# OnCo record india-new-drugs-rules-2019 (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/india-new-drugs-rules-2019/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "india-new-drugs-rules-2019" ;
  schema:name "India New Drugs and Clinical Trials Rules 2019"@en ;
  schema:alternateName "New Drugs and Clinical Trials Rules"@en, "NDCT Rules 2019"@en, "Drugs and Cosmetics Act 1940"@en, "CDSCO approval"@en, "DCGI approval"@en, "local clinical trial waiver"@en, "Subject Expert Committee"@en ;
  schema:description "India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs."@en ;
  schema:url <https://onco.cc/terms/india-new-drugs-rules-2019/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control_Organisation> ;
  schema:citation <https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control_Organisation>, <https://cdsco.gov.in/opencms/opencms/en/Home/> ;
  onco:tag "law", "in" ;
  onco:related <https://onco.cc/terms/regulatory-agencies/>, <https://onco.cc/terms/nexavar-compulsory-licence/>, <https://onco.cc/terms/novartis-glivec-ruling/>, <https://onco.cc/terms/ich-gcp/>, <https://onco.cc/terms/declaration-of-helsinki/>, <https://onco.cc/terms/china-drug-administration-law/>, <https://onco.cc/technologies/global-oncology-access/>, <https://onco.cc/terms/orphan-drug/> ;
  onco:institutions <https://onco.cc/institutions/cdsco/>, <https://onco.cc/institutions/icmr/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-global-access/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .