Government of India

Ministry of Science & Technology

Department of Biotechnology

In view of the recent developments in the field of Genome Editing Technologies a need was felt to bring out guidelines. After series of expert consultations, draft guidelines titled “Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment” has been prepared. The draft guidelines accommodates applicable laws, Acts, and procedures governing Genome Editing, general considerations and tiered approach for risk assessment of genome edited organisms and products derived thereof, regulatory approval road map, data requirement for risk assessment and institutional mechanism for governance and oversight.

The Department of Biotechnology invites comments on “Draft document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment” from the researchers/institutions and other stakeholders.

Click here to Download “Draft document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment”

It is requested that comments/ observations pertaining to the same may be conveyed, positively by February 08th, 2020 to rcgm.dbt@nic.in or ibkp2019@dbt.nic.in or send through the IBKP portal at https://ibkp.dbtindia.gov.in/Content/PublicConsultation


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Draft Document
on
Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment

Department of Biotechnology

Ministry of Science & Technology, Government of India

CONTENTS

  1. Background
  2. Indian Biosafety Regulatory Frameworks

  3. Other applicable Laws, Acts and Procedures Governing Genome Editing

  4. Application of Genome Editing Technologies in the Indian Context

  5. General Considerations for Risk Analysis of GEd Organisms and Products Derived Thereof

  6. Tiered approach for the risk assessment of GEd products / organisms
  7. Regulatory Approval Road Map for Genome Edited (GEd) organisms/ Products derived thereof

  8. Data Requirement for Risk Assessment

  9. Institutional Mechanisms for Governance and Oversight

OTHER APPLICABLE GUIDELINES and REFERRED DOCUMENTS

GLOSSARY

GUIDELINES FOR EVALUATION OF NANO-AGRIINPUT PRODUCTS AND NANO-AGRIPRODUCTS IN INDIA

1. Abbreviations

bp base pair
CRISPR Clustered Regularly Interspaced Short Palindromic Repeat
DNA Deoxyribonucleic Acid
DSB Double-Strand Break
GE Genetic Engineering
GEd Genetically Edited
EPA Environment Protection Act
HDR Homology-Directed Repair
HR Homologous Recombination
Indel Insertion/deletion
kbp Kilo base pair
MN Meganuclease
NHEJ Non-homologous End-Joining
nt Nucleotide
ODM Oligonucleotide-directed mutagenesis
PN Programmable Nuclease
rDNA Recombinant DNA
RGENs RNA-guided Engineered Nucleases
SSB Single-strand Break
SDN Site-directed Nuclease
TALEN Transcription Activator-like Effector Nucleases
ZFN Zinc-finger Nucleases
ZFP Zinc-finger Protein

GUIDELINES FOR EVALUATION OF NANO-AGRIINPUT PRODUCTS AND NANO-AGRIPRODUCTS IN INDIA

1. Background

Biotechnology is one of the sunrise sectors propelling growth in biomedical, animal and agriculture sectors and contributing to the Indian economy. India has emerged as a scientifically and technically strong nation that can utilize advanced tools and technologies to derive the benefits of biotechnology for the public good, nationally and globally.

In a very short span of time, Genome Editing (GEd) Technology has demonstrated its potential applications in a wide range of sectors covering human and animal health, food, agriculture, microbial biotechnology, bio-economy, etc. These potential applications include, but are not limited to, improved crop protection and livestock breeding, improved animal welfare, modification of animal donors for xenotransplantation, products of microbial biotechnology, gene- and cell-based therapies to control diseases and prevent the inheritance of disease traits, control of vector-borne diseases such as Malaria, Dengue, Chikungunya, etc, biofuels, pharmaceuticals, and other high-value chemicals.

Like with all new technologies, GEd technologies have dual-use potential and therefore involve both safety & security issues.

Therefore, adoption of appropriate biosafety frameworks for research, development and application of Genome Editing Technologies in various sectors lays a roadmap for the development and sustainable use of Genome Editing Technologies in India. The judicious application of this technology in different areas will be a reflection of Government of India’s long and underlying policies and commitment1,2 towards securing and translating the benefit of scientific knowledge without compromising safety and security of the nation as well as the globe.

2. Indian Biosafety Regulatory Frameworks

2.1 The process or product of genetic engineering technology in India is regulated under biosafety regulatory framework established under “Manufacture, use, import, export and storage of hazardous microorganisms/ genetically engineered organisms or cells, Rules 1989 (Rules 1989) under Environment (Protection) Act (EPA), 1986”.

2.2 Definitions in Rules 1989

  1. (i)  “Biotechnology” means the application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services;
  2. (ii)  “Cell hybridisation” means the formation of live cells with new combinations of genetic material through the fusion of two or more cells by means of methods which do not occur naturally;
  3. (iii)  “Gene Technology” means the application of the gene technique called genetic engineering, include self-cloning and deletion as well as cell hybridisation;
  4. (iv)  “Genetic engineering” means the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self-cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material;
  5. (v)  “Microorganisms” shall include all the bacteria, viruses, fungi, mycoplasma, cells lines, algae, protodones and nematodes indicated in the schedule and those that have not been presently known to exist in the country or not have been discovered so far.

Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment

2.3 Provisions applicable to new gene technologies under Rules 1989:

  1. (1)  These Rules 1989 are applicable to the research, manufacture, import and storage of micro- organisms and Gene-Technological products.
  2. (2)  These rules shall apply to genetically engineered organisms/micro-organisms and cells and correspondingly to any substances and products and food stuffs, etc., of which such cells, organisms or tissues hereof form part.
  3. (3)  These rules shall also apply to new gene technologies apart from those referred to in clauses (ii) and (iv) of rule 3 and these rules shall apply to organisms /micro-organisms and cells generated by the utilisation of such other gene-technologies and to substances and products of which such organisms and cells form part.
  4. (4)  These rules shall be applicable in the following specific cases:
  •   sale, offers for sale, storage for the purpose of sale, offers and any kind of handling over with or without a consideration;
  •   exportation and importation of genetically engineered cells or organisms;
  •   production, manufacturing, processing, storage, import, drawing off, packaging andrepackaging of the Genetically Engineered Products;
  •   production, manufacture etc. of drugs and pharmaceuticals and food stuffs distilleries andtanneries, etc. which make use of micro-organisms/ genetically engineered microorganisms one way or the other.

    Living cells and/or organisms with targeted genetic change(s) in genomes are generally referred as “Genome Edited cells/organisms”, “Gene Edited cells/organisms” or “Genetically Edited cells/organisms” (hereinafter referred as GEd organisms).
    The definition of gene technology under Rules 1989 covers genome editing, process and product.

3. Other applicable Laws, Acts and Procedures Governing Genome Editing

The Genome Editing Technologies also have implications to International treaties/ agreements like Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Biological Weapons Convention, Wassenaar Arrangement on Export Controls for Conventional Arms and

Dual-Use Goods and Technologies, Australia Group (AG). India being a party to these treaties/ agreements shall remain committed to the fulfilment of its obligations and shall take necessary steps to regulate genome editing whenever required.

The other applicable laws, acts & procedures related to biosafety and biosecurity are The

Biological Diversity Act, 2002; Drugs and Cosmetic Act 1940; Seed Act, 1966; Protection of

Plant Varieties and Farmers Rights, 2001; Food Safety and Standards Act, 2006; Plant

Quarantine Order 2003; The Unlawful Activities (Prevention) Act, 1967; Disaster Management

Act, 20053; Weapons of Mass Destruction and Their Delivery System (Prohibition of Unlawful

Activities) Act, 2005. Further, India is a signatory to The Convention on Biological Diversity

45 (CBD) and its subordinate protocols (Cartagena and Nagoya protocols) .

Export of hazardous microorganisms or toxins listed in SCOMET list and developed using genome editing technology shall require prior approval from DGFT as specified under Foreign Trade Policy of India. Biological Diversity Act, 2002 prohibits the acquisition of any biological resource6 occurring in India or knowledge associated thereto for research or for commercial utilisation or for bio-survey and bio-utilisation without the approval of National Biodiversity Authority. FSSAI under Food Safety and Standards Acts, 2006 is responsible to assess the safety of food and its ingredients where food contains or consists of genome edited products.

4. Application of Genome Editing Technologies in the Indian Context

Biotechnology offers safe and sustainable solutions to many environmental challenges. It is, therefore, envisioned that genome editing holds many promises to improve environmental quality as well as the quality of life and related services. The genome editing technologies offer solutions to address several issues related to Human & Animal Welfare and Protection of Environment.

Agriculture plays an important role to meet food and development needs of the Indian population and also as a source of increasing national economy through trade. New Technologies are anticipated to play a major role in meeting nation’s food security and in achieving Sustainable Development Goals of UN7 (for example- Goal 2: End Hunger, Achieve Food Security and Improve Nutrition, and Promote Sustainable Agriculture).

The Genome Editing Technology offers to increase yield and productivity of agricultural crops to meet constantly increasing demand for food and food security optimally by protecting them from various biotic and abiotic stresses and various other traits.

India is a fisheries giant with a total catch of about 3 million metric tons annually placing India among the world’s top 10 fishing nations. India’s livestock sector is also one of the largest in the world including broad spectrum of native breeds of cattle, buffalo, goats, sheep, swine, equine, camel and poultry with merits of adaptability to climate and nutrition, and resistance to diseases and stress.

The national targets for production of livestock and poultry products are 61% for milk, 76% for meat, 91% for fish, and 169% for eggs by the year 2020 over the base year TE 1999. The production potential in livestock is not realized fully because of constraints related to feeding, breeding, health, etc. Frequent outbreaks of diseases like FMD, BQ, PPR, Brucellosis, Swine fever, and Avian Influenza, etc. continue to reduce productivity and production.

With a minimal possibility of expansion of livestock population, the option available is to adopt systematic conservation, genetic improvement and sustainable utilization of indigenous breeds,

8,9

where the role of genome editing is very promising

.

In the healthcare sector, there are about 6000-8000 rare diseases known globally and out of which 450 of them have been reported in India. There are about 72-96 million people affected by such rare diseases. Some of them require treatment once in their lifetime whereas other diseases may require lifelong treatment and there are some diseases for which there is still no treatment available. About 95% of rare diseases have no approved treatment and where treatment is available they are very expensive and beyond the reach of the common man.

Genome editing tools offer new promise for protection of human health against various infectious and non-infectious diseases, prevention and treatment of rare diseases. A large number of efforts are going on at the international level to treat or cure fatal human diseases and rare genetic disorders using genome editing technologies. The somatic cell-based genome editing is considered as a better choice for treatment/cure of some of the rare genetic and other diseases and is currently being explored all over the world.

Research & experiments involving genome editing in germ-lines to understand basic biology under strict oversight and ethical monitoring is permitted but not beyond the two week stage in most of the countries. In India, as per the National Guidelines for Stem Cell Research (2017)10 of Indian Council of Medical Research (ICMR), Department of Health Research (DHR) and Department of Biotechnology (DBT), Genome modification including gene editing (for example by CRISPR-Cas9 technology) of stem cells, germ-line stem cells or gamete and human embryos is restricted only to in vitro studies. It will require thorough review by the IC-SCR, IEC and IBSC, and finally by Review Committee on Genetic Manipulation (RCGM). More recently, ICMR, DBT and CDSCO issued National Guidelines for Gene Therapy Product Development & Clinical Trials, 2019

5. General Considerations for Risk Analysis of GEd Organisms and Products Derived Thereof

For the safety assessment of genome edited organisms in general, the basic risk assessment framework published in “Risk Assessment Framework and Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants 2016” (http://geacindia.gov.in/resource- documents/biosafety-regulations/guidelines-and-protocols/ERA_GuideforStakeholders.pdf) has been adopted. However, GEd organisms differ from GE organisms in many respects. Genome editing is a precise molecular method of mutation leading to deletion or addition or substitution of target base pair(s) in the native genes/ nucleic acid sequences. On the contrary, GE organisms (also known as GMOs/LMOs) typically contain foreign genes or DNA (with/ without prior knowledge of genome structure and function) derived from related or unrelated organisms to modify an existing trait or introduce a new trait. In addition, genome editing also facilitates the introduction of a foreign gene(s) to introduce a new trait(s), which is similar to GE organisms, but the site of integration is predetermined in GEd organisms unlike in GE organisms where site of foreign gene integration in the genome is random.

Within the GEd organisms, there are several differences depending on the type or nature of Site Directed Nuclease (SDN) or Oligo Directed Mutagenesis (ODMs) used in genome editing process:

  •   The GEd organisms, may contain very specific modification of one or few base pairs within the existing genetic information of living organisms with known genome structure and function without involving foreign gene insertion.
  •   As a consequence of highly specific site of modification/integration, genome editing technologies may lead to products that might be undetectable and/or indistinguishable from the naturally occurring mutants and from organisms produced from conventional breeding and/or artificial/induced mutagenesis (e.g., chemical, radiation) (Figure 1).

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