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Annual Report 2003 - 2004
Technology Development
Department of Science & Technology under
its Instrumentation Development Programme (IDP) has been funding
projects on design and development of indigenous instruments
/ technologies for over two decades. As a result, instruments
such as IR Spectrometer, UVVIS Spectrophotometer, Atomic Absorption
Spectrometer, Soil Salinity Tester, Ion Selective Electrodes,
Digital Tide Gauge etc. have been developed at various R&D
institutions and know-how developed have been transferred
for commercial production to industry. During the 10th plan,
the Department has initiated the Instrument Development Programme
in mission mode for capacity building & development of
instruments in the country. The National Instrument Development
Board set up for the purpose and the Expert Panels meet periodically
to guide the Department in executing the programme. The following
thrust areas have been identified by the Board:
- Analytical / Optical Instrumentation;
- Medical Instrumentation;
- Industrial Instrumentation; and
- Imaging Techniques and Instrumentation.
Training programmes on Repair and Maintenance
of medical instruments have been supported at several places
for hospital doctors in various parts of the country.
Instruments/Systems under Development
Some of the major instruments / systems under
development are as follows:
Bio sensor with flow injection analysis system
for the online monitoring of glucose and fructose; continuous
infrared heating system for food processing, drying, baking
and roasting; vascular micro endoscope; treatment applicator
for treatment of carcinoma cervix for high and medium dose
rate radiation source; multidisciplinary microcomputer based
student laboratory; PC based semi optical inspection system
for printed circuit boards (PCBs) mounted with surface mounted
devices (SMDs) and conventional components; Setting-up of
National Facility for testing & calibration of sensors;
Development of Ammonia Sensor; Development of Electronic Nose;
Development of Oxygen Sensor; Development of prototype CO/NOx
Sensor; Development of Portable Metal Oxide Sensor for the
detection of Foul Odour; Development of laboratory type sensors
for LPG using Nanotechnology; Development of electrochemical
sensor for pollution control i.e. industrial and vehicular;
Development of process technology for LPG & CNG Sensors;
Development of LPG/Oxygen sensor based on Nano-materials;
Development of Fish Freshness Sensor; and Development of commercially
viable Humidity Sensor at IIT, New Delhi etc.
New Projects Supported
Development of following instruments/systems
was initiated and/or supported:
Controlled atmospheric instrumentation for long
shelf life of apples-humidity meters, particle size analyzer;
Isolation, purification and immobilization of urease for technical
development of urea biosensor; Development of Zeolite-Modified
Electrodes for environmental monitoring; Design of Electrochemical
Sensors for CO, SO2; and Development of multi-zone optical
fibre based perturbation sensing system.
Instruments/Systems Developed
Some of the major instruments/systems developed
are as follows:
a) Atomic Force Microscope (Figure 4.1);
b) Portable urea sensor and measuring system for detection
of adulteration in milk;
c) Metal oxide human breath sensor for detection of alcohol;
d) Technology development for low-cost user-friendly polyaniline
based sensor material for toxic gases;
e) Design and development of Force Transducer of the capacity
1MN (Figure 4.2);
f) Design and development of Confocal Microscope (Figure 4.3);
g) Design and development of Evaporation Rate Monitoring Unit;
h) Design and development of Ground Water Level Monitoring
Unit; and
i) Portable multiprobe Borehole Logger (Figure 4.4).

Figure. 4.1: Atomic Force Microscope
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Figure 4.2:Transducer for Force Measurement
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Figure 4.3: Confocal Microscope for Biological
applications |

Figure 4.4: Portable multi-probe Borehole
Logger |
Technology Development Board
The Government of India constituted the Technology
Development Board (TDB) in September 1996 for development
and commercialisation of indigenous technologies and adaptation
of imported technologies for wider domestic applications.
The Board, constituted under the provisions of the Technology
Development Board Act, 1995, administers the Fund for Technology
Development and Application. TDB provides financial assistance
in the form of equity, loans or grants to industrial concerns
and other agencies.
