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Last updated on : 11/01/2017
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BIOLOGICALS

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List of Qualified Inspectors for vaccine NEW pdf

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

pdf

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

Marketing Authorization (Form 46 & Form 45)  for the year 2015-2016

 pdf

List of Human Vaccine manufacturers, veterinary vaccine manufacturers, Blood Products Manufacturers, Recombinant  Drug manufacturers and Loan Licenses in India

 

List of additional veterinary drugs approved by CDSCO

 

Permission given for Clinical trial (r-DNA Based Drug Product) Jan2014 to Feb 2015

 CT jan 2014-2015 Feb

List of marketing authorization (Form 45 & Form 46) of Biological Division (Vaccine and r-DNA Products)

 

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 )

Bio Similar Guideline.pdf

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

annexure.doc

Vaccines Registered ( 24 Jul 2012 )

 

Notice for Submission of Biological Application ( 20 Jul 2012 )

Submission of Biological Application

Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products ( 20 Jul 2012 )

Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products.pdf

Office Orders and Circulars

Circulars and Office orders

Office Order Dated 01.09.2010 Cellular biology based Therapeutic Drug Evaluation committee

Office Order Dated 01.09.2010 Cellular biology based Therapeutic Drug Evaluation committee

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

Vaccine manufacturing units in 2015

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

 

 Vaccine manufacturing units in 2016

Procedure for Preparation of Risk Based Plan for Inspection of Vaccine manufacturing Facilities (SOP No. - QA-INS - 008)

SOP No. - QA-INS - 008)

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

Guideline on Good Distribution Practices for Biological Products

Guidelines

Guidelines on Recall and Rapid Alert System for Drugs.

Guidelines

Summary of Product Characteristic (SmPC)

Summary of Product Characteristic (SmPC)

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

Approvals of Stem Cells and Cell Based Products (SCCPs)

Notice Regarding Approvals of Stem Cells and Cell Based Products

Stem Cells and Cell Based Products

List of Status of Marketing Authorization (Form-46- Manufacturing Permission) of Vaccine and Import Permission (Form-45) of Vaccine 2013 to till March 2014

MA update on website 19-03-14

Pharmacovigilance Requirments For Biological Products

Biological Products

Clinical Trial Status of the r-DNA Product for The Year 2013

CT approval status 2013

Clinical Trial Status of the r-DNA Product for The Year2014

CT approval status 2014

Product Recalls

 Product Recalls

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

Application rejected by CDSCO

Status of Import License (Form 10) of Vaccines

Status of Registration Certificate (Form 41) of Vaccines 

Status of Manufacturing Permission (Form46) and Import Permission (Form 45 ) of  Human Vaccine Apr 2014 –March 2015

 

 

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

 

   

 

VACCINE PERMISSION RECALL AND SUSPENSIONS

 

 

 

 


                                                    

 

 

 

 

 

 

 

 

GUIDANCE FOR INDUSTRY

·         Submission of Clinical Trial Application for Evaluating Safety and Efficacy

·         Requirements for permission of Drugs Approval

·         Post approval changes in biological products: Quality safety and Efficacy Documents

·         Preparation of the Quality Information for Drug Submission for Drug Approval: Biotechnological/Biological Products

 

 

 

 

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