ANSWER: Clinical trials
Explanation:
- The committee was regarding the clinical trials.
- Committee has recommended major changes in the guidelines for approval of new drugs, clinical trials and banning of medicines.
- It suggested setting up of a council to oversee the accreditation of institutions, clinical investigators and institute ethics committees for clinical trials in the country.
- It suggested that academic research should be approved by the Institutional Ethics Committees.
- Government has implemented many recommendations from the committees report. It wants to create a system in which research and innovation are not caught in red tape. This is part of the government’s ease of regulation reforms.
- Many students test existing drugs and their study is delayed because of permissions required from the DCGI. Now, their institutions’ ethics committees are authorized to allow them, which should nurture an environment of research in the country.
- The only defence for this decision can be that this is academic, not commercial, research. These are academic exercises. They cannot experiment with new molecules. The element of risk is lower but ethics committees need to be independent. It will depend on the institutions how they use it, which leaves a huge loophole.
- In 2013, the Supreme Court banned trials after a public interest litigation petition brought to light that trials conducted in various parts of the country had violated patient rights as informed consent was not taken, and the patients subjected to clinical trials included newborns, children, pregnant women and mentally challenged persons.
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