Ethical and Legal Issues in Microbial Products in India

Abstract

A variety of microorganisms produce secondary metabolites, which serves as a source of natural products. These natural products have been an interest and a source of inspiration for scientists and researchers for the development and well-being of civilizations. Nowadays, modern technologies and effective scientific tools have made it possible to use such beneficiary microbes in the best possible way. Microbial-based products, especially biofertilizers and biopesticides, are known to be effective green alternatives to overcome adverse effect of chemical fertilizer and pesticides caused during green revolution. However, in India usage of such microbial-based products in agriculture is still at a very small scale. To overcome this issue, the Indian government has encouraged the use of biofertilizers and biopesticides by placing them into many of the agricultural schemes. Although, legal barriers imposed on their manufacturing, trade, import, storage, transport, and disposal restrict their production and adaptability hence, the declining interest of farmers have become a matter of concern. The main objective of this chapter is to highlight the legal provisions of the Indian laws regulating biofertilizers and biopesticides. Legal analysis stated in this chapter is based on published comparative legal research, which could enforce the manufacture process with high quality standard of biofertilizers and biopesticides present on the market and thus foster their use by farmers.

Appendices

Appendix 1

Appendix 2

Appendix 3: Technical Data Required for Registering a Biopesticide in India

• 1. Strain specification

  • Genus and species.

  • Rhizosphere competence.

  • Biological control capability.

  • Growth promotion capability.

  • Wide range of growth parameters like pH and temperature.

• 2. CFU count

  • The data required for claiming 1 year shelf life of the product is for 15 months for talc-based formulation, i.e., the microbe should remain viable for 15 months with a colony forming units (CFU) count not less than 2 × 106 spores/mL or g on selective media (SM).

  • Pathogenic contaminants such as Salmonella, Shigella, and Vibrio should not be present. Other microbial contaminants not to exceed 1 × 104 counts/mL or g.

• 3. Target fungi

• 4. Moisture content

  • Maximum moisture content of the product should not exceed more than 8% for dry formulation of fungi and 12% for bacteria.

• 5. Chemistry

  • Systematic name: Genus and species.

  • Common name, if any.

  • Natural occurrence: morphological description.

  • Manufacturing process: solid or liquid state fermentation.

  • Qualitative analysis.

  • CFU on selective medium.

  • Absence of Gram– bacterial contaminants (Salmonella, Shigella, and Vibrio).

  • Moisture content.

  • Shelf life claim: two different locations along with meteorological data.

• 6. Technical bulletin/Product profile.

  Bioefficiency:

  • Lab bioefficacy test: The product should be tested against target pathogen/pest at one of the laboratories of ICAR/SAUs/CSIR/ICMR system.

  • Field bioefficacy test: The intended product should be tested for field bioefficacy under Indian conditions.

  • Field bioefficacy guidelines have been recently revised/enhanced w.e.f. 01.01.2011.

    Field Bioefficiency:

  • 9(3B): Provisional Registration.

  • One crop: two seasons (rabi and kharif)/year, two agro-climatic conditions (four bioefficacy trial reports).

  • 9(3): Permanent Registration.

  • One crop: two seasons (rabi and kharif)/year, three agro-climatic conditions (six bioefficacy trial reports).

  • Safety data on nontarget organisms.

• 7. Toxicity

  • Toxicological studies may be conducted by recognized institutes viz. IITR Lucknow, IIBAT Chennai, JR Foundation Vapi, INTOX, Pune.

    • (a) (For formulated products to be directly manufactured).

      • Single dose oral—Rat (21 days) (Toxicity/Infectivity/Pathogenicity).

      • Single dose oral—Mouse (21 days) (Toxicity/Infectivity/Pathogenicity).

      • Single dose Pulmonary—Rat (14 days) (Toxicity/Infectivity/Pathogenicity).

      • Single dose Dermal—Rabbit (21 days) (Toxicity/Infectivity/Pathogenicity).

      • Single dose Dermal—Intraperitoneal (21 days) (Toxicity/Infectivity/Pathogenicity).

      • Primary skin irritation.

      • Eye irritation.

    • (b) Human Safety Records.

      • Environmental Toxicological Studies (For formulation only) On Nontarget Vertebrates.

        • Toxicity to chicken, pigeon, freshwater fish.

      • Dossier preparation for 9(3b) and 9(3) registration.