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Rachit Raj

Discuss the issues related to clinical trials in India? What are the implications of SupremeCourts latest ruling in this regard. (250 Words)

Indian laws encourage clinical trials to a greater extent but the gravest concern from the vantage pointof Indians and ethicist is the illegal and unethical clinical trials. Post liberalization manypharmaceuticals and MNCs found great deal of interest in developing nations and found India, one oftheir main hubs for untested clinical trials.

In support, Drug and Cosmetic Act, 1940, proved to be an efficient tool for them and the nexus betweenregulators and operators grows indefinitely. The DCGI which controls the clinical trial proved inefficientand granted many untested clinical trials in last two years which led to thousands of deaths and createdhavoc. Hitherto, there is no concern for subject on which clinical trials are done due to which big firmsand the regulators nexus have flourished in profit maximization.

They set their own ethical committees where members are from regulators. High handedness andnexus have governed the clinical trials with disastrous consequences and many untested drugs thatare banned outside are tested easily. Indian council of medical research (ICMR) which looks afterclinical trials had proved to be a failure because they do not have the authority to stop trials. Severalsuch loopholes in the laws have paralyzed our system and proved to be inefficient till strict regulationshave been formulated by Indian Supreme Court.

Recently, Supreme Court intervened as a result of a PIL by health activists and NHRC intervention andfound lack of governance in clinical trials in India and slashed the controlling authorities putting ban onuntested drugs and using Indian as guinea pig. In lieu of this a bill named Drugs and CosmeticRegulation, Bill, 2013 is drafted to amend the act of 1940. Now clinical trials will be monitored by Healthministry. Under new norms it will be mandatory for the companies to compensate the patients who maysuffer death or any severe problem.

Furthermore, there is an urgent need for independent ethical committees which will look after theconducts of regulators. They will decide about the compensation and standard of testing drugs onpatient.Supreme Court further directed the regulators to have video recordings of drugs in trials so thateffective measures are taken while operating patients.

Due to SCs stringent directions many big pharmaceuticals have abstained from further business in thefield of clinical trial and it has been seen as a great loss for Indian health enterprises. Many eminentadvocators of clinical trials see this as a great loss for India and research in the field of health andmedicines. No doubt this will hamper our medicinal and health research which is in dire need ofassistance but effective laws and peoples life are equally important which are the backbone of ourdemocratic principles.

Evergreening is a major obstacle in legal allocation of patents. Comment (100 Words)

Patents are necessary to promote the culture of research and development. In case of

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pharmaceuticals, new discoveries are essential to save people from the new forms of pathogens andexisting diseases like cancer, AIDS, Tuberculosis, etc. Recognising this many countries including Indiastrengthened the patent regime through allocation of product patents and also for complying with theWTO TRIPS regime. But multi-national companies are trying to extend their control over life-savingdrugs by making small changes to the molecules without any benefit to the therapeutic value andapplying for the patents for these drugs. This actually results in evergreening of patents beyond theirstipulated period and denying access to cheap generic drugs. The recent Supreme court verdict in theNovartis case has helped in stopping such a scenario. But India is under pressure from developedcountries of European Union and the United States in acceding to the TRIPS plus protocols whichsupports the evergreening of patents.

What are the specific provisions contained in the environment related international instrumentsregarding Transfer of Technology? Discuss the tussle between developed and developingnations for TOT. (250 Words)

DirectionsFirst question asks specifically about provisions contained in the environment related internationalinstruments regarding TOTSo there is specific need of mentioning themYou didnt answer the first question. Please note downwhat is asked exactly.While answering this we need to know what provisions under which international convention supportsTOT directly or indirectly.I am citing few of them here for reference.UNFCCC Articles 4 and 11Agenda 21: says about Environmentally Sound Technology(EST)Kyoto Protocol: Articles 3, 10, 11 and Clean Development Mechanism(12) that indirectly supportstransfer of technology for emission reduction.Bali Action Plan:Doha Ministerial Declaration 2001TRIPS: Article 7: Objective of Agreement, Articles: 8, 66 and 67 See, it is not possible to mention allarticles but we should remember the most contentious one and those which are there in newsparticularly.While answering the first part we need to mention atleast the broad points mentioned in allinternational frameworks for TOT. Then only the first part would be complete.For second part, specific mention of developed countries abstaining from ratifying few clauses need tobe emphasized. Then there is tussle over Access and Benefit Sharing under Nagoya protocol.Developed countries are trying to include countries like India, China and Brazil to the column ofDeveloped countries so as to put constraint on their demands and utilization of resources underDeveloping countries norms..Hope I am making points lucid and comprehensive to all.

