Promoting R&D in the Pharmaceutical Sector

Govt of India Initiatives

By Dr( Mrs) S.N.Khan,Scientist-F, TDT DivnDST, Ministry of Science & Technology

New Delhi-110016E-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 Studiesiii) 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 FacilitiesB. Soft Loan for Pharma Industrial R&D Projects.C. Grant-in-Aid to Pharmacveuticals Research

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.

Special Features Of DPRP (Contd)

Provision 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?

Previously.• Grants In Aid to Institution for Joint Projects with

Industry was provided.• No direct financial support to industry by

Government was provided.

Now • 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 alongwith 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 : 02Systems Of Medicine Covered

1. Projects under Modern/Novel drugs : 662. Projects under Ayurvedic System : 343. Projects under Siddha System : 054. Project under the Unani System : 015. Projects Under The Homeopathic System : NIL