Biosafety Regulation in India free essay sample

India has placed great importance on the development of a strong scientific sector since its early days as an independent country. As a subset of science and technology, India quickly identified the potential biotechnology had for fostering national development. The Sixth Five Year Plan, which set out the developmental priorities of India for 1980 1985, signalled out biotechnology as a useful tool to meet the health and agriculture needs of the Indian population. Later on, in February 1986, a full fledged Department of Biotechnology was created that was independent and which could independently pilot singularly the multi faceted development in biotechnology in the country. These development raised a lot of Biosafety concerns which led to development of regulatory regime around the world. India was one of the earliest countries to establish a biosafety system and Biosafety rules were introduced even before the Convention of Biosafety was adopted at Rio De Janeiro in 1992. The Ministry of Environment amp; Forests had enacted Environment and Protection Act in 1986 to provide for the protection and improvement of environment and the related matters. We will write a custom essay sample on Biosafety Regulation in India or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page Under this act, the Rules for Manufacture, Use/Import/ Export amp; Storage Of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells, 1989 were notified by MoEF through Notification No. 621 in Official Gazette of Govt. of India on December 5, 1989. India was thought to have a regulatory system which was in place to tackle any problem relating to bio safety but the failure of Bt cotton provoked a serious debate regarding the safety of Agriculture Biotechnology in the country. This was a major back to the government and clearly indicated the lack of regulations on the Biotechnology front. In a couple of years, there were a series of legislations to agnate Biosafety regulations which included mainly National Biosafety Act, 2002. There has been a constant chance in the Biosafety regime but the discussion on restructuring of Biosafety regulations never took a back seat and has been a concern even today after almost a decade. The seminar paper will essentially look into the Biosafety regulation in India, what are the lacunas in it. Part-I provides a very brief introduction to the topic. Part-II will be dealing with the framework of the Biosafety regulation in India. The Author has looked at both the national as well as international front. She has also tried to provide a structure of the entire regulatory framework in III part of the Paper. In Part-IV of the paper, the author will be elucidating the Biosafety regulation. The next part (Part-V) will assess the proposal for the structure change. Part V critiques the present structure which exists. Lastly, the author will conclude with certain recommendations. Part-II Framework of Biosafety Regulation When assessing the Indian legal framework for biotechnology, attention must be paid both to international compromises and internal norms. It is party to many treaties which have an impact on the domestic regulation. These treaties pertain to several public international law regimes, such as international trade law, international environmental law, intellectual property law and international human rights law. The National regime has mainly evolved from the EPA, 1986. International Level India is party to several international treaties that directly impact on biotechnology regulation and management. India is a signatory to an agreement establishing WTO, thus it is bound by its agreements and, among them two of them need to be looked into in particular: 1) the Technical Barriers to Trade Agreement The agreement prescribes the adjustment of national regulations to international standards, something which can be of relevance in case of standards aimed at safeguarding the quality, biosafety and efficacy of biotechnological products; and 2) the TRIPS agreement, It prescribes the patentability of inventions in any field of technology, including microorganisms. Indian Patent Law has also undergone a lot of changes for the need to adapt Indian law to the TRIPS Agreement. t. The Patents (Amendment) Act, 2002 introduced significant changes with regard to the patentability of biotechnological inventions. By specifically allowing for the patentability of microorganisms, the law complied with the requirement of article 27. 3(b) of the TRIPS Agreement. The exclusion of inventions which represent the ‘discovery of any living thing or non-living substance occurring in nature’, consists of ‘traditional knowledge’ or of ‘known properties of traditionally known components’ would lead to the exclusion from patentability of some biotechnology-based inventions. The Patents (Amendment) Ordinance, 2004, later replaced by the Patents (Amendment) Act, 2005 (Act 15 of 2005) introduced the third set of amendments to the 1970 Patent Act. The key modification was the introduction of product patents for fields of technology previously excluded from protection. This Amendment introduced a new provision (section 3(d)) aimed to prevent the grant of patents on ‘minor’ or ‘frivolous’ inventions. But the most important of them all is the CBD. Article 15. recognises the States sovereign rights over their resources and confers on them the â€Å"authority to determine access to genetic resources†. Article 15. 