The lack of scientific certainty should not be a reason to postpone cost effective measures toprevent climate change. Critically comment. (200 Words)

To deal with any imminent problem or threat one needs to know the magnitude of the problem and alsoits short & long term impacts. The possible causes which led to the occurrence of any ominoussituation also need to be analysed and debated because it is highly necessary to prevent the sameproblem from occurring again. The climate change issue presents the same difficult situation to theentire world where the possible causes are complex and scientific know how is very less on the issuebut that cannot be taken as an excuse for moving away from sharing responsibilities and takingcollective corrective actions. The results of the delays in taking strong actions by different governmentsaround the world has resulted in the recent disasters around the world, which include tsunamis,earthquakes, floods etc. The changing pattern of monsoons due to change in global climate around the

world has led to disruption in food supplies due to failure of crops in agriculture based economies.

There has been a lack of will on the part of developed nations to share the burden of reducing pollutionglobally under common but differentiated responsibility mechanism, which puts an obligation on theindustrialized nations to help the developing nations to achieve transition to green technologies bybearing the expensive cost of the technology. Thus in the light of the above reasoning it is the need ofthe hour to deal with the problem of climate change first for which may be the possible causes are notknown at the moment but at least the possible solution is clear to everyone.

The Biotechnology Regulatory Authority Bill, 2013, if passed, will adversely affect agriculture,health of humans and animals, and the environment, causing unparalleled harm. Criticallyexamine. (200 Words)

Indias Agriculture is seen as stagnating, thus demands a second green revolution. This demand isseen synonymous to inclusion of Genetically Modified Crops. But many case studies from around theglobe , reveal the health and environmental concerns which follow Bio-Technology. So in order to caterthe demands as well as promoting their safe use, the Government has brought a new BiotechnologyRegulatory Authority Bill, 2013.

The Bill provides for a Bio-Technology Regulatory Authority to regulate the use of Bio-Technology. Acommittee constituting five scientists will be given charge. This is being seen as a major conflict ofinterest. The Ministry of Science and Technology, which promotes use and inclusion of Bio-Technology,will regulate its use also. Plus its functioning will be out of RTI.

The resultant framework will also breach federalism. Agriculture is a state subject and this bill givesUnion the power to regulate and intervene. The 73rd and 74th amendments seek the gradualdevolution of power to local governments (PRIs). Agriculture should be foremost function controlled bythem, but this bill denies this provision of constitution.

Apart from these fundamental and constitutional neglects, the bill does not empower either the HealthMinistry or the Environment Ministry to intervene or monitor the use of Bt crops.

Hence such bill will adversely affect agriculture, health and environment owing to draconian powers itconfers to the body which is the nodal agency to promote Bio-technology itself.9Indias Agriculture isseen as stagnating, thus demands a second green revolution. This demand is seen synonymous toinclusion of Genetically Modified Crops. But many case studies from around the globe , reveal thehealth and environmental concerns which follow Bio-Technology. So in order to cater the demands aswell as promoting their safe use, the Government has brought a new Biotechnology RegulatoryAuthority Bill, 2013.

The Bill provides for a Bio-Technology Regulatory Authority to regulate the use of Bio-Technology. Acommittee constituting five scientists will be given charge. This is being seen as a major conflict ofinterest. The Ministry of Science and Technology, which promotes use and inclusion of Bio-Technology,will regulate its use also. Plus its functioning will be out of RTI.

The resultant framework will also breach federalism. Agriculture is a state subject and this bill givesUnion the power to regulate and intervene. The 73rd and 74th amendments seek the gradualdevolution of power to local governments (PRIs). Agriculture should be foremost function controlled bythem, but this bill denies this provision of constitution.

Apart from these fundamental and constitutional neglects, the bill does not empower either the HealthMinistry or the Environment Ministry to intervene or monitor the use of Bt crops.

Hence such bill will adversely affect agriculture, health and environment owing to draconian powers itconfers to the body which is the nodal agency to promote Bio-technology itself.

Always remember:

Your time on earth is a gift to be used wisely. Talent is a gift given by God and you haveto reciprocate Him by your deeds. Scatter the seeds of hope and great thoughts in theminds of people whose lives you touch daily. Open up new perspectives in them. Be likea rock, power house, light house, or a tower radiating great energy, enthusiasm andhope to all. Let a ray of hope touch them always and be imprinted on their minds.

SOME MAINS ANSWERS Make a practice to write effectively