During the year 2003-2004, TDB has signed 8
agreements (including 3 supplementary agreements for additional
loan assistance) with 8 commercial enterprises. The total
project cost of these agreements is Rs.43.94 crore including
TDBs committed financial assistance of Rs. 16.15 crore.
The financial assistance by TDB covers various
segments of the economy namely, Health and Medical, Chemicals,
Engineering, Transport, Information Technology, Agriculture
and Waste Utilisation. The technology providers included in-house
R&D Units in the industry, national laboratories, academic
institutions, private R&D laboratories and individuals.
National Awards on Technology
Day, 11th May 2003
Following the announcement of the Prime Minister Shri Atal
Behari Vajpayee, on 25th May 1998 that 11th May would henceforth
be celebrated as Technology Day, TDB instituted
a National Award for Successful Commercialisation of
Indigenous Technology by an industrial concern. The
national award consists of two components: (i) to the industrial
concern who successfully commercialised the indigenous technology
and (ii) to the developer/ provider of such technology. Each
component carries a cash award of five lakh rupees. The Selection
Committee recommended M/s Shantha Biotechnics Private Limited,
Hyderabad, for the National Award. This is the first company
in India to manufacture and commercialise recombinant Interferon
Alpha-2b based on indigenous technology, developed by its
in-house R&D Unit. The company has been able to make interferon
available at 1/3rd of the cost of the imported interferon
of similar quality. A patent was granted in India in 2001.
An international patent application was filed through the
PCT and the claims were reported to have been accepted in
2002. Shri Bhairon Singh Shekhawat, Vice President of India,
presented the award to M/s Shantha Biotechnics Private Limited
on 11th May 2003.
Launching of products
With the assistance of TDB, M/s Southern Petrochemical
Industries Corporation Limited, Chennai developed Tannase
enzyme formulation. The formulation is of bio-origin and found
to be cost effective in improving the overall quality of black
tea. M/s White Circle Oxides Limited, Hyderabad, commenced
the commercial production of Magnesium Aluminate Spinel Synthetic
Aggregates near Kakinada. The technology has been developed
by International Advanced Research Centre for Powder Metallurgy
and New Materials, Hyderabad. M/s Filtra Catalysts and Chemicals
Limited have manufactured Cresols and Xylenols at Chiplun.
M/s Clutch Auto Limited, New Delhi, introduced ceramic clutches
for commercial vehicles.
National Aerospace Laboratories (NAL), Bangalore,
has undertaken the task of design and development of a multi-role
Light Transport Aircraft (LTA), named SARAS. The LTA is a
9 to14 seater aircraft with short take-off and landing facility.
The first prototype rolled out in February 2003 at Bangalore.
The Governor of Andhra Pradesh, Shri Surjit
Singh Barnala, released the drug Indikinase developed
and produced by M/s Bharat Biotech International Limited,
Hyderabad in October 2003. TDB has provided financial assistance
to the company for the same (Streptokinase).
Review Committee on TDB
The Department of Science and Technology constituted
a committee, in August 2001, to review the performance of
TDB since its inception and to suggest new initiatives for
keeping TDB a vibrant, dynamic and responsive organisation.
The Committee presented its report on 26th February 2003.
The Report has reviewed the role played so far
by TDB and has commented as follows:
There are also distinct differences in
the expectations and management of venture funds and those
related to TDB funding. The primary objective of TDB funding
is to promote, in a purely altruistic sense, dissemination
of new technology based products. TDB has in the process served
the needs in an area bedeviled by dearth of readily accessible,
low-cost funds. Further, TDB has mostly catered to relatively
small and relatively unknown players and extended the much
needed financial assistance for their projects when they were
at an incipient stage of commercialization. In retrospect,
this was indeed the space in the innovation system that had
not been cared for earlier and therefore needed attention.
