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 calculation of Income Tax for the Financial Year 2024-25 2024-Sep-30 628 KB
2 Circulars dated 11.09.2024 2024-Sep-11 85 KB
3 Draft Guidelines on Good Distribution Practices for Pharmaceutical Products 2024-Aug-09 3609 KB
4 E-Governance Circular dated 09.08.2024 2024-Aug-09 44 KB
5 Implementation of Schedule M and WHO Technical Report Series 2024-Aug-07 845 KB
6 Income Tax Circular regarding Tax regime and Savings dated 31..07.2024 2024-Jul-31 339 KB
7 Circular regarding Requirement of Toxicity Studies for New Drugs SNDs and FDCs 2024-Jul-29 379 KB
8 Circular regarding The Blood Centre situated in Hospital based or Hospital Campus 2024-May-22 441 KB
9 Appointment of CPIO and ACPIO (Nodal Officer) for the purpose of RTI Matters 2024-May-17 33 KB
10 Circular Regulation of all Class C & D Medical Devices under Licensing regime w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020 2024-May-16 403 KB
11 Circular 16.05.2024 Digital Signature Certificate DSC is being used by CDSCO for signing the various online forms issuing NOCs through various online portals and digitally transmitted documents 2024-May-16 85 KB
12 Circular-Retention of license or certificates under Medical Devices Rules, 2017 2024-May-15 207 KB
13 Circular on Medical Device related Adverse Events reporting by Medical Device Licence Holder under Materiovigilance Programme of India 2024-May-15 106 KB
14 Transfer order of CDSCO 2024 2024-May-14 1463 KB
15 Office Memorandum dated 12.04.2024 Grievance Redressal Officer for redressing the grievances of Persons with Disabilities under Section 23 of RPWD Act 2016 for CDSCO 2024-Apr-12 186 KB
16 Circular Guidelines for risk based inspections of manufacturing facilities 2024-Mar-27 2755 KB
17 Circular regarding submission of PSUR of Medical devices/ IVD through Medical Devices Portal 2024-Mar-19 475 KB
18 Office memorandum regarding to provide information in respect of reporting/reviewing officers for creation workflow and generating APAR 2024-Mar-15 292 KB
19 Circular regarding subbission of online applications of PSURs MA of New Drugs SNDs FDCs Biologicals Veterinary 2024-Feb-26 263 KB
20 Circular Details of Cosmetics lmported by the Applicant Annually as per the Conditions of lmport Registration Number in Form Cos-4A under the Cosmetics Rules 2020 2024-Feb-23 304 KB
21 Corrigendum dated 13 Feb 2024 2024-Feb-13 90 KB
22 Regulatory guidelines for sampling of drugs cosmetics and medical devices by Drugs Inspectors of Central and State Drug Authorities 2024-Feb-09 1016 KB
23 Income Tax savings for FY- 2023-2024 2024-Feb-05 240 KB
24 Office Order regarding senitization programme on PoSH (Prevention of Sexual Harassment) 2024-Jan-16 1033 KB
25 Submission of Information of Immovable Property Return for the year 2023 through e-HRMS 2.0 in respect of all employees of CDSCO(HQ) Zone Sub-Zone Lab and Port Offices 2024-Jan-03 406 KB
26 Submission information of Immovable Property Return for the year 2023 in respect of Group-A & Group-B Gazetted and Group-B & Group-C Non-Gazetted (Ministerial and Non-Ministerial) Officers of CDSCO HQ and Zone Sub-Zone Lab and Ports Offices 2023-Dec-19 787 KB
27 Participation in National Programme for Civil Services Capacity Building (NPCSCB) Mission Karmayogi launched by the Government to promote role based capacity building of Civil Servants with the goal of offering a wide range of learning resources n the IGOT Karmayogi platform to enhance the knowledge skills and attitude of officials 2023-Dec-13 427 KB
28 Hospitality facility in respect of the officers of CDSCO Directorate General of Health Services 2023-Dec-07 388 KB
29 Participation in National Programme for Civil Services Capacity Building (NPCSCB) – Mission Karmayogi launched by the Government to promote role based capacity building of Civil Servants with the goal of offering a wide range of learning resources n the IGOT Karmayogi platform to enhance the knowledge skills and attitude of officials 2023-Nov-22 3069 KB
30 Circular Regarding Implement e-HRMS 2.0 Portal dated 16.11.2023 2023-Nov-16 259 KB
31 Corrigendum to Notice inviting Expression of Interest for development of Digital Drugs Regulatory System 2023-Nov-10 434 KB
32 Circular regarding online applicatioin for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for Human Vaccines and Anti-sera 2023-Nov-10 678 KB
33 Circular for PAC Online Applications for Clinical Trial of Vaccine 2023-Oct-26
34 Reconstitution of Internal Complaint Committee on Sexual Harassment HQ 2023-Oct-18 459 KB
35 Regulation of all Class C & D Medical Devices Under Licensing regime, w.e,f 01.10.2023 as per GSR102E dated 11.02.2020 2023-Oct-12 385 KB
36 Reconstitution of Internal Complaint Committee on Sexual Harassment Mumbai West Zone 2023-Oct-09 178 KB
37 Reconstitution of Internal Complaint Committee on Sexual Harassment 2023-Sep-29 124 KB
38 Hon'ble Supreme Court in Civil Apeal NO. 2482 of 2014 forwarded by Ministry of Health and Family Welfare, an Internal Complaints Committee (ICC) as per provision of PoSH Act has already been formed by CDSCO(HQ) 2023-Sep-20 80808 KB
39 Request for furnishing the details for timely generation of APARs on Sparrow portal through e-mail at apar.cdsco@gmail.com 2023-Sep-20 302 kb
40 Approval of NABL Accredited Private Testing Laboratory for Testing of Cough Syrup to be exported by the Manufacturer/Exporter 2023-Sep-13 2263 KB
41 Calculation of lncome Tax for the Financial Year 2O23-24 2023-Sep-11 392 KB
42 Reconstitution of Internal Complaint Committee on Sexual Harassment CDTL Hyderabad 2023-Sep-04 396 KB
43 Reconstitution of Internal Complaint Committee on Sexual Harassment North Zone 2023-Sep-04 160 KB
44 Reconstitution of Internal Complaint Committee on Sexual Harassment Hyderabad 2023-Sep-04 77 KB
45 Reconstitution of Internal Complaint Committee on Sexual Harassment Chennai 2023-Sep-04 57 KB
46 Reconstitution of Internal Complaint Committee on Sexual Harassment CDTL Mumbai 2023-Sep-04 318 KB
47 Reconstitution of Internal Complaint Committee on Sexual Harassment CDTL Kolkata 2023-Sep-04 248 KB
48 Reconstitution of Internal Complaint Committee on Sexual Harassment CDTL Kasauli 2023-Sep-04 591 KB
49 Reconstitution of Internal Complaint Committee on Sexual Harassment CDTL Chennai 2023-Sep-04 41 KB
50 Azadi Ka Amrit Mahotsav AKAM HarGhar Tiranga Campaign 2023-Aug-11 10055 KB
51 Office Memorandam regarding appoint of CPIO for the purpose of RTI Technical matter 2023-Aug-01 313 KB
52 Online Application for the issuance of Form 11 (Test License) for Veterinary Vaccines /Drugs 2023-Jul-20 286 KB
53 Reconstitution of Internal Complaint Committee on Sexual Harassment dated 18.07.2023 2023-Jul-18 423 KB
54 Transfer Policy for the officers/officials of CDSCO dated 03.07.2023 2023-Jul-03 69 KB
55 Transfer order of DDC(I) dated 14.06.2023 2023-Jun-14 1066 KB
56 Daily Updation of No. of Batches of Cough syrup sample for Export at Different Laboratories for testing 2023-Jun-13 1224 KB
57 Circular for Licensing of Class C D medical devices 2023-Apr-12 310 KB
58 Rotational Tansfer of Officers of CDSCO 2023-Mar-21 247 KB
59 Office Memorandum regarding RTI Act 2005 for RDTL Chandigarh 2023-Mar-16 308 KB
60 Circular regarding submission of Immovable property Return for the year of 2022 2022-Dec-21 630 KB
61 Information Document on Suspension 2022-Nov-04 430 KB
62 Information Document on Prevention of Sexual Harassment of Women at Workplace 2022-Nov-04 478 KB
63 Circular regarding information document on pay fixation issued by Department of personnel and Training 2022-Sep-13 684 KB
64 Circular regarding Information document on increment issued by Department of personnel and Training 2022-Sep-12 624 KB
65 Transfer order for the year 2022-2023-4 2022-Sep-08 10353 KB
66 Har Ghar Tiranga Campaign 2022-Jul-13 812 KB
67 Transfer order for the year 2022-2023-2 2022-Jul-05 4607 KB
68 Office Memorandum regarding Sexual Harassment of Women at work Place constitution of a complaints committee 2022-Jun-17 856 KB
69 Modification of Instructions regarding Booking of Air Tickets on Government account 2022-Jun-16 1453 KB
70 Transfer order for the year 2022-2023 2022-May-04 4429 KB
71 Transfer order for the year 2022-2023-1 2022-Mar-10 1334 KB
72 Circular regarding filling up for the post of Junior Scientific Assistant CDTL Mumbai 2022-Jan-12 5011 KB
73 Circular regarding attendance dated 7 Jan 2022 2022-Jan-07 116 KB
74 Circulars dated 27 Oct 2021 regarding 2021-Oct-27 901 KB
75 Prior approval for Global Tender Enquiry under rule 161(Vi) of General Financial Rules (GFRs) 2021-Oct-14 1338 KB
76 Office Order regarding the Leaves(s) in respect of the officers of CDSCO 2021-Oct-12 432 KB
77 Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2021-Sep-13 316 KB
78 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2021-Sep-13 316 KB
79 Office order regarding leaves granted to Officers of CDSCO 2021-Aug-19 930 KB
80 Circular regarding Azadi Ka Amrit Mahotsav 2021-Aug-12 2039 KB
81 Circular regarding attending office during Parliament Session 2021-Aug-03 1880 KB
82 Data for Income Tax Calculation for the Financial Year 2021-22 2021-Aug-02 3990 KB
83 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
84 Circular regarding attending office regularly dated 07.07.2021 2021-Jul-07 602 KB
85 Consolidated Instructions for Global Tender Enquiry (GTE) under Rule 161(iv) of General Financial Rules (GFRs), 2017 2021-Jul-07 3372 KB
86 Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 25 june 2021 2021-Jun-25 920 KB
87 RT-PCR Test for COVID-19 of the staff of CDSCO at FDA bhawan 2021-Apr-07 908 KB
88 Declaration of Holiday on 14th April 2021 Dr. B R Ambedkar 2021-Mar-31 334 KB
89 Office Meorandum regarding for pusuing higher qualification 2021-Mar-26 735 KB
90 Office Memorandum regarding submission of immovable property retrun for the year 2020 2021-Jan-05 1811 KB
91 Circulars dated 18 December 2020 2020-Dec-18 520 KB
92 Clarification regarding admissibility of Transport allowance druing Nation-Wide Lockdown due to COVID-19 pandemic 2020-Dec-08 328 KB
93 Clarification regarding reference standards 2020-Dec-04 260 KB
94 Submmission on Leave application in i-connect leave management System 2020-Oct-07 493 KB
95 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
96 Circular regarding Extension of validity of BA/BE Study Centres regarding 2020-Apr-30 344 KB
97 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB
98 Circular regarding exemption of biometric machine attendance till 31.03.2020 2020-Mar-06 857 KB
99 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
100 Circular regarding Disposal of the application of WHO-GMP 2020-Mar-03 617 KB
101 Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ 2020-Feb-17 116 KB
102 Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance 2019-Dec-23 766 KB
103 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
104 Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study 2019-Oct-18 668 KB
105 Clarification on stability data requirement in case of CT and BABE study 2019-Oct-18 516 KB
106 Circular regarding procedure for booking of air-tickets on LTC 2019-Sep-30 235 KB
107 Circulard dated 11 September 2019 2019-Sep-11 53 KB
108 Circular regarding WC dated 9.9.2019 2019-Sep-09 755 KB
109 Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site 2019-Aug-30 89 KB
110 NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose 2019-Aug-05 425 KB
111 Disposal of unserviceable/obsolete item of CDSCO 2018-Dec-21 322 KB
112 Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding 2018-Sep-27 735 KB
113 Creation of Veterinary cell at CDSCO(HQ), New Delhi 2018-Jul-03 388KB
114 Gazette Notification of Drug Inspector 2018-Apr-12 1,680lb
115 Additional information regarding Medical Devices Rules 2017 2018-Mar-16 1,230kb
116 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
117 Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission 2017-Aug-18 274kb
118 Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices 2017-Aug-09 562kb
119 Clarification regarding submission of application for post approval changes of human Vaccines 2017-Jul-18 302kb
120 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
121 Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) 2017-May-26 485kb
122 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb
123 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
124 Circular regarding Human Vaccine 2017-Feb-16 50kb
125 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
126 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
127 Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose 2016-Oct-27 309kb
128 Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA 2016-Aug-30 487kb
