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 attending office during Parliament Session 2021-Aug-03 1880 KB
2 Data for Income Tax Calculation for the Financial Year 2021-22 2021-Aug-02 3990 KB
3 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
4 Circular regarding attending office regularly dated 07.07.2021 2021-Jul-07 602 KB
5 Consolidated Instructions for Global Tender Enquiry (GTE) under Rule 161(iv) of General Financial Rules (GFRs), 2017 2021-Jul-07 3372 KB
6 Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 25 june 2021 2021-Jun-25 920 KB
7 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2021-Apr-13 373 KB
8 RT-PCR Test for COVID-19 of the staff of CDSCO at FDA bhawan 2021-Apr-07 908 KB
9 Declaration of Holiday on 14th April 2021 Dr. B R Ambedkar 2021-Mar-31 334 KB
10 Office Meorandum regarding for pusuing higher qualification 2021-Mar-26 735 KB
11 Office Memorandum regarding submission of immovable property retrun for the year 2020 2021-Jan-05 1811 KB
12 Circulars dated 18 December 2020 2020-Dec-18 520 KB
13 Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2020-Dec-18 983 KB
14 Clarification regarding admissibility of Transport allowance druing Nation-Wide Lockdown due to COVID-19 pandemic 2020-Dec-08 328 KB
15 Clarification regarding reference standards 2020-Dec-04 260 KB
16 Submmission on Leave application in i-connect leave management System 2020-Oct-07 493 KB
17 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
18 Circular regarding Extension of validity of BA/BE Study Centres regarding 2020-Apr-30 344 KB
19 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB
20 Circular regarding exemption of biometric machine attendance till 31.03.2020 2020-Mar-06 857 KB
21 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
22 Circular regarding Disposal of the application of WHO-GMP 2020-Mar-03 617 KB
23 Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ 2020-Feb-17 116 KB
24 Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance 2019-Dec-23 766 KB
25 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
26 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
27 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
28 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
29 Circulard dated 11 September 2019 2019-Sep-11 53 KB
30 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
31 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
32 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
33 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
34 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
35 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
36 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
37 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
38 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
39 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
40 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
41 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
42 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
43 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
44 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
45 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
46 Circular regarding Human Vaccine 2017-Feb-16 50kb
47 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
48 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
49 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
50 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
51 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
52 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
53 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
54 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
55 Pre-Screening work 2015-Dec-30 244kb
56 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
57 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
58 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
59 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
60 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
61 2015-Jun-17 337kb
62 Availability of H1N1 Vaccine 2015-Feb-17 48kb
63 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
64 Circular regarding written confirmation certificate 2014-Oct-22 92kb
65 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
66 Minutes of Meeting 2014-Sep-08 22kb
67 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
68 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
69 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
70 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
71 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
72 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
73 Circular 2014-Jul-17 306kb
74 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
75 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
76 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
77 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
78 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
79 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
80 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
81 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
82 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
83 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
84 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
85 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
86 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
87 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
88 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
89 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
90 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
91 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
92 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
93 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
94 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
95 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
96 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
97 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
98 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
99 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
100 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
101 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
102 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
103 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
104 Circular regarding import of Cosmetic 2011-Nov-16 148kb
105 Cosmetic NOC 2011-Nov-16 144kb
106 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
107 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
108 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
109 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
110 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb