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 09.11.2020 2020-Nov-09 489 KB
2 PCR Kits approved for testing of Covid-19 as on 09.11.2020 2020-Nov-09 413 KB
3 Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central Government officicals regarding 2020-Oct-12 1038 KB
4 Notice regarding List of medical devices testing Laboratory 2020-Oct-09 2927 KB
5 Notice for Vaccine Guidelines dated 21 Sept 2020 2020-Sep-21 392 KB
6 Regulatory guidelines for development of Vaccine 21.09.2020 2020-Sep-21 801 KB
7 Notice regarding documents required for the Import 2020-Sep-17 516 KB
8 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
9 Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices 2020-Sep-03 301 KB
10 Notice regarding classification of non notified medical devices 2020-Sep-03 613 KB
11 Notice regarding classification of non notified medical devices1 2020-Sep-03 12557 KB
12 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
13 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
14 Notice regarding Approved panel of experts for the Subject Expert Committees 2020-Aug-28 20279 KB
15 Submission of notarized/ apostilled documents for import and Registration of cosmetics in view of COVID-19 2020-Aug-19 279 KB
16 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
17 Approval of Favipiravir Tablets to Glenmark Pharmaceuticals and Remdesivir Injection to Cipla Ltd, Hetero Drugs and Mylan Labs 2020-Jul-02 410 KB
18 Information on convalescent plasma in Covid 19 2020-Jul-01 123 KB
19 Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose 2020-Jun-19 368 KB
20 Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19 2020-Jun-09 599 KB
21 GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS 2020-Jun-04 2174 KB
22 Radpid Response Regulatory Framework for COVID-19 vaccine development 2020-May-26 9005 KB
23 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
24 ICMR Convalescent plasma _protocol_v1.5.pdf 2020-May-11 276 KB
25 Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP) 2020-May-01 265 KB
26 Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April 2020-Apr-27 746 KB
27 Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19 2020-Apr-23 307 KB
28 amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent plasma_protocol_v1.4 2020-Apr-22 214 KB
29 Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of COVID 19 2020-Apr-20 313 KB
30 Clinical trial of convalescent plasma in COVID-19 Patients 2020-Apr-17 634 KB
31 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
32 Office Memorandum on COVID-19 2020-Apr-16 1786 KB
33 Submmission of notarized/apostilled documents for import and Registration of drugs in view of COVID 19 2020-Apr-15 284 KB
34 Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19 2020-Apr-07 424 KB
35 Public notice alerting about unlicensed kit of Bione for corona testing displayed on their website for sale 2020-Apr-05 235 KB
36 Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 2020-Mar-30 602 KB
37 Release of consignments of Vaccine and critical IVDs-certain instructions issued 2020-Mar-25 311 KB
38 Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes 2020-Mar-24 33 KB
39 Notice regarding COVID-19 outbreak 2020-Mar-23 833 KB
40 OM on Rapid Response Regulatory Framework for COVID-19 2020-Mar-20 611 KB
41 Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19 2020-Mar-19 453 KB
42 Notice regarding Measures to contain spread of COVID-19 2020-Mar-19 313 KB
43 Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19 2020-Mar-19 441 KB
44 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
45 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
46 Requirement of CMC documents for approval of additional indication of an already drug product 2020-Mar-13 45 KB
47 Testing of all categories of new drugs for their approval 2020-Mar-13 47 KB
48 Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. 2020-Mar-13 52 KB
49 Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. 2020-Mar-13 43 KB
50 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
51 Submission and processing of application for Registration Certificate and import License in parallel with New Drug application 2020-Feb-26 333 KB
52 Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) 2020-Feb-24 849 KB
53 Notice regarding Approval of FDCs Containing new drugs 2020-Feb-21 312 KB
54 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
55 Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export 2020-Feb-21 350 KB
56 Notice regarding Stability data for BA/BE study in Human for export 2020-Feb-21 384 KB
57 Notice regarding requirement of stability data of COPP 2020-Feb-21 346 KB
58 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
59 Notice regarding Pre-submission meeting 2020-Feb-21 300 KB
60 Notice regarding Permission to conduct BA/BE study and clinical trial 2020-Feb-21 346 KB
61 Notice regarding Fixing of limit of impurities in the specification of INDs 2020-Feb-21 347 KB
62 Notice Consideration of the direction of Hon'ble Supreme Court of India in the case of 294 FDCs regarding 2020-Feb-20 352 KB
63 Grant of License in Form 29 under the Drugs and Cosmetics Rules 1945 dated 20/2/2020 2020-Feb-20 366 KB
64 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
65 Targeted interanl timeline for processing and disposal of application by CDSCO 2020-Feb-20 1546 KB
66 Notice regarding New Drugs dated 18.02.2020 2020-Feb-18 943 KB
67 Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 2020-Feb-18 893 KB
68 PRO details of all Zones/Sub Zones 2020-Feb-13 619 KB
69 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
70 Draft of the Drugs and Magic Remedies objectional Advertisments Amendment Bill 2020 2020-Feb-03 233 KB
71 Notice regarding PRO Veterinary Division 31 jan 2020 2020-Jan-31 323 KB
72 Notices/Circular /Advisory regarding schedule H, H1 C & X 2020-Jan-31 2230 KB
73 Notice PRO 2020-Jan-31 313 KB
74 Publice Notice from veterinary Division 2020-Jan-31 320 KB
75 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
76 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
77 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
78 Notice regarding List of Reference Products for conduct of BE Study 2020-Jan-22 172 KB
79 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses/Permits/Certificates/Other Authorizations (LPCOs) by PGAs 2020-Jan-07 2252 KB
80 Office order dated 03.01.2019 2020-Jan-03 355 KB
81 DCGI New Year Massage for 2020 2019-Dec-31 237 KB
82 List of Notified Bodies registered with CDSCO under MDR-2017 2019-Dec-30 670 KB
83 Office Order PRO at CDSCO Zonal/Sub Zonal Office 12 Dec 2019 2019-Dec-12 704 KB
84 Setting of Public Relations Office at all Zonal and Sub-Zonal Office of CDSCO 2019-Dec-11 700 KB
85 Procedure for regularisation of FDCs w.r.t. payment of fees regarding 2019-Dec-05 345 KB
86 Public Notice regarding pharmacovigilance reporting for veterinary products in India 2019-Dec-02 264 KB
87 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
88 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
89 Strengthening of Materiovigilance Programme of India (MvPI) in the country 2019-Nov-26 56 KB
90 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
91 Notice regarding equipments which are non notified but associated with notified devices 2019-Nov-13 226 KB
92 Notice regarding environmental conditions for equipments 2019-Nov-08 235 KB
93 Notice regarding exemption of drugs Sale License 2019-Nov-08 235 KB
94 Notice regarding all implantable devices 2019-Nov-08 252 KB
95 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
96 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
97 Notice regarding Monitoring the end use of drugs which are meant for dual use 2019-Oct-18 352 KB
98 Notice dated 18-10-2019 2019-Oct-18 470 KB
99 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
100 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-09 2,653KB
101 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
102 Public Notice regarding PRO divisions wise schedule dated 04-10-2019 2019-Oct-04 248 KB
103 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
104 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
105 Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet-regarding 2019-Sep-19 503 KB
106 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
107 Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case of 294 FDCs 2019-Aug-27 233 KB
108 dvisory to follow the Apprentices Act, 1961-Regarding 2019-Aug-26 66 KB
109 Public Notice regarding payment of fees through Bharatkosh Portal alongwith the application for grant of various licences/Permission 2019-Aug-26 319 KB
110 Additional FAQ on New Drugs and Clinical Trial Rules, 2019 2019-Aug-23 152 KB
111 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
112 Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP) 2019-Aug-08 516 KB
113 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
114 List of Notified Bodies registered with CDSCO under MDR 2017 2019-Jul-31 526 KB
115 Public notice for online filing of applications for veterinary drugs 2019-Jul-29 280 KB
116 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
117 First Stakeholders National Consultation meeting of SNCM on 25th_july 2019 at ICMR New Delhi 2019-Jul-19 88 KB
118 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
119 Simplified auto-registration of beneficiaries (IEC holders) on ICEGATE for e-SANCHIT and other benefits 2019-Jun-25 2365 KB
120 Advisory to all Indian Pharmaceutical Industry Associations 2019-Jun-25 52 KB
121 Order regarding Luxury Lifestyle on 17.06.2019 2019-Jun-17 636 KB
122 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
123 National List of Essential Medicines 2015 2019-Jun-11 1717 KB
124 Details of IECGSTN code of all the beneficiaries (Stakeholders Importers Exporters Customs House Brokers)-Reg 2019-Jun-11 475 KB
125 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
126 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
127 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
128 Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs 2019-May-15 2021 KB
129 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
130 Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials 2019-Apr-26 478 KB
131 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