4 subjects access to foreign resources to â€Å"mutually agreed terms†, while article 15. 5 conditions it to the prior informed consent of the Party providing those resources. Article 15 also requires States to adopt measures to share in a fair and equitable way with the Party providing the genetic resources the r esults of research and development and the benefits deriving from their commercialization and other uses. Hence, disclosure of origin is an important element of the CBD access and benefit-sharing regime, and reflects the interrelationship of the CBD regime with the international intellectual property law system. Proving this interrelationship, in India, failure to disclose the source and origin can result in the invalidation of the patent. India is also a party to the 1977 Budapest Treaty on the Deposit of Microorganisms. Signatory States to this Treaty are obliged to recognise the deposit of a strain or sample of a microorganism claimed in a patent as disclosure of the invention. Patent applicants must deposit the material in an international depository authority. Article 10(4)(ii) of the Patents Act, 1970 alludes to the Budapest Treaty, and sets out the conditions governing the deposit of microorganisms. The Microbial Type Culture Collection and Gene Bank is a national facility established in 1986 which, since 2002, has become one of the international depository authorities capable of receiving strains or samples of microorganisms. Under the auspices of the CBD, the Cartagena Protocol was entered into force on September 11, 2003. The Protocol seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. It establishes an Advance Informed Agreement procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of such organisms into their territory. The Protocol most significantly enshrines the precautionary principle. The principle is codified in Article 10. of the Protocol, enabling importing countries to base their decision of banning an import due to the potential risk it poses to human health and environment even in the absence of sufficient scientific information about the kinds and extent of risk. India ratified the Protocol and by ratifying the protocol, India and other developing countries would be able to put in place safeguards to ensure safe transfer, handling and use of LMOs and protect biological diversity from the potential risks posed by LMOs,. Nat ional Level The present institutional framework is the outcome of a relatively unsystematic evolution which has in its origin the 1986 EPA. The EPA contains the legal foundations of the Indian biotechnology system. Sections 6, 8 and 25 are worth noting: Section 6 enables the Indian government to enact rules on procedures, safeguards, prohibitions and restrictions for the handling of hazardous substances; Section 8 subjects the handling of hazardous substances to safeguards and procedures; and Section 25 empowers the government to continue this task and adopt specific rules and guidelines in the field of biosafety. The provision of the Act provided for a legal background for the Rules for Manufacturing, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells. These rules were first notified under the EPA, 1986, including the elaboration of a series of guidance documents published by the DBT in 1990, 1998 and 1999. These rules cover the areas of research, development, large-scale use, and import of biotech organisms and their products. They are accompanied by a â€Å"Schedule†, which is a list that identifies and categorises animal and human pathogens according to their risk profile. The most significant provision is Rule 9, which prohibits deliberate or unintentional release of genetically-engineered organisms or cells covered under the schedule for experimental purposes, except when approved as a special case by the regulatory body concerned. It establishes that unless special permission by the Genetic Engineering Approval Committee is granted, it has prohibited the unintentional and deliberate release of genetically modified organisms and cells covered under the schedule for experimental purposes. It clarifies that â€Å"deliberate release† means intentional transfer of GMO/hazardous, microorganisms or cells to the environment or nature. As per Rule 7, the GEAC must also approve the import, export, transport, manufacture, process, use or sell of any hazardous microorganisms of GMO/substances or cells. Rule 8 requires previous approval of the regulatory body for production and discharge of genetically engineered organisms or cells into the environment. Rules 10 and 11 require permission and approval to be taken for substances, products and foodstuffs and additives that contain genetically-engineered organisms or cells. In what follows, the author describes the evolution of the Indian regulatory regime through three phases. Phase I: Establishment of Three-tier regime (1986-2002) In 1986, the government established the Department of Biotechnology imagining a new