DCGI Current Affairs - 2019

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Drugs and Clinical Trials Rules, 2019

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.

DCGI allows Indian firm to conduct phase 1 trials for Zika vaccine

The Drugs Controller General of India (DCGI) has granted permission to Indian firm to conduct Phase-I clinical trials for a Zika vaccine. It was announced by Union Minister of State (MoS) for Health and Family Welfare Ashwini Kumar Choubey in Lok Sabha.

Zika Virus

Zika Virus is vector borne diseases spread by Aedes egypti mosquito. Infections in pregnant women can cause children to be born with brain deficiencies (microcephaly) and Guillain-Barré syndrome (GBS). Microcephaly is condition where a baby’s head is much smaller than expected.

The World Health Organisation (WHO) had declared Zika virus as Public Health Emergency of International Concern in February 2016, following an outbreak in Brazil and other Latin American countries and its association with birth defects in newborns. It was revoked in November 2016

Background

The Indian firm had submitted an application along with non-clinical (animal) toxicity data, claiming 100% efficacy in animals to the DCGI to conduct Phase-I clinical trials of its Zika vaccine. Based on evaluation of application, in consultation with the Experts Committee, the DCG (I) has granted permission to conduct the Phase-I clinical trial. The Phase I trials ascertain safety, tolerability and physiological action of a compound inside the body.

Drugs Controller General of India (DCGI)

DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.

DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India. It acts as appellate authority in case of any dispute regarding quality of drugs. It prepares and maintains national reference standard. It brings about uniformity in enforcement of Drugs and Cosmetics Act. It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.