129 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb
130 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
131 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
132 Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 2016-Jan-01 39kb
133 Pre-Screening work 2015-Dec-30 244kb
134 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
135 Circular to all State/UT's Drugs Controller 2015-Aug-06 46kb
136 Draft Senority List of Assistant Drugs Inspectors CDSCO 2015-Jul-13 752kb
137 Draft Senority List of Drugs Inspectors CDSCO 2015-Jul-01 3,240kb
138 Circular regarding Import of Cosmetics 2015-Jun-29 428kb
139 2015-Jun-17 337kb
140 Availability of H1N1 Vaccine 2015-Feb-17 48kb
141 Exemption of Veterinary products from the purview of DCG(I) Letter 2015-Jan-15 361KB
142 Circular regarding written confirmation certificate 2014-Oct-22 92kb
143 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb
144 Minutes of Meeting 2014-Sep-08 22kb
145 Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country 2014-Sep-05 574kb
146 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
147 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
148 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
149 Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents 2014-Aug-07 359kb
150 Clarification on Form-29 for the Manufacture of Clinical Trial Material 2014-Jul-25 128kb
151 Circular 2014-Jul-17 306kb
152 Use of antibiotcs for Treatment of food producing animals and in animal feed 2014-Jun-06 286kb
153 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
154 Manufacture for sale in the country without due approval from office of DCG(I) 2014-May-26 174kb
155 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
156 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
157 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
158 Approval of the safety and efficacy of FDCs 2014-Mar-28 311kb
159 Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol 2014-Feb-14 138kb
160 Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets 2014-Feb-07 441kb
161 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) 2014-Feb-03 322KB
162 Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad 2014-Jan-28 504KB
163 Grant of Permission to Manufacture and Market FDC of Cefixime 200mg 2013-Nov-11 184KB
164 Grant of Permission to Manufacture and Market Certain FDC 2013-Nov-05 154kb
165 Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg 2013-Oct-17 147KB
166 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
167 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
168 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
169 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
170 Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad 2013-Jun-26 343kb
171 Circular regarding re-labeling/re-printing of revised prices as per NPPA's 2013-Jun-26 499kb
172 Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period 2013-May-23 244kb
173 Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) 2013-Mar-21 288kb
174 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
175 Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. 2013-Jan-10 400kb
176 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
177 General Information on antibiotics and antibiotic resistance. 2012-Dec-10 84kb
178 Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. 2012-Dec-05 384kb
179 Letter on Important safety label changes to cholesterol lowering stating drug. 2012-Nov-06 1,030kb
180 Order regarding “Box Warning” on label/package insert of formulations containing Nimesulide. 2012-Apr-14 280kb
181 Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. 2012-Apr-04 329kb
182 Cosmetic NOC 2011-Nov-16 144kb
183 Circular regarding import of Cosmetic 2011-Nov-16 148kb
184 Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products 2011-Sep-23 116kb
185 Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. 2011-Apr-25 110kb
186 Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW 2011-Feb-03 62kb
187 Letter regarding Prohibition of manufacture and sale of Rosiglitazone. 2010-Nov-16 156kb
188 Letter regarding Suspension of import/manufacture of rosiglitazone in the country. 2010-Oct-07 101kb