sector where India could be a global competitor. The Rules for Manufacturing, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells were notified under the EPA,1986 providing the core basis for regulating GM. The regulatory regime was structured into three tiers: firstly, an Institutional Biosafety Committee, the RCGM and lastly the GEAC. The author has described the function done by each of the committee in the later part of the paper. In 1990, DBT enacted the Recombinant DNA Safety Guidelines supplementing the Biosafety Rules, which have been revised on two occasions (1994, Revised Guidelines for Safety in Biotechnology and 1998, Revised Guidelines for Research in Transgenic Plants). These guidelines are crucial for conducting DNA research activities, experimentation, quality control and importation of products resulting from biotechnology. The biosafety rules have been supplemented by the Biotechnology Safety Guidelines issued by the DBT. These Guidelines have been issued in pursuance of Rule 4(2) of the Biosafety Rules, which require manuals of guidelines to be brought out by the Review Committee on Genetic Manipulation, a component of the biosafety decision-making apparatus that is serviced by the DBT. The guidelines carry detailed analysis and assessment of biosafety levels. The 1990 and 1994 DBT guidelines recommend appropriate practices, equipments and facilities necessary for safeguards in handling GMOs in agriculture and pharmaceutical sectors. These guidelines cover the Ramp;D activities on GMOs, transgenic crops, large-scale production and deliberate release of GMOs, plants, animals and products into the environment, shipment and importation of GMOs for laboratory research. The 1998 DBT guidelines cover areas of recombinant DNA research on plants including the development transgenic plants and their growth in soil for molecular and field evolution. Phase II: Peak period of Critique (2002-2005) The National Biodiversity Act 2002 and the Biological Diversity Rules aimed at implementing the CBD. The National Biotechnology Act states that its goal is the conservation, sustainable utilization and equitable sharing of the benefits that result from genetic resources. In order to achieve its goals, the Act provides for access and benefit sharing mechanisms (including the disclosure of origin of the genetic material) and incorporates conservation principles. The Act also created a new Institution: the National Biodiversity Authority. Other important norms influencing activities in the biotechnology field are the Protection of Plant Varieties and Farmers’ Rights Act 2001 (provides plant breeders with rights over new plant varieties), the Indian Patent Act (particularly important Section 3(d), regarding patentability criteria), Biosecurity Regulations, the Seed Act and Prevention of Food Adulteration Act. During the same time period, while the GEAC deliberated the release of the Bt Cotton varieties, news broke down that Bt cotton was in fact already planted in large area primarily in the state of Gujarat. The government eventually shut down the contraband seeds, the farmers had already managed to backcross it with their own seeds supply. In the wake of lack of legitimacy and credibility faced by the regulatory regime, a task force including some of the nations’ most distinguished scientists was invited to access the situation. The 2004 Report of the Task Force on the Application of Agricultural Biotechnology chaired by Prof. M. S. Swaminathan recommended the establishment of an autonomous, statutory and professionally-led National Biotechnology Regulatory Authority that would have two separate wings – one dealing with food and agricultural biotechnology, and the other with medical and pharmaceutical biotechnology. The Report provided a practical, specific blueprint for regulators to begin the process of renovation. Regulators integrated the recommendations into their ten year vision, the â€Å"National Biotechnology Development Strategy†, in 2005. Phase III: Peak period of transformation Under the regulatory mechanisms, the new authority recommended a competent single National Biotechnology Regulatory Authority be established with separate divisions for agriculture products/transgenic crops, pharmaceuticals/drugs and industrial products; and transgenic food/feed and transgenic animal/aquaculture. The authority is to be governed by an independent administrative structure with common chairman. The inter-ministerial group will evolve suitable proposals for consideration of the government. As regards the regulation of biotechnology, the Strategy states that the NBRA will be established as an independent, autonomous and professionally led body to provide a single window mechanism for biosafety clearance of genetically modified products and processes. DBT has been given the responsibility to set up the NBRA and until such time as the NBRA is fully functional, biotechnology regulation will continue under the existing regulatory framework. The NBRA requires the passing of its new draft bill in the Parliament before the official shift to the new regime can occur, but as of now it is yet to happen and there are no signs of the draft being introduced in House. It was supposed to be introduced in 2012 Budget session but was not owing to some technical issues. Part- III Structure There is no permanent secretariat to monitor the trials of the GMOs. Instead the regulations are implemented by various ad hoc committees. The biosafety rules are Multi-layered in nature, cross cutting between many ministries. The most important committees are: the Institutional Biosafety Committees, responsible for the local implementation of guidelines; the Review Committee on Genetic Manipulations responsible for issuing permits; and the Genetic Engineering Approval Committee responsible for monitoring the large ­scale and commercial use of transgenic materials. These committees have statutory authority. Most of the committee members are from the scientific community and staff of DBT and the Ministry of Environment and Forestry. DBT appoints the members to the committees. The GEAC is supposed to be assisted by the State Biotechnology Coordination Committees and District Level Committees (DLC). However, none of the 26 states have established SBCC and DLC committees, not even in areas where field trials are already taking place. Through the biosafety regulations, Government of India established a three-tier regulatory structure at the central level in New Delhi comprising three committees: 1. Genetic Engineering Appraisal Committe This committee is under Ministry of Environment and Forests. It approves the use of bioengineered products for commercial applications. This Committee is also responsible for approving activities involving large scale use of bioengineered organisms and recombinants in research and industrial production from an environmental safety angle. Imports of bioengineered food/feed or processed product derived thereof also requires the committees approval. The committee consult RCGM on technical matters relating to clearance of bioengineered crops/products. It takes punitive actions on those found violating GM rules under EPA, 1986. 2. Review Committee on Genetic Manipulation The review committee functions under Department of Biotechnology. It develops guidelines for the regulatory process for research and use of bioengineered products from a biosafety angle. It is also responsible for monitoring and reviewing all ongoing GM research projects up to the multi location restricted field trial stage. The Review Committee undertakes visits to trial sites to ensure adequate security measures are taken. It issues clearance for the import of raw materials needed in GM research projects. It scrutinizes the applications made to the GEAC for the import of bioengineered products. Form Monitoring and Evaluation Committee for biotech crop research projects is also done by this committee. It appoints sub-groups when required in topics of interest to the committee. 3. Recombinant DNA Advisory Committee This committee also function under the DBT. It takes note of developments in biotechnology at the national and international level and prepares suitable uidelines for safety in research and applications of GMOs. It also prepares other guidelines as may be required by the GEAC. 4. Monitoring Cum Evaluation Committee This committee is required to undertake field visits at experimental sites, suggest remedial measures to adjust original trial design, assist the RCGM in collecting and analysing field data and collect or cause to collect information on comparative agronomic advantages of transgenic plants. 5. Institutional Biosafety Committee The committee functions at research institution/Organization level. It develops a manual of guidelines for the regulatory process on bioengineered organisms in research, use and application to ensure environmental safety. It authorizes and monitors all ongoing biotech projects to the controlled multi location field stage. It also authorizes imports of bioengineered organisms/transgenic for research purposes. The committee coordinates with district and state level biotechnology committees. 6. State Biotechnology Coordination Committee It functions under the state government where biotech research occurs. It is responsible for periodical reviews the safety and control measures of institutions handling bio-engineered products. It also inspect and take punitive action through the State Pollution Control Boards or the Directorate of Health in case of violations. Nodal agency at the state level to assess damage, if any, due to release of bio-engineered organisms and take on-site control measures. 7. District-Level Committee DLC functions under the district administration where biotech research occurs. It monitors safety regulations in research and production installations. Investigate compliance with rDNA guidelines and report violations to SBCC or GEAC. It is a nodal agency at district level to assess damage, if any, due to release of bio-engineered organisms and take on-site control measures. DBT provides the secretariat for RCGM and MEC, and the MoEF for GEAC. The GoI also issued directives on the setting up a decentralised structure consisting of IBC, SBCCs and DLCs. The biosafety regulations indicate in broad terms the composition and responsibilities of all these six bodies. DBT is represented on all of them except the SBCCs and DLCs. Part III Criticism In the matter of biosafety laws and policies, India was one of the early movers in the developing world. But Indias encounter with Bt cotton – the countrys first genetically engineered crop was highly contested and it had rarely conformed to expectations. In the late 2002, Monsanto was able to get clearance for commercial planting of three varieties of genetically engineered Bt cotton from GEAC under Ministry of Environment and Forest. This started a huge debate for the sole reason that they managed to get the clearance despite the inadequate test of biosafety and viability. If that was not enough, the permission was granted without taking into consideration the fact that RFSTE had filed a case in Supreme Court the 1998 stating that there were numerous irregularities and violations of biosafety laws and guidelines in previous years trials. Even in such a situation permission was granted to Monsanto-Mahyco. There were reports pouring in from different parts of the country of a failed or unsatisfactory harvest of the first commercial transgenic Bt cotton crop. It raised several challenges for policy and governance, specially from the implementation aspect. For example, Environment (Protection) Act, 1986 provides penal provision under Section 15, which include fine and imprisonment the flagrant violation. In the case of Nav Bharat Seed Company, which released an illegal Bt Cotton variety in violation of all prescribed rules and procedures, there is no implementation of the law and they are not being punished till date. This clearly establishes ineffectiveness of the penal/liability provisions under the regime. The penal provisions are also not clear with respect to violation of the two guidelines published by the RCGM (DBT). But undoubtedly, the experience of Gujarat will be recalled in the history of biotechnology as one of the largest trial (with full public knowledge and without any responsible monitoring or evaluation by public agencies at similar scale) of an illegally released technology ever done by people themselves, oblivious of any environmental or other consequence. The iasco which happened more than a decade back where introduction of a genetically modified variety of cotton seed into the Indian agricultural system resulted in large scale crop failure, massive environmental degradation and innumerable farmer suicides shook the entire Indian legal and economic system awoke it to the fact that it was not entirely prepared to embrace what the world was hailing as a panacea to all problems of food scarcity-Genetically Modified Organisms (or GMOs). The controversy has moved from Bt cotton to futuristic GMO Bt Brinjal in the past 10 years. Biosafety regulations still comes under severe criticism even though efforts are put by the government from time to time. The biosafety framework lacks any clear hierarchy between the various bodies and there exists no demarcation between various bodies. The Monsanto-Mahyco fiasco highlighted the anomaly that existed between the understandings of field trials as mere experimental research by the DBT as opposed to deliberate release into the environment by the MoEF. In addition despite provision for authorities such as the SBCC and the DLC at the decentralized level these regulatory bodies have not been set up in most of the states and districts of the country. Industries claim that the absence of a transparent system has also led to an unnecessary doubts in the minds of the public about the implications of GMOs. Ideally, the process used to develop a national biosafety system should be transparent and the level of involvement of the public and/or stakeholder or special interest groups as legislation, regulations, or guidelines are being developed, ought to be considered. Moreover, the DBT deals with companies on a case  ­by  ­case basis. This prevents the industries from pleading their cases collectively. However, this also presents some advantage to the industries. For example, they do not have to take a public stand on any controversies regarding transgenics. Confusion exists with legislations also; At least five existing legislations in force in India have a potential impact on the regulation of GM products in the country. It is essential for the biosafety regulations to recognize them and work in tandem with them and reinforce each other. Among the most prominent problems resulting from this multiplicity is the alleged lack of coordination of the several agencies that play a role in the Indian biotech regulatory framework. These agencies are often placed under the control of different ministries, and operate at very different administrative levels. This makes it difficult to guarantee the consistency of their work and affects those who take part in the approval process of biotechnological products. With the multiplicity of authorities, the tedious and complex approval procedures have also been identified as challenges. The need for simplification and streamlining of procedures has already been acknowledged. In the specific field of agrobiotechnology, a Task Force created in 2003 came to the conclusion that the system needed â€Å"review and rationalization†, as well as a â€Å"reduction in the levels and number of steps