Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Biologics

About Biological

Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include
  • vaccines
  • blood and blood products for transfusion and/or manufacturing into other products
  • allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
  • human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
  • gene therapies
  • cellular therapies
  • tests to screen potential blood donors for infectious agents such as HIV

Functionalities

1. Human Vaccines (Bacterial ,Viral &Combination Vaccine ) Veterinary Vaccines

  • Grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of vaccines)
  • Approval of Clinical Trial.
  • Grant of Marketing Authorization.
  • Grant of Registration Certificate, Import License and Test Licence in Form 11.
  • Approval of Form 28-D Licensing (Vaccines) under CLAA Scheme.
  • Issuance of Export NOC and Permission under Rule 37.
  • Approval of Post Approval Changes.

2. r-DNA Products

  • Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of r-DNA products).
  • Approval of Clinical Trial.
  • Grant of Marketing Authorization.
  • Grant of Registration Certificate, Import License and Test Licence in Form 11.
  • Approval of Form 28-D Licensing (r-DNA) under CLAA Scheme.
  • Issuance of Export NOC and Permission under Rule 37.
  • Approval of Post Approval Changes.

3.Stem Cells and Cell based Products (Biological)

  • Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Stem cells and Cell based products).
  • Approval of Clinical Trial.
  • Grant of Marketing Authorization.
  • Grant of Registration Certificate, Import License and Test Licence in Form 11.

4.Blood & Blood Products (Biological)

  • Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Blood & Blood Products).
  • Approval of Clinical Trial.
  • Grant of Marketing Authorization.
  • Grant of Registration Certificate, Import License and Test Licence in Form 11.
  • Approval of Form 28-E Licensing (Blood Products) under CLAA Scheme.

5.Veterinary Vaccines

  • Grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Veterinary vaccines)
  • Grant of NOC for field trials.
  • Grant of Marketing Authorization.
  • Grant of Registration Certificate, Import License and Test Licence in Form 11.
  • Approval of Form 28-D Licensing (Veterinary Vaccines) under CLAA Scheme.
  • Issuance of Export NOC and Permission under Rule 37.
  • Approval of Post Approval Changes.

Processes

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Organogram

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Guideline

S.no Title Release Date Download Pdf Pdf Size
1 Biosimilar Guideline 2016 2020-Feb-07 2363 KB
2 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd dated 14-03-2018 2018-Mar-14 905KB
3 17list of vaccine manufacturing units inspected-rotated_2 2018-Feb-09 1353kb
4 1-Revoke order dated 19-08-2015 for the purpose of conducting clinical trial. 2015-Aug-19 54KB
5 Sub Standard Quality of Human Albumin IP/EP Albiomin Solution for infusion 2015-May-19 62KB
6 Action in pursuance to the investigation carried out at facility (M/s Wellness Solution) for administration of Dendritic cells for treatment of Cancer 2014-Aug-28 62KB
7 Action in pursuance to the investigation carried out at M/s Nichi-In Centre for Regenerative Medicine facility for administration of Dendritic Cells for treatment of cancer 2014-Aug-25 94KB
8 Action in pursuance to the investigation_Denvax Clinic 2013-Jul-23 360KB
S.no Title Release Date Download Pdf Pdf Size
1 2016inpect 2018-Feb-23 1156kb
S.no Title Release Date Download Pdf Pdf Size
1 Update on Information on Convalescent Plasma in COVID-19 2021-May-24 33 KB
2 Office Memorandum regarding grant of permission for carrying out overprinting/stickering/stamping of imported drugs in certain cases under the provisions of Rule 104A 2020-Jan-29 540 KB
3 Revised List of Oxytocin Manufacturer 2018-Jun-11 425KB
4 Minutes of the meeting of 14th CBBDTEC 2018-Jun-05 2,853KB
5 Speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 671KB
6 Office Memorandum regarding speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 666KB
7 notification 19-2015-2020 2018-Feb-23 422kb
8 Office Memorandum regarding Sampling of imported insuline formulations at port offices 2018-Feb-07 343KB
9 Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06 270KB
10 Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach 2016-Dec-20 304KB
11 Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated 20.12.2016 2016-Dec-20 290KB
12 Circular: NOC for export of biological products (Vaccine & r-DNA products) under form 29 License to manufacture drugs for purposes of examination, test or analysis 2016-Dec-13 236KB
13 Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis for biological products ( Vaccine & r-DNA Products) 2016-Dec-13 476Kb
14 Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change 2016-Dec-13 269KB
15 Order: Timeline for communication of recommendation to the stakeholders based on the minutes of meeting of various Committees 2016-Dec-13 229KB
16 Presentation for Rabies Vaccine- regarding 2016-Sep-08 218KB
17 Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics 2016 2016-Mar-26 48KB
18 Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016 2016-Mar-23 173KB
19 Notice 2016-Mar-11 108KB
20 Meeting of all Vaccine Manufacutres & Importers on 15th January 2015 2014-Dec-26 513KB
21 Notice Regarding Approvals of Stem Cells and Cell Based Products Dated 18.02.2014 2014-Feb-18 493KB
22 Notice dated 08.07.2013:- Revision of CDSCO Guidance for industry for biological products for applications under post approval changes PAC /1108 ver 1.1 2013-Jul-08 508KB
23 Notice - clarification and requirements related to post approval changes as per CDSCO Guidance for industry for biological products 2013-Jan-18 603KB
S.no Title Release Date Download Pdf Pdf Size
1 List of PUSR meeting17 2018-Feb-09 7kb