Constitution & Law Current Affairs - 2019
Summary of latest bill and acts passed or pending in 2019 in Parliament of India with their salient features and issues for Current Affairs 2019 preparation for various examinations such as UPSC, SSC, State Civil Services, CLAT, Judicial Services etc.
Category Wise PDF Compilations available at This Link
The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
Features of the New Rules
- The new 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 new rules state that in case of no communication from Drug Controller General of India (DCGI), the application will be deemed to have been approved.
- The new rules will ensure patient safety, as they would be enlisted for trials with informed consent and the ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
- The new rules mandates that in case of injury to the 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.
- Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General.
- The rules also waive off the requirement of a local clinical trial if the drug is approved and marketed in countries specified by the DCGI with the approval of government from time to time and certain other conditions.
- The DCGI has waived off the clinical trial for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US.
The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
Tags: Australia • Canada • Clinical trials • DCGI • Drug Controller General of India
The Supreme Court has censured the Uttarakhand High Court for framing a scheme to regularise hundreds of casual workers engaged by the Border Roads Organisation (BRO) under the Ministry of Defence in the construction of roads for Char Dham Yatra pilgrimage.
What was the Issue?
- A case was filed in the Uttarakhand High Court by unions representing the casual workers, including the All India Trade Union Congress against the centre alleging that the Centre had not regularised the labourers though they had worked for BRO for years.
- Disposing of the petition the Uttarakhand High Court itself framed a scheme to regularise the services of the casual labourers and granted them benefits similar to those of regular employees under the labour law.
Observations made by the Supreme Court
- It is the sole prerogative of the government to frame schemes and courts should stay out of governance.
- High Court has failed to see that it is not the function of the courts to frame any scheme but it is the sole prerogative of the government to do it.
- All that the High Court could have done is exercising of its the extraordinary power under Article 226 of the Constitution to direct the government to consider framing an appropriate scheme.
Article 226 empowers the High Court’s to issue, to any person or authority, including the government directions, orders or writs, including writs in the nature of habeas corpus, mandamus, prohibition, quo warranto, certiorari or any of them.