| 1 |
BE-NOC Prior Intimation (System of Notification for certain category of new drugs for conduct of "BA-BE Studies" for export purpose under Chapter V, NDCT Rule, 2019) and procedure for obtaining CT-16 application on NSWS Portal |
2026-May-22 |
|
3587 KB |
| 2 |
Use of Cosmetics |
2026-May-19 |
|
336 KB |
| 3 |
Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs |
2026-May-18 |
|
75 KB |
| 4 |
Rejection and Debarment of application for submission of fabricated documents by firm M/s. DMF Cosmo Private Limited |
2026-May-15 |
|
397 KB |
| 5 |
Appointment of CPIO for the purpose of RTI(Technical) Matters |
2026-May-12 |
|
94 KB |
| 6 |
Cancellation of a product "Elementre - MD Peel-Tri AHA" under Registration Certificate No. RC/COS-005139 dated 15-Jul2O24 valid upto 14-Jul2O29 for import under Cosmetics Rules, 2020- Regarding |
2026-May-11 |
|
563 KB |
| 7 |
Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response |
2026-May-04 |
|
779 KB |
| 8 |
COVID-19 vaccines approved in the country as on 22.04.2026 |
2026-Apr-23 |
|
536 KB |
| 9 |
Submission of Periodic Safety Update Reports (PSURs) for New Drugs via SUGAM Portal on deferred basis in case of delayed Marketing after Approval |
2026-Apr-21 |
|
341 KB |
| 10 |
Regulation & Mandatory Registration of Licensed Blood Centres on the e-RaktKosh Portal |
2026-Mar-18 |
|
5792 KB |
| 11 |
Manufacturing and marketing of unapproved drug product Sodium Hyaluronate Eye Drops 0.3% w/v |
2026-Mar-18 |
|
351 KB |
| 12 |
Guidance document on dossier based licensing of Drugs for uniform product licensing in the country |
2026-Mar-17 |
|
822 KB |
| 13 |
Transfer of certain functions and delegation of powers to the zonal offices of CDSCO under Rule 22 of the Drugs and Cosmetics Rules, 1945 |
2026-Mar-13 |
|
271 KB |
| 14 |
Addendum to Doc No. CDSCO. IVD. FAQ. 04. 2022 dated 13.03.2026 |
2026-Mar-13 |
|
321 KB |
| 15 |
Cancellation of products under RC/COS-005358, for import of Cosmetics under Cosmetics Rules, 2020 (M/s. Beauty Garage India Pvt ltd) |
2026-Mar-12 |
|
514 KB |
| 16 |
Advisory to all manufacturers, importers and marketing authorization holders |
2026-Mar-11 |
|
574 KB |
| 17 |
Testing Laboratories approved by Statas&UT in Form 37 of Drugs Rule 1945 and Cos 23 of Cosmetics Rule 2020 |
2026-Mar-10 |
|
432 KB |
| 18 |
Alert on theft of Lantus® SoloStar® (Insulin Glargine Injection IP, râDNA origin, 100 IU/mL Batch No. 5F0347B of M/s Sanofi India Limited during transit |
2026-Mar-03 |
|
69 KB |
| 19 |
Cancellation of Registration Certificates and lmport Registration Numbers for lmport of Cosmetics under the Cosmetics Rules, 2020- Regarding |
2026-Feb-23 |
|
1314 KB |
| 20 |
Doxycycline related CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness) - Recommendations for the change in Prescribing Information Leaflets (PILs) |
2026-Feb-17 |
|
562 KB |
| 21 |
Carbimazole related agranulocytosis - Recommendations for the change in Prescribing Information Leaflets (PILs) |
2026-Feb-17 |
|
518 KB |
| 22 |
Draft Guidance document for Import of In-vitro diagnostic Medical device for stakeholders comment (dated 30.01.2026) |
2026-Feb-02 |
|
2163 KB |
| 23 |
Cancellation of products underRC/COS-001655, for import of Cosmetics under Cosmetics Rules, 2020 |
2026-Jan-27 |
|
447 KB |
| 24 |
CDSCO updated list of Laboratories for conducting Performance Evaluation of In-Vitro Diagnostic Medical Device |
2026-Jan-19 |
|
608 KB |
| 25 |
Disposal/Rejection of Long-Pending Applications on Sugam Portal Awaiting Query Response |
2026-Jan-16 |
|
96 KB |
| 26 |
Risk classification list of medical devices pertaining to Oncology |
2026-Jan-02 |
|
308 KB |
| 27 |
FAQs on Drugs and Cosmetics (Compounding of Offences) Rules, 2025 |
2026-Jan-01 |
|
368 KB |
| 28 |
Guidelines on Compounding of Offences under the Drugs and Cosmetics Act, 1940 as per Drugs and Cosmetics (Compounding of Offences) Rules, 2025 |
2026-Jan-01 |
|
765 KB |
| 29 |
SoP - Compounding of Offences Rules, 2025 |
2026-Jan-01 |
|
2395 KB |
| 30 |
Compounding of Offences under the Drugs and Cosmetics Act, 1940 in accordance with the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 |
2026-Jan-01 |
|
348 KB |
| 31 |
Cancellation of registration of cosmetic product QR 678- Neo issued under RC/COS-OO1410 for import of Cosmetics under the Cosmetics Rules, 2020 |
2025-Dec-23 |
|
569 KB |
| 32 |
List of Ethics Committees cancelled by CLA |
2025-Dec-10 |
|
74 KB |
| 33 |
MedTech Mitra's In-Vitro Diagnostic Innovators Handbook |
2025-Dec-05 |
|
5974 KB |
| 34 |
Risk classification list of medical devices pertaining to Interventional Radiology |
2025-Nov-27 |
|
441 KB |
| 35 |
Risk classification list of medical devices pertaining to Radiotherapy |
2025-Nov-27 |
|
389 KB |
| 36 |
Risk based classification list of Class A(non-sterile and non-measuring) medical device |
2025-Oct-31 |
|
1069 KB |
| 37 |
Post Approval changes for clinical trials (Form CT-06) for CGTP through SUGAM Online Portal |
2025-Oct-29 |
|
585 KB |
| 38 |
Digital Monitoring System on the ONDLS portal for monitoring the supply chain of high-risk solvents |
2025-Oct-22 |
|
577 KB |
| 39 |
The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded in 2025 |
2025-Oct-22 |
|
367 KB |
| 40 |
Draft guidance document on conduct of Medical Device Software under MDR 2017 |
2025-Oct-21 |
|
1945 KB |
| 41 |
Notice for inviting comment to ensure a level playing field in new drug approval in India |
2025-Oct-08 |
|
597 KB |
| 42 |
Strict compliance with the Drugs Rules 1945 for testing of raw materials and finished formulations |
2025-Oct-07 |
|
418 KB |
| 43 |
Clarification for grant of permission for combipack product of lyophilised dry powder for injection /I.V infusion and diluents for reconstitution such as sterile water for injection / sodium Chloride Injection |
2025-Sep-29 |
|
301 KB |
| 44 |
ICMR-CDSCO Standard Performance Evaluation Protocols |
2025-Sep-17 |
|
7383 KB |
| 45 |
Clarification for regulatory pathway for Cocrystals |
2025-Sep-15 |
|
546 KB |
| 46 |
Separate provision for subsequent Importer in Online system for Medical Devices |
2025-Sep-15 |
|
477 KB |
| 47 |
Surrender of RC No. RC/COS-002850 valid upto 13'Dec-2026 issued to you for the purpose of import of cosmetics manufactured by M/s. Allergan Sales LLC, 2525 Dupont Drive,lrvine,CA 92612 |
2025-Sep-15 |
|
227 KB |
| 48 |
Stickering on Medical Products due to reduction in Goods Service Tax (GST) rate |
2025-Sep-11 |
|
86 KB |
| 49 |
Corrigendum to the letter dated 11.04.2025 on manufacturing and marketing of unapproved FDCs |
2025-Sep-10 |
|
433 KB |
| 50 |
Inviting comments on consideration of the proposal regarding problem faced by the blind or visually impaired people to read medicines tablets/capsules strips |
2025-Sep-09 |
|
714 KB |
| 51 |
Availability of Not Standard Quality (NSQ) Alert on New Link in CDSCO Website |
2025-Aug-28 |
|
2245 KB |
| 52 |
Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO |
2025-Aug-26 |
|
5218 KB |
| 53 |
Cancellation of products under RC/COS-003827, for import of Cosmetics under Cosmetics Rules, 2020 |
2025-Aug-21 |
|
536 KB |
| 54 |
Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 3 |
2025-Aug-12 |
|
4130 KB |
| 55 |
COVID-19 vaccines approved in the country as on 11.08.2025 |
2025-Aug-11 |
|
477 KB |
| 56 |
surrender RC letter dated 04.08.2025 (M/s. NKG Advisory Business and Consulting Services Pvt. Ltd) |
2025-Aug-05 |
|
382 KB |
| 57 |
Visitors management FDA Bhawan |
2025-Jul-25 |
|
462 KB |
| 58 |
Issues related to safety of Ranitidine drug due to presence of NDMA impurity |
2025-Jul-24 |
|
71 KB |
| 59 |
CDSCO Visitor Online System |
2025-Jul-24 |
|
600 KB |
| 60 |
THE SUBJECT EXPERT COMMITTEES GUIDANCE DOCUMENT |
2025-Jul-17 |
|
418 KB |
| 61 |
Revised Export NOC Guidance document for Manufacture of Unapproved / Approved New Drugs along with Annexures |
2025-Jul-17 |
|
714 KB |
| 62 |
DCGI Public Hearing Form for applicants |
2025-Jul-07 |
|
563 KB |
| 63 |
Regulatory requirements for outsourcing sterilization activity of medical devices by a manufacturer under Medical Device Rules 2017 |
2025-Jun-24 |
|
713 KB |
| 64 |
To Share the list of drug products manufacturing permissions issued by State licensing Authority SLA/FDA including antibiotics, FDCs and their premixes for Veterinary use |
2025-Jun-05 |
|
580 KB |
| 65 |
Antimicrobial Resistance AMR Mitigation |
2025-Jun-05 |
|
559 KB |
| 66 |
CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 04.06.2025 |
2025-Jun-04 |
|
617 KB |
| 67 |
Guidance document on disposal of expired/ unused drugs |
2025-May-27 |
|
588 KB |
| 68 |
Office Memorandum regarding Clarification of Comprehensive permission for products imported for overprinting/stickering/stamping as per Rule 104A of Drugs and Cosmetics Rules 1945 |
2025-May-26 |
|
438 KB |
| 69 |
Cancellation of products under RC/COS-003211, for import of Cosmetics under Cosmetics Rules, 2020 |
2025-May-21 |
|
582 KB |
| 70 |
Inviting comments on Revised Guidelines on Similar Biologics- Regulatory requirements for Marketing Authorization in India, 2025 drafted by CDSCO |
2025-May-06 |
|
1002 KB |
| 71 |
Public Notice on PRO Schedule |
2025-Apr-30 |
|
349 KB |
| 72 |
Examination of 2nd assessment report of Prof. Kokate Committee by Drugs Technical Advisory Board (DTAB) in its meeting dated 26.09.2022 |
2025-Apr-11 |
|
3102 KB |
| 73 |
Manufacturing and marketing of unapproved FDCs regarding |
2025-Apr-11 |
|
223 KB |
| 74 |
Provision for system auto-generated Neutral Code by the manufacturer for the export purpose under Medical Devices Rules 2017 |
2025-Apr-09 |
|
404 KB |
| 75 |
Provision for auto-generated Market Standing Certificate and Non-Conviction Certificate for licenced medical device |
2025-Apr-09 |
|
307 KB |
| 76 |
Provision for system auto-generated Neutral code by the manufacturer for the export purpose under Medical Devices Rules, 2017 |
2025-Apr-09 |
|
338 KB |
| 77 |
Prohibits to import manufacture sale and distribution and use in any food producing animal rearing system of drug formulations containing Chloramphenicol or Nitrofurans drug with immediate effect |
2025-Apr-02 |
|
490 KB |
| 78 |
Draft risk based classification list Cardiovascular and Neurological dated 01 04 2025 for stakeholder comments |
2025-Apr-01 |
|
1014 KB |
| 79 |
Surrender of lmport Registration Certificate under Cos-4A vide IRN/COS- 4N20221 000001 dated 29.04.2022 and I RN/COS- 4N20221 000006 dated 14.08.2022 |
2025-Mar-27 |
|
371 KB |
| 80 |
PAC Cancellation letter dated 12.03.2025 FSN brands Marketing Pvt Ltd |
2025-Mar-12 |
|
257 KB |
| 81 |
Launching of registration of Clinical Research Organisation applications through SUGAM Portal |
2025-Mar-04 |
|
1867 KB |
| 82 |
Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority |
2025-Feb-24 |
|
1884 KB |
| 83 |
Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority 24 Feb 2025 |
2025-Feb-24 |
|
1884 KB |
| 84 |
Submission of clinical trial site addition and change of principal Investigator applications through sugam portal |
2025-Feb-24 |
|
57 KB |
| 85 |
Prohibits to manufacture, sale and distribution and use of drug Nimesulide and its formulation for animal use with immediate effect |
2025-Feb-20 |
|
287 KB |
| 86 |
Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form |
2025-Feb-17 |
|
325 KB |
| 87 |
Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) |
2025-Feb-04 |
|
3922 KB |
| 88 |
Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 2 |
2025-Jan-29 |
|
1704 KB |
| 89 |
Guidance document Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) |
2025-Jan-16 |
|
2642 KB |
| 90 |
Grant of manufacturing licences for Large Volume Parenterals (Form 28D/Form 28DA) and endorsement of additional products in the licence through ONDLS portal |
2025-Jan-07 |
|
138 KB |
| 91 |
Updation of exisiting risk based classification list_draft_dated 06 01 2025 for stakeholder comments |
2025-Jan-06 |
|
3025 KB |
| 92 |
Merged existing Medical Devices risk-classification |
2025-Jan-01 |
|
33581 KB |
| 93 |
Submission of Clinical Trial Site Addition and change of Principal Investigator applications through SUGAM Portal |
2024-Dec-30 |
|
70 KB |
| 94 |
Reconstitution of Central Expert Committee to determine the quantum of compensation in respect of faulty ASR Hip implant manufactured by M/s. DePuy international Limited U.K now M/s. Johnson & Johnson Private Limited implanted in lndia |
2024-Dec-02 |
|
331 KB |
| 95 |
MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Version 1.2 |
2024-Oct-08 |
|
656 KB |
| 96 |
Draft Guidelines on Good Clinical Practices |
2024-Sep-12 |
|
3315 KB |
| 97 |
Baxter recall letter for Product Fibrin Sealant Kit Brand name Tisseel Lyo manufactured in Vienna Austria |
2024-Sep-02 |
|
1508 KB |
| 98 |
Approved panel of experts for the Subject Expert Committees |
2024-Aug-29 |
|
510 KB |
| 99 |
Appointment of CPIO for the purpose of RTI Technical Matters 7 Aug 24 |
2024-Aug-07 |
|
96 KB |
| 100 |
Names of countries under the Rule 101 of New Drugs and Clinical Trial Rules 2019 related to new drug approval |
2024-Aug-07 |
|
280 KB |
| 101 |
Surrender of Cosmetics Import Registration Certificates of M/s Johnson & Johnson Pvt. Ltd L.B.S. Marg Mulund Mumbai Maharashtra India |
2024-Aug-06 |
|
997 KB |
| 102 |
PRO feedback form Internal and Pro feedback form External |
2024-Jul-26 |
|
909 KB |
| 103 |
Public Notice regarding DCGI meeting with Stakeholders Dated 15.04.2024 for 2nd and 4th July 2024 Meeting cancellation |
2024-Jul-01 |
|
176 KB |
| 104 |
Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country |
2024-May-29 |
|
429 KB |
| 105 |
Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient with gBRCA mutution and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
2024-May-16 |
|
768 KB |
| 106 |
DTAB Sub-Committee to examine the proposal to regulate antibiotic and its irrational use date 16 may 2024 |
2024-May-16 |
|
447 KB |
| 107 |
List of meetings of Expert Committee for examination of vaccine PSUR 2023-24 |
2024-May-15 |
|
7 KB |
| 108 |
Circular-Retention of license or certificates under Medical Devices Rules, 2017 |
2024-May-15 |
|
207 KB |
| 109 |
NOC's for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose |
2024-Apr-30 |
|
454 KB |
| 110 |
Stakeholder consultation for feedback on SEC meetings dated 22.04.2024 |
2024-Apr-22 |
|
272 KB |
| 111 |
Manufacturing and marketing of unapproved drug Meropenam 1gm + EDTA for Injection |
2024-Apr-16 |
|
366 KB |
| 112 |
Public Notice regarding DCGI meeting with Stakeholders Dated 15.04.2024 for 18 April 2024 Meeting cancellation |
2024-Apr-15 |
|
143 KB |
| 113 |
Public Notice regarding Draft CDSCO Guidance for Industry Version 1.2 |
2024-Apr-10 |
|
1184 KB |
| 114 |
Public Notice regarding DCGI meeting with Stakeholders Dated 08.04.2024 for 16 April 2024 Meeting cancellation |
2024-Apr-08 |
|
142 KB |
| 115 |
Implementation and effective use of RTI-MIS Portal (e-Portal) for disposal of all RTI including Physical RTI through RTI-MIS across all the CDSCO offices as per DoPT Order dated 12th August 2013 under RTI Act 2005 |
2024-Apr-05 |
|
111 KB |
| 116 |
Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory |
2024-Apr-03 |
|
388 KB |
| 117 |
Public Notice regarding DCGI meeting with Stakeholders Dated 26.03.2024 for 28 march 2024 Meeting cancellation |
2024-Mar-26 |
|
142 KB |
| 118 |
Meeting through WebEx Video-conference of the DTAB-sub Committee on 05.04.2024 at 11.00 a.m. to 6:00 p.m. to Evaluation of 16 FDCs which were earlier considered as irrational in the Expert Committee report of the Prof. Kokate Committee |
2024-Mar-22 |
|
409 KB |
| 119 |
Manufacturing and marketing of unapproved drug Meropenem & Disodium EDTA for Injection |
2024-Mar-08 |
|
383 KB |
| 120 |
Public Notice regarding DCGI meeting with Stakeholders Dated 06.03.2024 |
2024-Mar-06 |
|
106 KB |
| 121 |
Draft CDSCO Guidance for Industry: Post Approval Changes in Biological Products |
2024-Feb-28 |
|
2317 KB |
| 122 |
Public Notice No. Admin-A012(12)/46/2024-eoffice dated 26.02.2024 |
2024-Feb-26 |
|
63 KB |
| 123 |
Public Notice dated 15.02.2024 |
2024-Feb-14 |
|
568 KB |
| 124 |
Online application for Neutral Code for manufacturing of Medical Devices for export purpose |
2024-Feb-12 |
|
305 KB |
| 125 |
SEC-IND Office order dated 31.01.2024 |
2024-Jan-31 |
|
182 KB |
| 126 |
Appointment of First Appellate Authority & CPIO for the purpose of RTI (Technical) matters |
2024-Jan-30 |
|
362 KB |
| 127 |
Launching of additional Forms on National Single Window System NSWS Portal |
2024-Jan-16 |
|
7274 KB |
| 128 |
Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2024 |
2024-Jan-12 |
|
18 KB |
| 129 |
Evaluation of certain pre 1988 permitted Fixed Dose Combinations FDCs de novo for manufacture for sale in the country without due approval from Central Licensing Authority |
2024-Jan-11 |
|
2341 KB |
| 130 |
PRO Details of Zonal, Sub zonal offices of CDSCO |
2024-Jan-09 |
|
26 KB |
| 131 |
Launching of National Single Window System (NSWS) Portal |
2024-Jan-01 |
|
3669 KB |
| 132 |
Submission of ppt via E-Vartalap Sugam Portal |
2023-Dec-19 |
|
298 KB |
| 133 |
To update package insertPromotional Literature of FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCl IP 5mg drop ml- |
2023-Dec-18 |
|
372 KB |
| 134 |
CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23 |
2023-Dec-06 |
|
654 KB |
| 135 |
Advisory to all manufacturer of cough syrup, various critical excipients |
2023-Dec-05 |
|
418 KB |
| 136 |
Surrender and Cancellation of Cosmetics Registration Certificate No. RC/COS-003067 dated 25.03.2022 (M/s. Abbott Health Care P Ltd) |
2023-Nov-28 |
|
325 KB |
| 137 |
Appointment of CPIO and CAPIO for the purpose of RTI for the O/o. Asstt. Drugs Controller (India), CDSCO, Airport, Aircargo, Mumbai |
2023-Nov-24 |
|
827 KB |
| 138 |
Corrigendum to Notice inviting Expression of Interest for development of Digital Drugs Regulatory System |
2023-Nov-10 |
|
434 KB |
| 139 |
Notice inviting Expression of Interest for development of Digital Drugs Regulatory System |
2023-Nov-02 |
|
998 KB |
| 140 |
Updation of classification in IVD medical devices under the provision of MD Rules 2017 |
2023-Oct-25 |
|
1473 KB |
| 141 |
Regulation of all Class C & D Medical Devices Under Licensing regime, w.e,f 01.10.2023 as per GSR102E dated 11.02.2020 |
2023-Oct-12 |
|
385 KB |
| 142 |
Clarification on the Circular no. 29/Misc/03/2023-DC(344) dated 12.10.2023 |
2023-Oct-12 |
|
22 KB |
| 143 |
Notice regaring submission of documents in scan copy |
2023-Oct-12 |
|
568 KB |
| 144 |
CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 26.09.2023 |
2023-Sep-29 |
|
654 KB |
| 145 |
List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 |
2023-Sep-15 |
|
1635 KB |
| 146 |
Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18/19, Verna Industrial Estate, Salcette, Goa-403722 |
2023-Aug-31 |
|
1049 KB |
| 147 |
Receipt of Cough Syrup of same batch No.by two different NABL Accredited Government Laboratories Manufactured by the same Manufacturers/Exporters |
2023-Jul-28 |
|
394 KB |
| 148 |
FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR QR CODE ON TOP 300 BRANDS |
2023-Jul-25 |
|
28 KB |
| 149 |
Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories for testing Request not to submit any sample of cough syrup to IPC Ghaziabad and CDTL Mumbai Lab |
2023-Jul-03 |
|
273 KB |
| 150 |
Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories for testing Request not to submit any sample of cough syrup to CDTL Mumbai Lab |
2023-Jun-21 |
|
1994 KB |
| 151 |
Implementation of Pre-shipment inspection under testing |
2023-Jun-20 |
|
4419 KB |
| 152 |
Daily Updation of No. of Batches of Cough syrup sample for Export at Different Laboratories for testing |
2023-Jun-13 |
|
1224 KB |
| 153 |
CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device |
2023-May-22 |
|
214 KB |
| 154 |
Cancellation letter of M/s. Crossline Communication |
2023-May-02 |
|
358 KB |
| 155 |
Circular for Licensing of Class C D medical devices dated 12.04.2023 |
2023-Apr-12 |
|
310 KB |
| 156 |
Clarification w.r.t. the new drug status of FDCs (Fixed Dose Combinations) which were scrutinized w.r.t. letter dated 15.1.2013 issued by this office and declared as rational |
2023-Apr-05 |
|
22146 KB |
| 157 |
List of Notified Bodies registered with CDSCO under MDR, 2017 |
2023-Apr-03 |
|
830 KB |
| 158 |
Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier considered as irrational in the Expert Commiteee report of the Prof.Kokate Committee |
2023-Mar-31 |
|
4207 KB |
| 159 |
Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2020 |
2023-Mar-15 |
|
7 KB |
| 160 |
Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2021 |
2023-Mar-15 |
|
7 KB |
| 161 |
Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2022 |
2023-Mar-15 |
|
7 KB |
| 162 |
Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 25.01.2023 |
2023-Jan-25 |
|
540 KB |
| 163 |
PCR Kits approved for testing of Covid-19 as on 25.01.2023 |
2023-Jan-25 |
|
512 KB |
| 164 |
Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2023 |
2023-Jan-20 |
|
18 KB |
| 165 |
Inspection/Audits of Pharmacovigilane(PV) system of importers and manufactures of human vaccine |
2022-Dec-28 |
|
322 KB |
| 166 |
Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer |
2022-Dec-22 |
|
412 KB |
| 167 |
Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022 |
2022-Oct-21 |
|
290 KB |
| 168 |
Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017 |
2022-Oct-11 |
|
817 KB |
| 169 |
Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 |
2022-Oct-10 |
|
764 KB |
| 170 |
Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020 |
2022-Sep-30 |
|
401 KB |
| 171 |
Strengthening of Medical Products Safety Surveillance System in North Eastern States of India on October 19 2022 at Government Pharmacy College Sajong Sikkim |
2022-Sep-29 |
|
1476 KB |
| 172 |
Report of National List of Essential Medicines 2022 |
2022-Sep-13 |
|
8599 KB |
| 173 |
National List of Essential Medicines 2022 |
2022-Sep-13 |
|
4579 KB |
| 174 |
Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures |
2022-Sep-09 |
|
524 KB |
| 175 |
List of the Certified Medical Device Testing Laboratory under MDR, 2017 |
2022-Aug-17 |
|
5938 KB |
| 176 |
Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devcies Rules 2017 |
2022-Aug-04 |
|
852 KB |
| 177 |
Notice dated July 11 2022 |
2022-Jul-11 |
|
370 KB |
| 178 |
Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022 |
2022-Jul-08 |
|
1051 KB |
| 179 |
Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) |
2022-Jul-07 |
|
594 KB |
| 180 |
Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) |
2022-Jul-07 |
|
702 KB |
| 181 |
Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) |
2022-Jul-07 |
|
781 KB |
| 182 |
Clarification regarding import of non-drug / lab kits shipments related to clinical trial / clinical research purposes. |
2022-Jul-07 |
|
341 KB |
| 183 |
Notice of Advisory for registration of blood centres on E-rakhtkosh |
2022-Jun-03 |
|
5660 KB |
| 184 |
Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017 |
2022-Jun-03 |
|
529 KB |
| 185 |
Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed |
2022-May-06 |
|
78 KB |
| 186 |
Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit |
2022-May-05 |
|
208 KB |
| 187 |
List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software |
2022-May-05 |
|
103 KB |
| 188 |
Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined' by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I) |
2022-Apr-28 |
|
385 KB |
| 189 |
Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 |
2022-Mar-16 |
|
813 KB |
| 190 |
Revised Schedule for Public hearing at PRO, CDSCO (HQ) |
2022-Feb-22 |
|
386 KB |
| 191 |
Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2022 |
2022-Feb-17 |
|
10 KB |
| 192 |
Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 11.02.2022 |
2022-Feb-11 |
|
510 KB |
| 193 |
Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority regarding |
2022-Jan-06 |
|
635 KB |
| 194 |
Vigil on the activities of distribution & sale of suspected spurious Tocilizumab 400 mg/20 ml Injections in India |
2021-Dec-28 |
|
404 KB |
| 195 |
Publice Notice dated 10.12.2021 |
2021-Dec-10 |
|
169 KB |
| 196 |
PCR Kits approved for testing of Covid-19 as on 09.12.2021 |
2021-Dec-09 |
|
479 KB |
| 197 |
List of approved veterinary vaccines |
2021-Dec-02 |
|
1138 KB |
| 198 |
Public notice on draft Recruitment rules for the post of LDC Central Drugs Laboratory Kolkata |
2021-Nov-26 |
|
412 KB |
| 199 |
Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with effect from April 1st 2021 |
2021-Nov-03 |
|
246 KB |
| 200 |
Notice regarding Review of regulatory regime for drug approval |
2021-Oct-14 |
|
348 KB |
| 201 |
Module for online processing of applications for registration of BA BE study centres (CT-08) |
2021-Oct-01 |
|
303 KB |
| 202 |
Organization of Voluntary Blood Donation Day Camp in Nirman Bhawan Premises on 01.10.2021 from 09.00 AM onwards |
2021-Sep-29 |
|
606 KB |
| 203 |
Submission of Post Approval Changes Applications through SUGAM Portal |
2021-Sep-29 |
|
199 KB |
| 204 |
Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017 |
2021-Sep-28 |
|
367 KB |
| 205 |
Registration and Labelling requirements of Medical Devices |
2021-Sep-28 |
|
366 KB |
| 206 |
Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017 |
2021-Sep-27 |
|
929 KB |
| 207 |
Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices |
2021-Sep-21 |
|
513 KB |
| 208 |
Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017 |
2021-Sep-13 |
|
698 KB |
| 209 |
Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017 |
2021-Sep-13 |
|
334 KB |
| 210 |
Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017 |
2021-Sep-13 |
|
674 KB |
| 211 |
Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017 |
2021-Sep-13 |
|
744 KB |
| 212 |
Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017 |
2021-Sep-13 |
|
804 KB |
| 213 |
Timelines for activities requiring minor and major procedures for cargo clearances at port offices of CDSCO |
2021-Sep-10 |
|
1097 KB |
| 214 |
Online Application for issuance of Written Confirmation Certificate WCC regarding |
2021-Sep-09 |
|
280 KB |
| 215 |
The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference |
2021-Sep-07 |
|
665 KB |
| 216 |
Manufacturing and marketing of FDC of Tolperisone HCL 150mg + Paracetamol IP 500mg tablet |
2021-Sep-01 |
|
73 KB |
| 217 |
Procedure to be followed for regularisation of FDCs declared as rational in respect of 249 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I) |
2021-Aug-27 |
|
140 KB |
| 218 |
List of Medical devices testing Laboratory for carry out test or evaluation of Medical device on behalf of Manufacturer registered with CDSCO under MDR |
2021-Aug-27 |
|
3982 KB |
| 219 |
Procedure to be follow for reqularisation of 19 FDCs out of 294 FDCs which required further generation of data which were licensed to manufacture and market by SLA withoout prior approval from DCG(I) |
2021-Aug-27 |
|
172 KB |
| 220 |
Manufacturing and marketing of certain FDCs as per directions of Hon'ble High Court Maharashtra Nagpur Bench |
2021-Aug-27 |
|
175 KB |
| 221 |
Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017 |
2021-Aug-23 |
|
955 KB |
| 222 |
Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017 |
2021-Aug-23 |
|
1120 KB |
| 223 |
PCR Kits approved for testing of Covid-19 as on 23.08.2021 |
2021-Aug-23 |
|
459 KB |
| 224 |
Evaluation of Certain Pre-1988 Permitted Fixed Dose Combinations (FDCs) De novo for manufacture for sale in the country without due approval from Central Licensing Authority |
2021-Aug-19 |
|
661 KB |
| 225 |
Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017 |
2021-Aug-09 |
|
889 KB |
| 226 |
Notice and additional set of FAQ Cosmetics division dated 06.08.2021 |
2021-Aug-06 |
|
741 KB |
| 227 |
Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 |
2021-Aug-06 |
|
601 KB |
| 228 |
Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 |
2021-Aug-06 |
|
606 KB |
| 229 |
Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 |
2021-Aug-06 |
|
628 KB |
| 230 |
Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017 |
2021-Jul-26 |
|
256 kB |
| 231 |
Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devcies Rules 2017 |
2021-Jul-26 |
|
618 KB |
| 232 |
Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devcies Rules 2017 |
2021-Jul-26 |
|
432 KB |
| 233 |
Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017 |
2021-Jul-26 |
|
523 KB |
| 234 |
Notice Evaluation of Certain pre 1988 permitted FDC de novo for manufacture of Sale in the Country without due approval from Central Licensing Authority |
2021-Jul-26 |
|
1216 KB |
| 235 |
Inviting Public comments, as steps are being taken by CDSCO to regulate the products like skin patches which are being used as cosmetic |
2021-Jul-26 |
|
331 KB |
| 236 |
Classification in IVD medical devices under the provision of MD Rules 2017 |
2021-Jul-23 |
|
45667 KB |
| 237 |
Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017 |
2021-Jul-12 |
|
200 KB |
| 238 |
List of medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer with CDSCO under MDR 2017 |
2021-Jul-07 |
|
4025 KB |
| 239 |
Notice Module for online processing of applications for issuance of Written Confirmation Certificate |
2021-Jul-07 |
|
375 KB |
| 240 |
Public notice on draft Recruitment rules for the post of Stenographer Grade-II in CDL, Kolkata |
2021-Jun-23 |
|
10196 KB |
| 241 |
Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for rrestriced use by US FDA |
2021-Jun-01 |
|
298 KB |
| 242 |
Update on Information on Convalescent Plasma in COVID-19 |
2021-May-24 |
|
33 KB |
| 243 |
Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings |
2021-May-16 |
|
735 KB |
| 244 |
SOP Guidance for import of vaccine by private sector or any person |
2021-May-04 |
|
7 KB |
| 245 |
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 |
| 246 |
Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021 |
2021-Apr-18 |
|
138 KB |
| 247 |
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 |
| 248 |
Submission of notarized/apostilled documents for Import and Registration of cosmetics in view of COVID-19 |
2021-Apr-13 |
|
363 KB |
| 249 |
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 |
| 250 |
Enforcement activities to stop hoarding/back marketing/overcharging of COVID Managment drug Remdesivir |
2021-Apr-10 |
|
398 KB |
| 251 |
Monitoring to ensure availability of Remdesivir and prevent its hoarding and black marketing |
2021-Apr-07 |
|
402 KB |
| 252 |
NDLS portal Public notice-31-03-2021 |
2021-Mar-31 |
|
175 KB |
| 253 |
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 |
| 254 |
Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits |
2021-Mar-22 |
|
586 KB |
| 255 |
Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding |
2021-Mar-16 |
|
919 KB |
| 256 |
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 |
| 257 |
Notice-Online Application for the issuance of Form 41 (Registration certificate) and Form 10 (Import License) for Veterinary Vaccines |
2021-Mar-05 |
|
2206 KB |
| 258 |
Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE's |
2021-Feb-25 |
|
59 KB |
| 259 |
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 |
| 260 |
Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021 |
2021-Jan-01 |
|
182 KB |
| 261 |
Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 |
2020-Dec-28 |
|
334 KB |
| 262 |
Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central Government officicals regarding |
2020-Oct-12 |
|
1038 KB |
| 263 |
Notice regarding List of medical devices testing Laboratory |
2020-Oct-09 |
|
2927 KB |
| 264 |
Notice for Vaccine Guidelines dated 21 Sept 2020 |
2020-Sep-21 |
|
392 KB |
| 265 |
Regulatory guidelines for development of Vaccine 21.09.2020 |
2020-Sep-21 |
|
801 KB |
| 266 |
Notice regarding documents required for the Import |
2020-Sep-17 |
|
516 KB |
| 267 |
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 |
| 268 |
Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices |
2020-Sep-03 |
|
301 KB |
| 269 |
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 |
| 270 |
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 |
| 271 |
Notice regarding Approved panel of experts for the Subject Expert Committees |
2020-Aug-28 |
|
20279 KB |
| 272 |
Submission of notarized/ apostilled documents for import and Registration of cosmetics in view of COVID-19 |
2020-Aug-19 |
|
279 KB |
| 273 |
Approval of Favipiravir Tablets to Glenmark Pharmaceuticals and Remdesivir Injection to Cipla Ltd, Hetero Drugs and Mylan Labs |
2020-Jul-02 |
|
410 KB |
| 274 |
Information on convalescent plasma in Covid 19 |
2020-Jul-01 |
|
123 KB |
| 275 |
Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose |
2020-Jun-19 |
|
368 KB |
| 276 |
Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19 |
2020-Jun-09 |
|
599 KB |
| 277 |
GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS |
2020-Jun-04 |
|
2174 KB |
| 278 |
Radpid Response Regulatory Framework for COVID-19 vaccine development |
2020-May-26 |
|
9005 KB |
| 279 |
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 |
| 280 |
ICMR Convalescent plasma _protocol_v1.5.pdf |
2020-May-11 |
|
276 KB |
| 281 |
Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP) |
2020-May-01 |
|
265 KB |
| 282 |
Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April |
2020-Apr-27 |
|
746 KB |
| 283 |
Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19 |
2020-Apr-23 |
|
307 KB |
| 284 |
amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent plasma_protocol_v1.4 |
2020-Apr-22 |
|
214 KB |
| 285 |
Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of COVID 19 |
2020-Apr-20 |
|
313 KB |
| 286 |
Clinical trial of convalescent plasma in COVID-19 Patients |
2020-Apr-17 |
|
634 KB |
| 287 |
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 |
| 288 |
Office Memorandum on COVID-19 |
2020-Apr-16 |
|
1786 KB |
| 289 |
Submmission of notarized/apostilled documents for import and Registration of drugs in view of COVID 19 |
2020-Apr-15 |
|
284 KB |
| 290 |
Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19 |
2020-Apr-07 |
|
424 KB |
