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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


Figure 4.2:Transducer for Force Measurement

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 TDB’s 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:

  1. 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.
  2. Structure Technology Systems for distress diagnostics, industrialised building systems and seismic protection etc.
  3. Information and Communication Technology System for cost effective Broadband Access Technology for rural areas and development of Farmer Advisory Systems
  4. 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.
  5. Surface Engineering modification and rejuvenation of traditional crafts
  6. Alternative fuel
  7. Waste utilisation recycling & management
  8. 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

     Figure 4.6: High Refractive Index
               Optical Plastics
  • 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

MOU’s 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 NCE’s 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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