Current Affairs 26 March Digest 5: New drugs and clinical trials rules notified, CBSE to include AI, yoga as new subjects
The Union Health Ministry has notified the new Drugs and Clinical Trials Rules, 2019 to promote clinical research in the country. The rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
Story 1- Government notifies new Drugs and Clinical Trials Rules 2019
The Union Health Ministry on March 25, 2019 notified the new Drugs and Clinical Trials Rules, 2019 to promote clinical research in the country. The rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
The key 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.
• The new rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.
• These rules provide for the disposal of clinical trial applications by way of approval or rejection or seeking further information within 30 days for drugs manufactured in India and 90 days for drugs developed outside India.
• In case of no communication from DCGI, the application will be deemed to have been approved.
• 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 Drugs Controller General with the approval of the government.
• The local clinical trial may also be waived if the application is for import of a new drug for which the DCGI had already granted permission to conduct a global clinical trial which is ongoing in India and in the meantime the new drug has been approved for marketing in a country specified by the DCGI and certain other conditions.
• 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.
• Also, the compensation in cases of death and permanent disability or other injury to a trial subject will be decided by the Drug Controller General.
The new rules will ensure patient safety, as they would be enlisted for trials with informed consent.
The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
Story 2- CBSE to introduce AI, yoga as new subjects
The Central Board of Secondary Education (CBSE) has decided to introduce artificial intelligence (AI), early childhood care education and yoga as new subjects in the school curriculum from the upcoming academic session.
The decision was taken at a recent meeting of the board’s governing body.
• CBSE would be introducing artificial intelligence as an optional sixth subject in Class IX from the 2019-2020 session onwards.
• The central board has decided that schools may start AI ‘inspire module’ of 12 hours in Class VIII itself, in order to enhance the multidisciplinary approach in teaching learning and also to sensitise the new generation.
• Further, the board has decided to introduce yoga and early childhood education as elective subjects at the senior secondary level.
• According to the norms, a skill subject, at the secondary level, may be offered as an additional sixth subject along with the existing five compulsory subjects.
In case a student fails in any one of the three elective subjects - science, mathematics and social science, then it will be replaced by the skill subject, which is offered as a sixth subject and the result of Class X will be computed based on the best five subjects.
At the same time, if students desire to reappear in the failed subject, they may appear along with the compartment examination.
At the senior secondary level, the board has advised schools to offer at least one or more skill-based subject as elective subject out of the 42 subjects.
The board will provide necessary support and guidance towards training and capacity building of teachers and other aspects for the successful implementation of skill subjects from time to time.