132 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs-regarding 2019-Apr-12 7,670KB
133 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
134 Notice Uploading of applications through Sugam Portal in accordance with New Drugs and Clinical Trials Rules 2019 2019-Apr-10 471 KB
135 FEEDBACK FORM to CDSCO (HQ) on the performance of PRO to improve the quality of services 2019-Apr-03 96 KB
136 Meeting Notice regarding Meeting with stakeholders for discussion on Zero Draft of new Veterinary Rules 2019-Apr-03 376 KB
137 Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131 2019-Apr-01 2894 KB
138 Cancellation of Registration Certificate No. SVH-101 and Import License SVH-101-112 2019-Apr-01 3016 KB
139 Order M/s Hasan Trading Inc Chennai 2019-Mar-29 546 KB
140 Order M/s united Distributors Incoporation 2019-Mar-29 538 KB
141 Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone sublingual tablets 2019-Mar-28 1098 KB
142 Safety warning for SGLT2 Inhibitors 2019-Mar-25 9560 KB
143 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
144 Draft Guidelines for Evaluation of Nanopharmaceuticals in India 2019-Mar-07 31990 KB
145 Import of duplicate product Siso Hair Color Shampoo regarding 2019-Mar-07 328 KB
146 Notice regarding of the goods to be disposed 28 February 2019 2019-Feb-28 290 KB
147 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
148 Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide 2019-Feb-25 1430 KB
149 Cancellation of Cosmetics Registration certificate No. RC/Cos-000107 M/s Aurelia International Pvt Ltd 2019-Feb-19 422 KB
150 Payment of Challan through Bharatkosh 15.02.2018 2019-Feb-15 287 KB
151 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
152 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
153 Meeting Notice regarding Issues related to payment of Challan through Bharatkosh 2019-Feb-11 397 KB
154 Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of LicensesPermitsCertificatesOther Authorizations (LPCOs) by PGAs 2019-Jan-29 1004 KB
155 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
156 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
157 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
158 Payment of Challan through Bharatkosh 2019-Jan-09 328 KB
159 Condemnation/Disposal of Wooden/Steel junks 2019-Jan-08 209 KB
160 DCG(I) New Year Message 2019 2018-Dec-31 313 KB
161 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
162 Disposal of unserviceable/obsolete item of CDSCO dated 21.12.2018 2018-Dec-21 322 KB
163 Safety guidelines for Isotretinoin dated 19.12.2018 2018-Dec-19 403 KB
164 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
165 Notice regarding sale of medicines without prescription 2018-Dec-15 84 KB
166 Office Memorandum dated 14.12.2018 (Ms. Galderma India) 2018-Dec-14 318 KB
167 Order (Skin Aesthetics) 2018-Dec-14 568 KB
168 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
169 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
170 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
171 Meeting Notice related to Draft Guidance for Industry Document for Veterinary Biologicals 2018-Dec-06 313
172 Feedback Form (Annexure-I) for Medical Device online portal 2018-Dec-05 14 KB
173 Feedback Form (Annexure-I) for SUGAM online portal 2018-Dec-05 14 KB
174 Public Notice for feedback on SUGAM Online Portal 2018-Dec-05 326 KB
175 Public Notice for feedback on Medical Device Online Portal 2018-Dec-05 325 KB
176 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
177 Health Ministry approves compensation formula for Hip implant cases 2018-Nov-29 157 KB
178 Notice regarding Implementation of e-Governance has launched an online protal SUGAM dated 29.11.2018 2018-Nov-29 292 KB
179 Notice regarding Uploading data of drug manufacturing facilities and approved drug formulations on SUGAM Portal dated 29.11.2018 2018-Nov-29 440 KB
180 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
181 Application Form for Compensation-DePuy J &J ASR Hip Implant 2018-Nov-20 168KB
182 Application form for Compensation-DePuy_Johnson 2018-Nov-15 118 KB
183 Notice- Inviting, any objections / suggestion on the Draft Rules as New Drugs and Clinical Trials Rules, 2018 2018-Nov-14 53 KB
184 To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants 2018-Nov-08 439 KB
185 Order SAE dated 29.10.2018 2018-Oct-29 61 KB
186 Order regarding receipt related to SAE of Clinical Trials 2018-Oct-25 2,210KB
187 PUBLIC NOTICE Video Conferencing Facility for promotion of innovation & start up business in Pharmaceutical sector 2018-Oct-03 559 KB
188 Advertisement of ADI 2018-Sep-30 425 KB
189 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
190 Notice-27.09.2018_Draft Pharmacovigilance System Inspection Guideline 2018-Sep-27 1567 KB
191 Draft Guidelines on Good Distribution Practices for Pharmaceutical Products 2018-Sep-25 2623 KB
192 Notice regarding sugam blood products dated 19.09.2018 2018-Sep-19 265 KB
193 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
194 Public notice related to ASR Hip Implants 2018-Sep-11 400 KB
195 Renaming of Central Drugs Standard Control Organization dated 06.09.2018 2018-Sep-07 496 KB
196 Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K 2018-Aug-30 72 KB
197 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
198 Notice for meeting of stake holders-Regarding ONLINE SUGAM PORTAL for blood product 2018-Aug-08 261 KB
199 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
200 Notice regarding list of Notified Bodies registered with CDSCO under MDR 2017 dated 06.08.2018 2018-Aug-06 328 KB
201 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
202 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
203 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
204 Notice regarding mandatory Ethics committee registration through SUGAM portal 2018-Aug-01 2,281,472 KB
205 Notice regarding Ethics committee registration through SUGAM portal 2018-Aug-01 2,170KB
206 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
207 Public Notice regarding Promotion of Innovation Startup business in India in Pharmaceutical sector 2018-Jul-20 700 KB
208 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
209 Public Notice for comments on proposed notification 2018-Jun-25 33KB
210 Office Memorandum 2018-Jun-14 333KB
211 Providing a separate shelf/rack for generic medicines in retail shops visible to the consumers 2018-Jun-12 495KB
212 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
213 Revised List of Oxytocin Manufacturer 2018-Jun-11 425KB
214 Publication of Gazette Notification of Drugs Inspectors in CDSCO under Section 21 of Drugs & Cosmetic Act, 1940-reg 2018-Jun-08 70KB
215 Constitution of India Drug/Pharamacueticals Association Forum-Reg. 2018-Jun-08 345KB
216 DTAB Committee Meeting from 5 June,2018 till 22 June,2018 2018-Jun-06 302KB
217 Minutes of the meeting of 14th CBBDTEC 2018-Jun-05 2,853KB
218 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
219 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
220 Office Order Disposal of matters referred by Public Relation Office, CDSCO (HQ) 2018-May-24 295KB
221 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
222 Office Memorandum regarding speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 666KB
223 Speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India 2018-May-21 671KB
224 Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO 2018-May-01 548KB
225 Notice regarding SUGAM for New Drugs FDC and SND 2018-Apr-27 372KB
226 Office Order regarding Public Relations Office at CDSCO (HQ) 2018-Apr-23 245KB
227 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
228 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
229 Name Of Approved Clinical Centres 2018-Apr-08 262kb
230 Notice regarding export NOC with respect to shipping Bills from the Port offices 2018-Mar-23 332KB
231 Grouping Guidelines for Medical Devices Applications 2018-Mar-16 1,984kb
232 Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum 2018-Mar-14 295KB
233 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
234 Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018 2018-Mar-07 310KB
235 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
236 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
237 Public Notice regarding Restriction on Import manufacture, sale and distribution of Oxytocin to curb its misuse 2018-Feb-27 572KB
238 rc & form 10 checklist 2018-Feb-23 170kb
239 Pre-screening checklist3 2018-Feb-23 158kb
240 FDC Guidelines _ Revised1 2018-Feb-23 422kb
241 notification 19-2015-2020 2018-Feb-23 422kb
242 Order regarding transfer of the Deputy Drug Controllers in CDSCO 2018-Feb-22 365KB
243 Office Memorandum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 346KB
244 Order regarding Drugs Inspector's/Technical officer's transfers 2018-Feb-20 931KB
245 Office Corrigendum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 204KB
246 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
247 Notice regarding Meeting of CDSCO with manufacturers of Oxytocin Formulation to discuss issue ralted to misuse of Oxytocin 2018-Feb-16 302KB
248 Office order regarding Grievance Redressal in CDSCO (HQ) 2018-Feb-13 304KB
249 List of meetings of Expert Committee for examination of vaccine PSUR 2018-Feb-09 7KB
250 Office Memorandum regarding Sampling of imported insuline formulations at port offices 2018-Feb-07 343KB
251 Order regarding creation of 'Ayush' vertical in CDSCO 2018-Feb-05 734KB
252 Office Memorandum regarding Rotational Transfer of CDSCO 2018-Jan-24 1.23MB
253 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
254 Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) 2018-Jan-22 875KB
255 Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis 2018-Jan-22 823KB
256 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
257 Office order regarding Import of Drugs by a Government Hospitals & Autonomus Medical Instituations under Form 11A 2018-Jan-02 205kb
258 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
259 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
260 Documents to be submitted for Bioequivalence Study for export applications 2018-Jan-01 92kb
261 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
262 Office order regarding SUGAM Portal of CDSCO 2017-Dec-11 180KB
263 Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh 2017-Dec-05 308kb