required in evaluation and environmental clearance of GM products/transgenics† and â€Å"transparency and professionalism in the regulatory process†. Additionally, the lack of clear guidelines enables industries to have more influence on the guideline formulation and implementation. Some industries claim that the regulatory authorities often come out with whimsical guidelines. When the guidelines need amendments, arbitrary arguments arise. The usual debate between industrial firms and DBT stems from the lack of data to serve as models for local experiments. DBTs knowledge base and scientific base for determining protocol for field testing remains weak. Industrial firms prefer to use data from other countries and suggest that there is no need to reinvent the wheel in experiments involving GMOs. Even the Environmental organizations such as the Gene Campaign and the Research Foundation for Science Technology and Ecology (RESTE) criticize biosafety policy for ignoring specific Indian needs and environmental conditions. For instance, copying the USA legislation, as some critics accuse India of, neglects the dangers of cross ­ fertilization. The danger is much higher in a biodiversity ­ rich country like India compared to a biodiversity ­ poor country like USA. There are criticism that the RCGM does not involve any participation from either research level (universities, research institutes) or user level (industry, consumers, farmers). As a consequence, both the governing bodies and the system of policy making lack transparency. The absence of NGO representation in any of the regulatory committees has been particularly noted. According to Vandana Shiva of RESTE, they have the technical experts in biosafety assessment to merit participation in these committees. In the symposium in New Delhi, representatives from the Ministry of Environment and Fishery openly admitted that they do not have the structure or resources in terms of finance, expertise and facilities to ffectively assess, enforce and monitor biosafety regulations in India. At this stage, Indias experience has been limited to small field trials. Doubts are being raised about the countrys preparedness to meet the potential risks arising from GMOs. For instance, when transgenic crops are commercialized on a large scale, can biosafety regulations be monitored? As of now, the absence of an effective system to monitor imports of agricultural commodities and plan t materials appears to be highly problematic. In India the dangers of GMOs receive a lot of public and media attention. The apprehensions about GMOs are linked, amongst others, with concerns for biodiversity preservation. Cross ­fertilization may result in the loss of indigenous species because of competition in the ecological system. The potential dangers include the displacement or destruction of indigenous or endemic species; and exposure of species to new pathogens. In response to such criticisms, DBT plans to conduct activities to enhance awareness and technical expertise about biosafety. This includes training of scientists, and visits to countries with biosafety policies such as the USA. DBT hopes to improve their data base on biosafety regulations. On the other hand, NGOs such as RESTE are contributing to the information campaign. However, the overall institutional capacity building to effectively enforce and monitor biosafety policies remain inadequate. Part-V Analysis-Proposed Structural Changes The Draft Biotechnology Bill, 2008 is already surrounded by controversies even before it can become a concrete law. There are several lacunas which need to be addressed before giving final shape to this bill. First of all, the bill is â€Å"National Biotechnology Regulatory Bill, 2008† but when declared in policy it clearly states that it aims to regulate modern biotechnology in which also they have included only the genetic engineering whose products or processes it is going to regulate(other methods involved in biotechnology are haploid culturing, sterile plant generation, etc by mutagenesis). This makes the title too broad as compared to the objectives of the bill. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics, organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. There are a series of other problem highlighted by the critique. There is a need to look into fact that we have a regulatory procedure in place already involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. We are first required to highlight the problems which subsists in the current procedure and then attempt to ensure that those lacuna does not exist in the new bill. There are many problems which persists in the current regulatory regime which are not addressed by the Draft Bill, 2008 as well. Taking the case where the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm, the draft bill is also silent. The central government has tried to setup a centralized authority to regulate modern biotechnology as this will enable better mobility of application forms and less problems for the applicant but, it has ignored the role of state governments in whose territory all the applications of modern biotechnology is going to take place. In case if any accident takes place for example, contamination