The Union Health Ministry notified New Drugs and Clinical Trials Rules, 2019. The aim is to promote clinical research
in India, have predictable, transparent and effective regulations for such trials and also make faster accessibility of
new drugs to the Indian population.”
Highlights of the rules:
Patients will be enlisted for trials with informed consent to ensure safety. The ethics committee will monitor the trials and
decide on the amount of compensation in cases of adverse events.
Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug
In case of injury to a 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.
Disposal of clinical trial applications by way of approval or rejection or seeking further information within 90 days for drugs
developed outside India.
However, in case of an application for conducting a clinical trial of a new drug or investigation new drug as part of discovery,
research and manufacture in India, the application is to be disposed of within 30 days.
In case of no communication from DCGI, the application will be deemed to have been approved, the rules stated.
The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of
the countries to be specified by the DCG with the approval of government from time to time and certain other conditions.
Studying animal sounds for conservation
Aimed at building capacity among Indian researchers to study bio acoustics, the 10-day workshop was conducted at the Indian Institute
of Science Education and Research (IISER), Tirupati. In brief:
Bio acoustics is the study of how humans and other animals use sound and acoustical perception, and how their various acoustical adaptations
reflect their relationships with their habitat and surroundings.The field is still in its nascent stages in India.
Though many Indian researchers are interested in studying bio acoustics, the lack of any training available in the country has been a problem.
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