What India Drugs and Cosmetics Act 1940 - CDSCO Drug Approval, Schedule M GMP and Clinical Trial Regulation requires
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)…
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Pillar: Pharmaceuticals & Life Sciences · Authority: Central Drugs Standard Control Organisation (CDSCO) / Drug Controller General of India (DCGI), Ministry of Health and Family Welfare · Version: 1.0.0 · Last updated:
Primary source: https://cdsco.gov.in/
SHA-256 integrity: d4d293b3379baf59450f8f6809977d00fdaa5894c05d90c629175d0ddc9906d0
Primary Citations — 6 traced to source
- 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) — Drugs and Cosmetics Act 1940 (as amended) - Ministry of Health and Family Welfare
- 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 — New Drugs and Clinical Trials Rules 2019 (NDCT Rules) - CDSCO
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/india-drugs-cosmetics-act-1940-cdsco.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/india-drugs-cosmetics-act-1940-cdsco.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/india-drugs-cosmetics-act-1940-cdsco
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