Professional Documents
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Pharma Sector
Healthcare Industry Worlds Largest $2.8 trillion Global pharmaceutical market $643bn(2006) - Will be $ 1.3 trillion (2020), Rs 4,50,000 crores
To facilitate Drug Research, Government has launched a Scheme entitled Drugs & Pharmaceuticals Research (DPRP) ).
Department of Scientific and Industrial Research (DSIR)- PATSER Programme Council of Scientific and Industrial Research (CSIR)
New Millennium Indian Technology Leadership Initiative (NMITLI) Small Business Innovation Research initiative
Demand of DPRP-DST
Confidentiality Efficiency & Speed Sharing of IPR & Legal Agreements State-of-the-art Infrastructures Ensuring Budget Strong Project by Project Monitoring Customer Friendly and proactive
IS TIME CONSUMING - It is a long drawn process and takes nearly 10 to 15 years to develop a drug.
IS MULTIDISCIPLINARY IN NATURE
Inputs from different disciplines in the form of a team work is required .
IS COST INTENSIVE
costs nearly 700 million US$ for development of a New Drug and nearly 200 million US$ for development of a new molecule
3 150
3
4 5 6 7 8 9
Epilepsy
Depression Diabetes Schizophrenia Asthma AIDS Alzheimer
8
10 25 10 40 5 1.5
10
11 12
Parkinson
Tuberculosis and Malaria Filariasis
2.5
15.0 50
2.
i) ii) iii)
Clinical Research
Involves the following steps:Phase-I Studies. Phase-II Studies Phase-III Studies & IND Filing
Collaborative Projects
Supports research in all systems of medicines including setting up of facilities. Supports joint research projects of industry and institution. Normally 50 : 50 sharing of financial requirements between industry and institution. Research undertaken by industry is funded 100% industry. Institution share is supported jointly by government and industry. Capital expenditure : 100% by Government, recurring expenditure: 70% by Government and 30% by industry. DSIR recognition is desirable.
DPRP
Currently: Grants In Aid to Institution Continues For Joint Projects. Window opended For Industries to Avail Loan For R&D Projects. Loan Amount upto 70% Of the Project Cost .
Terms of Loan(contd)
The Project Implementation Period Will be the moratorium period and will not be liable for repayment of instalments and interest. However, the interest accrued during the implementation period will be amortised and will be payable in maximum of 5 instalments alongwith the first instalment of principal amount. The Industrial partner must have an R&D centre which has valid recognition of the Department of Scientific and Induastrial Research (DSIR), govt of India. If not registered, the firm undertakes to get the R&D centre recognised within 12 months.
Research activities undertaken in the field of herbal medicines and success achieved in the recent years , challenges faced, efficacies of such drugs along with measures taken to popularise such medicines among people.
a) In the field of herbal medicine under this programme, a novel method has been standardized for the preparation of certain Asavas and Arishtas which is more innovative and less time consuming. During the last three years six projects related to R&D in the area of Herbal Medicines which are related to Development of adaptogens, Therapeutic Formulations for Management of Alopecia and other skin disorders, Herbal anti-malarial drugs, reno-protective effect of certain herbal compounds, antidiabetic herbal products and development of drug for medical therapy of glaucoma using natural products have been undertaken .
b) For popularization of the Programme for conducting R&D in the Herbal Drug sector, various Interaction Meetings (Industry-Institution Interaction) are conducted by the Department at various places . Such interaction meetings in the past have been held at Delhi (Jamia Hamdard), Varanasi (BHU), Ahmedabad (PERD Centre) .In these interaction meetings special emphasis is given to encourage the development of indigenous herbal drugs, besides standardization and scientific validation of the prevalent herbal formulations keeping into view the vast biodiversity of our country and the importance of herbal drugs.
Vision
Create more industry instititional alliances for development of Modern, AYUSH including veterinary drugs. More facilities on Pharma Informatics, Clinical Research Organisations, Standardisation and Quality Control to be set up. Evaluation of safety and efficacy of AYUSH Medicines for anaemia other disorders like atherosclerosis & lipid disorders, liver disorders, pscychological diseases, arthritis/inflammatory disorders, neurological disorders, menstrual disorders, menopausal syndrome, skin allergies and diseases, renal disorders, reproductive disorders, wound healing,chronic respiratory problems, diabetes, obesity, cancer, AIDS,and immunological disorders.
Vision- Contd
AYUSH medicines for comunciable diseases like gastrointestinal disorders, hepatitis, tuberculosis, malaria, leishmaniasis, filariasis, and leprosy to be developed. AYUSH Medicines for veterinary use
Diseases Covered
Assay Systems & Diagnostics Kit. i)Assay stystems developed fo r a) Study of inhibitors of enzymes Cox I and Cox II b) Mycobacterium tuberculosis DNA Gyrase inhibitors ii) Diagnostic Kit a) Indigenous diagnostic kit for assay of HIV-I & HIV-2. Novel Drug Delviery System. a) TMDDS (Transmucosal drug deliery systems) for an anti ulcer drug developed. Scientific validation of herbal formulations and process improvement 5 (Five) projects.
Department of Biotechnology (DBT) Aided Institutions National Institute of Immunology, New Delhi National Centre for Cell Sciences, New Delhi. Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad. National Brain Research Centre, New Delhi. National Centre for Plant Genome Research (NCPGR), JNU, New Delhi. International Centre for genetic Engineering and Biotechnology (ICGEB), New Delhi.
Industries
ALLIANCES(INSTITUTIONS /LABORATORIES
A. CSIR LABORATORIES
Indian Institute of Chemical Technology (IICT), Uppal Road, Hyderabad 500 007. Central Drug Research Institute (CDRI), Chattar Manzil Palace, Lucknow-226 001. Centre for Biochemical Technology (CBT), University Campus, Delhi 110 007. Regional Research Laboratory (RRL), Canal Road, Jammu- 180 001. Regional Research Laboratory (RRL), Indl Estate, Thiruvananthapuram 695 019. National Chemical Laboratory (NCL), Pashan Road, Pune 411 008. Indian Institute of Chemical Biology (IICB), Jadavpur, Calcutta700 032. Centre for Cellular & Molecular biology (CCMB), Uppal Road, Hyderabad-500 007.
Projects Funded for promoting R&D in the Pharma Sector ( Under the D&P Programme )
YEAR OF COMMENCEMENT : 1994-1995
TOTAL NO. OF PROPOSALS CONSIDERED : 256 ( Placed before the Expert Committee since August, 1994-till June , 2010) *PROJECTS SANCTIONED SO FAR :
125
: : : : 74 19 30 02
Research Projects Facilities Loan to Industries Grants in aid to industries Systems Of Medicine Covered
1. Projects under Modern/Novel drugs 2. Projects under Ayurvedic System 3. Projects under Siddha System 4. Project under the Unani System
5. Projects Under The Homeopathic System
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