The Genetic Engineering Approval Committee (GEAC) scrutiny will no longer be required for the biotech industry for import and marketing of products derived from Living Modified Organisms (LMOs) as drugs and pharmaceuticals in bulk and finished formulations, provided the end products being imported are not LMOs.
The Ministry of Environment and Forests has also relieved the indigenous biotech manufacturers using organisms falling under group I and group II of the recombinant DNA Safety Guidelines 1990, from the GEAC approval requirements. Since risk group I and risk group II cover almost all living microbial organisms that are utilized by Indian biotech industry, GEAC approval would now be a remote requirement for most of the Indian companies.
The classification in the Recombinant DNA Safety Guidelines 1990 puts most of the pathogens widely prevalent in the country under lower category of risk group. Only those micro organisms that are not present in the country have been assigned high risk classification. Thus, all bacterial, fungal, viral, rickettsial and chlamydial agents not included in higher classes according to "Basis for Agent Classifications" comes under risk group 1.In addition, Influenza virus A/PR8/34, Newcastle disease virus strains licensed for vaccine use Parainfluenza Virus 3, SF4 strain and Rinderpest attenuated virus strain (e.g. Kabatte-O) licensed for vaccine use also belong to risk group I that do not require GEAC clearance.
The risk group II includes bacterial, fungal, viral agents like Actinobacillus - all species except A. mallei, which is in risk group III, Arizona hinshawii - all serotypes, Bacillus anthracis, Bordetella all species, Borrelia recurrentis, B vincenti, Cl chauvoei, Cl difficle Cl fallax, Cl Haemolyticum, Cl histolyticum, Cl novvi, Cl perfringes, Cl septicum, Cl sordelbi, Corynebacteriumdiptheriae, C equi, C haemolyticum, C pseudotuberculosis, C pyogenes, C renale, Diplococcus (Streptococcus) pneumoniae, Erysipelothrix insidiosa. Escherichia coli-all enteropathogenic serotypes, Haemophilus ducreyi, H influenzae, H pneumoniae, Herellea vaginicola, Klebsiella-all species and all serotypes, Letionella, Leptospira interrogans all serotypes reported in India, Listeria, all species, Mima polymorpha, Moraxella-all species, Mycobacteria-all species including Mycobacterium avium, M bovis, M tuberculosis, M leprae, Mycoplasma-all species except M mycoides and M agalactiae, Neisseria gonorrhoeae, N meningitides, Pasteurella - all species except those listed in risk group III, Salmonella- all species and all serotypes, Shigella - all species and all serotypes, Sphaerophorus neorophorus, Staphylococcus aureus, Streptobacillus moniliformis, Streptococcus pyogenes, S equi, S pneumonine, Streptomyces madurae pelleteri somaliensis, Treptonema carateum, T pallidum and T pertenue, Vibrio foetus, V comma including biotype EIT or and V. parahemolyticus, Vibrio cholerae, Atinomycetes (including) Nocardia and Actinomyces and Arachina propionica, Aspergillus fumigatus.
Blastomyces dermatitidis, Cryptococus neoformans C. fersiminosos, Epidermophyton madurella, E. microsporon, Paracoccidioides brasiliensis (Sporothrix Trichoderma Trichophyton), Entamoeba histolytica,
Leishmania species, Naegleria gruberia, Plasmodium thcilera, Plasmodium fabesia, P falciparum, Schistosoma Toxoplasma gondii, Toxocara canis, Trichinella spiralis, Trichomonas, Trypanosoma cruzi, Adenoviruses - Human, all types, Avian loukosis, Cache Valley virus, CELO (avain adenovirus), Coxsackio A and B viruses,Corona viruses, Cytomegalo viruses, *Dengue virus, when used for transmission experiments, Echo viruses - all types, Encephalomyocarditis virus (EMC), Flanders virus, Hart Park virus, Hepatitis-associated antigen material - hepatitis A and B viruses, non A and non B, HDV Herpes, viruses - except herpes virus simiae (monkey B virus) which is in risk group IV, Infectious Bovine Rhinotraechitis virus (IBR), Infectious bronchitis, Infectious Bursal diseases of poultry, Infectious Laryngotraechitis (ILT), Influenza virus- all types, except A/PR8/34 which is in risk group I, Langat virus, Leucosis complex, Lymphogranuloma venereum agent, Marek's Disease virus, Measles virus, Mumps virus, Newcastle disease virus (other than licenses strain for vaccine use), Parainfluenza viruses - all types except Parainfluenza virus 3, SF4 strain, which is in risk group I, Polio viruses-all types, wild and attenuated, Poxviruses - all types except Alastrim, monkey pox, sheep pox and white pox, which depeinding on experiments are in risk group III or IV, Rabies virus - all strains except rabies street virus, which should be classified in risk group III when inoculated into carnivores, Reoviruses - all types, Respiratory syncytial virus, Rhinoviruses - all types, Rinderpest (other than vaccine strain in use), Rubella virus, Simian viruses - all types except herpes virus simiae (Monkey B Virus) which is in risk group IV.
Simian virus 40, Ad 7 SV 40 (defective), Sindibis virus, Rensaw virus, Turlock virus, Vaccinia virus, Varicella virus, Vole rickettsia, Yellow fever virus and 17D vaccine strain.
The ministry notified the amendments under the Rule 20 of the rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms / Genetically Engineered Organisms or Cells, Rules 1999 on October 4, 2006.
The Rule 20 allows exemption to Rules 7 - 11 (both inclusive), all of which pertains to GEAC permission before import, export, transport, manufacture, process, use or sell any hazardous microorganisms of genetically engineered organisms/substances or cells. Import or use of pathogenic microorgnisms or any genetically engineered organisms or cells for the purpose of research, GEAC approval for discharge of microorganisms/genetically engineered organisms or cells mentioned in the Schedule from the laboratories, hospitals and other areas, GEAC approval for scale up or pilot operations using genetically engineered organisms/microorganisms, licensing requirements, production approval, etc were all covered by 7 - 11 rules.