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 Circular regarding Extension of validity of BA/BE Study Centres regarding 2020-Apr-30 344 KB
2 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB
3 Circular regarding exemption of biometric machine attendance till 31.03.2020 2020-Mar-06 857 KB
4 Circular regarding disposal of the application of WC for active substances exported to the Eu for medicinal products for Human use in accordance with Acrticle 42(2) 2020-Mar-04 664 KB
5 Circular regarding Disposal of the application of WHO-GMP 2020-Mar-03 617 KB
6 Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ 2020-Feb-17 116 KB
7 Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance 2019-Dec-23 766 KB
8 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
9 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
10 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
11 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
12 Circulard dated 11 September 2019 2019-Sep-11 53 KB
13 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
14 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
15 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
16 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
17 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
18 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
19 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
20 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
21 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
22 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
23 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
24 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
25 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
26 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
27 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
28 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
29 Circular regarding Human Vaccine 2017-Feb-16 50kb
30 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
31 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
32 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
33 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
34 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
35 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
36 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
37 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
38 Pre-Screening work 2015-Dec-30 244kb
39 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
40 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
41 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
42 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
43 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
44 2015-Jun-17 337kb
45 Availability of H1N1 Vaccine 2015-Feb-17 48kb
46 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
47 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
48 Circular regarding written confirmation certificate 2014-Oct-22 92kb
49 Minutes of Meeting 2014-Sep-08 22kb
50 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
51 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
52 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
53 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
54 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
55 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
56 Circular 2014-Jul-17 306kb
57 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
58 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
59 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
60 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
61 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
62 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
63 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
64 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
65 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
66 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
67 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
68 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
69 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
70 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
71 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
72 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
73 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
74 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
75 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
76 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
77 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
78 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
79 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
80 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
81 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
82 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
83 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
84 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
85 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
86 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
87 Circular regarding import of Cosmetic 2011-Nov-16 148kb
88 Cosmetic NOC 2011-Nov-16 144kb
89 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
90 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
91 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
92 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
93 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb