Anti-COVID-19 drug developed by DRDO gets emergency use nod

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  • The Drugs Controller General of India (DCGI) has granted permission for emergency use of an anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG), developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories, Hyderabad.
  • An adjunct therapy refers to an alternative treatment that is used together with the primary treatment. Its purpose is to assist the primary treatment.

Drug 2-deoxy-D-glucose (2-DG)

  • INMAS-DRDO scientists conducted laboratory experiments of 2-DG with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad
  • They found that this molecule works effectively against the SARS-CoV-2 virus and inhibits viral growth.
  • Based on the results, the DCGI had in May 2020 permitted Phase-II clinical trial of 2-DG in Covid-19 patients.
  • In Phase-II trials (including dose-ranging) conducted from May to October 2020, the drug was found to be safe and showed significant improvement in the patients' recovery.
  • "Phase IIa was conducted in 6 hospitals and Phase IIb (dose-ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients
  • According to DRDO, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints in the efficacy trends.

Drug Controller General of India

The Drug Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO). CDSCO is the central drug authority in India.

  • CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.
  • The body is responsible for approving licenses for certain categories of drugs.
  • It is headquartered in New Delhi.
  • There are six functioning central drug testing laboratories under CDSCO.
  • The DCGI also establishes standards for the manufacturing, sales, import, and distribution of drugs in India.
  • The DCGI also regulates medical and pharmaceutical devices.
  • In case of any dispute with respect to the quality of the drug, the DCGI is the appellate authority.
  • The DCGI prepares and maintains the national reference standard for drugs.
  • He ensures that there is uniformity in the implementation of the Drugs and Cosmetics Act.
  • He is responsible for the training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
  • He is also in charge of the analysis of cosmetics received from the CDSCO as survey samples.
  • The DCGI is also the central licensing authority for medical devices which fall under the Medical Device Rules 2017.

 

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