264 Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO 2017-Nov-21 1.96MB
265 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
266 Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices 2017-Oct-31 665KB
267 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
268 NOTICE regarding Adhering to Rule 28 and 28A of Drugs and Cosmetics Act and Rules 1945 2017-Sep-28 257KB
269 NOTICE regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Sep-22 586KB
270 NOTICE regarding not of Standard Quality of Mediclone D 2017-Sep-15 59.9KB
271 NOTICE regarding Not of Standard Quality Combipack ABD 2017-Sep-15 72.8KB
272 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
273 NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories 2017-Sep-12 566KB
274 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
275 NOTICE regading Supreme court hearing in the matters relating to FDC 2017-Sep-07 8.02MB
276 NOTICE regading suggestions/comments of the stakeholders including manufacturers/marketers of HPMC capsules 2017-Sep-05 257KB
277 NOTICE to all State Drugs Controller 2017-Aug-09 325KB
278 NOTICE to all Drugs Manufacturers and Pharmaceuticals Association 2017-Aug-09 311KB
279 NOTICE - regardingLaunch of export NOC module under SUGAM Portal 2017-Jul-26 316KB
280 NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) 2017-Jul-17 182KB
281 NOTICE - regarding availability of essential mediines following implementation of GST 2017-Jul-13 637KB
282 corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit 2017-Jul-12 41.9KB
283 NOTICE - regarding meeting of the stakeholders for feedback on new modules in SUGAM 2017-Jul-12 372kb
284 NOTICE - Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST) 2017-Jul-10 418KB
285 Notice Order regarding Import of Cosmetic division Sugam Online 2017-Jul-06 351KB
286 Notice Order regarding draft classification of Medical Devices and IVDs 2017-Jun-29 1.83MB
287 Notice Order regarding Streamlining the regulatory procedures 2017-Jun-27 212KB
288 Notice Order regarding Oseltamivir and Zanamivir 2017-Jun-22 1.14MB
289 Notice Order regarding address the grievances/ appeals 2017-Jun-22 642kb
290 Notice Order regarding address the grievances appeals dated 22.06.2017 2017-Jun-22 643KB
291 Notice regarding Draft SOP for handling of NSQ samples 2017-Jun-13 5.57KB
292 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
293 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
294 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
295 Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017 2017-May-30 279KB
296 Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) 2017-May-16 471KB
297 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
298 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
299 Order regarding import of Radio-pharmaceuticals 2017-May-01 1.98MB
300 Office Memo Issue of reports for testanalysis in form 13 on SUGAM Portal-regarding 2017-May-01 329KB
301 Order regarding radiopharmaceuticals 2017-Apr-28 818KB
302 NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi 2017-Apr-24 37.5KB
303 Notice regarding Meeting for the registration of notified body through online portal 2017-Apr-07 542KB
304 Public Notice regarding Price Control dated 06.04.2017 2017-Apr-06 578KB
305 Notice regarding creation of databases of drug manufacturing facilities and approved drug formulation of SUGAM portal 2017-Apr-03 386KB
306 Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 2017-Mar-31 250KB
307 Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 213KB
308 Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 287KB
309 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
310 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
311 Pubic Notice Notice regarding Public Consulatation Regarding Regulation of Sale of Drugs in the Country 2017-Mar-16 429KB
312 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
313 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
314 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
315 Office Memorandum Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 291KB
316 Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017 2017-Feb-17 9728 KB
317 Notice regarding Human Vaccines dated 15.02.2017 2017-Feb-15 59KB
318 Public Notice regarding D-Penicillamine 2017-Feb-10 44.6KB
319 Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06 271KB
320 Notice regarding Ease of doing Business relating to export of Drugs 2017-Feb-06 305KB
321 Notice regarding Medical Devices Rules,2017 Notification No. 78E 2017-Feb-02 23.0KB
322 Notice regarding Streamline the grievance 2017-Feb-02 362KB
323 Notice regarding Rational use of antibiotics for limiting antimicrobial dated 01.02.2017 2017-Feb-01 343KB
324 Notice regarding Rational use of antibiotics fro limiting antimicrobial reistance dated 01.02.2017 2017-Feb-01 348KB
325 Notice- Extension of last date for submission of application for Skill development programme on pharmacovigilance 2017-Jan-31 240KB
326 Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 2017-Jan-17 47.6KB
327 Notice with respect to Antimicrobial resistance dated 16.01.2017 2017-Jan-16 601KB
