National Biosafety Policies in India

Questions and Answers

What was the aim of the Environment and Protection Act enacted in 1986?

To promote agricultural exports

To regulate the pharmaceutical industry

To protect and improve the environment (correct)

To enhance commercial farming practices

Which ministry is responsible for the notification of rules regarding GMOs?

Ministry of Agriculture

Ministry of Environment & Forests (correct)

Ministry of Commerce

Ministry of Health and Family Welfare

When was the notification regarding GMOs made by the Ministry of Environment and Forests?

1990

1994

1986

1989 (correct)

According to the current Drugs and Cosmetics Rules, how are all recombinant products classified?

As new products Signup and view all the answers

What year was the 8th Amendment of the Drugs and Cosmetics Rules revised?

1988 Signup and view all the answers

Which of the following guidelines relates specifically to the safety of transgenic plants?

Revised Guidelines for Safety in Biotechnology 1994 Signup and view all the answers

What does the abbreviation rDNA stand for?

Recombinant DNA Signup and view all the answers

In what context was the official Gazette of the Government of India mentioned?

Notifying regulations about GMOs Signup and view all the answers

What is the primary objective of the safety assessment of genetically engineered (GE) foods?

To determine if GE foods present greater risks compared to traditional foods. Signup and view all the answers

Which factor is NOT considered in the safety assessment of GE foods?

The environmental impact of GE food production. Signup and view all the answers

Which of the following elements is included in the evaluation of GE foods?

Transformation process of the recombinant DNA. Signup and view all the answers

What is a goal of assessing the composition of GE foods?

To ensure that nutritional status is not negatively affected. Signup and view all the answers

What might be a possible concern regarding the expression product of novel DNA in GE foods?

The potential for gene transfer to unintended organisms. Signup and view all the answers

What is the primary purpose of containment in a laboratory setting?

To manage and safely handle infectious agents. Signup and view all the answers

Which category requires the review and approval of competent authority for experiments involving genetically modified organisms?

Category III Signup and view all the answers

In the context of containment, what is biological containment?

Strategies to manage infectious agents within the laboratory. Signup and view all the answers

What is defined as a large-scale experiment according to the guidelines?

Experiments with a capacity exceeding 20 liters. Signup and view all the answers

What is required prior to the application of rDNA modified organisms in agriculture?

Evaluation of potential risks associated with the organisms. Signup and view all the answers

Which of the following represents physical containment conditions?

Physical barriers to prevent organism escape. Signup and view all the answers

What should be conducted for large-scale studies involving potential risks?

An independent review on a case-to-case basis. Signup and view all the answers

What is a characteristic of biological containment?

It includes methods for maintaining safety during handling of pathogens. Signup and view all the answers

What is one of the main focuses of the guidelines for the production of rDNA vaccines and diagnostics?

Safety, purity, potency, and effectiveness Signup and view all the answers

What method can be employed for sequence verification of rDNA products?

Restriction enzyme mapping Signup and view all the answers

What aspect does preclinical testing primarily aim to define?

Physiological, toxicological, and efficacious potential Signup and view all the answers

What is a primary purpose of biosafety regulation?

To safeguard biological resources Signup and view all the answers

What type of tests must be conducted to ensure the safety of recombinant vaccines?

General safety tests including sterility tests Signup and view all the answers

Which guideline was established first in the timeline of biosafety policy in India?

Recombinant DNA Safety Guidelines Signup and view all the answers

Which parameter is considered critical when selecting appropriate animal species for preclinical testing?

Physiological state of the species Signup and view all the answers

Which of the following is NOT a focus area of the guidelines for evaluating rDNA biologicals?

Market trends in vaccine development Signup and view all the answers

What potential risk is associated with the misuse of agrochemicals?

Destruction of natural habitats Signup and view all the answers

Which of the following statements is true about the historical public policy thrust of biological safety in Indian agriculture?

It has not been a strong public policy focus. Signup and view all the answers

What type of data must be included regarding the stability of the finished formulation as per the guidelines?

Data as per Indian Pharmacopia guidelines Signup and view all the answers

What is a primary characteristic of pharmacokinetics evaluated during preclinical testing?

Drug absorption, distribution, metabolism, and excretion Signup and view all the answers

Which aspect is not a potential risk due to the mismanagement of agricultural inputs?

Development of targeted biological resistance Signup and view all the answers

Study Notes

Need for Biosafety Regulation

Aims to protect human health and biological resources from potential risks.
Addresses careless use of agrochemicals leading to destruction of non-target biological entities.
Mitigates risks from mismanagement of agricultural inputs and potential human health threats due to GMOs.

Timeline of Biosafety Policy in India

Formal biosafety policy began in the 1980s with the rise of rDNA agricultural technologies.
Environmental Protection Act established in 1986 to safeguard the environment during the use of GMOs.
Key notifications by the Ministry of Environment and Forests began in the late 1980s.

Key Guidelines and Regulations

Recombinant DNA Safety Guidelines released in 1990.
Revised guidelines introduced for transgenic plants and bacterium experimentation, focusing on good laboratory practices.
Guidelines categorize experiments by risk level:
- Category I: Self-cloning experiments (exempt)
- Category II: Non-pathogenic DNA vector systems (notice to authorities)
- Category III: Risky experiments requiring full review and approval.

Large Scale Experiments

Defined as operations over 20 liters or beyond 20 acres for field trials.
Guidelines mandated evaluation of potential risks to the environment prior to large-scale application.
Emphasize occupational safety in laboratory settings.

Clinical Data Guidelines for rDNA Products

Established guidelines in 1999 for preclinical and clinical evaluation of rDNA vaccines and biologics.
Requirements for safety and efficacy data include potency checks and general safety tests per Indian Pharmacopia standards.
Objective is to ensure thorough verification of identity, purity, potency, and effectiveness prior to human studies.

Safety Assessment of GE Plant Foods

Formulated by the Indian Council of Medical Research in 2008.
Safety assessment to compare genetically engineered (GE) foods to traditional counterparts for any increased risks.
Factors include identity, source, composition, and effects of processing on health and nutritional status.
Includes consideration of gene transfer stability and expression products.

General Characteristics of Biosafety Guidelines

Stress importance of containment methods to manage infectious agents.
Physical and biological containment systems are put in place based on associated experiment type and potential risks.
Comprehensive review processes ensure that potential environmental impacts and health effects are adequately addressed before the introduction of GMOs into the market.

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Description

This quiz explores the essential biosafety regulations and policies in India, including the historical timeline and key guidelines for recombinant DNA and transgenic research. It is designed for those interested in biosafety standards and legal frameworks concerning biotechnology in the country.