Biotechnology Law In India

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).


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.