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Name
FileName
List of marketing authorization (Form 45 & Form 46) Human Vaccines
Clinical Trial NOC granted for Human Vaccines 2013-2017
List of Oversight Evaluation along with Protocol Number for the year 2017
List of Oversight Evaluations along with Protocol Number for the Year -2016
List of licensed Human Vaccine manufacturers in India
Pdf
List of licensed Human Vaccine manufacturing facilities in India
Approval Status of Post Approval Changes (Vaccine)
Guidance for Industry
Procedure / SOPs (Biological Including Human Vaccines and QA)
Drugs Alert for Human VaccinesNEW
Guideline on Good Distribution Practices for Biological Products
Guidelines on Recall and Rapid Alert System for Drugs.
Guidance for Industry on Pharmacovigilance Requirments For Biological Products
List of Qualified Inspectors for vaccine
Status of Import License (Form 10) of Vaccines
Status of Registration Certificate (Form 41) of Vaccines
List of vaccine menufacturing units inspected - Year 2016
List of vaccine menufacturing units inspected - Year 2015
List of vaccine menufacturing units inspected - Year 2014
Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2017
Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2016
Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2015
SOPs for Inspection
Detail of Batch of Various Vaccines / Antisera received in CDL Kasauli from 1st Jan2016 till 30 Sept 2016
Summary of Product Characteristic (SmPC)
List of State Immunization Officers (SEPIOs) for Contact in AEFI cases
List of District Immunization Officers (DIO) for Contact in AEFI cases
Inspection of sales premises with specific forms on vaccines
Import/export Policy for Human Biologicals Samples for Commercial Purpose: amendment Schedule-1 (Import Policy) Schedule-2 (Export Policy) of ITC (HS) 2012
List of veterinary vaccine manufacturers, Blood Products Manufacturers, Recombinant Drug manufacturers and Loan Licenses in India
List of additional veterinary drugs approved by CDSCO
List of marketing authorization (Form 45 & Form 46) r-DNA Products
List of Vaccines PSUR Expert Committee Meeting
As decided in the meeting held on 03/07/2012 at CDSCO HQ, FDA Bhawan, New Delhi, under the chairmanship of Dr. M.K.Bhan, Secretary, Department of Biotechnology Ministry of Science and Technology, the Guideline on "Similar Biologics: Regulatory requirements for Market Authorization in India" will be implemented from 15th Sept, 2012 ( 20 Jul 2012 )
Application Format for Obtaining the Export NOC of Biological Samples of Clinical Trial for Testing ( 20 Jul 2012 )
Notice for Submission of Biological Application ( 20 Jul 2012 )
Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products ( 20 Jul 2012 )
Office Order Dated 01.09.2010 Cellular biology based Therapeutic Drug Evaluation committee
Clinical Trial:- It is Mandatory to register Clinical Trial at ICMR clinical trial registry at www.ctri.nic.in before enrolling first subject in the study
Guidance Document for Regulatory Approvals of Stem Cells and Cell Based Products (SCCPs)
Product Recalls
Year Wise Details of Application rejected by CDSCO (2012-2014)
Guidelines on Similar Biologics Regulatory Requirements for Marketing Authorization in India 2016