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 Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 17.05.2021 2021-May-17 436 KB
2 PCR Kits approved for testing of Covid-19 as on 17.05.2021 2021-May-17 443 KB
3 Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings 2021-May-16 735 KB
4 SOP Guidance for import of vaccine by private sector or any person 2021-May-04 7 KB
5 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
6 Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021 2021-Apr-18 138 KB
7 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
8 Submission of notarized/apostilled documents for Import and Registration of cosmetics in view of COVID-19 2021-Apr-13 363 KB
9 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
10 Enforcement activities to stop hoarding/back marketing/overcharging of COVID Managment drug Remdesivir 2021-Apr-10 398 KB
11 Monitoring to ensure availability of Remdesivir and prevent its hoarding and black marketing 2021-Apr-07 402 KB
12 NDLS portal Public notice-31-03-2021 2021-Mar-31 175 KB
13 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
14 Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits 2021-Mar-22 586 KB
15 Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 2021-Mar-16 919 KB
16 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
17 Notice-Online Application for the issuance of Form 41 (Registration certificate) and Form 10 (Import License) for Veterinary Vaccines 2021-Mar-05 2206 KB
18 Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE's 2021-Feb-25 59 KB
19 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
20 Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021 2021-Jan-01 182 KB
21 Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 2020-Dec-28 334 KB
22 Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central Government officicals regarding 2020-Oct-12 1038 KB
23 Notice regarding List of medical devices testing Laboratory 2020-Oct-09 2927 KB
24 Regulatory guidelines for development of Vaccine 21.09.2020 2020-Sep-21 801 KB
25 Notice for Vaccine Guidelines dated 21 Sept 2020 2020-Sep-21 392 KB
26 Notice regarding documents required for the Import 2020-Sep-17 516 KB
27 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
28 Notice regarding classification of non notified medical devices1 2020-Sep-03 12557 KB
29 Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices 2020-Sep-03 301 KB
30 Notice regarding classification of non notified medical devices 2020-Sep-03 613 KB
31 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
32 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
33 Notice regarding Approved panel of experts for the Subject Expert Committees 2020-Aug-28 20279 KB
34 Submission of notarized/ apostilled documents for import and Registration of cosmetics in view of COVID-19 2020-Aug-19 279 KB
35 Procedure to be followed for subsequent applicant in respect of FDCs relating to Vitamins, Minerals, Micronutrients, etc. declared as rational by Prof. Kokate Committee and approved by DCG(I)-regarding 2020-Aug-03 290 KB
36 Approval of Favipiravir Tablets to Glenmark Pharmaceuticals and Remdesivir Injection to Cipla Ltd, Hetero Drugs and Mylan Labs 2020-Jul-02 410 KB
37 Information on convalescent plasma in Covid 19 2020-Jul-01 123 KB
38 Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose 2020-Jun-19 368 KB
39 Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19 2020-Jun-09 599 KB
40 GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS 2020-Jun-04 2174 KB
41 Radpid Response Regulatory Framework for COVID-19 vaccine development 2020-May-26 9005 KB
42 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
43 ICMR Convalescent plasma _protocol_v1.5.pdf 2020-May-11 276 KB
44 Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP) 2020-May-01 265 KB
45 Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April 2020-Apr-27 746 KB
46 Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19 2020-Apr-23 307 KB
47 amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent plasma_protocol_v1.4 2020-Apr-22 214 KB
48 Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of COVID 19 2020-Apr-20 313 KB
49 Clinical trial of convalescent plasma in COVID-19 Patients 2020-Apr-17 634 KB
50 Office Memorandum on COVID-19 2020-Apr-16 1786 KB
51 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
52 Submmission of notarized/apostilled documents for import and Registration of drugs in view of COVID 19 2020-Apr-15 284 KB
53 Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19 2020-Apr-07 424 KB
54 Public notice alerting about unlicensed kit of Bione for corona testing displayed on their website for sale 2020-Apr-05 235 KB
55 Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 2020-Mar-30 602 KB
56 Release of consignments of Vaccine and critical IVDs-certain instructions issued 2020-Mar-25 311 KB
57 Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes 2020-Mar-24 33 KB
58 Notice regarding COVID-19 outbreak 2020-Mar-23 833 KB
59 OM on Rapid Response Regulatory Framework for COVID-19 2020-Mar-20 611 KB
60 Notice regarding Measures to contain spread of COVID-19 2020-Mar-19 313 KB
61 Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19 2020-Mar-19 441 KB
62 Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19 2020-Mar-19 453 KB
63 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
64 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
65 Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. 2020-Mar-13 43 KB
66 Testing of all categories of new drugs for their approval 2020-Mar-13 47 KB
67 Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. 2020-Mar-13 52 KB
68 Requirement of CMC documents for approval of additional indication of an already drug product 2020-Mar-13 45 KB
69 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
70 Submission and processing of application for Registration Certificate and import License in parallel with New Drug application 2020-Feb-26 333 KB
71 Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) 2020-Feb-24 849 KB
72 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
73 Notice regarding Fixing of limit of impurities in the specification of INDs 2020-Feb-21 347 KB
74 Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export 2020-Feb-21 350 KB
75 Notice regarding Stability data for BA/BE study in Human for export 2020-Feb-21 384 KB
76 Notice regarding requirement of stability data of COPP 2020-Feb-21 346 KB
77 Notice regarding Approval of FDCs Containing new drugs 2020-Feb-21 312 KB
78 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
79 Notice regarding Pre-submission meeting 2020-Feb-21 300 KB
80 Notice regarding Permission to conduct BA/BE study and clinical trial 2020-Feb-21 346 KB
81 Grant of License in Form 29 under the Drugs and Cosmetics Rules 1945 dated 20/2/2020 2020-Feb-20 366 KB
82 Targeted interanl timeline for processing and disposal of application by CDSCO 2020-Feb-20 1546 KB
83 Notice Consideration of the direction of Hon'ble Supreme Court of India in the case of 294 FDCs regarding 2020-Feb-20 352 KB
84 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
85 Notice regarding New Drugs dated 18.02.2020 2020-Feb-18 943 KB
86 Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 2020-Feb-18 893 KB
87 PRO details of all Zones/Sub Zones 2020-Feb-13 619 KB
88 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
89 Draft of the Drugs and Magic Remedies objectional Advertisments Amendment Bill 2020 2020-Feb-03 233 KB
90 Notices/Circular /Advisory regarding schedule H, H1 C & X 2020-Jan-31 2230 KB
91 Notice PRO 2020-Jan-31 313 KB
92 Notice regarding PRO Veterinary Division 31 jan 2020 2020-Jan-31 323 KB
93 Publice Notice from veterinary Division 2020-Jan-31 320 KB
94 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
95 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
96 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
97 Notice regarding List of Reference Products for conduct of BE Study 2020-Jan-22 172 KB
98 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses/Permits/Certificates/Other Authorizations (LPCOs) by PGAs 2020-Jan-07 2252 KB
99 Office order dated 03.01.2019 2020-Jan-03 355 KB
100 DCGI New Year Massage for 2020 2019-Dec-31 237 KB
101 List of Notified Bodies registered with CDSCO under MDR-2017 2019-Dec-30 670 KB
102 Office Order PRO at CDSCO Zonal/Sub Zonal Office 12 Dec 2019 2019-Dec-12 704 KB
103 Setting of Public Relations Office at all Zonal and Sub-Zonal Office of CDSCO 2019-Dec-11 700 KB
104 Procedure for regularisation of FDCs w.r.t. payment of fees regarding 2019-Dec-05 345 KB
105 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
106 Public Notice regarding pharmacovigilance reporting for veterinary products in India 2019-Dec-02 264 KB
107 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
108 Strengthening of Materiovigilance Programme of India (MvPI) in the country 2019-Nov-26 56 KB
109 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
110 Notice regarding equipments which are non notified but associated with notified devices 2019-Nov-13 226 KB
111 Notice regarding exemption of drugs Sale License 2019-Nov-08 235 KB
112 Notice regarding all implantable devices 2019-Nov-08 252 KB
113 Notice regarding environmental conditions for equipments 2019-Nov-08 235 KB
114 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
115 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
116 Notice dated 18-10-2019 2019-Oct-18 470 KB
117 Notice regarding Monitoring the end use of drugs which are meant for dual use 2019-Oct-18 352 KB
118 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
119 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
120 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-04 2653 KB
121 Public Notice regarding PRO divisions wise schedule dated 04-10-2019 2019-Oct-04 248 KB
122 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
123 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 2019-Oct-03 645 KB
124 Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet-regarding 2019-Sep-19 503 KB
125 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
126 Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case of 294 FDCs 2019-Aug-27 233 KB
127 dvisory to follow the Apprentices Act, 1961-Regarding 2019-Aug-26 66 KB
128 Public Notice regarding payment of fees through Bharatkosh Portal alongwith the application for grant of various licences/Permission 2019-Aug-26 319 KB
129 Additional FAQ on New Drugs and Clinical Trial Rules, 2019 2019-Aug-23 152 KB
130 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
131 Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP) 2019-Aug-08 516 KB
132 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
133 List of Notified Bodies registered with CDSCO under MDR 2017 2019-Jul-31 526 KB
134 Public notice for online filing of applications for veterinary drugs 2019-Jul-29 280 KB
135 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
136 First Stakeholders National Consultation meeting of SNCM on 25th_july 2019 at ICMR New Delhi 2019-Jul-19 88 KB
137 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
138 Simplified auto-registration of beneficiaries (IEC holders) on ICEGATE for e-SANCHIT and other benefits 2019-Jun-25 2365 KB
139 Advisory to all Indian Pharmaceutical Industry Associations 2019-Jun-25 52 KB
140 Order regarding Luxury Lifestyle on 17.06.2019 2019-Jun-17 636 KB
141 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
142 Details of IECGSTN code of all the beneficiaries (Stakeholders Importers Exporters Customs House Brokers)-Reg 2019-Jun-11 475 KB
143 National List of Essential Medicines 2015 2019-Jun-11 1717 KB
144 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 2544 KB
145 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
146 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
147 Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs 2019-May-15 2021 KB
148 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
149 Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials 2019-Apr-26 478 KB
150 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
151 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs-regarding 2019-Apr-12 7,670KB
152 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
153 Notice Uploading of applications through Sugam Portal in accordance with New Drugs and Clinical Trials Rules 2019 2019-Apr-10 471 KB
154 FEEDBACK FORM to CDSCO (HQ) on the performance of PRO to improve the quality of services 2019-Apr-03 96 KB
155 Meeting Notice regarding Meeting with stakeholders for discussion on Zero Draft of new Veterinary Rules 2019-Apr-03 376 KB
156 Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131 2019-Apr-01 2894 KB
157 Cancellation of Registration Certificate No. SVH-101 and Import License SVH-101-112 2019-Apr-01 3016 KB
158 Order M/s Hasan Trading Inc Chennai 2019-Mar-29 546 KB
159 Order M/s united Distributors Incoporation 2019-Mar-29 538 KB
160 Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone sublingual tablets 2019-Mar-28 1098 KB
161 Safety warning for SGLT2 Inhibitors 2019-Mar-25 9560 KB
162 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
163 Import of duplicate product Siso Hair Color Shampoo regarding 2019-Mar-07 328 KB
164 Draft Guidelines for Evaluation of Nanopharmaceuticals in India 2019-Mar-07 31990 KB
165 Notice regarding of the goods to be disposed 28 February 2019 2019-Feb-28 290 KB
166 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
167 Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide 2019-Feb-25 1430 KB
168 Cancellation of Cosmetics Registration certificate No. RC/Cos-000107 M/s Aurelia International Pvt Ltd 2019-Feb-19 422 KB
169 Payment of Challan through Bharatkosh 15.02.2018 2019-Feb-15 287 KB
170 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
171 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
172 Meeting Notice regarding Issues related to payment of Challan through Bharatkosh 2019-Feb-11 397 KB
173 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
174 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of LicensesPermitsCertificatesOther Authorizations (LPCOs) by PGAs 2019-Jan-29 1004 KB
175 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
176 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
177 Payment of Challan through Bharatkosh 2019-Jan-09 328 KB
178 Condemnation/Disposal of Wooden/Steel junks 2019-Jan-08 209 KB
179 DCG(I) New Year Message 2019 2018-Dec-31 313 KB
180 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
181 Disposal of unserviceable/obsolete item of CDSCO dated 21.12.2018 2018-Dec-21 322 KB
182 Safety guidelines for Isotretinoin dated 19.12.2018 2018-Dec-19 403 KB
183 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
184 Notice regarding sale of medicines without prescription 2018-Dec-15 84 KB
185 Office Memorandum dated 14.12.2018 (Ms. Galderma India) 2018-Dec-14 318 KB
186 Order (Skin Aesthetics) 2018-Dec-14 568 KB
187 Procedure to be followed for subsequent applicants in respect of FDCs declared as rational by Prof.Kokate Committee and approved by DCG(I) 2018-Dec-12 772 KB
188 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
189 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
190 Meeting Notice related to Draft Guidance for Industry Document for Veterinary Biologicals 2018-Dec-06 313
191 Public Notice for feedback on SUGAM Online Portal 2018-Dec-05 326 KB
192 Feedback Form (Annexure-I) for Medical Device online portal 2018-Dec-05 14 KB
193 Feedback Form (Annexure-I) for SUGAM online portal 2018-Dec-05 14 KB
194 Public Notice for feedback on Medical Device Online Portal 2018-Dec-05 325 KB
195 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
196 Notice regarding Uploading data of drug manufacturing facilities and approved drug formulations on SUGAM Portal dated 29.11.2018 2018-Nov-29 440 KB
197 Health Ministry approves compensation formula for Hip implant cases 2018-Nov-29 157 KB
198 Notice regarding Implementation of e-Governance has launched an online protal SUGAM dated 29.11.2018 2018-Nov-29 292 KB
199 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
200 Application Form for Compensation-DePuy J &J ASR Hip Implant 2018-Nov-20 168KB
201 Application form for Compensation-DePuy_Johnson 2018-Nov-15 118 KB
202 Notice- Inviting, any objections / suggestion on the Draft Rules as New Drugs and Clinical Trials Rules, 2018 2018-Nov-14 53 KB
203 To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants 2018-Nov-08 439 KB
204 Order SAE dated 29.10.2018 2018-Oct-29 61 KB
205 Order regarding receipt related to SAE of Clinical Trials 2018-Oct-25 2,210KB
206 PUBLIC NOTICE Video Conferencing Facility for promotion of innovation & start up business in Pharmaceutical sector 2018-Oct-03 559 KB
207 Advertisement of ADI 2018-Sep-30 425 KB
208 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
209 Notice-27.09.2018_Draft Pharmacovigilance System Inspection Guideline 2018-Sep-27 1567 KB
210 Draft Guidelines on Good Distribution Practices for Pharmaceutical Products 2018-Sep-25 2623 KB
211 Notice regarding sugam blood products dated 19.09.2018 2018-Sep-19 265 KB
212 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
213 Public notice related to ASR Hip Implants 2018-Sep-11 400 KB
214 Renaming of Central Drugs Standard Control Organization dated 06.09.2018 2018-Sep-07 496 KB
215 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
216 Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K 2018-Aug-30 72 KB
217 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
218 Notice for meeting of stake holders-Regarding ONLINE SUGAM PORTAL for blood product 2018-Aug-08 261 KB
219 Notice regarding list of Notified Bodies registered with CDSCO under MDR 2017 dated 06.08.2018 2018-Aug-06 328 KB
220 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
221 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
222 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
223 Notice regarding mandatory Ethics committee registration through SUGAM portal 2018-Aug-01 2,281,472 KB
224 Notice regarding Ethics committee registration through SUGAM portal 2018-Aug-01 2,170KB
225 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
226 Public Notice regarding Promotion of Innovation Startup business in India in Pharmaceutical sector 2018-Jul-20 700 KB
227 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
228 Public Notice for comments on proposed notification 2018-Jun-25 33KB
229 Providing a separate shelf/rack for generic medicines in retail shops visible to the consumers 2018-Jun-12 495KB
230 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
231 Revised List of Oxytocin Manufacturer 2018-Jun-11 425KB
232 Publication of Gazette Notification of Drugs Inspectors in CDSCO under Section 21 of Drugs & Cosmetic Act, 1940-reg 2018-Jun-08 70KB
233 Constitution of India Drug/Pharamacueticals Association Forum-Reg. 2018-Jun-08 345KB
234 DTAB Committee Meeting from 5 June,2018 till 22 June,2018 2018-Jun-06 302KB
235 Minutes of the meeting of 14th CBBDTEC 2018-Jun-05 2,853KB
236 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
237 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
238 Office Order Disposal of matters referred by Public Relation Office, CDSCO (HQ) 2018-May-24 295KB
239 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
240 Speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 671KB
241 Office Memorandum regarding speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 666KB
242 Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO 2018-May-01 548KB
243 Notice regarding SUGAM for New Drugs FDC and SND 2018-Apr-27 372KB
244 Office Order regarding Public Relations Office at CDSCO (HQ) 2018-Apr-23 245KB
245 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
246 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
247 Name Of Approved Clinical Centres 2018-Apr-08 262kb
248 Notice regarding export NOC with respect to shipping Bills from the Port offices 2018-Mar-23 332KB
249 Grouping Guidelines for Medical Devices Applications 2018-Mar-16 1,984kb
250 Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum 2018-Mar-14 295KB
251 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 1.02MB
252 Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018 2018-Mar-07 310KB
253 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
254 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
255 Public Notice regarding Restriction on Import manufacture, sale and distribution of Oxytocin to curb its misuse 2018-Feb-27 572KB
256 FDC Guidelines _ Revised1 2018-Feb-23 422kb
257 Pre-screening checklist3 2018-Feb-23 158kb
258 rc & form 10 checklist 2018-Feb-23 170kb
259 notification 19-2015-2020 2018-Feb-23 422kb
260 Order regarding transfer of the Deputy Drug Controllers in CDSCO 2018-Feb-22 365KB
261 Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017 2018-Feb-21 9728KB
262 Office Corrigendum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 204KB
263 Office Memorandum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 346KB
264 Order regarding Drugs Inspector's/Technical officer's transfers 2018-Feb-20 931KB
265 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
266 Notice regarding Meeting of CDSCO with manufacturers of Oxytocin Formulation to discuss issue ralted to misuse of Oxytocin 2018-Feb-16 302KB
267 Office order regarding Grievance Redressal in CDSCO (HQ) 2018-Feb-13 304KB
268 List of meetings of Expert Committee for examination of vaccine PSUR 2018-Feb-09 7KB
269 Office Memorandum regarding Sampling of imported insuline formulations at port offices 2018-Feb-07 343KB
270 Order regarding creation of 'Ayush' vertical in CDSCO 2018-Feb-05 734KB
271 Office Memorandum regarding Rotational Transfer of CDSCO 2018-Jan-24 1.23MB
272 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
273 Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis 2018-Jan-22 823KB
274 Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) 2018-Jan-22 875KB
275 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
276 Office order regarding Import of Drugs by a Government Hospitals & Autonomus Medical Instituations under Form 11A 2018-Jan-02 205kb
277 Documents to be submitted for Bioequivalence Study for export applications 2018-Jan-01 92kb
278 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
279 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
280 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
281 Office order regarding SUGAM Portal of CDSCO 2017-Dec-11 180KB
282 Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh 2017-Dec-05 308kb
283 Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO 2017-Nov-21 1.96MB
284 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
285 Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices 2017-Oct-31 665KB
286 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
287 NOTICE regarding Adhering to Rule 28 and 28A of Drugs and Cosmetics Act and Rules 1945 2017-Sep-28 257KB
288 NOTICE regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Sep-22 586KB
289 NOTICE regarding not of Standard Quality of Mediclone D 2017-Sep-15 59.9KB
290 NOTICE regarding Not of Standard Quality Combipack ABD 2017-Sep-15 72.8KB
291 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
292 NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories 2017-Sep-12 566KB
293 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
294 NOTICE regading Supreme court hearing in the matters relating to FDC 2017-Sep-07 8.02MB
295 NOTICE regading suggestions/comments of the stakeholders including manufacturers/marketers of HPMC capsules 2017-Sep-05 257KB
296 NOTICE to all Drugs Manufacturers and Pharmaceuticals Association 2017-Aug-09 311KB
297 NOTICE to all State Drugs Controller 2017-Aug-09 325KB
298 NOTICE - regardingLaunch of export NOC module under SUGAM Portal 2017-Jul-26 316KB
299 NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) 2017-Jul-17 182KB
300 NOTICE - regarding availability of essential mediines following implementation of GST 2017-Jul-13 637KB
301 NOTICE - regarding meeting of the stakeholders for feedback on new modules in SUGAM 2017-Jul-12 372kb
302 corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit 2017-Jul-12 41.9KB
303 NOTICE - Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST) 2017-Jul-10 418KB
304 Notice Order regarding Import of Cosmetic division Sugam Online 2017-Jul-06 351KB
305 Notice Order regarding draft classification of Medical Devices and IVDs 2017-Jun-29 1.83MB
306 Notice Order regarding Streamlining the regulatory procedures 2017-Jun-27 212KB
307 Notice Order regarding address the grievances/ appeals 2017-Jun-22 642kb
308 Notice Order regarding address the grievances appeals dated 22.06.2017 2017-Jun-22 643KB
309 Notice Order regarding Oseltamivir and Zanamivir 2017-Jun-22 1.14MB
310 Notice regarding Draft SOP for handling of NSQ samples 2017-Jun-13 5.57KB
311 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
312 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
313 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
314 Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017 2017-May-30 279KB
315 Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) 2017-May-16 471KB
316 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
317 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
318 Order regarding import of Radio-pharmaceuticals 2017-May-01 1.98MB
319 Office Memo Issue of reports for testanalysis in form 13 on SUGAM Portal-regarding 2017-May-01 329KB
320 Order regarding radiopharmaceuticals 2017-Apr-28 818KB
321 NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi 2017-Apr-24 37.5KB
322 Notice regarding Meeting for the registration of notified body through online portal 2017-Apr-07 542KB
323 Public Notice regarding Price Control dated 06.04.2017 2017-Apr-06 578KB
324 Notice regarding creation of databases of drug manufacturing facilities and approved drug formulation of SUGAM portal 2017-Apr-03 386KB
325 Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 2017-Mar-31 250KB
326 Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 213KB
327 Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 287KB
328 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
329 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
330 Pubic Notice Notice regarding Public Consulatation Regarding Regulation of Sale of Drugs in the Country 2017-Mar-16 429KB
331 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
332 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
333 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
334 Office Memorandum Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 291KB
335 Notice regarding Human Vaccines dated 15.02.2017 2017-Feb-15 59KB
336 Public Notice regarding D-Penicillamine 2017-Feb-10 44.6KB
337 Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06 271KB
338 Notice regarding Ease of doing Business relating to export of Drugs 2017-Feb-06 305KB
339 Notice regarding Medical Devices Rules,2017 Notification No. 78E 2017-Feb-02 23.0KB
340 Notice regarding Streamline the grievance 2017-Feb-02 362KB
341 Notice regarding Rational use of antibiotics fro limiting antimicrobial reistance dated 01.02.2017 2017-Feb-01 348KB
342 Notice regarding Rational use of antibiotics for limiting antimicrobial dated 01.02.2017 2017-Feb-01 343KB
343 Notice- Extension of last date for submission of application for Skill development programme on pharmacovigilance 2017-Jan-31 240KB
344 Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 2017-Jan-17 47.6KB
345 Notice with respect to Antimicrobial resistance dated 16.01.2017 2017-Jan-16 601KB
346 Order of Annual Increments of CDSCO (HQ) Officials dated 06.01.2017 2017-Jan-06 847KB
347 Notice for Import of Radiopharmaceutical Products dated 03.01.2017 2017-Jan-06 29.4KB
348 List of clarifications and NOC issued from 2011 to 2017 2017-Jan-02 901kb
349 Document required for approval of BA-BE center 2017-Jan-01 58kb
350 Notice for Import of Radiopharmaceutical Products 2016-Dec-29 50.7kb
351 Notice 26.12.2016 2016-Dec-26 1.20MB
352 Notice Creation of Sub-login id(s) after primary registration in SUGAM portal 2016-Dec-21 283KB
353 Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach 2016-Dec-20 304KB
354 Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated 20.12.2016 2016-Dec-20 290KB
355 Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis for biological products ( Vaccine & r-DNA Products) 2016-Dec-13 476Kb
356 Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change 2016-Dec-13 269KB
357 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
358 Order: Timeline for communication of recommendation to the stakeholders based on the minutes of meeting of various Committees 2016-Dec-13 229KB
359 Notice Order regarding e-Governance project of CDSCO 2016-Dec-02 156KB
360 Pharmacovigilance Skill Development Programme 2016-Nov-28 101KB
361 Office Memorandum regarding clarification the receipt in G.R6 G.R 7 for payment made through Bharatosk 2016-Nov-21 337KB
362 Notice regarding NABL accredited Drug Testing Laboratories and Manufacturing Units certified withWHO-GMP for COPP 2016-Nov-11 216KB
363 Notice regarding Risk based inspections of the manufacturing facilities regarding 2016-Nov-09 29KB
364 Notice regarding D-Penicillamine Capsule 2016-Nov-08 260KB
365 Notice inviting quotation to dispose off unserviceable articles materials in CDL Kolkata Dated 08.11.2016 2016-Nov-08 714KB
366 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
367 Office memorandum regarding approval of the safety and efficacy of FDCs 2016-Oct-26 320KB
368 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
369 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
370 Notice Order 2016-Oct-06 729KB
371 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
372 Minutes of Meeting held on 30.09.2016 regarding the availabity of D-Penicillamine across India-Regarding 2016-Sep-30 17KB
373 Non availability of life saving drug(D-Penicillamine) across India-Regarding 2016-Sep-28 43KB
374 Notice regarding SUGAM Online 2016-Sep-21 1,820KB
375 Meeting notice of Vaccine manufacturers to discuss upon forthcoming NRA assesment and its tools 2016-Sep-21 576KB
376 Presentation for Rabies Vaccine 2016-Sep-08 219KB
377 Presentation for Rabies Vaccine- regarding 2016-Sep-08 218KB
378 Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. 2016-Sep-05 45KB
379 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
380 Notice regarding Upgradation of Skill sets of persons employed in pharma manufacturing units 2016-Aug-26 638KB
381 Notice regarding checklist 2016-Aug-23 292KB
382 Notice regarding for online BA/BE for Export 2016-Aug-22 1,290KB
383 Notice regarding on "online Process for Grant of NOC for clinical Trials" 2016-Aug-18 267KB
384 Public Notice regarding online portal SUGAM 2016-Aug-08 282KB
385 Order regarding the revised transfer policy of Drugs Inspectors 2016-Aug-03 796KB
386 Notice ande Feedback 2016-Aug-01 1,090KB
387 Notice regarding meeting 12 july 2016 CDSCO 2016-Jul-05 302KB
388 Notice regarding transfer folicy for the officers/ Officials of CDSCO 2016-Jun-24 290KB
389 Notice regarding Examination for safety and Efficacy of FDCs 2016-Jun-17 310KB
390 Notice regarding not attending SEC Meeting 2016-Jun-15 350KB
391 Alert Notice 2016-Jun-09 327KB
392 Notice regarding Cosmetics and Ethicss Committee on SUGAM 2016-Jun-07 317KB
393 Notice regarding Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
394 Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
395 Public Notice 2016-May-30 50KB
396 Notice dated 30.5.2016 regarding Launch of Registration of Cosmetics and Ethics Committee Modules in Sugam Portal 2016-May-30 487KB
397 Notice for dated 27.05.2016 regarding Launch of Test License Module in Sugam Portal 2016-May-27 630KB
398 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
399 Meeting Notice for medical devices and diagnostics stakeholders 2016-May-23 84KB
400 Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002 2016-May-20 94KB
401 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
402 Notice regarding documents for applying as subject experts in various panels of CDSCO 2016-May-10 1,220KB
403 Notice dated 09.05.2016 regarding Sugam Online Medical Devices 2016-May-09 264KB
404 Notice inviting comments / Suggestions of Pharma and Medical Device Associations for Brining in ease of Drug Regulation 2016-May-06 184KB
405 Extending the validity of Free Sale certificate for notified medical devices 2016-Apr-21 650KB
406 Notice regarding Pending status 2016-Apr-08 162KB
407 Delhi High Court order dated 4.4.2016 for information of all concerned 2016-Apr-04 1,510KB
408 Notice regarding Gelatin Capsules with cellulose 2016-Mar-30 18KB
409 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
410 Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics 2016 2016-Mar-26 48KB
411 Notice regarding Preparation for global switch from tOPV to bOPV, 2016 2016-Mar-23 174KB
412 Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016 2016-Mar-23 173KB
413 Meeting Notice 2016-Mar-21 658KB
414 Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs & Cosmetics Act, 1940 2016-Mar-12 147KB
415 Notice Track and Trace for Pharmaceutical Drug consignment 2016-Mar-07 150KB
416 Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics 2016-Mar-04 673KB
417 Notice regarding Creation of Speical Assistance Booth for addressing issues of submission of online applications 2016-Mar-04 629KB
418 Notice Regarding Online Portal Sugam 2016-Feb-18 714KB
419 Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen 2016-Feb-16 54KB
420 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
421 Sale of Drugs over Internet contravening the provisions of Drugs and Cosmetics Rules, 1945 2015-Dec-30 973KB
422 Clearance of Import and Export Consignments at Ports/Airports/Others Points 2015-Dec-29 310KB
423 National List of Essential Medicines (NLEM), 2015 2015-Dec-23 124KB
424 Notice 2015-Dec-11 269KB
425 Clarification for import of in Bulk form in Sutures 2015-Dec-08 258kb
426 Donation of organ(s) and/or tissues after being declared brain stem dead 2015-Nov-20 320KB
427 Public Notice 2015-Nov-19 230KB
428 Public Notice 2015-Sep-21 380KB
429 Notice Dated 17.09.2015 Format for MOU 2015-Sep-17 243KB
430 Notice Dated 11.09.2015 regarding DTAB 2015-Sep-11 707KB
431 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
432 Office Order 25.08.2015 regarding Parameter for writing and review of APAR's 2015-Aug-25 270KB
433 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
434 Notice 2015-Aug-11 312KB
435 Transfer order 2015-Jul-09 781KB
436 Relieving order of ADC(I) 2015-Jul-09 550KB
437 Office Order for Old Drugs TL BA/BE (export) 2015-Jul-03 366KB
438 Reminder 2015-May-12 52KB
439 Office Order 2015-Apr-17 54KB
440 Office Memorandum Nomination of representatives for e-governance 2015-Mar-26 62KB
441 Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue 2015-Feb-14 294KB
442 Office Memorandum Grant of NOC for procuring unapproved/Approved New Drug 2015-Feb-13 494KB
443 Circular 2015-Feb-03 291KB
444 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
445 Meeting of all Vaccine Manufacutres & Importers on 15th January 2015 2014-Dec-26 513KB
446 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
447 Notice dated 10.12.2014 2014-Dec-10 411KB
448 Notice 2014-Nov-10 35KB
449 Corrigendum 2014-Nov-10 21KB
450 Office order 2014-Oct-21 738KB
451 Office Order 2014-Oct-16 84KB
452 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
453 Office Memorandum dated 29.09.2014 reg. Relabeling or stickering on the label of cosmetics 2014-Sep-29 320KB
454 Notice 17 September 2014 2014-Sep-17 100KB
455 CBBBTDEC Meeting Shedule for Year 2014-2015 2014-Sep-12 31KB
456 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
457 Office order 29.08.2014 draft list of approved products for Veterinary drugs 2014-Aug-29 41KB
458 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
459 Letter for States regarding Regulatory Inspection Procedure 2014-Aug-06 148KB
460 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
461 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
462 Notice dated 7.07.2014 Hearing for redressal of Public Grievance 2014-Jul-07 222KB
463 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
464 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
465 Office Order dated 03.07.2014 - Approval of academic CT 2014-Jul-03 146KB
466 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
467 Office Order dated 03.07.2014 - Consideration of banning of a marketed drug 2014-Jul-03 145KB
468 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
469 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
470 Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs 2014-Jul-03 211KB
471 Office Order dated 03.07.2014 - Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies 2014-Jul-03 198KB
472 Office Order dated 03.07.2014 - Requirement for filing of application to market new Chemical Entities 2014-Jul-03 175KB
473 Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects 2014-Jul-03 156KB
474 Office Order dated 03.07.2014 - Procedure for review of application of CT and New drugs 2014-Jul-03 205KB
475 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
476 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
477 Office Order dated 27.6.2014 Daily Public hearing of respective division 2014-Jun-27 283KB
478 IVD Office Order 2014-Jun-24 1436 KB
479 Office Order dated 06.05.2014 reg. Constitution of Antimalarial Cell in CDSCO (HQ) 2014-May-06 287KB
480 Office Memorandum 2014-Mar-28 415KB
481 Inclusion of Schedule H1 under the Drugs and Cosmetics Rules Dated 19.03.2014 2014-Mar-19 340KB
482 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
483 Office Memorandum 2014-Mar-05 312KB
484 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
485 Notice Regarding Approvals of Stem Cells and Cell Based Products Dated 18.02.2014 2014-Feb-18 493KB
486 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
487 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
488 Notce 2014-Feb-13 297KB
489 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
490 Delegation of the Powers- Import of Small Quantities of Drugs for Personal Use 2014-Feb-12 462KB
491 Veterinary Cell Office Order 2014-Feb-07 251KB
492 Public Information Cell 2014-Feb-07 276KB
493 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv 2014-Feb-01 327kb
494 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-25 294kb
495 Notice-Meeting of the Pharmaceuticals Industry Associations 2014-Jan-07 256KB
496 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-04 140 KB
497 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
498 Notice Ethic Committee Clinical trial 2013-Jul-30 317KB
499 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
500 Office Order:-Constitution of High Powered Committee for the regulation of stem cell 2013-Jun-03 555KB
501 Delegation of powers of Licensing Authority under Rule 22 of Drugs & Cosmetics Rules 2013-May-23 343KB
502 Notice dated 08.05.2013: Clarification sought by the stakeholders 2013-May-08 312KB
503 Notice dated 10.04.2013 regarding prioritisation of activities at CDSCO 2013-Apr-10 420KB
504 Office Order dated 09.04.2013: International Cell in CDSCO(HQ) 2013-Apr-09 290KB
505 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
506 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
507 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
508 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
509 Notice - clarification and requirements related to post approval changes as per CDSCO Guidance for industry for biological products 2013-Jan-18 603KB
510 Notice - dated 17.01.2013: Admn 2013-Jan-17 285KB
511 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
512 Notice-dated 13.12.2012: DRUG ALERT 2012-Dec-13 378KB
513 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
514 Notice-dated 03.12.2012: Group A Officer of CDSCO issued by Ministry of Health. 2012-Dec-03 284KB
515 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
516 Office Order-dated 21.11.12: Delegation of power to CDSCO (NZ) Ghaziabad. 2012-Nov-21 311KB
517 E.U-API - Written Confirmations Certificate 2012-Nov-12 411KB
518 Clarification-dated 12.11.12: Directions issued under Section 33P of D & C Act 1940. 2012-Nov-12 1,070KB
519 Notice-dated 29.10.12: Interactive meeting with stakeholders. 2012-Oct-29 293KB
520 Notice-dated 29.10.12: CDSCO Sr. Officers Meeting. 2012-Oct-29 239KB
521 Notice-dated 12.10.2012: Directions issued under Section 33P of D & C Act 1940. 2012-Oct-12 1,220KB
522 Notice-dated 01.10.2012 : Extension of implementations of GSR No. 426(E) dt 19.05.2010 2012-Oct-01 101KB
523 Notice-dated 14.09.2012: Fake drug menace in India. 2012-Sep-14 316KB
524 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
525 Notice-dated 28.08.2012: Expansion of Experts panel for evaluation of application of New Drugs etc. 2012-Aug-28 1,260KB
526 Office Order-dated 28.08.2012: Submission of Periodic Safety Update Reports (PSURs). 2012-Aug-28 528KB
527 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
528 Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012 2012-Jul-13 201 KB
529 Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices 2012-Mar-05 74 KB
530 MISCELLANEOUS ORDER 2012-Feb-17 118 KB
531 REPRODUCTIVE & UROLOGY ORDER 2012-Feb-17 123 KB
532 ORTHOPAEDIC ORDER 2012-Feb-17 127 KB
533 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 KB
534 Advisory notice on clinical trial 2012-Feb-17 1273 KB
535 GENERAL ORDER 2012-Feb-17 140 KB
536 Clarification to Office Order dated 21.11.2011 for Pre Screening of Applications. 2011-Nov-21 57KB
537 Office Order- dated 21.11.2011: For Pre Screening Applications 2011-Nov-21 45KB
538 Office Order-dated 08.11.2011: Public Hearing and Monitoring Cell. 2011-Nov-08 346KB
539 Clarification for import of pre-filled syringe 2011-Nov-07 282kb
540 Office Order-dated 04.11.2011: Constitution of Special Public Hearing and monitoring cell. 2011-Nov-04 367KB
541 Clarification on regulation of staplers 2011-Oct-04 54kb
542 Office Memorandum-dated 16.08.2011: Monitoring of functioning of all Port Offices of CDSCO. 2011-Aug-16 55KB
543 Office Order-dated 01.06.2011 regarding delegation of powers to Zonal Officer of CDSCO. 2011-Jun-01 74KB
544 MDAC of General Expert Pool 2011-May-10 140 KB
545 MDAC Miscellaneous Devices 2011-May-10 118 KB
546 MDAC of Ophthalmic 2011-May-10 126 KB
547 MDAC Cardiovascular order dated 10 May 2011 2011-May-10 129 KB
548 MDAC of Orthopedic 2011-May-10 127 KB
549 MDAC of Reporductive and Urology 2011-May-10 123 KB
550 MDAC Dental 2011-May-10 119 KB
551 Clarification with respect of the manufacturing and marketing of New Drugs 2011-Mar-10 300 KB
552 DENTAL ORDER 2011-Feb-17 119 KB
553 CARDIOVASCULAR ORDER 2011-Feb-17 129 KB
554 OPHTHALMIC ORDER 2011-Feb-17 126 KB
555 Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) 2010-Sep-01 1248 KB
556 Testing of Biochemical kits for estimation of glucose 2010-Aug-26 133 KB
557 List of Notified Medical devices 2010-Apr-20 85 KB