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Last Updated on : 13/07/2017
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BIOLOGICALS

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List of marketing authorization (Form 45 & Form 46)  Human Vaccines

 

Clinical Trial NOC granted for Human Vaccines 2013-2017

Pdf

List of Oversight Evaluation along with Protocol Number for the year 2017

Pdf

List of Oversight Evaluations along with Protocol Number for the Year -2016

Pdf

List of licensed Human Vaccine manufacturers in India

Pdf

List of licensed Human Vaccine manufacturing facilities in India

Pdf

Approval Status of Post Approval Changes (Vaccine)

 

Guidance for Industry

Pdf

Procedure / SOPs (Biological Including Human Vaccines and QA)

 

Drugs Alert for Human Vaccines

Pdf

Guideline on Good Distribution Practices for Biological Products

Pdf

Guidelines on Recall and Rapid Alert System for Drugs.

Pdf

Guidance for Industry on Pharmacovigilance Requirments For Biological Products

Pdf

List of Qualified Inspectors for vaccine 

Pdf

Status of Import License (Form 10) of Vaccines

 

Status of Registration Certificate (Form 41) of Vaccines 

 

List of vaccine menufacturing units inspected - Year 2016

Pdf

List of vaccine menufacturing units inspected - Year 2015

Pdf

List of vaccine menufacturing units inspected - Year 2014

Pdf

Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2017

Pdf

Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2016

Pdf

Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2015

Pdf

SOPs for Inspection

 

Detail of  Batch  of  Various  Vaccines  / Antisera received in  CDL Kasauli from 1st Jan2016 till 30 Sept 2016

Pdf

Summary of Product Characteristic (SmPC)

 

List of State Immunization Officers (SEPIOs) for Contact in AEFI cases

Pdf

List of District  Immunization Officers (DIO) for Contact in AEFI cases

Pdf
Export NOC for unapproval drugs of r-DNA products and Vaccines
Pdf

Inspection of sales premises with specific forms on vaccines

Pdf

Import/export Policy for Human Biologicals Samples for Commercial Purpose: amendment Schedule-1 (Import Policy) Schedule-2 (Export Policy) of ITC (HS) 2012

 pdf

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

Pdf

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 )

Pdf

Application Format for Obtaining the Export NOC of Biological Samples of Clinical Trial for Testing ( 20 Jul 2012 )

Doc

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 )

Pdf

Office Order Dated 01.09.2010 Cellular biology based Therapeutic Drug Evaluation committee

Pdf

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

www.ctri.nic.in

Guidance Document for Regulatory Approvals of Stem Cells and Cell Based Products (SCCPs)

Pdf
Notice Regarding Approvals of Stem Cells and Cell Based Products Pdf

Product Recalls

Pdf

Year Wise Details of Application rejected by CDSCO (2012-2014)

Pdf

Guidelines on Similar Biologics Regulatory Requirements for Marketing Authorization in India 2016

 

 

 

 

 

 

 


 


 


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