Monday, July 20, 2009

Central Drugs Standard Control Organization (CDSCO) Initiative: Year 2008-2012

Central Drugs Standard Control Organization (CDSCO) announced its initiatives for the period 2008 - 22 and the following were noteworthy:

Clinical Trial:
  1. Mandatory registration of Clinical trials in centralized clinical trial registry (www.ctri.in) w.e.f 15th June 2009
  2. Registration of CROs, Ethics Committee & Clinical Trial Sites
  3. GCP Training of investigators by accredited body.
  4. Inspection of Clinical Trials
  5. Building of regulatory capacity in respect of First in man (i.e. Phase 0/Microdosing studies)

National Pharmacovigilance Program

All medical colleges, premium medical institutions, corporate hospitals etc to have a Pharmacovigilance center

Transparency & Accountability

  1. Regular posting of approvals on CDSCO website at www.cdsco.nic.in
  2. Regular posting of guideline document for industry/stakeholders.
  3. Display on 2 LCDs of various approvals at FDA Bhawan
  4. Turn around time for various applications such as BE, NOC for export, test licence tc.
  5. Interactive sessions with stake holders.

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