The rapidly changing economic, trade and intellectual property scenario, nationally and internationally poses many challenges including the challenge of becoming leaders and competitors globally. This necessitates a shift in the approach of pharmaceutical industry to move away from manufacturing only known drugs through innovative process routes to discovering and commercialising new molecules.
The accumulated knowledge of traditional medicinal system and large bio- diversity of our country offer a great advantage to drug industry. However, at present, most of the Indian drug firms, due to their small size compared to international operators, are not in a position to invest in a viable new drug development programme - drug development being a risky, resource intensive & time consuming process. At the same time several Indian academic institutions and national laboratories have established impressive infrastructure and developed excellent expertise in selected areas of drug development. Thus, this is a strong case for industry- institution interaction.
Recognising the profound influence of R&D on the prospects and opportunities for the growth of the Indian Drug Industry, Department of Science and Technology (DST), Government of India mounted the programme on drug development during 1994-95 for promoting collaborative R&D in drugs and pharmaceuticals sector with the following specific objectives :
- To synergise the strengths of publicly funded R&D institutions and Indian Pharmaceutical Industry.
- 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; and
- To enhance the nation's self-reliance in drugs and pharmaceuticals especially in areas critical to national health requirements.
During January 2004, Government of India established Drug Development Promotion Board (DDPB) under the administrative control of DST for supporting R&D projects jointly proposed by industry and academic institutions/ laboratories and to extend soft loan for R&D to drug industry.
Collaborataive R&D 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% by 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
Soft Loan for Pharma Industrial R&D Projects
- Loan amount upto 70% of the project cost.
- Loan will be an unsecured one carrying a simple interest of 3% on reducing amount.
- Repayment of the loan will be in 10 annual 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.
Grant-in-aid to Industry for Clinical trials for developing drugs for neglected diseases:Any Indian Pharma Industry including new and small for R & D projects involving clinical trials (phase-I, II and II) of developing drugs for neglected diseases like tuberculosis, malaria, kala-azar, filariasis, etc.
The programme supports both human and veterinary drug development for all types of medicinal systems, be it traditional Indian medicinal system or the modern one. The programme employs a two pronged approach involving exploratory drug design and drug development on candidate molecules already identified on one hand and providing a cutting edge to Indian Industry through innovative process for known/generic drugs as well as crucial intermediates on the other. Some of the areas where support could be considered are:
- any component/stage in the innovation chain of new drug development
- innovative/cleaner process technology for known drugs/key intermediates, where India has a competitive advantage
- chiral synthesis of drugs
- resolution of racemic drugs
- clinical studies
- development of new formulations and standardization/testing of traditional formulations.
Who Can Apply ?
Any Indian company/firm engaged in drug development manufacturing jointly with:
Evaluation Of The Proposals
Project proposals are first reviewed, in strict confidence, by an expert in the specific field and then considered by an Expert Committee.
Terms and Conditions
- National laboratory under CSIR, ICMR, etc.
- University department/other academic institution such as IIT, IISc., etc.
- Any other publicly funded R&D Institution
- An agreement amongst the collaborating parties specifying the rights and obligations and terms and conditions of the DST grant is essential. The terms and conditions inter-alia include:
- Ownership of intellectual property generated in the project on agreed terms
- Review of the project by a Monitoring Committee periodically
- 30% of the recurring expenditure (Institutional component) to be met by the collaborating industry.
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Format for Submitting R&D Projects Under DPRP
- Collaborative Project35.5 KB
- Facility Project34.5 KB
- Loan Project58 KB
- Grant in aid to Indian Pharma Industry27 KB
- Collaborative Project59.5 KB
- Facility Project81.5 KB
- Loan Project128 KB
- Grant in aid to Indian Pharma Industry97 KB
For more information contact:
Dr. Neeraj Sharma
Department of Science & Technology
Telefax : 011-26964781
|Scientist F||Scientist C|
|Ms Ritu Bhatnagar |
|Shri C Rajadurai |