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FAQs

GENERAL FAQs

What is genetic engineering?

Rules 1989 defines Genetic engineering as “the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self-cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material”

 What is a genetically modified organism (GMO) or a genetically engineered organism (GEO)?

GMOs (alternatively GEO) are organisms developed through genetic engineering.

 

What is a GM product?

A GM product is a preparation which may contain a GMO or a combination of a GMO or products derived from GMOs.

 

What is biosafety?

Biosafety refers to policies and procedures adopted to avoid risk to human health and safety and to the conservation of the environment as a result of the use of GMOs for research and trade.

 

What are the issues of concern related to GMOs for the environment?

Issues of concern include: capability of the GMO to escape and potentially introduce the engineered genes into wild populations; persistence of the gene after the GMO has been harvested; susceptibility of non-target organisms (e.g. insects which are not pests) to the gene product; stability of the introduced gene in the GMO; reduction in the spectrum of other plants including loss of biodiversity; and increased use of chemicals in agriculture.

 

Are GM foods safe?

Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.

However, GM foods that are currently available in the international market have passed safety assessments and are not likely to present any risk for human health and environment. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.

 

Have GM products on the international market passed a safety assessment?

The GM products that are currently on the international market have also passed all safety assessments conducted by national authorities. These different assessments in general follow the same basic principles, including an assessment of environmental and human health risk. The food safety assessment is usually based on Codex documents.

 

From where I will get information on International regulatory systems?

A comprehensive collection of websites specific to different functional regulatory systems operative globally may be found at Global websites (provide the link).

Regarding Roles and Responsibilities of Institutional Biosafety Committee (IBSC

What is an IBSC?

Institutional Biosafety Committees (IBSCs) were established as per the “Rules for the manufacture, use/import/export and storage of hazardous microorganisms/ genetically engineered organisms or cells, 1989” (commonly referred as Rules, 1989) notified by the Ministry of Environment Forests and Climate Change (MoEF&CC), Government of India under the Environment (Protection) Act (1986) to provide review at institutional level and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. Additional responsibility regarding biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens) is also assigned to them.

What are the responsibilities of institutions with regard to IBSCs?

It is the responsibility of each institution to ensure that all research involving recombinant or synthetic nucleic acid molecules either conducted at or sponsored by that institution is conducted in compliance with the Rules, for the safe conduct of the research at the local level. Each institution conducting or sponsoring research involving recombinant or synthetic nucleic acid molecules is responsible for:

•           Registering an IBSC with DBT;

•           Ensuring that the IBSC has adequate expertise and training

•           Providing appropriate training for the IBSC chairperson and members, Biosafety Officer (BSO), principal investigators (PI), and laboratory staff;

Establishing procedures that the IBSC shall follow in its initial, continuing review, in approval of applications, proposals, and activities; and upon request, making available to the public, all IBSC meeting minutes and any documents submitted to or received from funding agencies that those agencies must make available to the public.

 

What are the responsibilities of IBSCs? What matters should they consider in their review of research involving recombinant or synthetic nucleic acid molecules?

Following matters entails examination by IBSC, including:

•           Containment levels or its modification warranted; including physical containment, biological containment, physical containment for large-scale uses of organisms containing recombinant or synthetic nucleic acid molecules, physical and biological containment for recombinant or synthetic nucleic acid molecule research involving plants, physical and biological containment for recombinant or synthetic nucleic acid molecule research involving animals.

•           Facilities at the institute;

•           Institutional procedures and practices;

•           Training and expertise of personnel involved

•           Research projects are in compliance with the institution’s health surveillance requirements and data and adverse event reporting requirements.

•      Implement contingency plans for handling accidental spills and personnel infection resulting from research involving recombinant or synthetic nucleic acid molecules; and

•           Report to RCGM of any substantial problems or violations of the guidelines; and significant research related accidents or illnesses.

Regarding IBSC Composition

How many members are required for constituting an IBSC?

An IBSC must consist of at least head of the organisation or his designate (a suitable senior officer) as the Chairperson, three or more scientists engaged in rDNA work or molecular biology with at least one outside expert in the relevant discipline, a Biosafety Officer (medical doctor) and a DBT nominee There is no limit on the maximum number of members.

When proposing DBT nominee for an IBSC, what qualifications or experience should be considered in potential candidates?

The candidate proposed as DBT nominee should have experience and expertise in: Recombinant or synthetic nucleic acid molecule research; biosafety and physical containment; knowledge of institutional commitments and policies; applicable laws; standards of professional conduct and practice; Community attitudes; and environmental considerations. He/she should have the capability of assessing the safety of research involving recombinant and synthetic nucleic acid molecules and identifying potential risks to public health and safety.

What external expertise or perspectives are either required or recommended for the IBSC?

Every IBSC committee may use qualified experts / consultants, not affiliated with the institution, for representing the interest of the surrounding community with respect to health and protection of the environment. Participation of such external experts / consultants in meetings should be recorded in the minutes.

Who is responsible for ensuring that IBSC members are adequately trained to fulfil their responsibilities under the Rules 1989?

The Chairman is responsible for ensuring that IBSC members are appropriately trained.

Regarding Submission of IBSC Registration Information to DBT

How do institutions register a new IBSC with DBT?

Registration of an IBSC is mandatory. IBSC is required to register itself through this website.

I receive no funding from DBT. Still, do I have to register?

Yes. Regardless of funding source, if your research involves use of hazardous microorganism and/or genetically organisms or cells, you must register with an IBSC.

I am getting some recombinant materials from a lab with an investigator who is already registered with the IBSC.  Doesn’t that registration cover me as well?

