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 Submmission on Leave application in i-connect leave management System 2020-Oct-07 493 KB
2 circular regarding Special Condition under which the permission for import of drug with residual shelf life less than 60 % is allowed 2020-Jul-10 212 KB
3 Circular regarding Extension of validity of BA/BE Study Centres regarding 2020-Apr-30 344 KB
4 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB
5 Circular regarding exemption of biometric machine attendance till 31.03.2020 2020-Mar-06 857 KB
6 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
7 Circular regarding Disposal of the application of WHO-GMP 2020-Mar-03 617 KB
8 Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ 2020-Feb-17 116 KB
9 Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance 2019-Dec-23 766 KB
10 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
11 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
12 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
13 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
14 Circulard dated 11 September 2019 2019-Sep-11 53 KB
15 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
16 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
17 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
18 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
19 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
20 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
21 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
22 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
23 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
24 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
25 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
26 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
27 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
28 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
29 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
30 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
31 Circular regarding Human Vaccine 2017-Feb-16 50kb
32 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
33 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
34 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
35 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
36 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
37 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
38 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
39 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
40 Pre-Screening work 2015-Dec-30 244kb
41 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
42 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
43 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
44 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
45 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
46 2015-Jun-17 337kb
47 Availability of H1N1 Vaccine 2015-Feb-17 48kb
48 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
49 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
50 Circular regarding written confirmation certificate 2014-Oct-22 92kb
51 Circular 2014-Sep-19 418kb
52 Minutes of Meeting 2014-Sep-08 22kb
53 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
54 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
55 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
56 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
57 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
58 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
59 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
60 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
61 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
62 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
63 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
64 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
65 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
66 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
67 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
68 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
69 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
70 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
71 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
72 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
73 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
74 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
75 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
76 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
77 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
78 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
79 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
80 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
81 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
82 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
83 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
84 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
85 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
86 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
87 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
88 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
89 Circular regarding import of Cosmetic 2011-Nov-16 148kb
90 Cosmetic NOC 2011-Nov-16 144kb
91 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
92 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
93 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
94 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
95 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb