Japan Current Affairs - 2019

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Larus Labs partners with Global Fund for supply of AIDS drugs

Hyderabad-based pharma Laurus Labs Limited has announced that it has entered into a strategic partnership agreement with Global Fund for a period of 3.5 years. The agreement gives Laurus Labs volume commitments for drugs from the Global Fund for the treatment of HIV/AIDS.

Global Fund to Fight AIDS, Tuberculosis and Malaria

Global Fund to Fight AIDS, Tuberculosis and Malaria was created in 2002 to raise, manage and invest the world’s money to respond to three of the deadliest infectious diseases the world has ever known. The Global Fund was established with an objective to defeat these three diseases.

AIDS, TB and malaria are all preventable and treatable. The tackling of these disease requires the commitment not only of world leaders and decision-makers but also of those working on the ground to help the men, women and children living with these diseases.

The idea of Global fund was discussed in the G8 summit in Okinawa, Japan, in 2000 and the real commitment began to coalesce at the African Union summit in April 2001. The idea continued doing rounds at the United Nations General Assembly Special Session in 2001 and finally endorsed by the G8 at their summit in Genoa, Italy, in July 2001.

The public sector contributions have constituted 95 per cent of all financing raised by the Global Fund and the remaining 5 per cent came from the private sector or other financing initiatives such as Product Red.

Global Fund aims to attract, leverage and invest additional resources to end the epidemics of HIV/AIDS, tuberculosis and malaria to support attainment of the Sustainable Development Goals established by the United Nations.

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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.

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