of non-GMO farms due to nearby GMO farms, then how will National Biotechnology Regulatory Authority of India is going to compensate for such losses suffered by state (due to damage of its environment) and the farmer whose farm has suffered. Since, just levying fine on the guilty cannot solve the problem. The bill is supposedly up for public debate. They have ignored many stakeholders from the report who are directly going to get affected by biotechnology products or processes. Farmers are the largest stakeholders in the business of GMOs, yet their representation at the meetings appeared to be minimal and unrepresentative. In addition, the selection and eligibility criterion for selecting the person for a particular function is not mentioned properly. All this reduces the transparency of the proposed Bill. The proposed bill has little substantive content, and no rules and regulations have been circulated or debated. Whatever little substance it has, is entirely industry-centric and not people or farmer-centric. They have not mentioned the rules in detail, which is creating the mystery over the whole policy functioning. For example, they talk about taking measures to regulate the use of genetically engineered organisms and products derived thereof as, or in, food and use in human or animal health, agriculture or other applications in India. However, no description of the procedure is given. There are other provisions in the proposed legislation which are cause for concern. For example, there is provision for establishing a tribunal to try cases related to biotechnology. This means that any legal case pertaining to biotechnology will not be under the purview of the judiciary of the land, instead it will come under the purview of this specially constituted tribunal which is unlikely to dispense these cases with fairness. On the other hand, the law does not lay down any norms for the proper labeling of GM crops or food products derived from them. This regulation is essential because there is no other way to distinguish between GM and unmodified food crops. This regulation is strictly followed in all European countries, and if such a regulation is not followed in India all exports of food products, vegetables, flowers etc. to the European Union from India will be stopped. The major change that the Draft Bill brings is the establishment of the NBSA which is going to be an autonomous body. The proposed authority is top-heavy. It would make the processing of an application far more cumbersome than it is today. It has been said that the proposed authority will be autonomous but the bill does not say how that autonomy would be exercised. Finally, the use of term international standards is very much vague. Since, countries have their own policies, so which country policy are they referring as each country has its own policy. For example, will they follow Switzerland, which has put a moratorium on Genetically Modified Organisms (GMO) until 2012, or the European Union, which requires labeling of GM food, or the U. S. that, for all practical purposes, has no regulation of Genetically Modified Organisms (GMO). These are some of the issues which needs to be addressed and taken account of before passing yet another law in the series of law which already exists but fail to serve the purpose for which they exist. Part Conclusion As a developing country which is agrarian economy, India still has much to gain from the creation of the regulatory framework that can promote biosafe application of GE technology. Thus, the answer to the problems of biosafety regulations in India is neither simple nor straightforward. The debates on the success or failure of GM crops or biotechnology are going to continue but by trying to pass the Draft legislation the government is trying to send the message that no hindrance would be brooked in India on the path of widespread introduction of GM crops in India by the multinational corporations. But it is important to keep in mind that biotechnology-driven agriculture is so capital intensive that small farmers are not able to sustain it, and are driven off from their lands and livelihoods. The goal of the Indian regulatory system is to ensure that GM crops pose no major risk to food safety, environmental safety, and agricultural production, and that there are no adverse economic impacts on farmers. As more genetically engineered plants are being developed for commercial release, concerns have been expressed about their safety. The concept of food safety assurance has assumed importance as with any method of genetic manipulation, there is a possibility of introducing unintended changes along with intended changes, which in turn have an impact on the health and nutritional status of the consumer. The author did an extensive study of the regulatory regime and realised that the establishment of a transparent and credible biosafety regulatory framework is essential for the commercialization of biotechnology products. To sum up in the words of M. S. Swaminathan, â€Å"GM 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. Yet there are many challenges ahead for governments, especially in the areas of safety testing, regulation, industrial policy and food labeling.