Table 1
From the following article
India's health biotech sector at a crossroads
Sarah E Frew, Rahim Rezaie, Stephen M Sammut, Monali Ray, Abdallah S Daar & Peter A Singer
Nature Biotechnology 25, 403 - 417 (2007)
doi:10.1038/nbt0407-403
Table 1. Indian health biotech firms interviewed and their product/technology portfoliosa
| Company name | Products/technologies on the marketb | Products in development | International quality certification |
|---|---|---|---|
aAs of July 1, 2006 | |||
bFor the sake of completeness, both biological and pharmaceutical products are listed in some cases. EPO, erythropoietin; INF Interferon; DPT, diphtheria, pertussis, tetanus; FSH, follicle-stimulating hormone; HCG, human chorionic gonadotropin; g-CSF, granulocyte colony stimulating factor; GMP, good manufacturing practice; Hib, H. influenzae type B; MMR, measles, mumps, rubella; WHO, World Health Organization; tPA, tissue plasminogen activator. | |||
| Avestha Gengraine Technologies | A number of health foods, agbiotech and nutraceutical products and technologies. Also provides services such as plant genetic engineering for salt, drought and disease tolerance | Ten to eleven biosimilars, tuberculosis diagnostic microarray chip | — |
| Bharat Biotech International | Products include INDIKINASE (recombinant streptokinase for myocardial infarction), REGEN-D (recombinant epidermal growth factor for foot ulcers), ZELECT (oral rehydrating salts + zinc for treatment of diarrhea), Revac-B (recombinant Hep-B vaccine), BIOPOLIO (oral poliomyelitis vaccine), BIOGIT (yeast probiotic), BIO-ENOX (enoxaprin sodium injection) HEPASOLV heparin sodium injection | Vaccines (Japanese encephalitis, malaria (four strains), rabies, and rotavirus (two strains), avian flu, S. aureus); biotherapeutics (probiotic and antibiotic combinations and lysostaphin) | Korean FDA and WHO GMP certification |
| Bhat Bio-Tech India | Thirty-eight diagnostic tests, including blood grouping sera, urinalysis, hepatitis B and C, pregnancy, HIV, malaria, dengue and cancer markers; and recombinant proteins | Hep-B vaccine, insulin, tissue plasminogen activator (tPA), streptokinase, growth factors, interleukins, cardiac markers, PCR kits for detection of pathogens and other test kits (e.g., HIV-HCV combo test, pregnancy) | ISO 9001, ISO 13485 and GMP certified |
| Bharat Serums and Vaccines | Over 25 brands in several areas including plasma derivatives, monoclonals (anti Rho-D immunoglobulin), equine antitoxins and antisera, cardiovascular disease (streptokinase and urokinase), antifungals (amphotericin-B lipid complex and deoxycholate), anesthetics and hormones (human chorionic gonadotropin and follicle stimulating hormone) | Recombinant rotavirus antibody, mAb against tetanus, recombinant rabies vaccine, novel liposomal drug delivery systems, novel formulation for amphotericin (antifungal and leishmaniasis drug), and lipid-free propofol | WHO GMP certification |
| Biocon | A host of industrial enzymes, marketed globally. Therapeutic products include: five generic statins, and a number of products for diabetes including Insugen, a recombinant human insulin. | Recombinant protein therapeutics including oral insulin, monoclonal antibodies, erythropoietin (EPO), granulocyte colony-stimulating factor (g-CSF), streptokinase and human growth hormone | ISO 9001, GMP, approved by US FDA, College of American Pathologists (CAP) |
| Biological E | 500 products for various indications including gastrointestinal, respiratory, cardiovascular, antidiarrheal, antiinfectives and allergy medications as well as vaccines (tetanus toxoid, DPT, diphtheria toxoid, r-Hep-B) and antitetanus and antisnake venom sera | A host of vaccines including a tetravalent dengue vaccine, Japanese encephalitis, Hib conjugate, rotavirus, cholera, meningitis, measles and DPT-hep-B combination vaccines | Production facilities conform to GMP standards |
| Dr. Reddy's Laboratories | Several products marketed internationally (e.g.,  11 products in the US and 30 in the EU) including g-CSF, doxofylline (asthma medication) and GRAFEEL (hG-CSF for cancer patients suffering from chemotherapy-induced neutropenia) | Phase 1 completed in Canada for a leading compound targeted for the treatment of blood lipid dysfunction and clinical development of a cardiovascular drug candidate is underway in Ireland | FDA-approved manufacturing facilities for various products |
| GangaGen Biotechnologies | No products on the market as of July 2006. | Antibacterials for human diseases (such as tuberculosis), staphylococcal nosocomial interventions, and animal health and environmental products. | — |
