Drugs And Pharmaceuticals Research Programme

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Promoting R&D in the
Pharmaceutical Sector

Govt of India Initiatives


By

Dr( Mrs) S.N.Khan,Scientist
-
F, TDT Divn

DST, Ministry of Science & Technology

New Delhi
-
110016

E
-
mail : Samadk@nic.in
















Pharma Sector


Healthcare Industry World’s Largest $2.8
trillion


Global pharmaceutical market
$643bn(2006)

-

Will be $ 1.3 trillion (2020), Rs 4,50,000
crores

Need

For Strengthening Pharma R&D


Signatory of TRIPS/WTO.


Process To Product Patents.


Rich Biodiversity, Traditional System of Medicines.


Resource Intensive, high Risk Sector.


Chain of Laboratories/Academic Institutions.


Large Domestic Market


Significant Export Growth.


Export of Off
-
Patent Generic Drugs.


Tilt of Global market towards Natural products.


Trend For Outsourcing R&D In India.


Success of Contract Research Organisations (CROs).


Harmonisation of Product Patents Regime after January 2005.

Drug & Pharmaceutical Research

-
Drug research is a very time consuming affair& it takes nearly 12 to 15 years
to bring out a new drug.

-
It is knowledge as well as investment intensive
-

nearly US $ 900 million to
US $ 1.0 billion . This involves :
-

a)
Lead Discovery Research,

involving nearly six years & an expenditure of
nearly US $ 250 million (synthesis/screening, target validation, & lead
optimisation).

b)
Drug Development

involving nearly nine years and an expenditure of
nearly 650 million US $ (Pre clinical and clinical studies);


To facilitate Drug Research, Government has launched a
Scheme entitled “ Drugs & Pharmaceuticals Research”
(DPRP) ).

Growth of Indian Drug Industry

Year

Turnover (Rs .in millions)

1970


3,000

1990

50,000

2005

550,000

2010

1000,000

(Approximate)

Ongoing Initiatives in the Country



Public
-
public partnership Programmes


Public
-
private partnership Programmes


Private
-
Private partnership Programmes


Central
-
States partnership Programmes


Country
-
Country partnership Programmes


Country
-
International Agencies
(UNDP,WHO)

Some Government Initiatives To
Promote Indian Pharma Industry



Recognition of the Pharmaceutical industry as a knowledge
base industry.


Reduction in interest rates for export financing.


Additional tax deductions for R&D expenses.


Reduction in the price control of pharmaceuticals.


Establishment of new mechanisms to promote public
private partnership in R&D and to support new drug
-
development by way of providing soft loans to Pharma
Industry.


Public Private Partnership R&D
Programmes launched by Govt of India



Department of Science & Technology (DST)

-
Drugs and Pharmaceuticals Research Programme (DPRP)



Department of Scientific and Industrial Research
(DSIR)
-

PATSER Programme



Council of Scientific and Industrial Research (CSIR)

-
New Millennium Indian Technology Leadership Initiative
(NMITLI)

-
Department of Biotechnology (DBT)

-
Small Business Innovation Research initiative

Drugs & Pharmaceutical Research
Programme


The scheme was initiated by DST in 1994
-
95 for
promoting R&D in drugs and pharmaceuticals sector



Aims at enhancing capabilities of the Indian drugs
and pharmaceutical industry towards development of
new drugs



Synergising the strength of publicly funded R&D
institutions and Indian Pharmaceutical drug industry
for discovery and introducing new drugs

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

Nature of Drug Research





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





HIGHLY COMPETITIVE AND RISKY



10 out of 10,000 molecules synthesized successful as lead molecules
(
novel bioactive compounds)

and 1 out of 10 lead molecules succeeds in
clinical trial.


Disease Burden in India

(Based on
WHO
-
World
Health Reports 2002
-
2004 & Ministry of Health Statistics
)

Disease


Number of Patients in Millions

1

Cancer

3

2

Hypertension

150

3

Epilepsy

8

4

Depression

10

5

Diabetes

25

6

Schizophrenia

10

7

Asthma

40

8

AIDS

5

9

Alzheimer

1.5

10

Parkinson

2.5

11

Tuberculosis and Malaria

15.0

12

Filariasis

50

International Medical Research
Priorities


AIDS


Brain disorders


Alzheimer’s, Parkinson’s.


Neuro
-
degenerative condition.


Cardiovascular disease


coronary and hypertension.


Cancer


Diabetes mellitus


Endocrine / metabolic
-

Osteoporosis.


Fatty disorders


Obesity, Hyperlipidaemia.


Gastrointestinal


Irritable bowel syndrome, Inflammatory
bowel Disease.


Hepatitis.


Immunological disorders


Rheumatoid arithritis.

Steps in New Drug Development

1.

Pre
-
clinical Research
.


Involves the following steps:
-

i)
Chemical research

(involving Drug Design, Organic Synthesis and
Analytical Chemistry)

ii)
Biological Research

(Involving Pharmacological, Toxicological studies
& Pharmacokinetics)

iii)
Pharmaceutical Development

( Involving Study of Physico
-
chemical
Properties, Dosage Form & Bioavailaibility
)

2.
Clinical Research



Involves the following steps:
-

i)
Phase
-
I Studies.

ii)
Phase
-
II Studies

iii)
Phase
-
III Studies &
IND Filing

3.
Post Market Surveillance




DST
-
Led Drugs & Pharmaceuticals
Research Programme


DPRP is a unique effort by the Indian Government to
specifically promote Research and Development of new drugs
and pharmaceuticals by Indian Pharma Industry through
Public
-
Private partnership
.


DPRP has three types of funding

mechanisms:




During discovery phase, it provides support to public Institute/University
and the Partner company provides only 30% of the recurring expenses to the
Institute.





In the development phase, it provides soft loans to the industry to at least
partly offset the development cost.





It provides 70% support to the public Institutes for creating central facilities
which shall cater to the emerging needs of the industry.







DST
-
LED Technology Development Board

(TDB)


TDB provides financial assistance to industrial
concerns and other agencies for attempting
development and commercialisation of indigenous
technology or adapting imported technology to wider
domestic applications
.



The financial assistance is available in the form of
soft loan (upto 50% of the project cost with 5%
simple interest) and equity.

DRUGS AND PHARMACEUTICALS
RESEARCH PROGRAMME

AN OVERVIEW


-

Initiated during 1994


1995


Projects on modern/Indian systems of medicines both curative
and preventive)


Industry


Institutional participation.


Normally 50 : 50 sharing of financial requirements between
industry/institution


Industry portion funded by Industry


100%


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 not mandatory


-

Also supported establishing National Facilities.

Special Features of DPRP

A.
Grants
-
in Aid for Collaborative Projects & National Facilities

B.
Soft Loan for Pharma Industrial R&D Projects.

C.
Grant
-
in
-
Aid to Pharmacveuticals Research


C
ollaborative Project
s



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.

Special Features Of DPRP (Contd)


P
rovision of Loan For Pharma Industrial

R&D
Projects.


Loan amount upto 70% of the project cost can be provided.


Loan will be an unsecured one carrying a simple interest of 3% on
reducing amount.


Repayment of the loan will be in 10annual equal instalments after the
project period.


Interest during the implementation period will be amortized and will
be payable in maximum of 5 instalments after the project period along
with the instalment of principal amount
.


Drugs and Pharmaceuticals Research
Programme (DPRP) Of DST


An Overview
.


Initiated During 1994
-
95.]


R&D Projects on all systems of Medicines (Modern and Ayush).


Industry


Institutional Participation


Mandatory (Both
Technical and Financial)


Industry Portion (100%) Funded by Industry.


Institution Share is Supported Jointly By Government and Industry :


Govt Support : 100% of Capital





70% Recurring.

-
Industry Support 30% Recurring

-
Supported Establishing National Facilities.

-
Each Project Monitored on Yearly Basis.










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 (Salient Features)


The Loan will be An Unsecured Loan Carrying A Simple Interest Of 3%
And the Interest Will Be Charged On the Outstanding Amount of The
Loan.


Industrial Will Become Due from the date of release of funds in the Project
to Industrial Partner.


The repayment of the loan will be in 10 annual equal instalments.

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 implemen
-

tation 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.




Drugs & Pharmaceuticals Research
Program(DPRP
-
2004 ONWARDS)

How the current scheme is different?

P
revious
ly.


Grants In Aid to Institution for Joint Projects with
Industry was provided.


No direct financial support to industry by
Government was provided.

No
w


Financial support is also provided to industry by
Government in the form of a soft loan.








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, anti
-
diabetic 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.


Institutions involved with Pharmaceuticals Research



1.CSIR INSTITUTES



Central Drug Research Institute (CDRI), Lucknow.


Central Food Technological Research Instt., CFTRI, Mysore.


Central Institute of Medicinal & Aromatic Plants, Lucknow.


Centre for Biochemical Technology (CBT), New Delhi.


Centre for Cellular & Molecular Biology (IICB), Kolkata.


Indian Institute of Chemical Biology (IICB), Kolkatta.


Indian Institute of Chemical Technology, Hyderabad.


Industrial Toxicology Research Centre (ITRC), Lucknow.


Institute of Hymalayan Bioresources Technology (IHBT), Plampur.


National Chemical Laboratory, (NCL), Pune.


National Institute of Oceanography (NIO), Goa.


Regional Research Laboratory, Bhubaneshwar (RRL, BHU).


Regional Research Laboratory, Thiruvandthapuram, RRL
-
TVM


Institute of Microbial Technology, Chandigarh.

Institutions involved with Pharmaceuticals Research

Indian Council of Medical Research(ICMR
) Labs):


Malaria Research Centre.


Institute of Cytology and Preventive Oncology (ICPO).


Institute of Research in Medical Statistics.


Centre Jalma Instt of Leprosy.


National Institte of Cholera and Enteric Diseases.


Institute for Research in Reproduction .


Institute of Immunohaemotology (IIH).


Enterovirus Research Centre.


National Institute of Virology.


National AIDS Research Centre.


National Institute of Nutrition.


National Centre for Laboratory Animal Sciences.


Institutions involved with Pharmaceuticals Research

ICMR Laboratories

(Contd..)


Food and Drug Toxicology Research Centre


Tuberculosis Research Centre.


National Inst of epidemilogy.


Vector Control Research Centre.


Centre for Research in medical Entomology.

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.





MAJOR INDUSTY/INSTITUTIONAL ALLIANCES:





Under this programme, so far 54Industry
-
institutional alliances have taken place among the
following:


Industries



A. INDUSTRIES INVOLVED IN MODERN SYSTEM OF MEDICINE



* SPIC Pharma, SPIC Centre, 97, Mount Road, Guindy Campus, Chennai


600 032.


*Dr Reddy’s Foundation, 7
-
1
-
27, Ameerpet, Miyapur, Hyderabad
-
500 016.’


*Ranbaxy Laboratories Ltd, Sector 8, Udyog Vihar, Gurgaon
-
122 001.


*Dabur Research Foundation, 22, Site IV, Sahibabad, Ghaziabad
-
202 010.


*Recon Ltd., Kalana Agrahara Village, Bannerghatta Road, Bangalore
-
560 076.


*Bharat Biotech International Ltd., 726, Road 3, Banjara Hills, Hyderabad
-
500 034.


*Cadila Healthcare Ltd., Surkhej Bawla Highway, Ahmedabad
-
5000 034.


*Cadila Pharmaceutical Ltd, B/2 Mahalaxmi Chambers, Mumbai
-

400 026.


*Lupin Laboratories Ltd, 159
-
CST Road, Kalina Santacruz, Mumbai
-
400 026.


*LifeCare Innovations Pvt Ltd, Gurgaon


*FDC Ltd., Mumbai.


Sami Labs Ltd, Bangalore./



MAJOR INDUSTY/INSTITUTIONAL ALLIANCES:


B.
INDUSTRIES INVOLVED IN INDIAN SYSTEM OF MEDICINE



*Zandu Pharmaceuticals Works Ltd., Gokhale Road, Dadar, Mumbai
-
400
098.


*Dabur Research Foundation, 22, Site IV, Sahibabad, Ghaziabad
-
202 010.


* Indian Herbs Research and Supply Co. Ltd, Sahibabad, Ghaziabad
-
202
010.


*Indian Herbs Research and Supply Co. Ltd, Sharda Nagar, Saharanpur
-
247 001.


*Arya Vaidya Sala, Kottakkal


676 503 (Kerala)


*Dey’s Medical Stores Mfg ltd., 6/D Lindsay Street, Kolkata
-
7000 017.


Life Pharmaceutical Pvt Ltd., 3/2B, Orient Row, Kokata
-
700017.


Herbochem Remedies India (P) Ltd., Narendrapur, 10, Muslaman Para
Road, Distt 24, Parganas (South), West Benagal
-
743508.


M/s Natural Remedies Pvt Ltd., Bangalore


M/s Citadel Fine Pharmaceuticals Ltd, Chennai.




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, Calcutta
-

700 032.


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


Research Projects : 74


Facilities : 19


Loan to Industries : 30


Grants in aid to industries



: 02

Systems Of Medicine Covered



1.
Projects under Modern/Novel drugs : 66

2. Projects under Ayurvedic System : 34

3. Projects under Siddha System : 05

4. Project under the Unani System : 01

5. Projects Under The Homeopathic System : NIL