There are about 65 recommendations of the Review
Committee which are grouped under Statutory, Promotional,
Procedural, Organisational and Future Directions. TDB has,
so far, accepted 56 recommendations including 4 recommendations
with some modifications; one recommendation has not been accepted.
Eight recommendations are still under consideration of TDB.
Interactive Meetings
TDB organized and participated in exhibitions as well as in
a number of interactive meetings with industry, industry associations,
R&D organisations, academic institutions and potential
entrepreneurs.
Joint Technology Projects
Technology Systems
Under the Technology Systems Programme, activities aimed at
developing technological capabilities and competence in certain
hi-tech areas; developing applications of modern technologies
for providing solutions to socio-economic problems; modernization
of traditional technologies, crafts, tools and skills; enhancing
technical & export capabilities and operational performance
of traditional/non-traditional items and promoting R&D
applications, activities are supported to develop appropriate
technology system through integration of various technology
components. Under the programme, pooling of expertise available
in various institutions is encouraged to formulate multi-disciplinary
projects in core/critical areas like molecular electronics
including conducting polymers, water purification and bio-degradable
polymers, waste management, alternate fuels, structure related
systems, application of surface engineering for rejuvenation
of traditional crafts, information and communication technologies
having application in rural and remote areas etc. In addition
to this, technology upgradation programmes on Glass, Gold,
Vision & Laser Applications are also being implemented.
During the year, a number of activities in the
area of technology development and applications were undertaken.
Special attention was given on developing clean and green
technologies. During the year, 16 projects were approved.
Following major areas for initiating activities were given
special thrust:
- Water treatment and rural micro-water management
- Defluoridation of ground water by Membrane Technology;
- Low-cost adsorbent and household model for removal
of Arsenic;
- Removal of arsenic using polymeric membranes;
- Pilot scale and field scale studies on removal of
arsenic from drinking water including sludge management;
and
- Ground water quality assessment and zonation.
- Structure Technology Systems for distress diagnostics,
industrialised building systems and seismic protection etc.
- Information and Communication Technology System for cost
effective Broadband Access Technology for rural areas and
development of Farmer Advisory Systems
- Molecular electronic devices including conducting polymers
- Micro patterning of solid surfaces;
- DNA Biosensors;
- Intelligent embedded sensor system for soil;
- Biosensor for tea quality assessment; and
- Enzyme electrodes for the determination of creatinine.
- Surface Engineering modification and rejuvenation of
traditional crafts
- Alternative fuel
- Waste utilisation recycling & management
- Green Technologies
The Department made conscious efforts to review
the progress of various on-going projects so that the developmental
work can be taken up at the envisaged pace and midcourse correction
can be implemented. Keeping this in mind, the projects entitled
Study of electrical characteristics of DNA for fabrication
of Bio-Molecular electronic devices; Development
of immuno-biosensor system for specific & sensitive detection
of pesticides, herbicides and insecticides; Development
of an EEG based communication device for the handicapped;
Non-invasive optical fibre probe based near infrared
spectroscopy (NIRS) for assessing brain activities and
Integrated technology for the removal of Arsenic from
ground water were reviewed during the year. An experimental
model for pesticides monitoring has been developed at IMTECH,
Chandigarh. The results of the feasibility study for development
of EEG based communication devices have been quite encouraging
and the device is likely to be developed in the next phase.
Glass Technology Upgradation
Programme
Under the Glass Technology Upgradation Programme, projects
aiming at technology development and upgradation have been
initiated in the areas of optical glass, ophthalmic glass
and unorganized small scale sector glass industry of consumer
items (Firozabad cluster of glass industries).
New projects supported
- CDGI successfully designed, developed and installed a
1000 kg Day Tank Furnace. The furnace was designed to achieve
higher energy efficiency, higher productivity and better
quality throughput at an optimal investment. The burner
design is based on eco and environment friendly natural
gas. The furnace performance was evaluated during trial
and commercial runs for white glass melting.
- Technology for Scratch Resistant Anti-Reflection (SRAR)
coatings on polycarbonate ophthalmic lenses and sheets/panels
by inorganic-organic hybrid SOL-GEL processing has been
successfully developed by a research group at CGCRI, Kolkata.
An Indian Patent was also filed.
Projects and Achievements
- The project team at CSIO, Chandigarh has designed and
fabricated 45 D plastic lenses using PMMA. Prototype units
of this lens are currently under evaluation by ophthalmologist
(Figure 4.5). The design and fabrication of 20D, 28D, 78D
& 90D lenses are in process.
- A project was initiated to design, develop and construct
a proper Pot Arch Furnace with CDGI as the work centre and
in association with an identified industrial partner. CDGI
started construction of Pot Arch Furnace at the site of
M/s Saraswati Glass Works, Firozabad and the systematic
trials will begin shortly.
Figure
4.5: 45 Diopter Plastic
Aspherelens
developed at CSIO
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Figure
4.6: High Refractive Index
Optical
Plastics
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- Venu Eye Institute & Research Centre, New Delhi has
successfully developed the technology for Tumble Polishing
of Plastic Lenses for Spectacles. The main objective
of this project was to develop this technology further,
to extend its usage for polishing of plastic spectacle lenses
of size up to 60mm diameter. The research aimed at improving
the surface quality of currently available acrylic/plastic
lenses up to 2 lambdas by tumble polishing technology. Technology
for tumble polishing of 60 mm spectacle lens blanks has
been developed.
- SRI has successfully developed colourless, clear and transparent
polythiols which were cast into 2 mm, 4 mm and 8 mm thick
polythiourethane lenses having Refractive Index of 1.663,
90% Transmittance, 26 Abbe number and good machinability,
dye ability impact resistance. Use of this material for
spectacle lenses shall enable availability of flatter, thinner,
lighter in weight, cosmetically attractive and comfortable
products (Figure 4.6). Industrial partners for pilot scale
production of polythiols and polyurethane were explored.
- A project entitled Glass design studio at NID
has been sanctioned to NID, Ahmedabad in collaboration with
CDGI, Firozabad. As a result, National Institute of Design
(NID) started a Post Graduation Programme in Ceramic
& Glass Design from the current semester i.e.
June, 2003.
- A project entitled Use of Image Intensification
Technology in Retinal Angiography System was supported during
the year. This project aims to integrate Image Intensification
technology, so far used mainly for military applications,
with the ophthalmic medical instrumentation. The main objective
of this project is to create a Retinal Angiography System
in which the diagnostic mapping of the retinal blood vessels
can be done with low intensity continuous light or low intensity
flash light by attaching an image intensification device
to the fundus camera. This shall enable avoiding trauma
of high intensity flashes of light and photo-toxicity and
increase patient comfort level.
Gold Technology Upgradation
Programme
DST sought to intervene in Gold Jewellery Sector through S&T
inputs to provide fairer deal to the consumers, improve the
lot of goldsmiths, research and develop new alloys, surface
engineering technique and improve work ethics. The main objective
of the programme is to promote activities for improving methods,
practices, tools/implements, equipment and working environmental
conditions of goldsmiths.
Vision Technology Programme
This programme aims at developing preventive,
diagnostic and curative technologies for ophthalmic (eye-related)
diseases. Many innovative and high technology projects have
been initiated under this programme to achieve these objectives.
Laser Applications
The main objectives of this programme are to
promote projects and schemes aimed at development and implementation
of application specific laser based techniques, products,
devices and instruments. Under this programme, IIT, Delhi
has undertaken to develop optical correlation technique based
equipment for finger print identification.
Inter-Sectoral Science and Technology
Advisory Committee (IS-STAC)
Inter-Sectoral Science and Technology Advisory
Committee (IS-STAC) mechanism has been created with a view
to guide various socio-economic ministries in formulation
of long term S&T plans and for promotion of Science and
Technology programs relevant to the concerned sectors.
