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Clinical Trials in India – Conflict between Public Health Vs Safety

The New Drugs and Clinical Trial Rules, 2019 released by the government seeks to enable faster approvals and to cut down on red tape with respect to the clinical trials in India. It seeks to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by guaranteeing faster accessibility of new drugs to the Indian population. Thus it has the potential to reinvigorate the clinical research industry, which was almost on its death bed a few years ago.

This article answers the following questions in an analytical manner.

  1. What are clinical trials?
  2. What is the need for clinical trials?
  3. How Clinical trials are conducted?
  4. Why is India a popular destination for Clinical trials?
  5. What is the regulatory mechanism for Clinical Trials in India?
  6. What are the key Issues regarding Clinical Trials in India?
  7. What are the measures taken by the government to solve those issues?
  8. What are the features and significances of the new rules of 2019?
  9. What are the suggestions to further improve the scenario?

Abortion in India & Medical Termination of Pregnancy (Amendment) Bill, 2020

The union cabinet recently approved the Medical Termination of Pregnancy (Amendment) Bill, 2020. The move is expected to liberalise the practice of abortion and is long overdue. The move has been called for by many women’s rights groups and even the Supreme Court. The move is also significant as liberal abortion laws have been linked with a decline in unsafe abortions and abortion rates in general.

Foreign Contribution (Regulation) Amendment Bill, 2020

Recently, Parliament has passed the Foreign Contribution (Regulation) Amendment Bill 2020 (FCRA) in its monsoon session which would greatly tighten and restrict the existing Foreign Contribution Regulation Act (FCRA). Though The bill is receiving backslash from the NGOs and the Opposition with regards to the encroachment of NGOs financial administration, it has been passed with a view of increasing transparency in the working of an organization receiving foreign funds.

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