328 Order of Annual Increments of CDSCO (HQ) Officials dated 06.01.2017 2017-Jan-06 847KB
329 Notice for Import of Radiopharmaceutical Products dated 03.01.2017 2017-Jan-06 29.4KB
330 List of clarifications and NOC issued from 2011 to 2017 2017-Jan-02 901kb
331 Document required for approval of BA-BE center 2017-Jan-01 58kb
332 Notice for Import of Radiopharmaceutical Products 2016-Dec-29 50.7kb
333 Notice 26.12.2016 2016-Dec-26 1.20MB
334 Notice Creation of Sub-login id(s) after primary registration in SUGAM portal 2016-Dec-21 283KB
335 Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach 2016-Dec-20 304KB
336 Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated 20.12.2016 2016-Dec-20 290KB
337 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
338 Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis for biological products ( Vaccine & r-DNA Products) 2016-Dec-13 476Kb
339 Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change 2016-Dec-13 270KB
340 Order: Timeline for communication of recommendation to the stakeholders based on the minutes of meeting of various Committees 2016-Dec-13 229KB
341 Public Notice 2016-Dec-08 2.21MB
342 Notice Order regarding e-Governance project of CDSCO 2016-Dec-02 156KB
343 Pharmacovigilance Skill Development Programme 2016-Nov-28 101KB
344 Office Memorandum regarding clarification the receipt in G.R6 G.R 7 for payment made through Bharatosk 2016-Nov-21 337KB
345 Notice regarding NABL accredited Drug Testing Laboratories and Manufacturing Units certified withWHO-GMP for COPP 2016-Nov-11 216KB
346 Notice regarding Risk based inspections of the manufacturing facilities regarding 2016-Nov-09 29KB
347 Notice inviting quotation to dispose off unserviceable articles materials in CDL Kolkata Dated 08.11.2016 2016-Nov-08 714KB
348 Notice regarding D-Penicillamine Capsule 2016-Nov-08 260KB
349 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
350 Office memorandum regarding approval of the safety and efficacy of FDCs 2016-Oct-26 320KB
351 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
352 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
353 Notice Order 2016-Oct-06 729KB
354 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
355 Minutes of Meeting held on 30.09.2016 regarding the availabity of D-Penicillamine across India-Regarding 2016-Sep-30 17KB
356 Non availability of life saving drug(D-Penicillamine) across India-Regarding 2016-Sep-28 43KB
357 Notice regarding SUGAM Online 2016-Sep-21 1,820KB
358 Meeting notice of Vaccine manufacturers to discuss upon forthcoming NRA assesment and its tools 2016-Sep-21 576KB
359 Presentation for Rabies Vaccine- regarding 2016-Sep-08 218KB
360 Presentation for Rabies Vaccine 2016-Sep-08 219KB
361 Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. 2016-Sep-05 45KB
362 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
363 Notice regarding Upgradation of Skill sets of persons employed in pharma manufacturing units 2016-Aug-26 638KB
364 Notice regarding checklist 2016-Aug-23 292KB
365 Notice regarding for online BA/BE for Export 2016-Aug-22 1,290KB
366 Notice regarding on "online Process for Grant of NOC for clinical Trials" 2016-Aug-18 267KB
367 Public Notice regarding online portal SUGAM 2016-Aug-08 282KB
368 Order regarding the revised transfer policy of Drugs Inspectors 2016-Aug-03 796KB
369 Notice ande Feedback 2016-Aug-01 1,090KB
370 Notice regarding meeting 12 july 2016 CDSCO 2016-Jul-05 302KB
371 Notice regarding transfer folicy for the officers/ Officials of CDSCO 2016-Jun-24 290KB
372 Notice regarding Examination for safety and Efficacy of FDCs 2016-Jun-17 310KB
373 Notice regarding not attending SEC Meeting 2016-Jun-15 350KB
374 Alert Notice 2016-Jun-09 327KB
375 Notice regarding Cosmetics and Ethicss Committee on SUGAM 2016-Jun-07 317KB
376 Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
377 Notice regarding Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 2016-Jun-06 225KB
378 Notice dated 30.5.2016 regarding Launch of Registration of Cosmetics and Ethics Committee Modules in Sugam Portal 2016-May-30 487KB
379 Public Notice 2016-May-30 50KB
380 Notice for dated 27.05.2016 regarding Launch of Test License Module in Sugam Portal 2016-May-27 630KB
381 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
382 Meeting Notice for medical devices and diagnostics stakeholders 2016-May-23 84KB
383 Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002 2016-May-20 94KB
384 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
385 Notice regarding documents for applying as subject experts in various panels of CDSCO 2016-May-10 1,220KB
386 Notice dated 09.05.2016 regarding Sugam Online Medical Devices 2016-May-09 264KB
387 Notice inviting comments / Suggestions of Pharma and Medical Device Associations for Brining in ease of Drug Regulation 2016-May-06 184KB
388 Extending the validity of Free Sale certificate for notified medical devices 2016-Apr-21 650KB
389 Notice regarding Pending status 2016-Apr-08 162KB
390 Delhi High Court order dated 4.4.2016 for information of all concerned 2016-Apr-04 1,510KB
391 Notice regarding Gelatin Capsules with cellulose 2016-Mar-30 18KB
