India on Sale - Analysis of Biotechnology Regulatory Authority Bill (BRAI)
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India on Sale - Analysis of Biotechnology Regulatory Authority Bill (BRAI)

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Analysis of Biotechnology Regulatory Authority Bill (BRAI):: The issue is not limited to Bt Brinjal or Bt bacteria alone, the Part I - Schedule I of the proposed legislation also allows the companies ...

Analysis of Biotechnology Regulatory Authority Bill (BRAI):: The issue is not limited to Bt Brinjal or Bt bacteria alone, the Part I - Schedule I of the proposed legislation also allows the companies to make genetically modified animals and even Clones of animals. Despite such serious implications, there is no punishment prescribed if someone violates the provisions of clinical trial as provided in part I. neither is there any safeguard or liability clause provided. Clearly the bill has been written by the Corporate and not the Government. It looks like that our ministers have not even read the bill.

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India on Sale - Analysis of Biotechnology Regulatory Authority Bill (BRAI) India on Sale - Analysis of Biotechnology Regulatory Authority Bill (BRAI) Presentation Transcript

  • Biotechnology Regulatory Authority of India Bill An assessment of how we all Indian’s (and all our future generations) are being put up for SALE By the very Government you & me have elected Hemant Goswami
  • Will BRAI be actually a Regulatory Authority?
    • The layout and provisions of the structure clearly shows that BRAI is not going to be a regulatory authority but an APPROVAL agency .
    • It will help Multinational companies who want to control the food-chain and patent all life forms, so as to help them consolidate their position and have dominance.
    • It intends to make it difficult for common man to have any say or opinion on the issue of what he eats and how he interacts with nature.
    • It’s a total plan to sell out our sovereignty and rights of our farmers and people
    • ……… .. We have seen enough regulatory authorities in India, and we understand how they function and what they do …. But in this case, it will directly affect our and our future generations life and existence.
  • The foundation on which BRAI will stand
    • GEAC in itself was illegal. All approvals it had given since its existence are illegal and without authority.
    • GEAC was brought into existence under the Environment Protection Act (EPA)
    • EPA does not in any way provide for formation of such a body, approving food and Genetically modified organisms. In-fact the Ministry of Environment has no scientist having the requisite qualification to even understand what was happening.
    • All GEAC members met over a cup of tea/coffee every month for a couple of hours. There was hardly any discussion analyzing the study. There were no field investigation/ inspection or visits. They relied on all the data which was supplied by the corporate “MONSANTO” and the company they held, “MAHYCO”
  • Agriculture as in Article 246 of Constitution
    • LIST II of 7 th Schedule [Exclusive State List]
    • Item 14:
    • Agriculture, including agricultural education and research, protection against pests and prevention of plant diseases
  • But What BRAI intends
    • Section 2:- It is hereby declared that it is expedient in the public interest that the Union should take under its control the regulation of organisms, products and processes of modern biotechnology industry.
    • Section 81: Save as otherwise provided, the provisions of this Act shall have effect, notwithstanding anything inconsistent therewith contained in any other law for the time being in force or in any instrument having effect by virtue of any law other than this Act.
    • The ACT will override all laws made by the STATE Government and will gain exclusive control over item specified in list II of VIIth Schedule without actually going in for an amendment
  • Some Provisions of BRAI
    • Section 63: Whoever, without any evidence or scientific record misleads the public about the safety of the organisms and products specified in Part I or Part II or Part III of the Schedule I, shall be punished with imprisonment for a term which shall not be less than six months but which may extend to one year and with fine which may extend to two lakh rupees or with both.
  • No RTI: Everything is a Trade Secret [Food was never a trade secret]
    • Section 3(h): "confidential commercial information" means, - (i) a trade secret or any other information which has a commercial or other value which would be, or could reasonably be expected to be, destroyed or diminished if such information was disclosed; or (ii) such other information which relates to lawful commercial or financial affairs of a person, organisation or undertaking dealing with organisms or products specified under Part I or Part II or Part III of Schedule I which, if disclosed, could adversely affect such person, organisation or undertaking;
