India’s biotechnology industry has witnessed remarkable innovation and growth, fueled by research and technological developments. The applications of biotechnology pose a number of safety, ethical, and efficacy concerns. Appropriate legislation is required to address these issues. This sector is governed by several important organizations, such as the Drugs Controller General of India (DCGI), the Department of Biotechnology (DBT), and the Genetic Engineering Appraisal Committee (GEAC). The purpose of this study is to analyze biotechnology and regulatory agencies in India.
Department of Biotechnology
- Seeing the immense advantage biotechnology can bring with its help towards human and animal health, agriculture, and the maintenance of the environment, the government formed the National Biotechnology Board (NBTB) in 1982, which is a multi-agency board that has the participation of DST, UGC, ICMR, and CSIR, and was intended to promote activities in the field of biotechnology.
- Later, with the upgrading of the National Board in 1986 to the full-fledged Department of Biotechnology under the Ministry of Science and Technology, biotechnology received the boost it was lacking.
- The Department of Biotechnology seeks to realise its goals by fostering the development of an ecosystem that nurtures excellence and continues to innovate by introducing innovative schemes/programmes and institutional frameworks to:
- Ensure the presence of the necessary numbers of world-class scientists and professionals pertinent to R&D and technology development, together with an adequately trained and skilled technical support staff for industry;
- Provide a fiscal, regulatory and legal framework that encourages risk taking by investors.
- From the setting up of a National Biotechnology Board in 1982, to a full-fledged Department in 1986, the DBT had attained several milestones in its 30-years journey.
Read our detailed article on Biotechnology.
Genetic Engineering Appraisal Committee (GEAC)
- The Ministry of Environment, Forest & Climate Change (MoEFCC) initiated the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells (Hazardous Micro Organisms Rules) in 1989 to safeguard the environment, ecology, and health concerning gene technology and microorganisms.
- These rules, which are commonly referred to as ‘Rules 1989’, address all aspects of research as well as large-scale applications of GMOs and their products, including experimental field trials and seed production.
- The Genetic Engineering Approval Committee (GEAC), formed by MoEFCC, is the main authority to grant approvals as per the Rules of 1989.
The functions of GEAC as prescribed in the Rules 1989 are as follows:
- From an environmental perspective, to evaluate activities involving the large-scale use of hazardous microorganisms and recombinants in research and industrial production.
- To evaluate proposals for the release of genetically engineered organisms and products into the environment, including field trials.
- The committee or any person authorized by it has the authority to take punitive action under the Environment Protection Act.
Read our detailed article on Genetic Engineering.
Biotechnology Regulatory Authority Bill, 2013
The salient features of the Bill are:
- Ever since its establishment, the authority has been named, the Biotechnology Regulatory Authority of India, and it has a team of one chairperson, two full-time members, and two part-time members.
- Managing the research, transport, import, containment, environmental release, manufacturing, and use of organisms and products of modern biotechnology are the functions of the BRAI.
- For this, BRAI will have three units—Risk Assessment Unit (RAU), Product Rulings Committee (PRC), and Environmental Appraisal Panel (EAP).
- The Authority is also empowered to request information, carry out investigations, and issue directions with regard to the safety of products or processes of modern biotechnology.
- If the Authority deems products such as genetically engineered plants and animals, or animals not genetically modified but their clones, that can be applied in agriculture, fisheries, or the food industry, to be products of modern biotechnology in need of aid to be developed, field trials for such organisms or products shall be conducted.
- In order to implement safety assessment procedures and processes, the Authority’s Regulatory divisions have been created. The divisions are (i) Agriculture, Forests and Fisheries, (ii) Human health and veterinary products, and (iii) industrial and environmental applications.
- A State Biotechnology Regulatory Advisory Committee will act as a nodal agency between the state government and the Authority with regard to the regulation of modern biotechnology.
- A Biotechnology Regulatory Appellate Tribunal will hear appeals against the decisions, orders or directions of the Authority.
Appellate Tribunals are the part of the judicial system that is responsible for hearing and reviewing appeals from legal cases that have already been heard in a trial-level or other lower court.
- In Biotechnology, the well-being and advancement of humanity should be the primary focus of the Government and the only basis of all its policies and regulations.
- The monitoring of the research process to ensure safety is an important part of the process and would aid in dealing with any research work that could be dangerous to humanity, so some type of monitoring should be in place.
- District level committees would be in a better position to understand and evaluate the effect on the local population, so the proposal to constitute them should be made.
- The important issues of modern biotechnology need to be addressed unambiguously. The responsibility for any damage caused by the misuse or mishandling of the product of biotechnology needs to be determined unambiguously.
- The Bill can enable India to unlock great opportunities from Biotechnology. The Government cares about Public Welfare so Public objections/suggestions will be heard, which is a good move.
- Nonetheless, as part of the issues that need to be addressed to realize holistic and sustainable development through the use of Biotechnology, the clarity of the bill’s wordings, and research oversight need to be tackled.
National Guidelines for Stem Cell Research
- It mentioned that the commercial banking of all biological materials except for Umbilical Cord Blood (UCB) is banned until further notification.
- It is indeed UCB stem cells, because they are the only ones with verified clinical uses, which banks try to commercially procure and store, as ICMR mentioned reference to stem cells, other than UCB, is not supported by any scientific evidence.
- Therefore, the banking of stem cells extracted from cord tissue, the placenta, tooth extract, adipose tissue, dental pulp, menstrual blood, and olfactory ensheathing cells is not allowed to be done.
- ICMR has given the go-ahead for the use of stem-cell therapies for around 30 different disease categories, mostly cancers.
- For adults, it has permitted stem-cell treatments for 20 types of conditions (diseases), and for children under the age of 18, ICMR has approved these treatments for 13 other types of conditions.
- The rest of the uses of stem cells for treatments should be classified as experimental and tested only through clinical trials following the proper regulatory authorities’ approvals, as the guidelines also state.
- These guidelines are applicable to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and all others associated with both basic and clinical research involving any kind of human stem cells and their derivatives.
- It does not apply to research using non-human stem cells or tissues.
- Intellectual Property Rights (IPRs) associated with the outcome of research on stem cells may have commercial value.
- The option of sharing such IPRs should be indicated in the informed consent form which must be procured before the commencement of the research.
Conclusion
The control of biotechnology in India is aligned with maintaining safety, ethics, and sustainable development. The Department for Biotechnology (DBT) and the Genetic Engineering Appraisal Committee (GEAC) monitor research, product creation, and their subsequent release into the environment. The Bill for the Biotechnology Regulatory Authority, 2013 Draft seeks to expand supervision and nurture innovation in a responsible manner, while the National Guidelines for Stem Cell Research confirm clarity and safety.
Such policies provide assurance to the public, reduce potential dangers, and maintain a suitable balance between creativity and safety. This enables India to make effective use of biotechnology in health, agriculture, industry, and environmental conservation. Further public engagement, clarity, and oversight will improve an already good regulatory framework.
