Biotechnology
Laws in India
Biotechnology is the science of modifying DNA
present in a plant or animal to get desired results and enhance its functions.
Making bread using yeast, production of wine or beer by fermentation, etc. are
some of the examples of using biotechnology using the biological structure of
different organisms. But today biotechnology has taken greater meaning, and we
all are affected by it. By using this technology scientist can create vaccines,
many diseases that were thought to be incurable now have medicines to control
or eradicate it. Biotechnology has proven to be a boon for humankind and helped
us in every sector, such as in the fuel sector and also in agriculture.
Biotechnology Laws in India
The main agency that governs and work in this
industry is Department of Biotechnology that made under the Ministry of Science
and Technology. Another agency, named Genetic Engineering and Approval
Committee made under the Ministry of Environment and Forest, also works in the
same field. Both the organizations have worked and framed different laws in
India for the development and governance of Biotechnology.
The Biotechnology industry in India is
governed by the following enactments depending upon their
relevance/applicability on case to case basis:
1. Environment Protection Act, 1986
2. EXIM Policy
3. Foreign Exchange Management Act, 1999
4. Laws pertaining to Intellectual Property
Rights
5. Rules for the Manufacture,
Use/Import/Export and Storage of Hazardous Micro-Organisms/Genetically
Engineered Organisms or Cells, 1989 notified by Ministry of Environment &
Forests December 5, 1989, under Environment and Protection Act, 1986.
6. Revised Recombinant DNA Safety Guidelines
7. National Seed Policy, 2002
8. Guidelines for Research in Transgenic Plants &
Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds,
Plants and Plant Parts, 1998
9. Seeds Act, 1966
10. Drugs & Cosmetic
Act 1940 along with Drugs and Cosmetic Rules
11. The Plants, Fruits and
Seeds [Regulation of import in India] Order 1989 issued under the Destructive
Insects and Pests Act, 1914.
12. Guidelines for
Generating Preclinical and Clinical Data for rDNA Therapeutics, 1999
13. Drug Policy, 2002.
14. Biological Diversity Act
Several other committees have been established
to regulate the activities involving handling, manufacturing, storage, testing,
and releasing genetically modified materials in India. Most of these
committees' members are from the scientific community of the Department of
Biotechnology and Ministry Environment and Forest.
The most important committees are:
· The Institutional
Biosafety Committees (IBSC), responsible for the local
implementation of guidelines,
· Review Committee on
Genetic Manipulations (RCGM)
accountable for issuing permits;
· GEAC accountable for monitoring the large
scale and commercial use of transgenic materials.
Research and Development
To carry out the research and development in
the field of recombinant DNA, the company has to submit the rDNA research
proposal to IBSC constituted by it. The proposal should contain the prescribed
particulars viz., rationale, molecular biology of genetically modified
organisms, containment facility, risk management.
The IBSC will make an application to RCGM for
permission of experiments (up to 20 liters of capacity).RCGM upon giving its
approval shall also intimate its decision to State Biotechnology Coordination
Committee (SBCC) and Drug Controller General of India (DCGI).
Manufacture
The manufacture of new rDNA drug involves the following
steps:
1. Production of Test Batch
An application has to be made to the DCGI
seeking permission to manufacture trial batches of the drug. After obtaining
the permission, five of such batches has to manufactured that are characterized
as physicochemical, biological and contaminants.
2. Animal Trials
The preclinical studies begin with the animal
trials to define the physiological, toxicological and efficacious potential of
rDNA product. An application must be made to the Institutional Animal Ethics
Committee (IAEC) seeking permission to conduct animal trials. After getting
permission, the proposal is submitted to RCGM for animal study.
3. Human Trials
The human trials are conducted in the
following three phases:
Phase I: It involves preliminary evaluation of the
safety of the drug in healthy volunteers.
Phase II: It involves an initial efficacy trial on a
small number of patients.
Phase III: It involves assessment of safety and
efficacy of large scale multicentric trials on patients.
Biosafety Regulations
Potential Risks are involved with the use of
genetically modified organisms in both agriculture and healthcare to human
health and the environment. International attempts are made for biosafety under
the Convention on Biological Diversity (CBD). The Cartagena Protocol on
Biosafety was negotiated and adopted under the aegis of CBD on January 29,
2000. The protocol protects the biological diversity from the potential risks.
India is a party to the CBD and a signatory to Cartagena Protocol on Biosafety
and has also decided to ratify the same. Presently, India has rDNA Safety
Guidelines, 1990, which were revised in 1994.