Article · 18 min read

Indian Cosmetics Regulatory Framework Explained: CDSCO Rules, Licensing, and Compliance

PharmaRegulatory.in editorial team · PharmaRegulatory.in Free Intermediate India

Once you know cosmetics fall under CDSCO, this is the step-by-step of actually getting the license: the two routes (manufacturing license Form COS-8, import license Form COS-2), the SUGAM portal filing flow, and the GMP plus ingredient safety data that trip up most first applications. The case studies of approvals delayed by missing safety dossiers or GMP gaps show you where founders lose weeks, so you build the dossier right the first time.

  • Cosmetics are governed by the Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020, with CDSCO as the licensing authority via the online SUGAM portal.
  • You file either a manufacturing license (Form COS-8) or an import license (Form COS-2), backed by formulation and ingredient safety data and GMP compliance.
  • Incomplete ingredient safety data or GMP gaps are the top reasons approvals stall, so prepare the full dossier before you submit.
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The question it answers

  1. I'm selling a physical D2C product (cosmetics, supplements, wellness). What product approvals do I need before I list?

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