India Current Affairs 2018

Latest India Current Affairs and Current Affairs related to Government policy, polity and administration in India. India’s National Current Affairs updates for 2018.

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Govt contemplating key changes in rules for clinical trials

The Union Government is pondering to bring major changes in the Drugs & Cosmetics Act, 1940, and its Rules, to address the problem of inadequate monitoring of clinical trials in the country. As per the proposed changes:

  • Mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.
  • DGCI will form a committee of experts to analyze the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and to recommend the exact quantum of compensation in case of trial-related injury or deaths within 3 months.
  • Mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.
  • Specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.
  • Modifications in the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned.

What are the existing procedures regarding SAEs?

As per the current procedure, Investigator reports all Serious Adverse Events (SAEs) to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then forwards the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that arrived on the cause of the injury or death, and declares compensation accordingly.

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Gujarat tops in private sector investments across India

As per an analysis titled ‘Composition of Outstanding Investments Across States,’ carried out by Assocham, Gujarat has the biggest share of 12.5% in total outstanding private sector investments ((including both domestic and foreign private sectors) across India as of June 2012. As per the analysis top 4 states are:

  1. Gujarat (12.5%)
  2. Odisha (10.7%)
  3. Maharashtra (8.9%)
  4. Andhra Pradesh (8%)

With a share of over Rs 82.9 lakh crore, the private sector accounts for over 59% of the total outstanding investments across India worth over Rs 140 lakh crore as of June 2012.
Kerala, Himachal Pradesh, Jammu and Kashmir, Uttarakhand and Assam have the smallest share of less than 1%.

Month: Categories: India Current Affairs 2018

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