{
  "node_id": "india-drugs-cosmetics-act-1940-cdsco",
  "title": "India Drugs and Cosmetics Act 1940 - CDSCO Drug Approval, Schedule M GMP and Clinical Trial Regulation",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2026-05-09",
  "bluf": "India's Drugs and Cosmetics Act 1940 (D&C Act) and the New Drugs and Clinical Trials Rules 2019 (NDCT Rules), administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drug Controller General of India (DCGI)…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "related_frameworks",
      "industry_mapping",
      "eu_ai_act_relevance"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "fda-21-cfr-210-211-current-good-manufacturing-practice"
  ],
  "primary_citations_count": 6,
  "workflow_steps_count": 9,
  "schema_fields_count": 18,
  "citation_preview": [
    {
      "title": "Drugs and Cosmetics Act 1940 (as amended) - Ministry of Health and Family Welfare",
      "url": "https://cdsco.gov.in/",
      "section": "Section 12 (import licence); Section 18(c) (manufacturing licence); Section 23A (drug recall); D&C Rules 1945 Rule 24 and 68-A; Schedule M (GMP); Schedule H and H1 (prescription categories)"
    },
    {
      "title": "New Drugs and Clinical Trials Rules 2019 (NDCT Rules) - CDSCO",
      "url": "https://cdsco.gov.in/",
      "section": "Rule 4 (new drug definition); Rules 18-40 (clinical trial approval); Rule 101 (waiver for ICH-member country approvals); Form CT-04 (clinical trial application); SUGAM portal submission process"
    }
  ]
}