• Draft guideline on Good Distribution Practices for Biological 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
• Application Format for Obtaining the Export NOC of Biological Samples of Clinical Trial for Testing^NEW!!                                                       
• ^{Vaccines Registered}  
• ^{Status of Marketing Authorization (Form 46-Manufacturing Permission) of Vaccine from 2009 to 31th August 2012}
• ^{Status of Import Permission (Form 45) of Vaccine from 2009 to 31th August 2012.}

• ^{Notice for Submission of Biological Application NEW!!}

• ^{Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products}

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