Under the scheme, specific support is provided
by DST for activities which can be demonstrated on industrial
scale through research & development efforts and are conducive
for strengthening technological capabilities in the country.
The energy & environment concerns have added a new dimension
to the development projects in socio-economic sectors. For
achieving such linkages with industry, a priority is being
given to Research, Development and Demonstration (RD&D)
projects relevant to the concerned sectors in these areas.
Objectives
- To provide inter-disciplinary inputs in S&T Programs/Plans
of socio-economic ministries/ departments;
- To identify inter-disciplinary R&D programs of common
interest for multi-partnership funding as Joint Technology
Projects;
- Information Exchange on work of STACs in different Ministries
through STAC Scan Plus newsletter and other publications;
and
- To promote Joint Technology Projects by providing part
funding to the R&D projects, considered important by
the user Ministry or to those that are in the emerging areas.
Major Achievements
Highlights of the achievements in the
ongoing joint technology projects were as follows:
- A Patent Application on Modularized Ship Hull Form Design
Process has been filed by IIT, Kharagpur out of the research
work carried out on the joint technology project with Ministry
of Shipping on Ship Design for Efficiency & Economy.
- Under the joint technology project with Ministry of Steel,
entitled To study various tolerable non-coking coal
sources with the aim of maximizing the usage of domestic
noncoking coal in the COREX Process, plant scale trials
were conducted at JVSL in two phases. In both phases, imported
coal could be successfully replaced to the extent of 10%
without any problems. The replacement ratio of imported
coal to Singareni coal was around 0.8 which means 100 Kg
of Singareni coal could replace 80 Kg of imported coal.
In order to enlarge the base of indigenous coal sources
suitable for COREX, 5000 tonnes of C grade coal is being
procured which will be washed and plant trials will be conducted
shortly in COREX.
- Under the joint technology project with Ministry of Mines,
entitled Studies on Production of Alloyed Pig Iron
and Low Alloyed Steel using Chromite Overburden, a
new technology has been successfully developed for utilizing
the mining waste (Chromite Overburden) for production of
alloyed pig iron for the first time in the country.
- The joint technology project with DAE, entitled Pilot
Enrichment Plant and Purification Center for Helium from
Hydrothermal Sources has been successfully completed.
A ational Facility for enrichment and purification of Helium
(Grade-A Helium of 99.995% purity level) has thus been created
at Saha Institute of Nuclear Physics, Kolkata.
- The joint technology project with Ministry of Mines, entitled
Evaluation of Process Variables in Continuous Scale
Bio-oxidation of Complex Sulphide Ores/ Concentrates of
Ambamata/Sikkim has also been completed successfully.
A demonstration plant has also been put up.
New projects evolved/launched
During the year, the following new joint technology
projects have been launched:
- Recovery of values from wastes of Base Metal Industry
(Joint Technology Project with Ministry of Mines);
- Recovery of Tungsten from Tungsten Alloy Swarf (Joint
Technology Project with Ministry of Mines);
- Exploration of Helium from hot springs (Himachal Pradesh,
Assam, Orissa) and evelopment of Infrastructure for Gas
Collection at Tantloi (Jharkhand) (Joint Technology Project
with Department of Atomic Energy); and
- Scale-up Studies for the recovery of helium by PSA Technology.
U-PROBE Pilot Experiment
Under this program, the following new projects
were launched:
- Establishment of Nodal Center at GB Pant Institute of
Himalayan Environment & Development, Almora;
- Seasonal behaviour of atmosphere pollutants and surface
ozone at a road site in Delhi
a pilot study; and
- Development of Dynamic Website for PROBE program.
New Initiatives
Extension of PROBE program in two other states
viz. Orissa and National Capital Region (NCR), Delhi.
Drugs & Pharmaceuticals Research
Programme
Recognizing the profound influence of R&D
on the prospects and opportunities for the growth of the Indian
Drug Industry, the scheme on Drugs and Pharmaceuticals Research
was initiated by DST in 1994-95 for promoting Industry-Institutional
Collaboration R&D in drugs and pharmaceuticals sector.
This programme aims at enhancing capabilities of institutions
and the Indian Drugs & Pharmaceuticals Industry towards
development of New Drugs in all Systems of Medicine. The specific
objectives of this scheme are:
- To synergise the strengths of publicly funded R&D
institutions and Indian Pharmaceutical Industry in developing
drugs in areas of national relevance.
- To create an enabling infrastructure, mechanisms and linkages
to facilitate new drug development.
- To stimulate skill development of human resources in R&D
for drugs and pharmaceuticals.
Achievements
A total number of sixteen proposals were considered
for financial support under the Drugs & Pharmaceuticals
Research Programme . Ten proposals were recommended
by the Expert Committee for funding including nine Industry-Institutional
collaborative research proposals and one National Facility.
Three new collaborative projects have already
been sanctioned after signing of agreements and are related
to development of a novel herbal ectoparasiticidal product
( a veterinary product), study of safety and efficacy profile
of Kodiveli a siddha medicine in use for
the management of rheumatoid arthritis and development of
a novel controlled/ sustained release formulation for cardiovascular
& inflammatory diseases.
The other seven proposals likely to be sanctioned
during the year, once the terms and conditions of the MOU
are finalized, are related to development of novel TB vaccine
candidates, Designer Polymers for Tailored Oral Drug Delivery
Systems, study of molecular mechanism of action of Cardoguard
and its efficacy in the regression of ventricular hypertrophy,
Efficacy and Safety evaluation of a Siddha medicine HIVS-2003
for HIV/AIDS, development of herbo mineral and plant based
disease oriented immuno-modulator formulations, increase efficacy
of herbal medicines and standardization and modernization
of ayurvedic/herbal formulations using modern techniques.
National Facility
During the current financial year, it is planned
to collaborate with Institute of Genomics and Integrative
Biology (IGIB) to set up a National Facility for Genomic Services
to assist in drug discovery.
An interaction meet entitled National
Workshop on Institute-Industry Interaction on Research in
Unani Medicine was organized during 7-9 January 2004
at Hamdard University, New Delhi. Another interaction meet
related to Modern Trends in Pharmaceuticals Research
is also planned to be conducted.
Agreements Signed
MOUs have been finalized between DST,
Industry and Collaborating Research Institutions during the
year 2003-2004 and some more are likely to be signed in the
near future during the year.
Industries like M/s Natural Remedies Pvt Ltd; Sami Labs Ltd,
Bangalore; and Citadel Fine Pharmaceuticals Ltd, Chennai;
along with the institutions like Central Institute for Research
on Goats (CIRG), Mathura; JSS College of Pharmacy, Ootacamund;
and SASTRA(Deemed University), Thanjavur, Tamilnadu; are involved
as the collaborating partners in the Agreements signed so
far.
Monitoring of Projects
All the projects which have either been completed or have
been running more than a year were monitored by the Experts.
Some of the significant results obtained out of these projects
are as follows:-
- 16 process/product patents were filed in India and abroad
(USA, Australia, Canada, Europe, Israel and Japan).
- Several novel anti cancer compounds were synthesized for
testing against cancer. Few NCEs which have shown encouraging
initial activity data were identified for further structural
modification for achieving the target of lead molecule through
QSAR. Some of the compounds are water soluble and retained
its biological activity.
- Bioefficacy and Analytical Evaluation of a herbal drug
have facilitated the development of a rapid HPTLC method
to generate finger prints, highlighted the uniqueness of
sugar/glucose, sterol/Glucose ratios as important finger
print for Ayurvedic preparations and introduction of pre
chilled water in circulation so as to prevent loss of volatile
essential oil in the preparation. Effective extraction method
for an Ayurvedic product was developed by introducing pressure
gauge to monitor pressure of steam. Introduction of such
a tool has minimized batch to batch variation of ingredients
of the Ayurvedic drugs.