| Indian Immunologicals | Sixteen products produced in-house including foot-and-mouth disease vaccine, human rabies vaccine, recombinant hepatitis B vaccine, and several animal and human-health products. | Pediatric and childhood vaccines, r-hep-B, DPT, hepatitis E vaccines and a novel DNA-based vaccine for rabies | ISO 9002 & WHO GMP Certification |
| LifeCare Innovations | Fungisome (lysosomal-mediated delivery of amphotericin B for treatment of fungal or leishmania cells) and Fungitericin (amphotericin B for treatment of systemic mycosis and visceral leishmaniasis), Fungitrace (itraconezole; oral antifungal for subacute and chronic infections), Psorisome (dithranol; topical treatment for psoriasis) | Drug candidates for psoriasis and TB (based on their lysosomal drug delivery system) are entering phase 1 | Production facilities conform to GMP standards |
| Nicholas Piramal India | Two hundred and fifty different brands, some of which are produced for export. The products cover a large number of indications in addition to diagnostics and vitamins | A cdk4 inhibitor for cancer treatment is in clinical trials in Canada and India. Has an anti-fungal herbal product in phase 2 and a drug candidate against methicillin resistant Staphylococcus aureus and vancomycin resistant enterococcus in late pre-clinical development. | Manufacturing plant approved by US FDA, MCA of UK, TGA of Australia and the European and Canadian Drug Authorities |
| Panacea Biotec | Vaccines (oral polio, Hep-B, Hep-B+DPT, Hib+DPT, Hep-B+DPT+Hib), and over 40 drugs/formulations for at least ten human indications including pain management, diabetes and renal disease | Vaccines against dengue, Japanese encephalitis and anthrax | WHO GMP facility for vaccine production |
| Reliance Life Sciences | Blood plasma proteins, recombinant proteins, DNA-based diagnostic testing services, cytogenetic testing services, plant products and software to manage clinical trials | Working on products in several areas including stem cell therapeutics, monoclonal antibodies and novel proteins | GMP facility for recombinant protein production |
| Serum Institute of India | Manufacture and marketing of 15–20 products, for domestic and international markets. Products include antisera (polyvalent anti-snake venom), vaccines (MMR, DPT, r-Hep-B vaccines and others) | DNA-based rabies vaccine, a novel peptide vaccine for measles, DPT/Hep-B combination vaccine and a pentavalent vaccine by combining the latter with Haemophilus influenza type b vaccine | WHO GMP certification |
| Shantha Biotechnics Pvt. | r-Hep-B vaccine, r-INF -2b), r-streptokinase, r-EPO, combination vaccine DPT/Hep-B, and a few diagnostic kits | Typhoid and Japanese encephalitis vaccines, a pentavalent vaccine (DPT+Hep-B+Hib), insulin, growth factor and human monoclonal antibodies for four oncology indications | WHO GMP certification |
| Strand Life Sciences | Products include Admetis (platform for modeling and predicting drug-relevant properties of molecules in silico), Avadis (technology platform for data analysis and visualization), and target-focused synthetic compound libraries | Bioinformatics-based toxicity prediction software for novel drug development and next generation bioinformatics software tools for Affymetrix arrays | — |
| Transgene Biotek | Some technologies and products ready to be outlicensed including a novel drug-delivery technology (for insulin and Hep-B), and three biogenerics (pegylated-EPO, r-tPA, and pegylated-INF-2b) | Meningococcal meningitis polyvalent conjugate vaccine, recombinant meningococcal meningitis B vaccine, Hib conjugate vaccine, hepatitis-B vaccine (oral delivery) and transgenic rabies vaccine, interferon  2b and  , and two cancer drugs for colon and breast cancers using short interfering RNA (siRNA)-targeted approach | — |
| Wockhardt | Hep-B vaccine, EPO, insulin, an automatic insulin delivery injection pen, interferon (INF-2b), granulocyte g-CSF and glargine (a long-acting insulin analog) | Twenty-five products (mostly generics, for various indications including anemia, diabetes and antivirals) in various approval phases in various countries including recent approval from the US FDA for marketing cefuroxime axetil and Zonegran (zonisamide). | Manufacturing plants approved by various regulatory agencies including TGA of Australia, US FDA, and UK's MHRA |
| Exclusive service companies and services provided | |||
| Clinigene | Contract clinical trials services | N/A | College of American Pathologists (CAP) |
| SIRO Clinpharm | Contract clinical trials services | N/A | — |
| Syngene | Contract services in basic research and synthetic chemistry | N/A | ISO 14000 |
