian pharmaceuticals industry.India needed to get in a product patent regime in line with WTO requirements. Indian pharma companies have been preparing for a product patent regime, with the result that there are 71 drug manufacturing units in India which are approved by the United States Food and Drug Administration and 40 units approved by the Medical and Healthcare products Regulatory Agency of the United kingdom, possibly the highest number in the world. This article further discusses the following details:
  • Consolidation
  • Generic drugs
  • Regulatory Approvals
  • Out sourcing
  • Mergers and Acquisitions
  • Custom manufacturing
  • India, China favourite drug discovery outsourcing markets-Finds of the study
India is forging ahead in developing novel biopharmaceuticals, generic drugs, diagnostics and agricultural biotechnology products and handling contract services right from R&D to manufacturing. It is also becoming a serious contender as a biotech outsourcing destination * The global biotech industry size is currently $54 billion * Indian biotech industry was a near $2 billion business in 2004-05. It is projected to touch $4 billion by 2006-07 * Generic versions of patent-protected biotech drugs could be the next big thing for Indian biotech firms * The growth engines are contract research, clinical trials, data informatics and vaccines Global collaboration is likely to steadily increase with India implemeting intellectual property protection with the passing of the amended patent law in 2005 and the intellectual property will be shared between companies in the West and those in India. The arrival of stronger IP protection makes it necessary for Indian companies to develop their own innovative pipelines. In an ongoing trend, more conglomerates and pharmaceutical companies are diversifying into biotechnology and established players are preparing plans for an aggressive expansion programme. This article discusses the following details:
  • Biogenerics
  • Vaccines
  • Stem cells research
  • Bioinformatics
  • Capacity expansion
  • Building bio-bridges
  • Policy initiatives
  • Training programme
DISPOSABLE BIOREACTORS Two-compartment bioreactors combine high cell density yields with an easy-to-use design for optimum biomanufacturing results. The use of disposable cell culture systems for the manufacturing of biological products in mammalian cells is advantageous because it facilitates minimization of necessary validation efforts, as well as circumvention of up-front sterilization and subsequent cleaning steps. For research-scale applications, culture systems typically used are tissue culture flasks, roller bottles, or spinner bottles, and 1 to 50 mg of proteins in total volumes up to 2 L are produced . In biopharmaceutical development or for manufacturing of antibody-based diagnostics, a scale-up of production to reach protein yields of 50 to 1,000 mg is often necessary. For volume scale-up, increasing the number of cell-culture disposables is cumbersome because handling-time and space requirements increase accordingly, inevitably resulting in higher manufacturing costs. A more economic solution is provided by bag-based disposable systems, available in working volumes of up to 500 L, providing an alternative to stainless steel bioreactors. However, working with bag-based bioreactors requires capital investment in specific equipment and trained personnel. Another possibility is to use disposable two-compartment bioreactors that allow production of recombinant proteins in a highly concentrated form. The two-compartment technology has been widely adopted in recent years, as it does not require any additional investment in specific equipment and can be easily handled by staff experienced with standard cell-culture systems. FOCUS ON CHITIN AND CHITOSAN Chitin Chitin is the second most abundant natural biopolymer in the world, behind only cellulose. It is also the most abundant naturally occurring polysaccharide that contains amino sugars. This abundance, combined with the specific chemistry of Chitin and its derivative Chitosan , make for the array of potential applications. Chitin occurs as a component of crustacean shells, insect exoskeletons, fungal cell walls, microfauna and plankton. It is found in association with proteins and minerals such as calcium carbonate. Different sources of Chitin differ somewhat in their structure and percentage of Chitin content. Cellulose is a homopolymer, while Chitin and Chitosan are heteropolymers. The major source of raw material is shells of crabs or lobsters (shellfish discards) and products that can be produced are Chitin , Chitosan and cartenoproteins. The major countries for shrimp culture / capture are China, India, Vietnam, Brazil, Ecuador and Thailand. Not every unit of naturally occurring Chitin is acetylated; about 16% are deacetylated. Chitosan Chemical name of Chitosan : 2-amino-_-1,4-glucose-polymer Molecular formula ::(C6H11O4N)n Chitosan, is the deacetylated product of Chitin Chitosan is also known as soluble Chitin . Generally, about 80% of the units are deacetylated, with the remaining 20% acetylated. These values can vary with Chitin sources and with processing methods. Chitosan has decomposability, good membrane forming state, biocompatibility, antifungal and antitumour function. Chitosan enjoys high reputation as a kind of multipoly saccharide. Most commercial applications use which is the deacetylated derivative, Chitosan , rather than Chitin  This article further discusses the following details:
