Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Public Notices

S.no Title Release Date Download Pdf Pdf Size
1 DTAB Sub-Committee to examine the proposal to regulate antibiotic and its irrational use date 16 may 2024 2024-May-16 447 KB
2 Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient with gBRCA mutution and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy 2024-May-16 768 KB
3 List of meetings of Expert Committee for examination of vaccine PSUR 2023-24 2024-May-15 7 KB
4 NOC's for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose 2024-Apr-30 454 KB
5 Stakeholder consultation for feedback on SEC meetings dated 22.04.2024 2024-Apr-22 272 KB
6 Manufacturing and marketing of unapproved drug Meropenam 1gm + EDTA for Injection 2024-Apr-16 366 KB
7 Public Notice regarding DCGI meeting with Stakeholders Dated 15.04.2024 for 18 April 2024 Meeting cancellation 2024-Apr-15 143 KB
8 Public Notice regarding Draft CDSCO Guidance for Industry Version 1.2 2024-Apr-10 1184 KB
9 Public Notice regarding DCGI meeting with Stakeholders Dated 08.04.2024 for 16 April 2024 Meeting cancellation 2024-Apr-08 142 KB
10 Implementation and effective use of RTI-MIS Portal (e-Portal) for disposal of all RTI including Physical RTI through RTI-MIS across all the CDSCO offices as per DoPT Order dated 12th August 2013 under RTI Act 2005 2024-Apr-05 111 KB
11 Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory 2024-Apr-03 388 KB
12 Public Notice regarding DCGI meeting with Stakeholders Dated 26.03.2024 for 28 march 2024 Meeting cancellation 2024-Mar-26 142 KB
13 Meeting through WebEx Video-conference of the DTAB-sub Committee on 05.04.2024 at 11.00 a.m. to 6:00 p.m. to Evaluation of 16 FDCs which were earlier considered as irrational in the Expert Committee report of the Prof. Kokate Committee 2024-Mar-22 409 KB
14 Manufacturing and marketing of unapproved drug Meropenem & Disodium EDTA for Injection 2024-Mar-08 383 KB
15 Public Notice regarding DCGI meeting with Stakeholders Dated 06.03.2024 2024-Mar-06 106 KB
16 Draft CDSCO Guidance for Industry: Post Approval Changes in Biological Products 2024-Feb-28 2317 KB
17 Public Notice No. Admin-A012(12)/46/2024-eoffice dated 26.02.2024 2024-Feb-26 63 KB
18 Public Notice dated 15.02.2024 2024-Feb-14 568 KB
19 Online application for Neutral Code for manufacturing of Medical Devices for export purpose 2024-Feb-12 305 KB
20 SEC-IND Office order dated 31.01.2024 2024-Jan-31 182 KB
21 Appointment of First Appellate Authority & CPIO for the purpose of RTI (Technical) matters 2024-Jan-30 362 KB
22 Launching of additional Forms on National Single Window System NSWS Portal 2024-Jan-16 7274 KB
23 Evaluation of certain pre 1988 permitted Fixed Dose Combinations FDCs de novo for manufacture for sale in the country without due approval from Central Licensing Authority 2024-Jan-11 2341 KB
24 PRO Details of Zonal, Sub zonal offices of CDSCO 2024-Jan-09 26 KB
25 Launching of National Single Window System (NSWS) Portal 2024-Jan-01 3669 KB
26 Submission of ppt via E-Vartalap Sugam Portal 2023-Dec-19 298 KB
27 To update package insertPromotional Literature of FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCl IP 5mg drop ml- 2023-Dec-18 372 KB
28 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23 2023-Dec-06 654 KB
29 Advisory to all manufacturer of cough syrup, various critical excipients 2023-Dec-05 418 KB
30 COVID-19 vaccines approved in the country as on 29.11.2023 2023-Nov-29 531 KB
31 Surrender and Cancellation of Cosmetics Registration Certificate No. RC/COS-003067 dated 25.03.2022 (M/s. Abbott Health Care P Ltd) 2023-Nov-28 325 KB
32 Appointment of CPIO and CAPIO for the purpose of RTI for the O/o. Asstt. Drugs Controller (India), CDSCO, Airport, Aircargo, Mumbai 2023-Nov-24 827 KB
33 Corrigendum to Notice inviting Expression of Interest for development of Digital Drugs Regulatory System 2023-Nov-10 434 KB
34 Notice inviting Expression of Interest for development of Digital Drugs Regulatory System 2023-Nov-02 998 KB
35 Updation of classification in IVD medical devices under the provision of MD Rules 2017 2023-Oct-25 1473 KB
36 Clarification on the Circular no. 29/Misc/03/2023-DC(344) dated 12.10.2023 2023-Oct-12 22 KB
37 Notice regaring submission of documents in scan copy 2023-Oct-12 568 KB
38 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
39 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 26.09.2023 2023-Sep-29 654 KB
40 List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 2023-Sep-15 1635 KB
41 Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18/19, Verna Industrial Estate, Salcette, Goa-403722 2023-Aug-31 1049 KB
42 Receipt of Cough Syrup of same batch No.by two different NABL Accredited Government Laboratories Manufactured by the same Manufacturers/Exporters 2023-Jul-28 394 KB
43 FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR QR CODE ON TOP 300 BRANDS 2023-Jul-25 28 KB
44 Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories for testing Request not to submit any sample of cough syrup to IPC Ghaziabad and CDTL Mumbai Lab 2023-Jul-03 273 KB
45 Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories for testing Request not to submit any sample of cough syrup to CDTL Mumbai Lab 2023-Jun-21 1994 KB
46 Implementation of Pre-shipment inspection under testing 2023-Jun-20 4419 KB
47 Daily Updation of No. of Batches of Cough syrup sample for Export at Different Laboratories for testing 2023-Jun-13 1224 KB
48 CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device 2023-May-22 214 KB
49 Cancellation letter of M/s. Crossline Communication 2023-May-02 358 KB
50 Circular for Licensing of Class C D medical devices dated 12.04.2023 2023-Apr-12 310 KB
51 Clarification w.r.t. the new drug status of FDCs (Fixed Dose Combinations) which were scrutinized w.r.t. letter dated 15.1.2013 issued by this office and declared as rational 2023-Apr-05 22146 KB
52 List of Notified Bodies registered with CDSCO under MDR, 2017 2023-Apr-03 830 KB
53 Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier considered as irrational in the Expert Commiteee report of the Prof.Kokate Committee 2023-Mar-31 4207 KB
54 Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 25.01.2023 2023-Jan-25 540 KB
55 PCR Kits approved for testing of Covid-19 as on 25.01.2023 2023-Jan-25 512 KB
56 Inspection/Audits of Pharmacovigilane(PV) system of importers and manufactures of human vaccine 2022-Dec-28 322 KB
57 Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer 2022-Dec-22 412 KB
58 Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022 2022-Oct-21 290 KB
59 Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017 2022-Oct-11 817 KB
60 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 2022-Oct-10 764 KB
61 COVID-19 vaccines approved in the country as on 04.10.2022 2022-Oct-04 96 KB
62 Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020 2022-Sep-30 401 KB
63 Strengthening of Medical Products Safety Surveillance System in North Eastern States of India on October 19 2022 at Government Pharmacy College Sajong Sikkim 2022-Sep-29 1476 KB
64 Report of National List of Essential Medicines 2022 2022-Sep-13 8599 KB
65 National List of Essential Medicines 2022 2022-Sep-13 4579 KB
66 Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures 2022-Sep-09 524 KB
67 List of the Certified Medical Device Testing Laboratory under MDR, 2017 2022-Aug-17 5938 KB
68 Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devcies Rules 2017 2022-Aug-04 852 KB
69 Notice dated July 11 2022 2022-Jul-11 370 KB
70 Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022 2022-Jul-08 1051 KB
71 COVID-19 vaccines approved in the country 2022-Jul-08 300 KB
72 Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 781 KB
73 Clarification regarding import of non-drug / lab kits shipments related to clinical trial / clinical research purposes. 2022-Jul-07 341 KB
74 Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 594 KB
75 Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 702 KB
76 Notice of Advisory for registration of blood centres on E-rakhtkosh 2022-Jun-03 5660 KB
77 Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017 2022-Jun-03 529 KB
78 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed 2022-May-06 78 KB
79 Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit 2022-May-05 208 KB
80 List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software 2022-May-05 103 KB
81 Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined' by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I) 2022-Apr-28 385 KB
82 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 2022-Mar-16 813 KB
83 Revised Schedule for Public hearing at PRO, CDSCO (HQ) 2022-Feb-22 386 KB
84 Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2022 2022-Feb-17 10 KB
85 Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 11.02.2022 2022-Feb-11 510 KB
86 Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority regarding 2022-Jan-06 635 KB
87 Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority 2021-Dec-28 123 KB
88 Vigil on the activities of distribution & sale of suspected spurious Tocilizumab 400 mg/20 ml Injections in India 2021-Dec-28 404 KB
89 Publice Notice dated 10.12.2021 2021-Dec-10 169 KB
90 PCR Kits approved for testing of Covid-19 as on 09.12.2021 2021-Dec-09 479 KB
91 List of approved veterinary vaccines 2021-Dec-02 1138 KB
92 Public notice on draft Recruitment rules for the post of LDC Central Drugs Laboratory Kolkata 2021-Nov-26 412 KB
93 Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with effect from April 1st 2021 2021-Nov-03 246 KB
94 Notice regarding Review of regulatory regime for drug approval 2021-Oct-14 348 KB
95 Module for online processing of applications for registration of BA BE study centres (CT-08) 2021-Oct-01 303 KB
96 Submission of Post Approval Changes Applications through SUGAM Portal 2021-Sep-29 199 KB
97 Organization of Voluntary Blood Donation Day Camp in Nirman Bhawan Premises on 01.10.2021 from 09.00 AM onwards 2021-Sep-29 606 KB
98 Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017 2021-Sep-28 367 KB
99 Registration and Labelling requirements of Medical Devices 2021-Sep-28 366 KB
100 Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017 2021-Sep-27 929 KB
101 Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices 2021-Sep-21 513 KB
102 Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017 2021-Sep-13 804 KB
103 Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017 2021-Sep-13 744 KB
104 Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017 2021-Sep-13 698 KB
105 Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017 2021-Sep-13 334 KB
106 Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017 2021-Sep-13 674 KB
107 Timelines for activities requiring minor and major procedures for cargo clearances at port offices of CDSCO 2021-Sep-10 1097 KB
108 Online Application for issuance of Written Confirmation Certificate WCC regarding 2021-Sep-09 280 KB
109 The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference 2021-Sep-07 665 KB
110 Manufacturing and marketing of FDC of Tolperisone HCL 150mg + Paracetamol IP 500mg tablet 2021-Sep-01 73 KB
111 Procedure to be followed for regularisation of FDCs declared as rational in respect of 249 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I) 2021-Aug-27 140 KB
112 Manufacturing and marketing of certain FDCs as per directions of Hon'ble High Court Maharashtra Nagpur Bench 2021-Aug-27 532 KB
113 Procedure to be follow for reqularisation of 19 FDCs out of 294 FDCs which required further generation of data which were licensed to manufacture and market by SLA withoout prior approval from DCG(I) 2021-Aug-27 172 KB
114 List of Medical devices testing Laboratory for carry out test or evaluation of Medical device on behalf of Manufacturer registered with CDSCO under MDR 2021-Aug-27 3982 KB
115 PCR Kits approved for testing of Covid-19 as on 23.08.2021 2021-Aug-23 459 KB
116 Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017 2021-Aug-23 955 KB
117 Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017 2021-Aug-23 1120 KB
118 Evaluation of Certain Pre-1988 Permitted Fixed Dose Combinations (FDCs) De novo for manufacture for sale in the country without due approval from Central Licensing Authority 2021-Aug-19 661 KB
119 Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017 2021-Aug-09 889 KB
120 Notice and additional set of FAQ Cosmetics division dated 06.08.2021 2021-Aug-06 741 KB
121 Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 606 KB
122 Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 628 KB
123 Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 601 KB
124 Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 618 KB
125 Notice Evaluation of Certain pre 1988 permitted FDC de novo for manufacture of Sale in the Country without due approval from Central Licensing Authority 2021-Jul-26 1216 KB
126 Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017 2021-Jul-26 523 KB
127 Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 256 kB
128 Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 432 KB
129 Inviting Public comments, as steps are being taken by CDSCO to regulate the products like skin patches which are being used as cosmetic 2021-Jul-26 331 KB
130 Classification in IVD medical devices under the provision of MD Rules 2017 2021-Jul-23 45667 KB
131 Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017 2021-Jul-12 200 KB
132 Notice Module for online processing of applications for issuance of Written Confirmation Certificate 2021-Jul-07 375 KB
133 List of medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer with CDSCO under MDR 2017 2021-Jul-07 4025 KB
134 Public notice on draft Recruitment rules for the post of Stenographer Grade-II in CDL, Kolkata 2021-Jun-23 10196 KB
135 Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for rrestriced use by US FDA 2021-Jun-01 298 KB
136 Update on Information on Convalescent Plasma in COVID-19 2021-May-24 33 KB
137 Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings 2021-May-16 735 KB
138 SOP Guidance for import of vaccine by private sector or any person 2021-May-04 7 KB
139 Supply of essential In-Vitro Diagnostic testing reagents / kits for inflammatory markers such as IL-6 (Interleukin 6), D-Dimer and C-reactive protein (CRP) 2021-Apr-29 968 KB
140 Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021 2021-Apr-18 138 KB
141 Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 2021-Apr-15 3354 KB
142 Public notice hearing on irrational FDCs which meeting to be held from 19.04.2021 to 07.05.2021 by DTAB Subcommittee 2021-Apr-12 468 KB
143 Enforcement activities to stop hoarding/back marketing/overcharging of COVID Managment drug Remdesivir 2021-Apr-10 398 KB
144 Monitoring to ensure availability of Remdesivir and prevent its hoarding and black marketing 2021-Apr-07 402 KB
145 NDLS portal Public notice-31-03-2021 2021-Mar-31 175 KB
146 Meeting of DTAB Sub Committee through WebEx (Video Conference) w.e.f. 19.04.2021 to 07.05.2021 for examining the Fixed Dose Combinations (FDCs) considered as irrational by Prof. Kokate Committee and to provide hearing to the stakeholders 2021-Mar-23 10818 KB
147 Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits 2021-Mar-22 586 KB
148 Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 2021-Mar-16 919 KB
149 Notice-Online Application for the issuance of Form 41 (Registration certificate) and Form 10 (Import License) for Veterinary Vaccines 2021-Mar-05 2206 KB
150 Meeting of DTAB Sub Committee for examining the Fixed Dose Combinations (FDCs) considered as irrational by Prof. Kokate Committee and to provide hearing to the stakeholders-regarding. 2021-Mar-05 825 KB
151 Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE's 2021-Feb-25 59 KB
152 Notice regarding FAQ/Guidance Document for grant/retention of registration certificate/license for import or manufacture of cosmetics in India under the Cosmetics Rules 2020 2021-Jan-19 318 KB
153 Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021 2021-Jan-01 182 KB
154 Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 2020-Dec-28 334 KB
155 Submission of notarized/apostilled documents for Import and Registration of cosmetics in view of COVID-19 2020-Dec-18 298 KB
156 Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central Government officicals regarding 2020-Oct-12 1038 KB
157 Notice regarding List of medical devices testing Laboratory 2020-Oct-09 2927 KB
158 Notice for Vaccine Guidelines dated 21 Sept 2020 2020-Sep-21 392 KB
159 Regulatory guidelines for development of Vaccine 21.09.2020 2020-Sep-21 801 KB
160 Notice regarding documents required for the Import 2020-Sep-17 516 KB
161 Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I) 2020-Sep-08 4491 KB
162 Notice regarding classification of non notified medical devices 2020-Sep-03 613 KB
163 Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices 2020-Sep-03 301 KB
164 Notice regarding classification of non notified medical devices1 2020-Sep-03 12557 KB
165 Submission of notarized/apostilled documents for import of medical device and in-vitro diagnostic kits in view of Covid-19 2020-Aug-31 343 KB
166 Requirement of fees for change in address of authorized agent without change in constitution as post approval Change under MDR 2017 2020-Aug-31 362 KB
167 Notice regarding Approved panel of experts for the Subject Expert Committees 2020-Aug-28 20279 KB
168 Submission of notarized/ apostilled documents for import and Registration of cosmetics in view of COVID-19 2020-Aug-19 279 KB
169 Approval of Favipiravir Tablets to Glenmark Pharmaceuticals and Remdesivir Injection to Cipla Ltd, Hetero Drugs and Mylan Labs 2020-Jul-02 410 KB
170 Information on convalescent plasma in Covid 19 2020-Jul-01 123 KB
171 Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose 2020-Jun-19 368 KB
172 Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19 2020-Jun-09 599 KB
173 GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS 2020-Jun-04 2174 KB
174 Radpid Response Regulatory Framework for COVID-19 vaccine development 2020-May-26 9005 KB
175 Advisory Notice regarding voluntary registration of personal protection equipment coveralls at CDSCO and ites testing at Labs recognised by Ministry of Textiles 2020-May-22 880 KB
176 ICMR Convalescent plasma _protocol_v1.5.pdf 2020-May-11 276 KB
177 Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP) 2020-May-01 265 KB
178 Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April 2020-Apr-27 746 KB
179 Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19 2020-Apr-23 307 KB
180 amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent plasma_protocol_v1.4 2020-Apr-22 214 KB
181 Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of COVID 19 2020-Apr-20 313 KB
182 Clinical trial of convalescent plasma in COVID-19 Patients 2020-Apr-17 634 KB
183 Advisory issued by Ministry of Health and Family Welfare, Govt. of India to spread awareness to general public for the use of COVID-19 medicines 2020-Apr-16 2833 KB
184 Office Memorandum on COVID-19 2020-Apr-16 1786 KB
185 Submmission of notarized/apostilled documents for import and Registration of drugs in view of COVID 19 2020-Apr-15 284 KB
186 Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19 2020-Apr-07 424 KB
187 Public notice alerting about unlicensed kit of Bione for corona testing displayed on their website for sale 2020-Apr-05 235 KB
188 Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 2020-Mar-30 602 KB
189 Release of consignments of Vaccine and critical IVDs-certain instructions issued 2020-Mar-25 311 KB
190 Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes 2020-Mar-24 33 KB
191 Notice regarding COVID-19 outbreak 2020-Mar-23 833 KB
192 OM on Rapid Response Regulatory Framework for COVID-19 2020-Mar-20 611 KB
193 Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19 2020-Mar-19 453 KB
194 Notice regarding Measures to contain spread of COVID-19 2020-Mar-19 313 KB
195 Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19 2020-Mar-19 441 KB
196 Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940 and Rules made thereunder and expediting the licensing of manufacturers of such products 2020-Mar-18 369 KB
197 Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940 and Rules made thereunder and expediting the licensing of manufacturers of such products dated 17 March 2020 2020-Mar-17 273 KB
198 Testing of all categories of new drugs for their approval 2020-Mar-13 47 KB
199 Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. 2020-Mar-13 43 KB
200 Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. 2020-Mar-13 52 KB
201 Requirement of CMC documents for approval of additional indication of an already drug product 2020-Mar-13 45 KB
202 Notice regarding Clarification for utilization of same fees in case of inadvertent submission of online applications along with fees meant for a specific divison submitted to other division of CDSCO HQ 2020-Mar-11 431 KB
203 Submission and processing of application for Registration Certificate and import License in parallel with New Drug application 2020-Feb-26 333 KB
204 Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) 2020-Feb-24 849 KB
205 Notice regarding Approval of FDCs Containing new drugs 2020-Feb-21 312 KB
206 Notice regarding Pre-submission meeting 2020-Feb-21 300 KB
207 Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export 2020-Feb-21 228 KB
208 Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP 2020-Feb-21 9066 KB
209 Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export 2020-Feb-21 350 KB
210 Notice regarding Stability data for BA/BE study in Human for export 2020-Feb-21 384 KB
211 Notice regarding requirement of stability data of COPP 2020-Feb-21 346 KB
212 Notice regarding Permission to conduct BA/BE study and clinical trial 2020-Feb-21 346 KB
213 Notice regarding Fixing of limit of impurities in the specification of INDs 2020-Feb-21 347 KB
214 Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019 2020-Feb-20 254 KB
215 Grant of License in Form 29 under the Drugs and Cosmetics Rules 1945 dated 20/2/2020 2020-Feb-20 366 KB
216 Notice Consideration of the direction of Hon'ble Supreme Court of India in the case of 294 FDCs regarding 2020-Feb-20 352 KB
217 Targeted interanl timeline for processing and disposal of application by CDSCO 2020-Feb-20 1546 KB
218 Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 2020-Feb-18 893 KB
219 Notice regarding New Drugs dated 18.02.2020 2020-Feb-18 943 KB
220 PRO details of all Zones/Sub Zones 2020-Feb-13 619 KB
221 Notice Pathway for subsequent manufacture of category d FDCs as per Prof. Kokate Committee Report-extenon in time limit for submission of application 2020-Feb-07 426 KB
222 Draft of the Drugs and Magic Remedies objectional Advertisments Amendment Bill 2020 2020-Feb-03 233 KB
223 Notice PRO 2020-Jan-31 313 KB
224 Notice regarding PRO Veterinary Division 31 jan 2020 2020-Jan-31 323 KB
225 Publice Notice from veterinary Division 2020-Jan-31 320 KB
226 Notices/Circular /Advisory regarding schedule H, H1 C & X 2020-Jan-31 2230 KB
227 Office Memorandum regarding grant of permission for carrying out overprinting/stickering/stamping of imported drugs in certain cases under the provisions of Rule 104A 2020-Jan-29 540 KB
228 Procedure to be followed for subsequent application in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2020-Jan-28 1694 KB
229 Processing of Post Approval Changes to BA/BE permission issued in CT-07 and Import Licence issued in Form CT-17 for Export 2020-Jan-27 261 KB
230 Notice regarding List of Reference Products for conduct of BE Study 2020-Jan-22 172 KB
231 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses/Permits/Certificates/Other Authorizations (LPCOs) by PGAs 2020-Jan-07 2252 KB
232 Office order dated 03.01.2019 2020-Jan-03 355 KB
233 DCGI New Year Massage for 2020 2019-Dec-31 237 KB
234 Office Order PRO at CDSCO Zonal/Sub Zonal Office 12 Dec 2019 2019-Dec-12 704 KB
235 Setting of Public Relations Office at all Zonal and Sub-Zonal Office of CDSCO 2019-Dec-11 700 KB
236 Procedure for regularisation of FDCs w.r.t. payment of fees regarding 2019-Dec-05 345 KB
237 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
238 Public Notice regarding pharmacovigilance reporting for veterinary products in India 2019-Dec-02 264 KB
239 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
240 Strengthening of Materiovigilance Programme of India (MvPI) in the country 2019-Nov-26 56 KB
241 Processing of application for product approved as medical device in the country of origin, but covered under the definition of drug in the country-reg 2019-Nov-15 289 KB
242 Notice regarding equipments which are non notified but associated with notified devices 2019-Nov-13 226 KB
243 Notice regarding environmental conditions for equipments 2019-Nov-08 235 KB
244 Notice regarding all implantable devices 2019-Nov-08 252 KB
245 Notice regarding exemption of drugs Sale License 2019-Nov-08 235 KB
246 Inviting public comments, as steps are being taken taken by CDSCO to regulate the products like adhesives for fixing wigs on scalp or hair, products which are used for cleansing scalp artificial nail systems, as cosmetic 2019-Nov-04 411 KB
