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India Drafts New Drugs, Medical Devices and Cosmetics Law to Give CDSCO Enforcement Powers

Officials say the overhaul targets quality lapses spotlighted by recent child deaths.

Overview

  • DCGI Rajeev Raghuvanshi presented the draft Drugs, Medical Devices and Cosmetics Act 2025 at a high-level Health Ministry meeting chaired by J P Nadda.
  • The proposal would replace the Drugs and Cosmetics Act of 1940 and align oversight with international standards.
  • CDSCO would gain statutory authority for strict quality checks, market surveillance and swift action against fake or substandard products.
  • Plans include a fully digitised licensing system, stronger coordination with state regulators and upgrades to testing laboratories.
  • The push follows child deaths in Madhya Pradesh linked to contaminated cough syrup, with WHO advising against Coldrif, Respifresh TR and ReLife, and CDSCO reporting 3.2% substandard or spurious samples in 2023–24 with over 40 units facing action.