  • Specification
  • Application
  • Application Development
  • Imports and Exports
  • Indian Scenario
  • Demand Drivers
  • Manufacturing Process
  • Yield
  • Global Scenario
  • Major producers in China
  • Price
  • Technology source
  • Process of heterogeneous deacetylation of Chitin and/or Chitosan in soft conditions
  • Chitin from Potatoes
  • Future Scenario
  • Location Requirement
  • Raw Material
GLUCOSAMINE FROM CHITIN D-Glucosamine Hydrochloride is a derivative that is made from natural chitin. It is a white crystal powder, optically active, odourless and somewhat sweet.. The D-glucosamine Hydrochloride has good antibacterial and antiphlogistic function. It is sweet but will not increase blood sugar. As additive for medicine preparations, example for mixed with antibiotic, it can improve diffusion and absorption, and decrease side-effect of the latter. Commercially Glucosamine is available in the form of Glucosamine Hydrochloride and Glucosamine sulphate In this article, following details are provided:
  • Specification
  • Product application
  • Manufacturing Process
  • Global Scenario
  • Chinese Producers
  • Global Price
  • Indian Producers
  • Import/Export details
STATUS OF STEM CELL RESEARCH As of now, the three broad applications of stem cells are: * They provide deeper insights into embryonic development. * They can cure such debilitating diseases as Parkinson's, Alzheimer's or diabetes; and * They can aid pharma companies in early stage screening of drugs, thus cutting on costs and bringing life-saving drugs to the market faster. Given the huge disease burden, the need for organs, affordable diagnostics and medicines, the promise that stem cells offer needs to be exploited to the fullest. However, there are pitfalls, in the form of false claims, unethical methods to get quick results or unregulated practices to harvest these 'miracle' cells. In India,strict guidelines need to be put in place to put stem cells research on a strong footing. Overall, research efforts by the scientific community or industry are still at modest levels, though a few major groups are working in specific areas. As early as 2001, Reliance Life Sciences and National Centre for Biological Sciences, Pune, had built up facilities to preserve seven and three stem cell lines respectively. This article further described the following details
  • All India Institute for Medical Sciences (AIIMS)
  • Centre for Cellular and Molecular Biology (CCMB)
  • Clone Derived Calls
  • Foetus Cells
  • Questionable scientific claims
  • International Policy Initiatives
APPROVAL SYSTEM FOR BIOTECH PRODUCTS - FDA'S APPROACH In drug manufacturing, R & D now accounts for 25 percent of industry expenses - and it takes years to bring up new production site to full capacity. While Food and Drug Administration (FDA) ,USA may be receiving fewer applications for truly innovative therapies, many of the applications filed involve more complex products that require high-level expertise for appropriate evaluation. Manufacturers also are submitting hundreds of investigational new drug applications (INDs) and thousands of manufacturing supplements, adding to the agency's workload. The remedy lies in establishing a system that rewards manufacturers for adopting modern processing and testing approaches and for submitting information to FDA that documents such efforts. This article discusses the following details:
  • Good manufacturing practice
  • QbD approach
  • Generic version of Biotech Therapies
  • Review process
DIOXIN REMOVAL: TECHNOLOGY FOR REMOVAL OF DIOXINS FROM GASES There are a number of technologies available for removing or destroying dioxins from gases,such as baghouse filters and catalysts.The investment and/or running costs of these technologies are usually high. Adiox (patent pending) is a new dioxin removal technology that has established itself as an efficient and economic way to reduce dioxin emissions and is marketed and sold by Gotaverken Miljo AB as material deliveries, package units or turn key flue gas treatment systems. Adiox is an innovative technology for removing toxic dioxins from gases. Tower packings, droplet separators and fixed bed fillings can be made of this dioxin absorbing material. The use of this novel technology under wet and dry conditions is discussed. COURTESY:Filtration + Separation,December 2005
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  • Chemicals Imported at Chennai Port During the Month of October 2005
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