247 Notice regarding Monitoring the end use of drugs which are meant for dual use 2019-Oct-18 352 KB
248 Notice regarding Notification to notify all the medical device under sub-section (b) of Section 3 of th Drugs and Cosmetics Act 1940 to regulate them as per the provisions of the Act and Medical Devices Rules 2017 2019-Oct-18 1962 KB
249 Notice dated 18-10-2019 2019-Oct-18 470 KB
250 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
251 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-09 2,653KB
252 Expansion of testing of IVDs for Clinical Chemistry reagents/Kits at NIB Noida under the provision of Medical Device Rules 2017 2019-Oct-07 995 KB
253 Public Notice regarding the process of regulatory guidance from specific division of CDSCO will be available at PRO CDSCO HQ 2019-Oct-04 244 KB
254 Public Notice regarding PRO divisions wise schedule dated 04-10-2019 2019-Oct-04 248 KB
255 Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet-regarding 2019-Sep-19 503 KB
256 Details of IEC/GSTN code of all the beneficiaries (Stakeholders/importers/exporters, customs house brokers) in case of import of cosmetics into India 2019-Sep-13 309 KB
257 Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case of 294 FDCs 2019-Aug-27 233 KB
258 Public Notice regarding payment of fees through Bharatkosh Portal alongwith the application for grant of various licences/Permission 2019-Aug-26 319 KB
259 dvisory to follow the Apprentices Act, 1961-Regarding 2019-Aug-26 66 KB
260 Additional FAQ on New Drugs and Clinical Trial Rules, 2019 2019-Aug-23 152 KB
261 Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I)-regarding 2019-Aug-19 56 KB
262 Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP) 2019-Aug-08 516 KB
263 Details of IEC/GSTN Code of all the beneficiaries Stakeholder/Importer/Exporters, Customs House brokers in the case of Import of Cosmetics Into India 2019-Aug-08 274 KB
264 Public notice for online filing of applications for veterinary drugs 2019-Jul-29 280 KB
265 Constitution of Medical Devices Technical advisory group (MDTAG) to advise CDSCO on matter related to regulation of medical devices-Reg 2019-Jul-22 650 KB
266 First Stakeholders National Consultation meeting of SNCM on 25th_july 2019 at ICMR New Delhi 2019-Jul-19 88 KB
267 Notice regarding Evaluation of Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier considered as irrational in the assessment report of the Prof. Kokate Committee 2019-Jul-01 1660 KB
268 Advisory to all Indian Pharmaceutical Industry Associations 2019-Jun-25 52 KB
269 Simplified auto-registration of beneficiaries (IEC holders) on ICEGATE for e-SANCHIT and other benefits 2019-Jun-25 2365 KB
270 Order regarding Luxury Lifestyle on 17.06.2019 2019-Jun-17 636 KB
271 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses PermitsCertificatesOther Authorizations (LPCOs) by Participating Government Agencies (PGAs) 2019-Jun-14 2172 KB
272 National List of Essential Medicines 2015 2019-Jun-11 1717 KB
273 Details of IECGSTN code of all the beneficiaries (Stakeholders Importers Exporters Customs House Brokers)-Reg 2019-Jun-11 475 KB
274 Updated list of WHO GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPP) in various States of India as on May 2019 2019-May-30 2141 KB
275 Notice regarding Evaluation of FDC by DTAB Sub-Committee which were ealier Considered as irrational in the assessment report of the Prof.Kokate Committee 2019-May-29 768 KB
276 Procedure to be followed for subsequnt applicants in respect of FDCs falling under category 'd' as per Prof. Kokate Committee report (i.e. FDCs which require generation of data)-regarding 2019-May-22 1110 KB
277 Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs 2019-May-15 2021 KB
278 List of Private drugs testing laboratories approved in form 37 of schedule A of drugs and Cosmetics Act 1945 in the country 2019 2019-May-13 58 KB
279 Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials 2019-Apr-26 478 KB
280 Procedure to be followed for subsequent applicants in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2019-Apr-12 312KB
281 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs in respect of FDCs which require further generation of data 2019-Apr-12 396KB
282 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs-regarding 2019-Apr-12 7,670KB
283 Notice Uploading of applications through Sugam Portal in accordance with New Drugs and Clinical Trials Rules 2019 2019-Apr-10 471 KB
284 FEEDBACK FORM to CDSCO (HQ) on the performance of PRO to improve the quality of services 2019-Apr-03 96 KB
285 Meeting Notice regarding Meeting with stakeholders for discussion on Zero Draft of new Veterinary Rules 2019-Apr-03 376 KB
286 Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131 2019-Apr-01 2894 KB
287 Cancellation of Registration Certificate No. SVH-101 and Import License SVH-101-112 2019-Apr-01 3016 KB
288 Order M/s united Distributors Incoporation 2019-Mar-29 538 KB
289 Order M/s Hasan Trading Inc Chennai 2019-Mar-29 546 KB
290 Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone sublingual tablets 2019-Mar-28 1098 KB
291 Safety warning for SGLT2 Inhibitors 2019-Mar-25 9560 KB
292 Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Pro. Kolate Committee and approved by DCG(I) 2019-Mar-20 432 KB
293 Draft Guidelines for Evaluation of Nanopharmaceuticals in India 2019-Mar-07 31990 KB
294 Import of duplicate product Siso Hair Color Shampoo regarding 2019-Mar-07 328 KB
295 Notice regarding of the goods to be disposed 28 February 2019 2019-Feb-28 290 KB
296 Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I) 2019-Feb-27 679 KB
297 Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide 2019-Feb-25 1430 KB
298 Cancellation of Cosmetics Registration certificate No. RC/Cos-000107 M/s Aurelia International Pvt Ltd 2019-Feb-19 422 KB
299 Payment of Challan through Bharatkosh 15.02.2018 2019-Feb-15 287 KB
300 Public notice regarding Consideration of orders of High Court of Karnataka dated 14.08.2013 &24.07.2017 to examine the issue of safety and efficacy of Fixed dose combination of Flupenthixol +Melitracin for human use in light of notifications G.S.R. 377(E) dated 18.06.2013 & G.S.R. 498(E) dated 11.07.2014 and to provide hearing to the petitioners/manufacturers 2019-Feb-13 1297 KB
301 Meeting Notice regarding Meeting of Stakeholders to discuss the matter related to Draft Guidance for Industry Document for Veterinary Biologicals 2019-Feb-12 211 KB
302 Meeting Notice regarding Issues related to payment of Challan through Bharatkosh 2019-Feb-11 397 KB
303 Amedment to the Drugs and Cosmetics rules, 1945 regarding uploading data of Drug manufacturing facilities and approved drug formations on SUGAM 2019-Jan-29 483 KB
304 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of LicensesPermitsCertificatesOther Authorizations (LPCOs) by PGAs 2019-Jan-29 1004 KB
305 Prohibition of 80 fixed Dose combinations by the Central Government vide Gazette notification nos S.O 180 (E) to S.O 259 (E) 2019-Jan-22 351 KB
306 Inviting suggestions/comments on the recommendations of Expert Working Group constituted by the National Blood Transfusion Council (NBTC) on ‘review and recommendations of manpower norms for blood bank 2019-Jan-10 41 KB
307 Payment of Challan through Bharatkosh 2019-Jan-09 328 KB
308 Condemnation/Disposal of Wooden/Steel junks 2019-Jan-08 209 KB
309 DCG(I) New Year Message 2019 2018-Dec-31 313 KB
310 Meeting Notice regarding 8th meeting of Central Expert Committee to determine quantum of compensation in respect of faulty ASR Hip Implants manufactured by M/s DePuy International Ltd., U.K. and implanted in India 2018-Dec-28 10 KB
311 Disposal of unserviceable/obsolete item of CDSCO dated 21.12.2018 2018-Dec-21 322 KB
312 Safety guidelines for Isotretinoin dated 19.12.2018 2018-Dec-19 403 KB
313 Implementation of increase in application fees for grant of various import licences, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations under the provisions of Drugs & Cosmetics Rules,1945 2018-Dec-17 826 KB
314 Notice regarding sale of medicines without prescription 2018-Dec-15 84 KB
315 Office Memorandum dated 14.12.2018 (Ms. Galderma India) 2018-Dec-14 318 KB
316 Order (Skin Aesthetics) 2018-Dec-14 568 KB
317 Consideration of the directions of Hon'ble Supreme Court in the case of 294 FDCs in respect of FDCs with require further generation / submission of data 2018-Dec-12 3432 KB
318 Consideration of the directions of Hon'ble Supreme Court in the case of 294 FDCs in respect of FDCs with require further generation of data 2018-Dec-12 8860 KB
319 Meeting Notice related to Draft Guidance for Industry Document for Veterinary Biologicals 2018-Dec-06 313
320 Feedback Form (Annexure-I) for SUGAM online portal 2018-Dec-05 14 KB
321 Public Notice for feedback on Medical Device Online Portal 2018-Dec-05 325 KB
322 Feedback Form (Annexure-I) for Medical Device online portal 2018-Dec-05 14 KB
323 Public Notice for feedback on SUGAM Online Portal 2018-Dec-05 326 KB
324 Formula for grant of Compensation to the patients who were implanted with ASR Hip and Constitution of the state Level Committee 2018-Nov-30 2586 KB
325 Notice regarding Implementation of e-Governance has launched an online protal SUGAM dated 29.11.2018 2018-Nov-29 292 KB
326 Health Ministry approves compensation formula for Hip implant cases 2018-Nov-29 157 KB
327 Notice regarding Uploading data of drug manufacturing facilities and approved drug formulations on SUGAM Portal dated 29.11.2018 2018-Nov-29 440 KB
328 Public Notice for proposal to include surgical gowns and drapes under the purview of section 3(b)(iv) of Drugs & Cosmetics Act, 1940 2018-Nov-27 267 KB
329 Application Form for Compensation-DePuy J &J ASR Hip Implant 2018-Nov-20 168KB
330 Application form for Compensation-DePuy_Johnson 2018-Nov-15 118 KB
331 Notice- Inviting, any objections / suggestion on the Draft Rules as New Drugs and Clinical Trials Rules, 2018 2018-Nov-14 53 KB
332 To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants 2018-Nov-08 439 KB
333 Order SAE dated 29.10.2018 2018-Oct-29 61 KB
334 Order regarding receipt related to SAE of Clinical Trials 2018-Oct-25 2,210KB
335 PUBLIC NOTICE Video Conferencing Facility for promotion of innovation & start up business in Pharmaceutical sector 2018-Oct-03 559 KB
336 Advertisement of ADI 2018-Sep-30 425 KB
337 Constitution of State level Committee Regarding the Faulty ASR HIP Implant manufatured by M/s DePuy International Ltd U K 2018-Sep-28 352 KB
338 Notice-27.09.2018_Draft Pharmacovigilance System Inspection Guideline 2018-Sep-27 1567 KB
339 Draft Guidelines on Good Distribution Practices for Pharmaceutical Products 2018-Sep-25 2623 KB
340 Notice regarding sugam blood products dated 19.09.2018 2018-Sep-19 265 KB
341 Prohibition of 328 fixed dose combinations by the central Government vide Gazette notification nos. S.O. 4379 (E) to S.O. 4706 (E) regarding 2018-Sep-14 471 KB
342 Public notice related to ASR Hip Implants 2018-Sep-11 400 KB
343 Renaming of Central Drugs Standard Control Organization dated 06.09.2018 2018-Sep-07 496 KB
344 Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K 2018-Aug-30 72 KB
345 Constitution of Central Expert Committee to determine the quantum of compensation in respect of faulty ASR Hip Implants manufactured by M/s DePuy International Limited U.K and implanted in India 2018-Aug-30 20 KB
346 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
347 Notice for meeting of stake holders-Regarding ONLINE SUGAM PORTAL for blood product 2018-Aug-08 261 KB
348 Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import of Oxytocin in India -All State/UT Drugs Controllers 2018-Aug-02 968 KB
349 Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import of Oxytocin in India -All Port offices of CDSCO 2018-Aug-02 980 KB
350 Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import of Oxytocin in India -All Zonal/Sub Zonal offices of CDSCO 2018-Aug-02 964 KB
351 Notice regarding Ethics committee registration through SUGAM portal 2018-Aug-01 2,170KB
352 Notice regarding mandatory Ethics committee registration through SUGAM portal 2018-Aug-01 2,281,472 KB
353 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
354 Public Notice regarding Promotion of Innovation Startup business in India in Pharmaceutical sector 2018-Jul-20 700 KB
355 Office Order regarding appoint of Sh.P.B.N Prasad DDC(I) as first Appellate Authority u/s 5 of RTI Act 2005 CDSCO WZ Mumbai 2018-Jul-06 341 KB
356 Public Notice for comments on proposed notification 2018-Jun-25 33KB
357 Office Memorandum 2018-Jun-14 333KB
358 Providing a separate shelf/rack for generic medicines in retail shops visible to the consumers 2018-Jun-12 495KB
359 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
360 Revised List of Oxytocin Manufacturer 2018-Jun-11 425KB
361 Publication of Gazette Notification of Drugs Inspectors in CDSCO under Section 21 of Drugs & Cosmetic Act, 1940-reg 2018-Jun-08 70KB
362 Constitution of India Drug/Pharamacueticals Association Forum-Reg. 2018-Jun-08 345KB
363 DTAB Committee Meeting from 5 June,2018 till 22 June,2018 2018-Jun-06 302KB
364 Minutes of the meeting of 14th CBBDTEC 2018-Jun-05 2,853KB
365 Public Notice regarding Meeting of DTAB sub Committee w.ef 05.06.2018 to 22.06.2018 in the office of DCGI to examine the344 FDCs+05 FDCs and to provide hearing to the petitioners/appellants reg.28.5.2018 2018-May-28 6,757KB
366 Meeting of DTAB sub Committee for examining the 344 FDCs+05FDCs and to provide hearing to the petitioner/appellants including AIDAN regarding 2018-May-24 342KB
367 Office Order Disposal of matters referred by Public Relation Office, CDSCO (HQ) 2018-May-24 295KB
368 Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344 FDCs+05 FDCs probibited Vide S.O No. 705(E) to 1048(E) dated 10.03.2016 and S.O. No. 1851 (E) to 1855 (E) dated 08.06.2017 and Consitution of a sub-committee for having a relook in these cases 2018-May-24 2,322KB
369 Office Memorandum regarding speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 666KB
370 Speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 671KB
371 Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO 2018-May-01 548KB
372 Notice regarding SUGAM for New Drugs FDC and SND 2018-Apr-27 372KB
373 Office Order regarding Public Relations Office at CDSCO (HQ) 2018-Apr-23 245KB
374 Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344 FDCs+05 FDCs probibited Vide S.O No. 705(E) to 1048(E) 2018-Apr-20 378KB
375 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
376 Name Of Approved Clinical Centres 2018-Apr-08 262kb
377 Notice regarding export NOC with respect to shipping Bills from the Port offices 2018-Mar-23 332KB
378 Grouping Guidelines for Medical Devices Applications 2018-Mar-16 1,984kb
379 Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum 2018-Mar-14 295KB
380 Notice regarding consideration of the directions of the Hon'ble Supreme Court of India in the Case of 344 FDCs + 05 FDCs prohibited vide S.O.no. 705 (E) to 1048(E) dated 10.3.3.2016 and S.O No. 1851 (E) to 1855 (E) dated 08.06.2017 and Constitution of a sub-Committee for having a relook in these cases 2018-Mar-12 1.52MB
381 Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018 2018-Mar-07 310KB
382 Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017 2018-Mar-01 638KB
383 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
384 Public Notice regarding Restriction on Import manufacture, sale and distribution of Oxytocin to curb its misuse 2018-Feb-27 572KB
385 notification 19-2015-2020 2018-Feb-23 422kb
386 Pre-screening checklist3 2018-Feb-23 158kb
387 FDC Guidelines _ Revised1 2018-Feb-23 422kb
388 rc & form 10 checklist 2018-Feb-23 170kb
389 Order regarding transfer of the Deputy Drug Controllers in CDSCO 2018-Feb-22 365KB
390 Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017 2018-Feb-21 9728KB
391 Office Memorandum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 346KB
392 Office Corrigendum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 204KB
393 Order regarding Drugs Inspector's/Technical officer's transfers 2018-Feb-20 931KB
394 Report of the Expert Committee to address the Issue of Faulty ASR™ Hip Implants (Dr. Arun Kumar Aggarwal, The Chairman of the Expert Committee) 2018-Feb-19 34851 KB
395 Notice regarding Meeting of CDSCO with manufacturers of Oxytocin Formulation to discuss issue ralted to misuse of Oxytocin 2018-Feb-16 302KB
396 Office order regarding Grievance Redressal in CDSCO (HQ) 2018-Feb-13 304KB
397 List of meetings of Expert Committee for examination of vaccine PSUR 2018-Feb-09 7KB
398 Office Memorandum regarding Sampling of imported insuline formulations at port offices 2018-Feb-07 343KB
399 Order regarding creation of 'Ayush' vertical in CDSCO 2018-Feb-05 734KB
400 Office Memorandum regarding Rotational Transfer of CDSCO 2018-Jan-24 1.23MB
401 Notice regarding application were called for engagement of Research Scientist medical Device and Diagnostic on contractual basis under CDSCO H/Q 2018-Jan-23 606KB
402 Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis 2018-Jan-22 823KB
403 Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) 2018-Jan-22 875KB
404 Notice for filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs in SUGAM Portal 2018-Jan-15 338KB
405 Office order regarding Import of Drugs by a Government Hospitals & Autonomus Medical Instituations under Form 11A 2018-Jan-02 205kb
406 Guidance document for approval of ba/be noc for export purpose as per schedule y & test licence in form 11 of drugs and cosmetics rules, 1945 2018-Jan-01 934kb
407 NOTICE - regarding Draft guidance documents on essential principles for safety and performance of medical devices as per medical devices rules 2017 2018-Jan-01 1.16MB
408 Documents to be submitted for Bioequivalence Study for export applications 2018-Jan-01 92kb
409 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
410 Office order regarding SUGAM Portal of CDSCO 2017-Dec-11 180KB
411 Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh 2017-Dec-05 308kb
412 Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO 2017-Nov-21 1.96MB
413 Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017 2017-Nov-01 4,147 KB
414 Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices 2017-Oct-31 665KB
415 NOTICE regarding Procedure to be followed for subsequent applicants in respect of FDCs declared as rational by Kokate Committee and approved by DCGI 2017-Oct-05 314KB
416 NOTICE regarding Adhering to Rule 28 and 28A of Drugs and Cosmetics Act and Rules 1945 2017-Sep-28 257KB
417 NOTICE regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Sep-22 586KB
418 NOTICE regarding not of Standard Quality of Mediclone D 2017-Sep-15 59.9KB
419 NOTICE regarding Not of Standard Quality Combipack ABD 2017-Sep-15 72.8KB
420 NOTICE regarding the SLP No.7061/2017 titled under Union of India Vs Pfizer and Ors and other connected matter relating to FDC drugs Cases Pending before the Hon'ble Supreme Court 2017-Sep-15 238KB
421 NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories 2017-Sep-12 566KB
422 NOTICE regading List of Private drugs testing approved in form 37 of schedule A of drugs and Cosmetics Act 1945 in the country 2017-Sep-11 947KB
423 NOTICE regading Supreme court hearing in the matters relating to FDC 2017-Sep-07 8.02MB
424 NOTICE regading suggestions/comments of the stakeholders including manufacturers/marketers of HPMC capsules 2017-Sep-05 257KB
425 NOTICE to all Drugs Manufacturers and Pharmaceuticals Association 2017-Aug-09 311KB
426 NOTICE to all State Drugs Controller 2017-Aug-09 325KB
427 NOTICE - regardingLaunch of export NOC module under SUGAM Portal 2017-Jul-26 316KB
428 NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) 2017-Jul-17 182KB
429 NOTICE - regarding availability of essential mediines following implementation of GST 2017-Jul-13 637KB
430 NOTICE - regarding meeting of the stakeholders for feedback on new modules in SUGAM 2017-Jul-12 372kb
431 corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit 2017-Jul-12 41.9KB
432 NOTICE - Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST) 2017-Jul-10 418KB
433 Notice Order regarding Import of Cosmetic division Sugam Online 2017-Jul-06 351KB
434 Notice Order regarding draft classification of Medical Devices and IVDs 2017-Jun-29 1.83MB
435 Notice Order regarding Streamlining the regulatory procedures 2017-Jun-27 212KB
436 Notice Order regarding address the grievances appeals dated 22.06.2017 2017-Jun-22 643KB
437 Notice Order regarding address the grievances/ appeals 2017-Jun-22 642kb
438 Notice Order regarding Oseltamivir and Zanamivir 2017-Jun-22 1.14MB
439 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
440 Notice regarding Draft SOP for handling of NSQ samples 2017-Jun-13 5.57KB
441 Notice regarding Pocedure to be followed for subsequent application in respect of FDCs declared as rational by Kokate Committee and approved by DCG(I)Notice regarding Pocedure to be followed for subsequent application in respect of FDCs declared as rational by Kokate Committee and approved by DCG(I) 2017-Jun-05 416KB
442 Notice regarding Examination for safety and efficacy of FDCs Licensed for manufacture for sale in the country without due approval form DCG(I) 2017-Jun-05 386KB
443 Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017 2017-May-30 279KB
444 Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) 2017-May-16 471KB
445 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
446 Office Memorandum permission to affix the sticker indicating date of manufacture and Date of expiry with respect of Medical Devices under the provision of Drugs and Cosmetic Rules 2017-May-04 60.1KB
447 Order regarding import of Radio-pharmaceuticals 2017-May-01 1.98MB
448 Office Memo Issue of reports for testanalysis in form 13 on SUGAM Portal-regarding 2017-May-01 329KB
449 Order regarding radiopharmaceuticals 2017-Apr-28 818KB
450 NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi 2017-Apr-24 37.5KB
451 Notice regarding Meeting for the registration of notified body through online portal 2017-Apr-07 542KB
452 Public Notice regarding Price Control dated 06.04.2017 2017-Apr-06 578KB
453 Notice regarding creation of databases of drug manufacturing facilities and approved drug formulation of SUGAM portal 2017-Apr-03 386KB
454 Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 2017-Mar-31 250KB
455 Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 213KB
456 Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 287KB
457 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
458 Notice regarding Regulatory approvals relating to combination products for HIV Hepatitis B&C which are recommended for Concomitant use by WHO 2017-Mar-20 432KB
459 Notice regarding Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2017-Mar-16 704kb
460 Pubic Notice Notice regarding Public Consulatation Regarding Regulation of Sale of Drugs in the Country 2017-Mar-16 429KB
461 Notice regarding Examination for safety and Efficacy of FDCs licensed for manufacture for sale in country without due approval form office of DCG(I) 2017-Mar-01 349kb
462 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
463 Office Memorandum Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 291KB
464 Notice regarding Human Vaccines dated 15.02.2017 2017-Feb-15 59KB
465 Public Notice regarding D-Penicillamine 2017-Feb-10 44.6KB
466 Notice regarding Ease of doing Business relating to export of Drugs 2017-Feb-06 305KB
467 Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06 271KB
468 Notice regarding Streamline the grievance 2017-Feb-02 362KB
469 Notice regarding Medical Devices Rules,2017 Notification No. 78E 2017-Feb-02 23.0KB
470 Notice regarding Rational use of antibiotics fro limiting antimicrobial reistance dated 01.02.2017 2017-Feb-01 348KB
471 Notice regarding Rational use of antibiotics for limiting antimicrobial dated 01.02.2017 2017-Feb-01 343KB
472 Notice- Extension of last date for submission of application for Skill development programme on pharmacovigilance 2017-Jan-31 240KB
473 Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 2017-Jan-17 47.6KB
474 Notice with respect to Antimicrobial resistance dated 16.01.2017 2017-Jan-16 601KB
475 Notice for Import of Radiopharmaceutical Products dated 03.01.2017 2017-Jan-06 29.4KB
476 Order of Annual Increments of CDSCO (HQ) Officials dated 06.01.2017 2017-Jan-06 847KB
477 List of clarifications and NOC issued from 2011 to 2017 2017-Jan-02 901kb
478 Document required for approval of BA-BE center 2017-Jan-01 58kb
479 Notice for Import of Radiopharmaceutical Products 2016-Dec-29 50.7kb
480 Notice 26.12.2016 2016-Dec-26 1.20MB
481 Notice Creation of Sub-login id(s) after primary registration in SUGAM portal 2016-Dec-21 283KB
482 Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated 20.12.2016 2016-Dec-20 290KB
483 Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach 2016-Dec-20 304KB
484 Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis for biological products ( Vaccine & r-DNA Products) 2016-Dec-13 476Kb
485 Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change 2016-Dec-13 269KB
486 Order: Timeline for communication of recommendation to the stakeholders based on the minutes of meeting of various Committees 2016-Dec-13 229KB
487 Circular: NOC for export of biological products (Vaccine & r-DNA products) under form 29 License to manufacture drugs for purposes of examination, test or analysis 2016-Dec-13 236KB
488 Notice Order regarding e-Governance project of CDSCO 2016-Dec-02 156KB
489 Pharmacovigilance Skill Development Programme 2016-Nov-28 101KB
490 Office Memorandum regarding clarification the receipt in G.R6 G.R 7 for payment made through Bharatosk 2016-Nov-21 337KB
491 Notice regarding NABL accredited Drug Testing Laboratories and Manufacturing Units certified withWHO-GMP for COPP 2016-Nov-11 216KB
492 Notice regarding Risk based inspections of the manufacturing facilities regarding 2016-Nov-09 29KB
493 Notice inviting quotation to dispose off unserviceable articles materials in CDL Kolkata Dated 08.11.2016 2016-Nov-08 714KB
494 Notice regarding D-Penicillamine Capsule 2016-Nov-08 260KB
495 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
496 Office memorandum regarding approval of the safety and efficacy of FDCs 2016-Oct-26 320KB
497 Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I) 2016-Oct-17 338KB
498 Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I) 2016-Oct-14 373KB
499 Notice Order 2016-Oct-06 729KB
500 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
501 Minutes of Meeting held on 30.09.2016 regarding the availabity of D-Penicillamine across India-Regarding 2016-Sep-30 17KB
502 Non availability of life saving drug(D-Penicillamine) across India-Regarding 2016-Sep-28 43KB
503 Meeting notice of Vaccine manufacturers to discuss upon forthcoming NRA assesment and its tools 2016-Sep-21 576KB
504 Notice regarding SUGAM Online 2016-Sep-21 1,820KB
505 Presentation for Rabies Vaccine 2016-Sep-08 219KB
506 Presentation for Rabies Vaccine- regarding 2016-Sep-08 218KB
507 Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. 2016-Sep-05 45KB
508 Notice regarding Examination for safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from office of DCG(I) 2016-Sep-01 310KB
509 Notice regarding Upgradation of Skill sets of persons employed in pharma manufacturing units 2016-Aug-26 638KB
510 Notice regarding checklist 2016-Aug-23 292KB
511 Notice regarding for online BA/BE for Export 2016-Aug-22 1,290KB
512 Notice regarding on "online Process for Grant of NOC for clinical Trials" 2016-Aug-18 267KB
513 Public Notice regarding online portal SUGAM 2016-Aug-08 282KB
514 Order regarding the revised transfer policy of Drugs Inspectors 2016-Aug-03 796KB
515 Notice ande Feedback 2016-Aug-01 1,090KB
516 Notice regarding meeting 12 july 2016 CDSCO 2016-Jul-05 302KB
517 Notice regarding transfer folicy for the officers/ Officials of CDSCO 2016-Jun-24 290KB
518 Notice regarding Examination for safety and Efficacy of FDCs 2016-Jun-17 310KB
519 Notice regarding not attending SEC Meeting 2016-Jun-15 350KB
520 Alert Notice 2016-Jun-09 327KB
521 Notice regarding Cosmetics and Ethicss Committee on SUGAM 2016-Jun-07 317KB
522 Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
523 Notice regarding Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
524 Notice dated 30.5.2016 regarding Launch of Registration of Cosmetics and Ethics Committee Modules in Sugam Portal 2016-May-30 487KB
525 Public Notice 2016-May-30 50KB
526 Notice for dated 27.05.2016 regarding Launch of Test License Module in Sugam Portal 2016-May-27 630KB
527 Checklist -Public Notice regarding Self assessment tools for drug regulator/stakeholders for Good Manufacturing Practices (GMP)/Good Laboratory Practices (GLP) and other documents 2016-May-26 1,440KB
528 Meeting Notice for medical devices and diagnostics stakeholders 2016-May-23 84KB
529 Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002 2016-May-20 94KB
530 Notice dated 12.05.2016 regarding FDC Court cases pending before the Delhi High Court alongwith notification wise list of matters 2016-May-12 1,050KB
531 Notice regarding documents for applying as subject experts in various panels of CDSCO 2016-May-10 1,220KB
532 Notice dated 09.05.2016 regarding Sugam Online Medical Devices 2016-May-09 264KB
533 Notice inviting comments / Suggestions of Pharma and Medical Device Associations for Brining in ease of Drug Regulation 2016-May-06 184KB
534 Extending the validity of Free Sale certificate for notified medical devices 2016-Apr-21 650KB
535 Notice regarding Pending status 2016-Apr-08 162KB
536 Delhi High Court order dated 4.4.2016 for information of all concerned 2016-Apr-04 1,510KB
537 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
538 Notice regarding Gelatin Capsules with cellulose 2016-Mar-30 18KB
539 Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics 2016 2016-Mar-26 48KB
540 Notice regarding Preparation for global switch from tOPV to bOPV, 2016 2016-Mar-23 174KB
541 Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016 2016-Mar-23 173KB
542 Meeting Notice 2016-Mar-21 658KB
543 Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs & Cosmetics Act, 1940 2016-Mar-12 147KB
544 Notice Track and Trace for Pharmaceutical Drug consignment 2016-Mar-07 150KB
545 Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics 2016-Mar-04 673KB
546 Notice regarding Creation of Speical Assistance Booth for addressing issues of submission of online applications 2016-Mar-04 629KB
547 Notice Regarding Online Portal Sugam 2016-Feb-18 714KB
548 Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen 2016-Feb-16 54KB
549 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
550 Sale of Drugs over Internet contravening the provisions of Drugs and Cosmetics Rules, 1945 2015-Dec-30 973KB
551 Clearance of Import and Export Consignments at Ports/Airports/Others Points 2015-Dec-29 310KB
552 National List of Essential Medicines (NLEM), 2015 2015-Dec-23 124KB
553 Notice 2015-Dec-11 269KB
554 Clarification for import of in Bulk form in Sutures 2015-Dec-08 258kb
555 Donation of organ(s) and/or tissues after being declared brain stem dead 2015-Nov-20 320KB
556 Public Notice 2015-Nov-19 230KB
557 Public Notice 2015-Sep-21 380KB
558 Notice Dated 17.09.2015 Format for MOU 2015-Sep-17 243KB
559 Notice Dated 11.09.2015 regarding DTAB 2015-Sep-11 707KB
560 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
561 Office Order 25.08.2015 regarding Parameter for writing and review of APAR's 2015-Aug-25 270KB
562 Office Order 18.08.2015 regarding delegation of Power to grant NOC for Manufacture of unapproved/approved and banned drugs in Karnataka State for export purpose 2015-Aug-18 245KB
563 Relieving order of ADC(I) 2015-Jul-09 550KB
564 Transfer order 2015-Jul-09 781KB
565 Office Order for Old Drugs TL BA/BE (export) 2015-Jul-03 366KB
566 Notice 2015-Jun-04 359KB
567 Reminder 2015-May-12 52KB
568 Office Memorandum Nomination of representatives for e-governance 2015-Mar-26 62KB
569 Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue 2015-Feb-14 294KB
570 Office Memorandum Grant of NOC for procuring unapproved/Approved New Drug 2015-Feb-13 494KB
571 Circular 2015-Feb-03 291KB
572 Office Order Dated 06.01.2015- Transfer of certain functions and delegation of powers to the zonal office of CDSCO under Rule 22 of the Drugs and Cosmetics Rules, 1945 2015-Jan-06 85KB
573 Meeting of all Vaccine Manufacutres & Importers on 15th January 2015 2014-Dec-26 513KB
574 Office Order Dated 24 .12.2014 reg. constitution of a committee for examining and recommending amendments in the Drugs and Cosmetics,1945 2014-Dec-24 116KB
575 Notice dated 10.12.2014 2014-Dec-10 411KB
576 Corrigendum 2014-Nov-10 21KB
577 Office Order 2014-Nov-07 492KB
578 Office order 2014-Oct-21 738KB
579 Office Order Dated 30.09.2014 reg. Transfer of certain functions and delegations of powers to the Zonal offices of CDSCO 2014-Sep-30 522KB
580 Office Memorandum dated 29.09.2014 reg. Relabeling or stickering on the label of cosmetics 2014-Sep-29 320KB
581 Notice 17 September 2014 2014-Sep-17 100KB
582 CBBBTDEC Meeting Shedule for Year 2014-2015 2014-Sep-12 31KB
583 Office Order dated 05.09.2014 reg. Information required in respect of Conduct of the Clinical Trial of New Drugs and GCT in India 2014-Sep-05 503KB
584 Office Memorandum 2014-Sep-04 317KB
585 Office order 29.08.2014 draft list of approved products for Veterinary drugs 2014-Aug-29 41KB
586 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
587 Letter for States regarding Regulatory Inspection Procedure 2014-Aug-06 148KB
