Drug Controller General of India 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.

Month: Categories: Constitution & Law

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Government notifies four commonly used medical devices as drugs

Union Ministry of Health & Family Welfare has notified four medical devices including blood pressure monitors, nebulisers, digital thermometers and glucometers as drugs under Drugs and Cosmetics Act, 1940. The decision will enable the government to ensure their quality and performance. Drug Controller General of India (DCGI) will regulate import, manufacture and sale of these devices from January 2020.

Key Facts

Companies which are engaged in manufacture and import of these equipment will have to seek necessary permission or license from DCGI from January 1, 2020 onward. All these devices will have to be registered under quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by Bureau of Indian Standard (BIS) certification.

With addition of these four new devices, the number of medical devices falling under definition of drugs under this law goes up to 27. Prior to this, only 23 medical devices were monitored for quality by DCGI. The other medical equipments are sold without any quality checks or clinical trials. Drug Technical Advisory Body (DTAB), the country’s highest drug advisory body earlier had approved the proposal to include these four medical devices under purview of Drug law.

Background

Union Health Ministry has proposed expanding list of medical devices in eight new categories under definition of ‘drugs’ to bring them under purview of Drugs and Cosmetics Act, 1940. The eight categories include implantable medical devices, CT scan equipment, MRI equipment, defibrillators, implants, PET equipment, dialysis machines, X-ray machines and bone marrow cell separator.

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.

Month: Categories: Governance & Politics

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