No – Each investigator handling recombinant DNA materials for research must register their work with the IBSC.  Please see Guidelines describing Process for Exchange (inter-state and inter- institutional supply/receive within India), Import and Export of GMOs and product(s) thereof for Research purpose.

What subsequent reports must be made to DBT about the IBSC?

Each IBSC has to furnish an annual report to RCGM in prescribed proforma (as mentioned on website) regarding the observance of the safety guidelines including the progress on the ongoing projects in the organisation, as well as minutes of at least two meetings held every year as well as to notify any membership changes that may occur on the IBC throughout the course of the year.

What is the deadline for an IBSC’s annual report?

Each IBSC must report at least annually on their IBSC's membership. Thus, the deadline for next update can be one year after the receipt date of their last report or in the month of January not later than 31st January.

How do I deactivate an IBSC registration?

If for any reason, an institution decides to deactivate its IBSC registration with DBT, then that institution should notify DBT of that fact in writing. This enables DBT in maintaining the current status of all IBSC registrations.

Regarding Conduct of IBSC Meetings and Reporting of Minutes

How often should IBSCs meet?

The frequency of IBSC meetings should be commensurate with the volume of protocols needing review, the nature and risks of the research, and the need for continuing oversight. Although the Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017 do not set a minimum threshold for meeting frequency, IBSCs are expected to meet at least twice in a year thereby reviewing recombinant DNA research conducted at the institution and ensuring compliance with the current guidelines.

How detailed should the minutes of IBC meetings be?

The Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017 do not prescribe the intricacies to be represented in IBSC meeting minutes. In general, minutes should reflect the date and place of the meeting, whether minutes of the prior meeting were approved, individuals attendance, all major points of discussion, whether unanimity was observed, the committee’s rationale for particular decisions, documenting that the IBSC has fulfilled its review and oversight responsibilities and the time of meeting adjournment.

Regarding Submission of Reports of Incidents, Accidents, or Violations to DBT

What kinds of incidents involving recombinant DNA must be reported to DBT?

Any significant problems, violations of the rDNA safety guidelines, 1990, or any significant research-related accidents and illnesses" to DBT within 30 days. Certain types of accidents must be reported on a more expedited basis. Spills or accidents in BSL2, BSL3 or BSL4 laboratories resulting in an overt exposure must be immediately reported to DBT (as well as the IBSC). Any spill or accident involving recombinant DNA that otherwise leads to personal injury or illness or to a breach of containment must be reported to Biosafety Officer. These kinds of events might include skin punctures with needles containing recombinant DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials occurring outside of a biosafety cabinet. Failure by an investigator to adhere to the containment and biosafety practices articulated in the guidelines must also be reported to DBT. Minor spills of low-risk agents not involving a breach of containment that were properly cleaned and decontaminated generally do not need to be reported. Concerned DBT staff should be consulted if IBSCs, investigators, or other institutional staff are uncertain whether the nature or severity of the incident warrants reporting to DBT.

Does the responsibility to report incidents only apply to IBSCs?

No. In addition to IBSCs, incident reporting is also articulated as a responsibility of institutions, Biosafety Officer and PIs. Institutions have the discretion to determine which party should make these reports, and one report for each incident or set of information is generally sufficient.

What information should incident reports include?

Incident reports should include adequate information so as to make understanding of the nature, cause as well as consequences of the incident, feasible. The report should also include in detail, the measures that the institution took in response to mitigate the problem and to preclude its reoccurrence.

Whether DBT can ask for any additional information and what does it do with the information?

Depending on the severity of the incident, DBT may require the IBSC meeting minutes documenting: approval conditions for the research, review of the incident, policies in place at the time the incident occurred, or any revised policies prepared in response to the incident. Training records for the personnel involved in the incident may also be requested.

DBT reviews incident reports and information to assess whether the institutional response was adequate and sufficient. DBT may ask the institution to take additional measures as appropriate to promote safety and compliance with the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.

Regarding Indian biotechnology regulatory system

 Which activities are regulated in India?

In India, the manufacture, import, use, research and release of GE organisms including GE crops are governed by Rules 1989 of Environmental (Protection) Act 1986in process, product and product thereof level.

 Who regulates biotechnology in India?

Under influence of the Rules 1989 of Environment (Protection) Act, 1986 six competent authorities regulate all activities on biotechnology in India. For details see Committee

What are the policies applicable for regulation of biotechnology in India?

Indian Law and Cartagena Protocol to which India is a signatory is primarily responsible for regulation of activities on GMOs. In addition, several cross sectorial concerns in use of GMOs are governed by different policies and may be obtained from Rules, Act and Guidelines

 On what basis the safety assessment of GMOs are performed in India?

The principles for safety assessment are elaborated in details in Risk Analysis Framework. Different section of food, feed and environmental safety assessment are performed in accordance to regulatory guidelines that Govt. of India published time to time keeping view of international best practices and nation’s need. The relevant documents may be obtained from Rules, Act and Guidelines.

 Can I change the information I inserted in my application after I submitted it?

No. Please ensure that all information is correct before submitting to RCGM.

 How can I check the status of my application?

Check the progress in Application helpdesk.

 Will I be notified if my application is unsuccessful?

Yes. You will be notified to your registered email id. You can also check the same by logging to your account.

 I am a new applicant. How do I prepare an application?

Registration of a new IBSC is mandatory for submission of an application. After successful registration, please follow step by step application submission process that is self-explanatory.

 How long does RCGM secretariat evaluation take?

This is a case by case task. No specific deadline could be prescribed.

 Do I need to pay?

No. Submission of application to RCGM is free and should be made online.