1.For a wider pool (The Hindu)
2.Over The Barrel (The Indian Express)
1.For a wider pool (The Hindu)
Synoptic line: It throws light on the clinical trials and why it must not fall only on the poor and vulnerable. (GS paper III)
- Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Clinical trials involving human subjects have long been a flashpoint between bioethicists and clinical research organisations (CROs) in India.
- There is need of more regulations to ensure truly ethical research.
- Landmark amendments to the Drugs and Cosmetics Act in 2013 led to better protection of vulnerable groups such as illiterate people, Clinical trials are defined in relation to drugs, cosmetics and medical, and involve their systematic study with the objective of determining their safety, efficacy, performance or tolerance.
- Anyone initiating a clinical trial has to register with the Central Drug Authority (CDA) and get approval from an Ethics Committee registered with it. The act created provisions for the medical treatment and compensation in case of injury or death of a person during participation in a clinical trial or due to it.
- Clinical research organisations (CROs) in India, have argued that more rules will stifle the industry, the truth is that ethical science is often better science. The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects, as sometimes CROs recruit them selectively, exploiting financial need and medical ignorance; at other times people over-volunteer for the money.
- Such over-volunteering occurs more frequently in bioequivalence studies, which test the metabolism of generics in healthy subjects. Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial. This results in an incentive to lie about one’s medical history or enrol in multiple trials to maximise one’s income.
- In recent years, several Indian CROs were found by European drug regulators and the World Health Organisation to be fudging bioequivalence data. While such duplicity by a CRO is likely to be found out, volunteer deception, which can impact data greatly, can slip under the radar. Unsafe drugs can make their way into the market as a result, or safe drugs can get rejected.
How can regulators ensure this?
- Firstly the potential solution is a national registry of trial volunteers, which will alert a CRO when someone signs up for two studies simultaneously. But this will need work, because volunteer privacy cannot be compromised. So regulators need to create a system that anonymises each participant’s data.
- Secondly to pay volunteers less, taking away the financial incentive to fudge their participation history. But this measure, in isolation, would reduce trial participation dramatically: an unacceptable side-effect because clinical trials are essential to drug research.
- A third, more sustainable solution is to encourage a wider cross-section of society to participate in research on human subjects.
- Society at large must realise the valuable service that clinical research subjects perform by making drugs safe for the rest of us. It is imperative that this burden not fall completely on the vulnerable groups. Instead, the educated and affluent, who have greater access to the drugs that emerge from clinical research, must grasp the criticality of this research and pull their weight.
Question: Selectiveness in recruiting subjects for clinical trials leads not only to human rights violations but also to bad science. Analyse and also highlight why civil society’s vigilance is vital.
2.Over The Barrel (The Indian Express)
Synoptic line: It throws light on the energy related challenges the government must look in the coming year. (GS paper II)
- The energy conundrum is how to square the circle between the government’s commitment to provide universal access to affordable and reliable energy on one hand, and the imperative to weaken the linkage between economic growth, energy demand and environmental degradation on the other.
- New year day is an opportune occasion for reflection and re-emphasis
- The conundrum can be tackled by establishing an integrated planning process that factor in the implications of decisions concerning fossil fuels on renewables and vice versa, and by developing a policy mindset that enables the fulfilment of short-term objectives without compromising longer-term goals.
- There is short term challenge to correct the imbalances in the energy value chain, to minimise avoidable losses and create a unified energy market. There is currently, for example, surplus generating power capacity but approximately 40 per cent of the country still faces power shortages and has no access to electricity.
- There are leakages across the transmission and distribution chain. The government is having difficulty in implementing the solutions because of competitive Centre-state politics, status quo-driven vested interests and lack of resources.
- There is no easy answer on how they can overcome these obstacles but the “successful” conclusion of GST offers a direction. The government could contemplate something similar for the energy sector. A nationwide system that condenses the existing variances into a simplified, transparent and national regulatory tariff and policy platform.
- The medium-to-long-term challenge is to redesign and restructure the institutions of energy governance to enable and facilitate holistic energy planning and an integrated energy market. As a first step in that direction, the government should consider legislating an omnibus “energy responsibility and security act”. This will raise public awareness on the interconnections between the various components of energy and between energy and the rest of the economy.
- Another issue is that cities are the reasons for surging energy demand and air pollution. The government should devolve the energy administration of cities to an autonomous and constitutionally safeguarded “city energy ombudsman”.
- These ombudsmen should be empowered to tackle issues related to energy efficiency, demand conservation, waste management, urban redesign and transportation and to develop and implement focused, small-scale and distributed solutions.
- Another issue is as India imports more than 80 per cent of its crude oil requirements. The international oil market is, therefore, a matter of strategic and commercial significance. Currently, this market appears to be in no-man’s land.
- Analysts cannot make up their mind, their discussion centres around geopolitics; the sustainability of the OPEC-Russia agreement to cut production; the elasticity of response of US shale to higher prices and demand. Irrespective of the eventual trend, India should hedge against unexpected volatility.
- Six, the growing bonhomie between Russia and China and their increasing engagement with the energy sector in the Middle East present India with an opportunity and a threat. An opportunity to move into the space vacated by the US. Russia and China are looking to fill that space but they do not have the “soft” power that India can exercise.
- Also, the opportunity to resurrect economically compelling projects of mutual interest to all three countries (transnational gas pipelines). A threat in that China will use its economic weight to secure oil on preferential, exclusionary terms to the possible detriment of India’s supply relations.
- Seven, China and Russia’s growing involvement in the Middle East is one further reason to proactively reduce our import dependence on the region. Eight, exploration and production is a long-gestation, capital-intensive and high-risk business; India does not have undiscovered reserves of “low-cost, easy oil”. And oil is a tradable, so we need to ask whether ONGC should remain a predominantly petroleum EP company or broaden its footprint to become a world-class energy company.
- Nine, the government has set itself ambitious targets for renewables and electric vehicles. To give itself a reasonable chance of success, it will have to invest in supportive infrastructure, regulations, skills and innovation.
- A cross-country analysis of 104 technologies across 161 countries by two Dartmouth economists concluded that it takes almost 45 years for countries to fully adopt a new technology. Niti Aayog must carry out a similar detailed study on what will be required to shift from the incumbent fossil fuel energy system to a “clean energy” system.
- Ten, India does not have the luxury to develop now and “clean up” later. Given the long lead times involved in transiting from one energy system to another, it needs a “bridge” fuel. Natural Gas is that fuel. Unfortunately, GAIL has been stymied in its efforts to create a national gas pipeline grid by jurisdictional, land use, financial and bureaucratic hurdles.
Question: Explain the challenges faced by energy sector in India and suggest solutions.