392 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
393 Notice 2016-Mar-29 708KB
394 Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics 2016 2016-Mar-26 48KB
395 Notice regarding Preparation for global switch from tOPV to bOPV, 2016 2016-Mar-23 174KB
396 Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016 2016-Mar-23 173KB
397 Meeting Notice 2016-Mar-21 658KB
398 Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs & Cosmetics Act, 1940 2016-Mar-12 147KB
399 Notice Track and Trace for Pharmaceutical Drug consignment 2016-Mar-07 150KB
400 Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics 2016-Mar-04 673KB
401 Notice regarding Creation of Speical Assistance Booth for addressing issues of submission of online applications 2016-Mar-04 629KB
402 Notice 2016-Mar-03 780KB
403 Notice Regarding Online Portal Sugam 2016-Feb-18 714KB
404 Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen 2016-Feb-16 54KB
405 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
406 Sale of Drugs over Internet contravening the provisions of Drugs and Cosmetics Rules, 1945 2015-Dec-30 973KB
407 Clearance of Import and Export Consignments at Ports/Airports/Others Points 2015-Dec-29 310KB
408 National List of Essential Medicines (NLEM), 2015 2015-Dec-23 124KB
409 Clarification for import of in Bulk form in Sutures 2015-Dec-08 258kb
410 Donation of organ(s) and/or tissues after being declared brain stem dead 2015-Nov-20 320KB
411 Public Notice 2015-Sep-21 380KB
412 Notice Dated 17.09.2015 Format for MOU 2015-Sep-17 243KB
413 Notice Dated 11.09.2015 regarding DTAB 2015-Sep-11 707KB
414 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
415 Office Order 25.08.2015 regarding Parameter for writing and review of APAR's 2015-Aug-25 270KB
416 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
417 Notice 2015-Aug-11 312KB
418 Relieving order of ADC(I) 2015-Jul-09 550KB
419 Transfer order 2015-Jul-09 781KB
420 Office Order for Old Drugs TL BA/BE (export) 2015-Jul-03 366KB
421 Reminder 2015-May-12 52KB
422 Office Memorandum Nomination of representatives for e-governance 2015-Mar-26 62KB
423 Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue 2015-Feb-14 294KB
424 Office Memorandum Grant of NOC for procuring unapproved/Approved New Drug 2015-Feb-13 494KB
425 Circular 2015-Feb-03 291KB
426 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
427 Meeting of all Vaccine Manufacutres & Importers on 15th January 2015 2014-Dec-26 513KB
428 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
429 Notice dated 10.12.2014 2014-Dec-10 411KB
430 Corrigendum 2014-Nov-10 21KB
431 Office order 2014-Oct-21 738KB
432 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
433 Office Memorandum dated 29.09.2014 reg. Relabeling or stickering on the label of cosmetics 2014-Sep-29 320KB
434 Notice 17 September 2014 2014-Sep-17 100KB
435 CBBBTDEC Meeting Shedule for Year 2014-2015 2014-Sep-12 31KB
436 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
437 Office Memorandum 2014-Sep-04 317KB
438 Office order 29.08.2014 draft list of approved products for Veterinary drugs 2014-Aug-29 41KB
439 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
440 Letter for States regarding Regulatory Inspection Procedure 2014-Aug-06 148KB
441 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
442 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
443 Notice dated 7.07.2014 Hearing for redressal of Public Grievance 2014-Jul-07 222KB
444 Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects 2014-Jul-03 156KB
445 Office Order dated 03.07.2014 - Requirement for filing of application to market new Chemical Entities 2014-Jul-03 175KB
446 Office Order dated 03.07.2014 - Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies 2014-Jul-03 198KB
447 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
448 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
449 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
450 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
451 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
452 Office Order dated 03.07.2014 - Approval of academic CT 2014-Jul-03 146KB
453 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
454 Office Order dated 03.07.2014 - Consideration of banning of a marketed drug 2014-Jul-03 145KB
455 Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs 2014-Jul-03 211KB
456 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
457 Office Order dated 03.07.2014 - Procedure for review of application of CT and New drugs 2014-Jul-03 205KB
458 Office Order dated 27.6.2014 Daily Public hearing of respective division 2014-Jun-27 283KB
459 IVD Office Order 2014-Jun-24 1436 KB
460 Office Order dated 06.05.2014 reg. Constitution of Antimalarial Cell in CDSCO (HQ) 2014-May-06 287KB
461 Inclusion of Schedule H1 under the Drugs and Cosmetics Rules Dated 19.03.2014 2014-Mar-19 340KB
462 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
463 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
464 Notice Regarding Approvals of Stem Cells and Cell Based Products Dated 18.02.2014 2014-Feb-18 493KB
465 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
