November 2, 2025
  • Ministry of Health and Family Welfare (MoHFW) is preparing a proposal to create a centralised system of drug registration under Central Drugs Control Standard Organisation (CDSCO) to keep a close watch on drug quality.
  • This plan comes in backdrop of string of scandals abroad over toxic Indian drugs like cough syrups causing children’s deaths in Gambia and Uzbekistan etc.
  • It involves repurposing CDSCO’s online portal Sugam which maintain quality checks on new drugs.

Drug regulation in India

  • CDSCO, central drug authority under MoHFW, regulates quality, safety, and efficacy of drugs including vaccines under New Drugs and Clinical Trials Rules 2019, and Drugs and Cosmetics Act, 1940.
  • It also regulates market authorization of new drugs and clinical trials standards; supervises drug imports and approves licenses to manufacture.
  • CDSCO along with state drug regulators are responsible for grant of licenses for certain specialized categories of critical Drugs such as blood, vaccines, etc.
  • CDSCO is headed by Drug controller general of India (DCGI). DCGI acts as an appellate authority if there is any dispute with respect to drugs quality.
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