- Out of 29 NCEs synthesized as potential anti-fungal agents,
2 compounds have shown good anti fungal activity against
Candida albicans, one NCE showed activity against Aspergillus
niger and another NCE depicted activity against Fusarium
proliferatum.
- Efforts were made for screening a large number of chemical
entities for potential anti cancer and anti-inflammatory
activities using High Throughput Screening (HTS) Systems.
Under this screening, a library of pre characterized molecules
for anti-cancer and anti-inflammatory activities for identification
of hit molecules for these indications were undertaken.
Out of 11000 molecules available with CDRI, in the primary
screening, 6910 molecules were screened in 5 adenocarcinomas
of which 310 molecules have been identified as HITS.
Secondary screening was carried out in six human cancer
cell lines (Pancreatic, Ovarian, Prostate, Breast, Colon
and normal fibroblasts). About 70 molecules have been identified
as Secondary hits. These molecules represent
17 different classes of molecules which have been assessed
for novelty determination to decide future course of action.
- Protocols were standardized for large scale purification
of COX-I. Enzyme assays for COX-I and COX-2 were standardized.
Cloning and expression of COX-2 in E-coli and yeast expression
systems was also carried out. Protocol was also standardized
for COX-I and COX-2 assays compatible for HTS and 5520 compounds
were screened against COX-I with HTS.
- Besides the 50 NCEs synthesized in the previous
year, additional 62 NCEs were synthesized during the current
year as Beta-3 adrenergic receptor antagonists which might
lead to development of a novel therapy for obesity. Out
of these compounds, when evaluated for biological activity,
one compound exhibited more than 90% activity which
was further studied after carrying out enantiomeric separation.
- The national facility set up for the Transgenic and Gene
Knockout Mice at CCMB, Hyderabad, continued its mission
to produce Transgenic and Gene Knockout Mice specific to
different ailments.
- The Pharmacokinetic Facility created at CDRI, Lucknow
developed a bio-analytical method for an anti-malarial drug
in human plasma. An assay method for the simultaneous estimation
of an anti-malarial agent Bulaquine and its metabolite Primaquine
in Plasma with a lower limit of quantitation was also validated.
This method is being utilized for preclinical pharmacokinetic
studies of Bulaquine. Studies for finger printing and to
establish pharmacokinetics of three herbal preparations
are also in progress using LC-MS-MS.
National Good Laboratory Practice (GLP)
Programme
Chemicals, be they pharmaceuticals, cosmetics,
food additives, pesticides, insecticides are required to be
evaluated to determine their potential hazards. All over the
world, manufacturers perform laboratory studies on such products
for their properties & safety and submit the results of
these studies to Government/Regulatory Authorities for the
assessment of potential hazards to human health and the environment.
For ensuring the quality of the data that are produced in
the laboratories engaged in this kind of activity, adherence
to the principles of GLP and obtaining GLP recognition is
of utmost importance. The non-existence of such a system had
been a point of concern for the Indian test facilities, regulatory
authorities, and the concerned chemical industry. At the initiative
of the Department of Science & Technology, National
GLP Compliance Monitoring Authority was created by obtaining
the approval of the Cabinet in April 2002. Since then, a number
of activities were completed to make the GLP program operational
and from May 2003, inspections of the applicant test facilities
have begun.
So far, three test facilities have been given
GLP recognition, under the programme. The major activities
completed to make the program operational included among others
Documentation on GLP Programme; Government Notification; Newspaper
advertisement inviting applications for GLP Certification;
Launching of the GLP Program, Organising (i) two three-day
Workshops on Good Laboratory Practice, (ii) One-day
Workshop on GLP & Regulatory Issues and (iii)
Inspectors Training Course with OECD support. The special
feature of the programme is that it has adopted Organisation
for Economic Co-operation & Development (OECD) Principles
of GLP and norms and thus Indian programme would have international
equivalence and acceptance in OECD member countries.
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