    • Section 27: (1) In case an application to be submitted under sub-section (1) of section 24 or sub-section (1) of section 26 require the disclosure of confidential commercial information, such information shall, notwithstanding anything contained in the Right to Information Act, 2005, be retained as confidential by the Authority and not be disclosed to any other party. (2) If the Authority is satisfied that the public interest outweighs the disclosure of confidential commercial information or such disclosure shall not cause harm to any person, it may refuse to retain that the information as confidential commercial information.
    • Section 81: Save as otherwise provided, the provisions of this Act shall have effect, notwithstanding anything inconsistent therewith contained in any other law for the time being in force or in any instrument having effect by virtue of any law other than this Act.
  • Drug/Food Safety Act
    • PROPOSED AMENDMENT: Schedule II
    • DRUG ACT - 2. After section 37, the following section shall be inserted, namely:- " 37A. Nothing contained in this section shall apply to the genetically modified or engineered organisms or any matter or thing connected with it to which are covered under the Biotechnology Regulatory Authority of India Act, 2009.“
    • FOOD SAFETY ACT - 1. In section 13, in sub-section (3), in clause (c), the words "organisms and" shall be omitted.
    • [Section 13 provides for appointment of Scientific Panel on “Genetically Modified Organisms.”]
    • The Power of the MoH to have scientific panel on GMO has been taken away
  • What about Clinical Trials
    • Section 3(g): "clinical trial" means systematic study of any new organism or product specified in Schedule I in human for the purpose of generating data for discovering or verifying its clinical, pharmacological (including pharmacodynamic and pharmacokinetic) biological, or, adverse effects with the objective of determining safety, efficacy or tolerance of that organism or product;
  • Penal Clauses
    • Section 61 and 62 too weak and vague – Nobody can ever be penalized for these violations – too many deliberate loopholes
    • No provision for penalty for concealment of information and for concealment or misrepresentation about safety of GE products
    • No class action provisions
    • Civil procedure suggested though it would be a criminal wrong
    • Bar on action unless a person goes through the cumbersome BRAI procedure
    • Offences not cognizable
    • In a Nut Shell – No body would ever be punished for pushing the human race to death, disease and devastation
  • Composition of the Committee
    • Three member weak body with short term of 3 years and reappointment provision
    • No representation of State Governments
    • No bar on subsequent employment like the Human Rights commission. Too weak (and full of loop holes) provisions for employment in private sector by the members of the commission and the advisory body.
    • Toothless Advisory body and scientific panels
    • Advisory body and scientific bodies can have endless members from PRIVATE sector. In-fact all members can be from Private Companies
  • See Schedule I – Part I
    • SCHEDULE I
    • (See section 18)
    • PARTI
    • 1. Organisms and products mentioned under sub-paragraph (a) to (c) of this Part which shall be regulated by the Authority.
    • (a) Any genetically engineered plant, animal, micro-organism, virus or other animate organism that may have application in agriculture, fisheries (including aquaculture), forestry or food production;
    • (b) Any genetically engineered plant, animal, micro-organism, virus or other animate organism used as food;
    • (c) Any animal clones that may have application in agriculture, fisheries or food production.
  • And Penal Provision for Violating
    • Section 62(5): Whoever, himself or by any other person on his behalf, conducts field trials with organisms or products specified in Part I or Part III of Schedule I, in contravention of section 33 shall be punished with imprisonment for a term which shall not be less than six months but which may extend to one year and with fine which may extend to two lakh rupees or with both.
    • Interesting to Note: Word Clinical trial is missing from the penal provision. No other penal provision for violation of any condition related to Part I of Schedule I. Field trials are also weakly defined in Section 3(n). No body can ever be punished for it.
    • Section 3(n): "Field trials" means a field experiment of growing a genetically engineered organism in the environment under specified terms and conditions which are intended to mitigate the establishment and spread of the organism;
  • What’s the Conclusion
    • India, Indian’s and all our children are up
    • FOR SALE
      • By Corrupt Politicians and Bureaucrats
    • [The Game is to control the world by controlling the entire food chain and getting the chemicals and proteins into our body which will help them consolidate their position further. Imagine, someone will get royalty and commission every time you feel hungry and every bite of food you take. The diseases caused by the GE products would be treated only by the GE medicines they will have. We are standing on door way of permanent slavery and disaster.]
  • Thank You
    • Questions
    • & Comments
    Bt Cotton is not pest-resistant as claimed earlier - MONSANTO