Clinical trials: stringent draft rules put onus of injuries, death on drugmakers

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Clionical trials, bioavailability, bioequivalence

Mains level: Risk associated with clinical trials of drugs and measures to avert it


News

Draft rules for clinical trials

  1. Pharmaceutical firms conducting clinical trials of drugs in India will no longer be able to escape responsibility in case of injury or death of participants
  2. If the sponsor fails to provide “medical management” to their trials, not only will the trial be canceled, but the company will also be restricted from holding any more trials

Ease of doing trials

  1. For drugs proposed to be manufactured and marketed in India, the permission for trials will be granted within 45 days
  2. The proposed regulatory framework also suggests doing away with clinical trials for drugs that have proved their efficacy in developed markets, in a move to speed up the availability of drugs in India

Other measures

  1. Companies will have to pay compensation if the drug fails to provide the intended therapeutic effect
  2. The sponsor of the trial for bioavailability or bioequivalence (BA/BE) study of a new drug will have to provide free medical management for as long as required
  3. BA/BE studies measure the rate and extent of absorption of drugs in the human body
Health Sector – UHC, National Health Policy, Family Planning, Health Insurance, etc.
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