588 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
589 Office Order dated 09.07.2014 Clarification for regulation of Medical devices under the provision of Drugs and Cosmetics Acts and Rules 2014-Jul-09 437KB
590 Notice dated 7.07.2014 Hearing for redressal of Public Grievance 2014-Jul-07 222KB
591 Office Order dated 03.07.2014 - Consideration of banning of a marketed drug 2014-Jul-03 145KB
592 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
593 Office Order dated 03.07.2014 - Requirement of local trial for a generics or similar biologics (bio similar) in other country like USA for its approval in the country 2014-Jul-03 186KB
594 Office Order dated 03.07.2014 - Requirement for filing of application to market new Chemical Entities 2014-Jul-03 175KB
595 Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects 2014-Jul-03 156KB
596 Office Order dated 03.07.2014 - Procedure for review of application of CT and New drugs 2014-Jul-03 205KB
597 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
598 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
599 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
600 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
601 Office Order dated 03.07.2014 - Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies 2014-Jul-03 198KB
602 Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs 2014-Jul-03 211KB
603 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
604 Office Order dated 03.07.2014 - Approval of academic CT 2014-Jul-03 146KB
605 Office Order dated 27.6.2014 Daily Public hearing of respective division 2014-Jun-27 283KB
606 IVD Office Order 2014-Jun-24 1436 KB
607 Office Order dated 06.05.2014 reg. Constitution of Antimalarial Cell in CDSCO (HQ) 2014-May-06 287KB
608 Inclusion of Schedule H1 under the Drugs and Cosmetics Rules Dated 19.03.2014 2014-Mar-19 340KB
609 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
610 Office Order Dated 26.02.2014 Regarding Transfer of Certain Functions and Delegations of Powers to Zonal Office to CDSCO Under Rule 22 of Drugs and Cosmetics Rules 2014-Feb-26 315KB
611 Notice Regarding Approvals of Stem Cells and Cell Based Products Dated 18.02.2014 2014-Feb-18 493KB
612 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
613 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
614 Notce 2014-Feb-13 297KB
615 Office Order Dated 13.02.2014 Regarding Transfer of Certain Functions and Delegations of Powers to Zonal Office to CDSCO Under Rule 22 of Drugs and Cosmetics Rules 2014-Feb-13 460KB
616 Delegation of the Powers- Import of Small Quantities of Drugs for Personal Use 2014-Feb-12 462KB
617 Veterinary Cell Office Order 2014-Feb-07 251KB
618 Public Information Cell 2014-Feb-07 276KB
619 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv 2014-Feb-01 327kb
620 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-25 294kb
621 Requirement of Obtaining Approval from the Office of Drugs Controller General of India (DCGI) Prior to Initiation of activity of Bio Analytical Laboratory for the Purpose of Analysis of Samples Obtained from Bio Availablity and Bio Equivalence Studies 2014-Jan-09 140kb
622 Notice-Meeting of the Pharmaceuticals Industry Associations 2014-Jan-07 256KB
623 Office Order 2013-Dec-18 308KB
624 Office Order: 13.08.2013 Constitution of and expert Committee to guide DCG(I) in matters related to regulation of Biotech Products 2013-Aug-13 391KB
625 Notice Ethic Committee Clinical trial 2013-Jul-30 317KB
626 Notice dated 08.07.2013:- Revision of CDSCO Guidance for industry for biological products for applications under post approval changes PAC /1108 ver 1.1 2013-Jul-08 508KB
627 Office Order:-Constitution of High Powered Committee for the regulation of stem cell 2013-Jun-03 555KB
628 Delegation of powers of Licensing Authority under Rule 22 of Drugs & Cosmetics Rules 2013-May-23 343KB
629 Notice dated 08.05.2013: Clarification sought by the stakeholders 2013-May-08 312KB
630 Notice dated 10.04.2013 regarding prioritisation of activities at CDSCO 2013-Apr-10 420KB
631 Office Order dated 09.04.2013: International Cell in CDSCO(HQ) 2013-Apr-09 290KB
632 Delegation of powers to the officers in the DCG(I) Office to sign certain licences under Rule 22 of Drugs & Cosmetics Rule, 1945 2013-Mar-20 528KB
633 Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders Monitoring of Clinical Trials - regarding 2013-Feb-17 733 KB
634 Order Dated 06.02.2013: "System for supervision Clinical trials on new Chemical entities in the light of direction of Hon'ble Supreme Court of India" 2013-Feb-06 739KB
635 Order Dated 06.02.2013: "Expert Committees to formulate Policy Guidelines and SOPs for approval of new Drugs clinical trials, banning of drugs and FDCs" 2013-Feb-06 790KB
636 Notice - clarification and requirements related to post approval changes as per CDSCO Guidance for industry for biological products 2013-Jan-18 603KB
637 Notice - dated 17.01.2013: Admn 2013-Jan-17 285KB
638 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
639 Notice-dated 13.12.2012: DRUG ALERT 2012-Dec-13 378KB
640 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
641 Notice-dated 03.12.2012: Group A Officer of CDSCO issued by Ministry of Health. 2012-Dec-03 284KB
642 Notice-dated 29.11.2012: Cautionary note under Rule 97 of D & C Rules for Sch. H and Sch G drugs. 2012-Nov-29 1,010KB
643 Office Order-dated 21.11.12: Delegation of power to CDSCO (NZ) Ghaziabad. 2012-Nov-21 311KB
644 Clarification-dated 12.11.12: Directions issued under Section 33P of D & C Act 1940. 2012-Nov-12 1,070KB
645 E.U-API - Written Confirmations Certificate 2012-Nov-12 411KB
646 Notice-dated 29.10.12: Interactive meeting with stakeholders. 2012-Oct-29 293KB
647 Notice-dated 29.10.12: CDSCO Sr. Officers Meeting. 2012-Oct-29 239KB
648 Notice-dated 12.10.2012: Directions issued under Section 33P of D & C Act 1940. 2012-Oct-12 1,220KB
649 Notice-dated 01.10.2012 : Extension of implementations of GSR No. 426(E) dt 19.05.2010 2012-Oct-01 101KB
650 Notice 2012-Sep-21 252KB
651 Notice-dated 14.09.2012: Fake drug menace in India. 2012-Sep-14 316KB
652 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
653 Notice-dated 28.08.2012: Expansion of Experts panel for evaluation of application of New Drugs etc. 2012-Aug-28 1,260KB
654 Office Order-dated 28.08.2012: Submission of Periodic Safety Update Reports (PSURs). 2012-Aug-28 528KB
655 Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012 2012-Jul-13 201 KB
656 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
657 Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices 2012-Mar-05 74 KB
658 ORTHOPAEDIC ORDER 2012-Feb-17 127 KB
659 Advisory notice on clinical trial 2012-Feb-17 1273 KB
660 GENERAL ORDER 2012-Feb-17 140 KB
661 REPRODUCTIVE & UROLOGY ORDER 2012-Feb-17 123 KB
662 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 KB
663 MISCELLANEOUS ORDER 2012-Feb-17 118 KB
664 Clarification to Office Order dated 21.11.2011 for Pre Screening of Applications. 2011-Nov-21 57KB
665 Office Order- dated 21.11.2011: For Pre Screening Applications 2011-Nov-21 45KB
666 Office Order-dated 08.11.2011: Public Hearing and Monitoring Cell. 2011-Nov-08 346KB
667 Clarification for import of pre-filled syringe 2011-Nov-07 282kb
668 Office Order-dated 04.11.2011: Constitution of Special Public Hearing and monitoring cell. 2011-Nov-04 367KB
669 Clarification on regulation of staplers 2011-Oct-04 54kb
670 Office Memorandum-dated 16.08.2011: Monitoring of functioning of all Port Offices of CDSCO. 2011-Aug-16 55KB
671 Office Order-dated 01.06.2011 regarding delegation of powers to Zonal Officer of CDSCO. 2011-Jun-01 74KB
672 MDAC of Ophthalmic 2011-May-10 126 KB
673 MDAC Miscellaneous Devices 2011-May-10 118 KB
674 MDAC Dental 2011-May-10 119 KB
675 MDAC Cardiovascular order dated 10 May 2011 2011-May-10 129 KB
676 MDAC of General Expert Pool 2011-May-10 140 KB
677 MDAC of Orthopedic 2011-May-10 127 KB
678 MDAC of Reporductive and Urology 2011-May-10 123 KB
679 Clarification with respect of the manufacturing and marketing of New Drugs 2011-Mar-10 300 KB
680 CARDIOVASCULAR ORDER 2011-Feb-17 129 KB
681 OPHTHALMIC ORDER 2011-Feb-17 126 KB
682 DENTAL ORDER 2011-Feb-17 119 KB
683 Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) 2010-Sep-01 1248 KB
684 Testing of Biochemical kits for estimation of glucose 2010-Aug-26 133 KB
685 List of Notified Medical devices 2010-Apr-20 85 KB