Riding on the support of the Drugs and Pharmaceutical Research Programme (DPRP) under the Department of Science and Technology (DST), four new products were commercialized during the last five years and nine new molecules were taken to different phases of trial.
While countering the reports that the programme had lost its sheen, the DST sources said Bengaluru-based Natural Remedies Pvt Ltd commercialized alquit (a herbal product for the control of animal ecto-parasites) while Virchow Biotech of Hyderabad brought Bonista (parathyroid hormone as injectable for osteoporosis) to the market under the scheme.
Receptol (a colostrums based protein for the management of HIV/AIDS) by Biomix Networks Ltd., Mumbai and Rhoclone (anti-Rho-D immunoglobulin Injection (Monoclonal) 300 mcg developed for haemolytic disease of the new born) by Bharat Serums & Vaccines Ltd, Mumbai were the other two products commercialized.
“Three new molecules under phase-I trials are RBx 7644 (anti-biotic by Ranbaxy, Gurgaon), LL-4858 (anti-tubercular by Lupin Ltd., Pune), CT1 (anti-hyperglycaemic agent by CDRI, Lucknow), TRC-4186 (diabetes and ageing related vascular complications by Torrent Pharmaceuticals Ltd. Three new molecules under the phase-II clinical trial are RBx 11160 (anti-malarial by Ranbaxy, Gurgaon), DRF-7295 (anti-cancer by Dabur Research Foundation), Mw+ Chemotherapy (cancer by Cadila Pharmaceuticals Ltd.). Similarly, one new molecule permitted for phase-III clinical trial is 80/574 (hypolipidemic agent by CDRI, Lucknow),” sources said.
So far 22 product patents and 13 process patents have been obtained and the programme has also enabled the training of young scholars in handling sophisticated instruments, sources said, adding that it had made comprehensive plans to make it more attractive.
Extensive efforts for funding projects resulted in providing grant-in-aid to 39 projects (23 public private partnership collaborative projects, 14 projects for creation of national facilities and two grants-in-aid projects to industry for neglected diseases besides that 30 loan projects to pharma R&D industries, during the last five year plan period.
“The PPP projects were implemented for development of drugs for diseases such as leprosy, malaria, tuberculosis, Japanese Encephalitis, Syphillis, Leishmaniasis, Filariasis, HIV/AIDS, tetanus, measles, drug resistant enteric fever, hepatitis B, skin disorders like leucoderma and psoriasis, gastrointestinal disorders like diarrhoea and cholera besides infections leading to Trypansomiasis and Ascariasis. Diabetes, hypertension, cardiovascular disorders, and dengue besides addressing neurological diseases like dementia and Parkinsons disease. Joint research proposals are also supported for the drug development involving the Ayurvedic, Unani and Siddha systems of medicine for the scientific validation of at least five formulations of the Indian System of Medicine (ISM) including veterinary medicines,” sources said.
During this period, 14 national facilities were created in different national labs, public funded educational institution/universities on Bio-safety level-4, standardization and quality control on medicinal plants, cGMP pilot plant for extraction, formulation and packaging of traditional herbal medicinal formulation, clinical research facility for stem cell, nano-microparticle based biomaterials advanced drug delivery systems, upgradation of clinical trial infrastructure of Unani System, drug targets through functional cell dynamics, herbo-metallic preparations, bio-equivalence, Rasayana products, clinical facility with GLP & GCP standards for ISM etc.
During this period, 30 loan projects were funded to the industry for development of drugs such as inhibitors of Undecaprenyl pyrophosphate Synthase, process for co-enzyme Q10 from solanesol, inhibitor for chronic obstructive pulmonary disease (COPD), vaccine for pancreatic cancer, drug delivery system for treatment of osteoporosis, manufacture of immunodiagnostic kits for rabies, synthetic ribozyme - anti-cancer agents, research facility for large animals (beagle dogs), ayurvedic formulation for allergic diseases, H-1 receptor agonist for allergic disorders, drug for treatment of controlled hypertension and end organ damage, treat acute kidney injury, etc.
Also two grants-in-aid projects funded for conducting clinical trials in neglected diseases such as malaria and kala azar.