Japan Current Affairs - 2019

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Drugs and Clinical Trials Rules, 2019

The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.

Features of the New Rules

  • The new rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  • The new rules state that in case of no communication from Drug Controller General of India (DCGI), the application will be deemed to have been approved.
  • The new rules will ensure patient safety, as they would be enlisted for trials with informed consent and the ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
  • The new rules mandates that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator or till such time it is established that the injury is not related to the clinical trial.
  • Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General.
  • The rules also waive off the requirement of a local clinical trial if the drug is approved and marketed in countries specified by the DCGI with the approval of government from time to time and certain other conditions.
  • The DCGI has waived off the clinical trial for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US.

The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.

Month: Categories: Constitution & Law

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Global Energy Transition Index 2019

The Global Energy Transition index 2019 report has been released by the World Economic Forum (WEF). The index compares the energy sectors of 115 countries and analyses their readiness for energy transition. The index benchmarks the countries energy systems based on an “energy triangle”, comprised of energy security and access, economic development and growth, environmental sustainability and how well they are set-up to succeed in the future.

The index takes into account six individual indicators: capital and investment, regulation and political commitment, institutions and governance, institutions and innovative business environment, human capital and consumer participation, and energy system structure.

Global Energy Transition Index 2019

  • Sweden has topped the index and is followed by Switzerland and Norway in the top three.
  • China is ranked even lower than India in the 82nd position.
  • The United Kingdom (UK) is ranked seventh and Singapore has been ranked thirteenth, while Germany, Japan and the US have bagged the seventeenth, eighteenth and the twenty-seventh place respectively.
  • Among the Asian Countries, Malaysia is ranked highest at 31st, Sri Lanka is 60th, Bangladesh 90th and Nepal 93rd.
  • The report states that the world’s transition to secure, affordable and sustainable energy has stagnated, with little or no progress achieved in the past five years.
  • The index notes that continued use of coal for power generation in Asia, increasing commodity prices and slower-than-needed improvements in energy intensity have contributed to this year’s stagnation in performance.
  • Even though more people across the globe have access to energy, this has been offset by reduced affordability and almost no progress in making energy systems environmentally sustainable.

Where does India stand?
  • India has moved up two places to rank 76th and the report states that India is amongst the countries with high pollution levels and has a relatively high CO2 intensity in its energy system.
  • The report also acknowledges the significant strides made by India to improve energy access in recent years. India scores well in the area of regulation and political commitment towards energy transition.
  • The report suggests a ground of optimism regarding India despite the current outdated energy system not being ready for the transition because an enabling environment is being built to support the future transition.
  • India has ranked low in terms of system performance (ranking 97 and 86, respectively) and has been ranked considerably higher when it comes to readiness (45 and 61, respectively).
  • India is the second best in the BRICS group of emerging economies, with Brazil being the best at 46th place globally. India is the only BRICS country to improve its rank since last year.

The Index considers both the current state of the countries’ energy system and their structural readiness to adapt to future energy needs.

Month: Categories: Business, Economy & BankingUPSC

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