Central Drugs Standard Control Organization

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

Circulars

S.no Title Release Date Download Pdf Pdf Size
1 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
2 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
3 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
4 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
5 Circulard dated 11 September 2019 2019-Sep-11 53 KB
6 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
7 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
8 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
9 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
10 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
11 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
12 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
13 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
14 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
15 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
16 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
17 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
18 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
19 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
20 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
21 Merit List based on the written examination held on 09.04.2017 at NIB Noida for WHO Roational Fellowhip Selection 2017-Apr-10 3,500kb
22 Circular regarding Human Vaccine 2017-Feb-16 50kb
23 Circular regarding first time import/manufacture in the country of Active Pharmaceutical Ingredient API of a drug which has earlier been approved as New Drug in Finished Formulation for import and marketing and /or allowed for import under import registration and Licensing 2016-Dec-30 396kb
24 Circular regarding NOC for export of biological products (Vaccine and r-DNA products) under Form 29 license to manufacture drugs for purposes of examination, test or analysis 2016-Dec-13 237kb
25 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
26 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
27 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
28 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
29 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
30 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
31 Pre-Screening work 2015-Dec-30 244kb
32 Requirement of approval of Review Committee on Generic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like Insulin, Monoclonal antibody, etc 2015-Nov-10 242kb
33 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
34 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
35 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
36 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
37 2015-Jun-17 337kb
38 Availability of H1N1 Vaccine 2015-Feb-17 48kb
39 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
40 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
41 Circular regarding written confirmation certificate 2014-Oct-22 92kb
42 Minutes of Meeting 2014-Sep-08 22kb
43 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
44 Seventh Meeting of the Expert Committee on 29.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) 2014-Aug-29 262kb
45 Sixth Meeting of the Expert Committee on 27.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) 2014-Aug-27 274kb
46 Postponement of the Seventh Expert Committee Meeting from 29.08.2014 to 05.09.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) 2014-Aug-22 376kb
47 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
48 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
49 Circular 2014-Jul-17 306kb
50 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
51 Approval of the safety and efficacy of FDC permitted for manufacture for sale in the country without due approval form office of DCG(I) 2014-Jun-05 167kb
52 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
53 Third Meeting of the Expert Committee on 04.06.2014 to examine the matters related to approval of the safety and efficacy of FDC permitted for manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 170kb
54 Fourth Meeting of the Expert Committee on 11.06.2014 to Examine the Matters Related to Approval of the safety and efficacy of FDC Permitted 2014-May-26 132kb
55 Second Meeting of the Expert Committee on 23.04.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) 2014-Apr-04 668kb
56 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
57 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
58 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
59 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
60 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
61 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
62 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
63 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
64 Approval of the safety and efficacy of Fixed Dose Combinations(FDCs) permitted for manufacture for sale in country without due approval from office of DCG(I) 2013-Sep-02 866kb
65 Furnishing of information in respect of financial support, fees, honorarium, payments in kind etc to be paid to the investigator as per contract entered into by the sponsor with the investigator/ insititution in clinical trials 2013-Aug-30 310kb
66 Approval of the safety and efficacy of FDCs permitted for manufacture for sale in country without due approval form office of DCG(I) 2013-Aug-26 567kb
67 Circular dated 05.07.2013 regarding approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the country without due approval from office of DCG(I) 2013-Jul-05 912kb
68 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
69 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
70 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
71 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
72 Letter Approval of the safety and efficacy of Fixed Dose Combinations Permitted for manufacture for sale in the country without due approval form office of DCG(I) 2013-Jan-15 681kb
73 Letter Cancellation of permission/License in case an applicant/manufacturer fails to launch their product within a period of six month from obtaining the permission/license from CDSCO 2013-Jan-10 365kb
74 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
75 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
76 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
77 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
78 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
79 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
80 Circular regarding import of Cosmetic 2011-Nov-16 148kb
81 Cosmetic NOC 2011-Nov-16 144kb
82 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
83 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
84 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
85 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
86 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb