India’s biotechnology regulatory system

In the last 50 years, biotechnology has become a tool for enhancing economic growth and to revolutionize food security. However given that GMO (genetically modified organisms) are not naturally occurring organisms and have been tempered by human beings, there is a possibility that the GMO may effect the environment adversely either in the short term or in the long term. Indeed there have been many instances where adverse effects have been documented. It therefore becomes imperative to establish a regulatory authority to conduct appropriate tests both before introduction of the GMO to the environment as well as after its introduction by way of monitoring to ensure that there is no significant impact on the environment. Also given that GMO can become a tool of great destruction in the wrong hands such as in case of bio-terrorism, the regulatory authority also has a very sensitive role to play in the defence of a nation. To that extent, it is crucial for a nation’s regulatory system to have a series of transparent and well documented checks and balances by way of evaluating and monitoring the effect of the GMO on the environment (biotic and a biotic aspects of the eco system). This article seeks to examine if the Indian regulatory system have fulfilled these requirements.


* Pest resistance

*Disease resistance

*Herbicide tolerance

*Cold tolerance

*Drought tolerance/salinity tolerance Nutrition

Environmental hazards:-

•Unintended harm to other organisms Laboratory study proved that pollen from B.t. corn caused high mortality rates in monarch butterfly caterpillars. Monarch caterpillars consume milkweed plants, not corn, but the fear is that if pollen from B.t. corn is blown by the wind onto milkweed plants in neighboring fields, the caterpillars could eat the pollen and perish. Unfortunately, B.t. toxins kill many species of insect larvae indiscriminately; it is not possible to design a B.t. toxin that would only kill crop-damaging pests and remain harmless to all other insects.

• Reduced effectiveness of pesticides Just as some populations of mosquitoes developed resistance to the now-banned pesticide DDT, many people are concerned that insects will become resistant to B.t. or other crops that have been genetically-modified to produce their own pesticides.

• Gene transfer to non-target species Another concern is that crop plants engineered for herbicide tolerance and weeds will cross-breed, resulting in the transfer of the herbicide resistance genes from the crops into the weeds. These ”superweeds” would then be herbicide tolerant as well. Other introduced genes may cross over into non-modified crops planted next to GM crops. The possibility of interbreeding is shown by the defense of farmers against lawsuits filed by Monsanto. The company has filed patent infringement lawsuits against farmers who may have harvested GM crops. Monsanto claims that the farmers obtained Monsanto-licensed GM seeds from an unknown source and did not pay royalties to Monsanto. The farmers claim that their unmodified crops were cross-pollinated from someone else’s GM crops planted a field or two away.

Human health risks:-

• Allergenicity Many children in the US and Europe have developed life-threatening allergies to peanuts and other foods. There is a possibility that introducing a gene into a plant may create a new allergen or cause an allergic reaction in susceptible individuals. A proposal to incorporate a gene from Brazil nuts into soybeans was abandoned because of the fear of causing unexpected allergic reactions.

• Unknown effects on human health There is a growing concern that introducing foreign genes into food plants may have an unexpected and negative impact on human health.

GM foods regulated and the government’s role in this process:-

Governments around the world are hard at work to establish a regulatory process to monitor the effects of and approve new varieties of GM plants. In Japan, the Ministry of Health and Welfare has announced that health testing of GM foods will be mandatory as of April 2001. Currently, testing of GM foods is voluntary. Japanese supermarkets are offering both GM foods and unmodified foods, and customers are beginning to show a strong preference for unmodified fruits and vegetables.

India’s government has not yet announced a policy on GM foods because no GM crops are grown in India and no products are commercially available in supermarkets yet.India is, however, very supportive of transgenic plant research. It is highly likely that India will decide that the benefits of GM foods outweigh the risks because Indian agriculture will need to adopt drastic new measures to counteract the country’s endemic poverty and feed its exploding population.

Some states in Brazil have banned GM crops entirely, and the Brazilian Institute for the Defense of Consumers, in collaboration with Greenpeace, has filed suit to prevent the importation of GM crops,. Brazilian farmers, however, have resorted to smuggling GM soybean seeds into the country because they fear economic harm if they are unable to compete in the global marketplace with other grain-exporting countries.

In Europe, anti-GM food protestors have been especially active. In response to the public outcry, Europe now requires mandatory food labeling of GM foods in stores, and the European Commission (EC) has established a 1% threshold for contamination of unmodified foods with GM food products.In the United States, the EPA Environmental Protection Agency evaluates GM plants for environmental safety, the USDA United States Department of Agriculture evaluates whether the plant is safe to grow, and the FDA U S Food and Drug Administration the regulatory process in United States, is confused because these three different government agencies that have jurisdiction over GM foods.

Regulation of GM foods in india:-

GM foods are regulated under the following statute:-

The Food Safety and Standards Authority under the Food Safety and Standards Act, 2006 (FSSA, 2006).

Product safety, efficacy, clinical trials and market authorization of recombinant drugs are regulated by the Drug Controller General of India (DCGI) under the authority of the Drugs and Cosmetics Rules 1945 (Rules

,• Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989 issued underEnvironment (Protection) Act, 1986

• Drugs and Cosmetics Rules (8th Amendment), 1988• Plant Quarantine (Regulation for Import into India) Order 2003

• Seeds Bill, 2004

Department of Biotechnology (DBT) under the National Biotechnology Strategy has drafted The Biotechnology Regulatory Authority of India bill 2009 which provide the provision for the establishment of National Biotechnology Regulatory Authority. NBRA.

The National Biotechnology Regulatory Authority. NBRA shall perform the following duties:-

• To provide objective, scientific information on potential environmental risks and benefits oftransgenic fish for scrutiny by the scientific community and the public;

• To help identify any potential risks that may be associated with introducing GM foods;

• To assess the strengths and weaknesses of current regulations and guidelines in India, compile and analyze international approaches to regulating GM foods, and provide recommendations toimprove the risk assessment framework for GM foods;

• To evaluate if additional scientific capacity may need to be developed within the NBRA to support future safety assessments of GM foods

.• Ensure that the processes and criteria for risk assessment and risk management are easily accessible so that product developers, stakeholders, and the public can be confident that the biotechnology regulatory system is both credible and predictable.

• Be responsible for notifying the public of all applications for field and clinical trials and the commercial release of GMOs and of all regulatory decisions that are made.

• Develop public outreach programs to inform the public about the mandate and programs of theNBRA.

• Coordinate stakeholder consultations, opportunities for public participation in the regulatory system, and will be the primary point of contact for public, media or other enquiries to the NBRA.


Genetically-modified foods have the potential to solve many of the world’s hunger and malnutrition problems, and to help protect and preserve the environment by increasing yield and reducing reliance upon chemical pesticides and herbicides. Yet there are many challenges ahead for governments, especially in the areas of safety testing, regulation, international policy and food labeling. Many people feel that genetic engineering is the inevitable wave of the future and that we cannot afford to ignore a technology that has such enormous potential benefits. However, we must proceed with caution to avoid causing unintended harm to human health and the environment as a result of our enthusiasm for this powerful technology.