466 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
467 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
468 Notce 2014-Feb-13 297KB
469 Delegation of the Powers- Import of Small Quantities of Drugs for Personal Use 2014-Feb-12 462KB
470 Public Information Cell 2014-Feb-07 276KB
471 Veterinary Cell Office Order 2014-Feb-07 251KB
472 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv 2014-Feb-01 327kb
473 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-25 294kb
474 Notice-Meeting of the Pharmaceuticals Industry Associations 2014-Jan-07 256KB
475 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
476 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
477 Notice Ethic Committee Clinical trial 2013-Jul-30 317KB
478 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
479 Office Order:-Constitution of High Powered Committee for the regulation of stem cell 2013-Jun-03 555KB
480 Delegation of powers of Licensing Authority under Rule 22 of Drugs & Cosmetics Rules 2013-May-23 343KB
481 Notice dated 08.05.2013: Clarification sought by the stakeholders 2013-May-08 312KB
482 Office Order 2013-Apr-16 391KB
483 Notice dated 10.04.2013 regarding prioritisation of activities at CDSCO 2013-Apr-10 420KB
484 Office Order dated 09.04.2013: International Cell in CDSCO(HQ) 2013-Apr-09 290KB
485 Office Order 2013-Mar-20 223KB
486 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
487 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
488 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
489 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
490 Notice - clarification and requirements related to post approval changes as per CDSCO Guidance for industry for biological products 2013-Jan-18 603KB
491 Notice - dated 17.01.2013: Admn 2013-Jan-17 285KB
492 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
493 Notice-dated 13.12.2012: DRUG ALERT 2012-Dec-13 378KB
494 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
495 Notice-dated 03.12.2012: Group A Officer of CDSCO issued by Ministry of Health. 2012-Dec-03 284KB
496 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
497 Office Order-dated 21.11.12: Delegation of power to CDSCO (NZ) Ghaziabad. 2012-Nov-21 311KB
498 E.U-API - Written Confirmations Certificate 2012-Nov-12 411KB
499 Clarification-dated 12.11.12: Directions issued under Section 33P of D & C Act 1940. 2012-Nov-12 1,070KB
500 Notice-dated 29.10.12: Interactive meeting with stakeholders. 2012-Oct-29 293KB
501 Notice-dated 29.10.12: CDSCO Sr. Officers Meeting. 2012-Oct-29 239KB
502 Notice-dated 12.10.2012: Directions issued under Section 33P of D & C Act 1940. 2012-Oct-12 1,220KB
503 Notice-dated 01.10.2012 : Extension of implementations of GSR No. 426(E) dt 19.05.2010 2012-Oct-01 101KB
504 Notice-dated 14.09.2012: Fake drug menace in India. 2012-Sep-14 316KB
505 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
506 Office Order-dated 28.08.2012: Submission of Periodic Safety Update Reports (PSURs). 2012-Aug-28 528KB
507 Notice-dated 28.08.2012: Expansion of Experts panel for evaluation of application of New Drugs etc. 2012-Aug-28 1,260KB
508 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
509 Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012 2012-Jul-13 201 KB
510 Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices 2012-Mar-05 74 KB
511 GENERAL ORDER 2012-Feb-17 140 KB
512 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 KB
513 ORTHOPAEDIC ORDER 2012-Feb-17 127 KB
514 MISCELLANEOUS ORDER 2012-Feb-17 118 KB
515 Advisory notice on clinical trial 2012-Feb-17 1273 KB
516 REPRODUCTIVE & UROLOGY ORDER 2012-Feb-17 123 KB
517 Office Order- dated 21.11.2011: For Pre Screening Applications 2011-Nov-21 45KB
518 Clarification to Office Order dated 21.11.2011 for Pre Screening of Applications. 2011-Nov-21 57KB
519 Office Order-dated 08.11.2011: Public Hearing and Monitoring Cell. 2011-Nov-08 346KB
520 Clarification for import of pre-filled syringe 2011-Nov-07 282kb
521 Office Order-dated 04.11.2011: Constitution of Special Public Hearing and monitoring cell. 2011-Nov-04 367KB
522 Clarification on regulation of staplers 2011-Oct-04 54kb
523 Office Memorandum-dated 16.08.2011: Monitoring of functioning of all Port Offices of CDSCO. 2011-Aug-16 55KB
524 Office Order-dated 01.06.2011 regarding delegation of powers to Zonal Officer of CDSCO. 2011-Jun-01 74KB
525 MDAC Cardiovascular order dated 10 May 2011 2011-May-10 129 KB
526 MDAC of General Expert Pool 2011-May-10 140 KB
527 MDAC Miscellaneous Devices 2011-May-10 118 KB
528 MDAC of Reporductive and Urology 2011-May-10 123 KB
529 MDAC of Ophthalmic 2011-May-10 126 KB
530 MDAC Dental 2011-May-10 119 KB
531 MDAC of Orthopedic 2011-May-10 127 KB
532 Clarification with respect of the manufacturing and marketing of New Drugs 2011-Mar-10 300 KB
533 CARDIOVASCULAR ORDER 2011-Feb-17 129 KB
534 OPHTHALMIC ORDER 2011-Feb-17 126 KB
535 DENTAL ORDER 2011-Feb-17 119 KB
536 Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) 2010-Sep-01 1248 KB
537 Testing of Biochemical kits for estimation of glucose 2010-Aug-26 133 KB
538 List of Notified Medical devices 2010-Apr-20 85 KB