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 Circulars dated 27 Oct 2021 regarding 2021-Oct-27 901 KB
2 Prior approval for Global Tender Enquiry under rule 161(Vi) of General Financial Rules (GFRs) 2021-Oct-14 1338 KB
3 Office Order regarding the Leaves(s) in respect of the officers of CDSCO 2021-Oct-12 432 KB
4 Office order regarding leaves granted to Officers of CDSCO 2021-Aug-19 930 KB
5 Circular regarding Azadi Ka Amrit Mahotsav 2021-Aug-12 2039 KB
6 Circular regarding attending office during Parliament Session 2021-Aug-03 1880 KB
7 Data for Income Tax Calculation for the Financial Year 2021-22 2021-Aug-02 3990 KB
8 Clarification if change in a) Polymorphs/crystalline/amorphous/solvates/hydrate etc (b) salt and (c) Derivative/analogue/ester etc of already approved active substance to be considered as new drug if main active moiety (Active Pharmaceutical Ingredient-API) is same? 2021-Jul-23 131 KB
9 Circular regarding attending office regularly dated 07.07.2021 2021-Jul-07 602 KB
10 Consolidated Instructions for Global Tender Enquiry (GTE) under Rule 161(iv) of General Financial Rules (GFRs), 2017 2021-Jul-07 3372 KB
11 Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 25 june 2021 2021-Jun-25 920 KB
12 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2021-Apr-13 373 KB
13 RT-PCR Test for COVID-19 of the staff of CDSCO at FDA bhawan 2021-Apr-07 908 KB
14 Declaration of Holiday on 14th April 2021 Dr. B R Ambedkar 2021-Mar-31 334 KB
15 Office Meorandum regarding for pusuing higher qualification 2021-Mar-26 735 KB
16 Office Memorandum regarding submission of immovable property retrun for the year 2020 2021-Jan-05 1811 KB
17 Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2020-Dec-18 983 KB
18 Circulars dated 18 December 2020 2020-Dec-18 520 KB
19 Clarification regarding admissibility of Transport allowance druing Nation-Wide Lockdown due to COVID-19 pandemic 2020-Dec-08 328 KB
20 Clarification regarding reference standards 2020-Dec-04 260 KB
21 Submmission on Leave application in i-connect leave management System 2020-Oct-07 493 KB
22 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
23 Circular regarding Extension of validity of BA/BE Study Centres regarding 2020-Apr-30 344 KB
24 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB
25 Circular regarding exemption of biometric machine attendance till 31.03.2020 2020-Mar-06 857 KB
26 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
27 Circular regarding Disposal of the application of WHO-GMP 2020-Mar-03 617 KB
28 Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ 2020-Feb-17 116 KB
29 Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance 2019-Dec-23 766 KB
30 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
31 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
32 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
33 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
34 Circulard dated 11 September 2019 2019-Sep-11 53 KB
35 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
36 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
37 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
38 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
39 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
40 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
41 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
42 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
43 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
44 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
45 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
46 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
47 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
48 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
49 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
50 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
51 Circular regarding Human Vaccine 2017-Feb-16 50kb
52 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
53 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
54 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
55 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
56 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
57 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
58 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
59 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
60 Pre-Screening work 2015-Dec-30 244kb
61 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
62 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
63 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
64 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
65 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
66 2015-Jun-17 337kb
67 Availability of H1N1 Vaccine 2015-Feb-17 48kb
68 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
69 Circular regarding written confirmation certificate 2014-Oct-22 92kb
70 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
71 Circular 2014-Oct-01 111kb
72 Minutes of Meeting 2014-Sep-08 22kb
73 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
74 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
75 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
76 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
77 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
78 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
79 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
80 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
81 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
82 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
83 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
84 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
85 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
86 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
87 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
88 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
89 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
90 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
91 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
92 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
93 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
94 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
95 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
96 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
97 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
98 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
99 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
100 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
101 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
102 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
103 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
104 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
105 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
106 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
107 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
108 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
109 Circular regarding import of Cosmetic 2011-Nov-16 148kb
110 Cosmetic NOC 2011-Nov-16 144kb
111 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
112 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
113 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
114 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
115 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb