MARINE BIOTECHNOLOGY INDUSTRY MANAGEMENT

Kumar KashyapM. Tech Marine Biotechnology2nd SemNCAAHCUSAT

INDEX

• Biotechnology Regulatory Processes

• Biotechnology Regulatory Agencies

• Legal Aspects of Biotechnology

• Intellectual Property Rights

Biotechnology Regulatory Processes

• The regulation of genetic engineering concerns approaches taken by governments to assess and manage the risks associated with the use of genetic engineering technology, and the development and release of genetically modified organisms (GMO), including genetically modified crops and genetically modified fish.

• Biotech crops undergo more testing and oversight before commercialization than any other agricultural products, including conventional crops. Before we submit a biotech crop to regulatory agencies for approval, the research teams have put it through numerous tests to ensure and prove it’s as safe as its conventional equivalent. Here’s how the process works:

• Characterizing a New Biotech Product• At this stage in the regulatory process, Monsanto must prove the

gene inserted is safe and the protein produced by the inserted DNA is also safe.

• This includes:• Verifying we’ve inserted only one copy of the gene, the copy is

intact and we have not inserted any other portions of DNA.• And• Demonstrating the protein produced by the new DNA is safe for

human and animal consumption.• Once this testing is complete and data has been generated, our

Product Safety Centre takes over for further testing—this time to conduct safety assessments to determine food and feed safety.

• In some cases RNA interference is used to express a trait. RNAi is a mechanism used naturally by cells to regulate gene expression. It is recognized by the U.S. Food and Drug Administration (FDA) as “Generally Regarded as Safe” (GRAS) and as such, consumption is not regulated.

• Compositional Analysis• This stage includes a comparative safety assessment. With the comparative

safety assessment, Monsanto seeks to establish substantial equivalence, meaning we’re testing to see if a biotech product (a soybean, for example) is compositionally and nutritionally the same as the conventional soybean (one without any biotech traits).

• Animal Performance Assessments• Even if Monsanto knows the new biotech products are compositionally the

same as their conventional counterparts, we generate additional assurances that food and feed from these products are as safe as food and feed from existing conventional products--through animal performance assessments.

• Environmental Safety• A part of the regulatory process includes environmental safety testing. This

involves a study of the plant’s impact on the environment including growth, development, interactions with insects, diseases and other stresses.

Biotechnology Regulatory Agencies

• U.S. Food and Drug Administration (FDA)

• Any new product developed through food and plant biotechnology innovations falls under the approval and review process of the FDA.

• U.S. Department of Agriculture (USDA)

• The USDA Animal and Plant Health Inspection Service (APHIS) regulates how biotechnology improves new crop varieties.

• U.S. Environmental Protection Agency (EPA)

• EPA works with FDA and USDA to regulate new biotechnology crops to ensure these crops don't harm the environment, including other plant and animal species.

• The Biotechnology Regulatory Authority of India (BRAI) is an proposed regulatory body in India for uses of biotechnology products including genetically modified organisms(GMOs)

Legal aspects of Biotechnology Regulatory Frame work in India

Some of the key steps taken by the State Governments includes: announcing separate Biotechnology Policy for their States. setting up of Task Forces with experts to guide them on policy issues. setting up of exclusive Biotechnology Parks with agriculture. health biotechnology as key areas.

Department of Biotechnology [DBT]

Genetic Engineering and Approval Committee[GEAC]

The Institutional Biosafety Committees (IBSC), responsible for the local implementation of guidelines.

Review Committee on Genetic Manipulations (RCGM) responsible for issuing permits.

GEAC responsible for monitoring the large scale and commercial use of transgenic materials.

The MOST important committees The MOST important committees

IBSC

research activities involving genetic manipulation of microorganisms.

All research carried out by the applicant company shall designate a Principal Investigator [PI].

RCGM

It comprises representatives of a)DBTb)Indian Council for Medical Researchc)Indian Council for Agricultural Researchd)Council for Scientific and Industrial Research

After reviewing the application from IBSC it recommend the application to Monitoring cum Evaluation Committee [MEC] of the DBT for agronomic benefits and evaluation.

After reviewing the application from IBSC it recommend the application to Monitoring cum Evaluation Committee [MEC] of the DBT for agronomic benefits and evaluation.

GEAC In case of large scale field trials, deregulation and commercialization, in

addition to the DBT approval process, permission of GEAC constituted under the MoEF is also required.

Approval of the GEAC is required from the environmental angle on:

i. Import, export, transport, manufacture, process, selling of any microorganisms or genetically engineered substances or cells including food stuffs and additives that contain products derived by gene therapy.ii. Discharge of genetically engineered/classified organisms/cells from Laboratory, hospitals and related areas into environment.iii. Large scale use of genetically engineered organisms/classified microorganisms in industrial production and applications. iv. Deliberate release of genetically engineered organisms.

Approval of the GEAC is required from the environmental angle on:

i. Import, export, transport, manufacture, process, selling of any microorganisms or genetically engineered substances or cells including food stuffs and additives that contain products derived by gene therapy.ii. Discharge of genetically engineered/classified organisms/cells from Laboratory, hospitals and related areas into environment.iii. Large scale use of genetically engineered organisms/classified microorganisms in industrial production and applications. iv. Deliberate release of genetically engineered organisms.

Pharmaceutical BiotechnologyPharmaceutical Biotechnology

Industrial licensing under the Industrial [Development & Regulation] Act, 1951 is compulsory for:

• bulk drugs produced by the use of recombinant DNA technology• bulk drugs requiring in-vivo use of nucleic acids• specific cell/tissue targeted formulations

Procedure Procedure

Research & DevelopmentResearch & Development

ImportsImports

ManufactureManufacture

Intellectual property rightsIntellectual property rights

Intellectual property (IP) is the creation of the human mind—the intangible intellect that can translate into tangible products.

Intellectual property rights (IPR) protect the use of these human creations.

The major elements or forms of intellectual property rights today include patents, utility models, industrial designs, trademarks and service marks, geographical indications and layout of integrated circuits, copyright, and plant breeder’ rights.

There are currently two main systems of protection for biotechnology: rights in plant varieties patents:

“The right to exclusively produce, use and/or market a

• Product

• Process

• Application”

Today, IPR plays an important role in every sector and has become an important aspect of research for Pharma and research oriented industries. The continuous efforts of the government in policy establishment, IT protection, infrastructure, IPR search portals and manpower made this Industry a step ahead.

Categories of Intellectual PropertyCategories of Intellectual Property

• Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source.

• Copyright, which includes artistic works such as novels, poems and plays, films, musical works, dance, artistic works such as drawings, paintings, photographs , sculptures, and architectural designs.

• Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs.

References• http://www.monsanto.com/products/pages/biotechnology-regulatory-process.aspx• http://en.wikipedia.org/wiki/Biotechnology#Regulation• http://en.wikipedia.org/wiki/Biotechnology_Regulatory_Authority_of_India• http://www2.dupont.com/Biotechnology/en_US/products/product_saf

ety/links.html• http://en.wikipedia.org/wiki/Compulsory_license• http://www.nolo.com/legal-encyclopedia/enforcing-patent-faq-29148-

2.html• http://economie.fgov.be/en/entreprises/Intellectual_property/Patents/

Conditions_of_patentability/#.VPwXGPmUdg0• http://www.out-law.com/page-5699• http://www.slideshare.net/shrutigupta439/biotechnology-regulation-

legal-aspects-intellectual-property-rights