| 291 |
Public notice alerting about unlicensed kit of Bione for corona testing displayed on their website for sale |
2020-Apr-05 |
|
235 KB |
| 292 |
Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 |
2020-Mar-30 |
|
602 KB |
| 293 |
Release of consignments of Vaccine and critical IVDs-certain instructions issued |
2020-Mar-25 |
|
311 KB |
| 294 |
Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes |
2020-Mar-24 |
|
33 KB |
| 295 |
Notice regarding COVID-19 outbreak |
2020-Mar-23 |
|
833 KB |
| 296 |
OM on Rapid Response Regulatory Framework for COVID-19 |
2020-Mar-20 |
|
611 KB |
| 297 |
Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19 |
2020-Mar-19 |
|
441 KB |
| 298 |
Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19 |
2020-Mar-19 |
|
453 KB |
| 299 |
Notice regarding Measures to contain spread of COVID-19 |
2020-Mar-19 |
|
313 KB |
| 300 |
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 |
| 301 |
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 |
| 302 |
Testing of all categories of new drugs for their approval |
2020-Mar-13 |
|
47 KB |
| 303 |
Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. |
2020-Mar-13 |
|
43 KB |
| 304 |
Requirement of CMC documents for approval of additional indication of an already drug product |
2020-Mar-13 |
|
45 KB |
| 305 |
Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. |
2020-Mar-13 |
|
52 KB |
| 306 |
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 |
| 307 |
Submission and processing of application for Registration Certificate and import License in parallel with New Drug application |
2020-Feb-26 |
|
333 KB |
| 308 |
Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) |
2020-Feb-24 |
|
849 KB |
| 309 |
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 |
| 310 |
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 |
| 311 |
Notice regarding requirement of stability data of COPP |
2020-Feb-21 |
|
346 KB |
| 312 |
Notice regarding Pre-submission meeting |
2020-Feb-21 |
|
300 KB |
| 313 |
Notice regarding Approval of FDCs Containing new drugs |
2020-Feb-21 |
|
312 KB |
| 314 |
Notice regarding Fixing of limit of impurities in the specification of INDs |
2020-Feb-21 |
|
347 KB |
| 315 |
Notice regarding Stability data for BA/BE study in Human for export |
2020-Feb-21 |
|
384 KB |
| 316 |
Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export |
2020-Feb-21 |
|
350 KB |
| 317 |
Notice regarding Permission to conduct BA/BE study and clinical trial |
2020-Feb-21 |
|
346 KB |
| 318 |
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 |
| 319 |
Targeted interanl timeline for processing and disposal of application by CDSCO |
2020-Feb-20 |
|
1546 KB |
| 320 |
Grant of License in Form 29 under the Drugs and Cosmetics Rules 1945 dated 20/2/2020 |
2020-Feb-20 |
|
366 KB |
| 321 |
Notice Consideration of the direction of Hon'ble Supreme Court of India in the case of 294 FDCs regarding |
2020-Feb-20 |
|
352 KB |
| 322 |
Notice regarding New Drugs dated 18.02.2020 |
2020-Feb-18 |
|
943 KB |
| 323 |
Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 |
2020-Feb-18 |
|
893 KB |
| 324 |
PRO details of all Zones/Sub Zones |
2020-Feb-13 |
|
619 KB |
| 325 |
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 |
| 326 |
Draft of the Drugs and Magic Remedies objectional Advertisments Amendment Bill 2020 |
2020-Feb-03 |
|
233 KB |
| 327 |
Notice regarding PRO Veterinary Division 31 jan 2020 |
2020-Jan-31 |
|
323 KB |
| 328 |
Notice PRO |
2020-Jan-31 |
|
313 KB |
| 329 |
Publice Notice from veterinary Division |
2020-Jan-31 |
|
320 KB |
| 330 |
Notices/Circular /Advisory regarding schedule H, H1 C & X |
2020-Jan-31 |
|
2230 KB |
| 331 |
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 |
| 332 |
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 |
| 333 |
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 |
| 334 |
Notice regarding List of Reference Products for conduct of BE Study |
2020-Jan-22 |
|
172 KB |
| 335 |
Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses/Permits/Certificates/Other Authorizations (LPCOs) by PGAs |
2020-Jan-07 |
|
2252 KB |
| 336 |
Office order dated 03.01.2019 |
2020-Jan-03 |
|
355 KB |
| 337 |
DCGI New Year Massage for 2020 |
2019-Dec-31 |
|
237 KB |
| 338 |
Office Order PRO at CDSCO Zonal/Sub Zonal Office 12 Dec 2019 |
2019-Dec-12 |
|
704 KB |
| 339 |
Setting of Public Relations Office at all Zonal and Sub-Zonal Office of CDSCO |
2019-Dec-11 |
|
700 KB |
| 340 |
Procedure for regularisation of FDCs w.r.t. payment of fees regarding |
2019-Dec-05 |
|
345 KB |
| 341 |
List of approved Clinical Trial Sites & Investigators for Global Clinical Trials |
2019-Dec-02 |
|
347 KB |
| 342 |
List of approved Clinical Trial Sites and Investigators |
2019-Dec-02 |
|
1932 KB |
| 343 |
Public Notice regarding pharmacovigilance reporting for veterinary products in India |
2019-Dec-02 |
|
264 KB |
| 344 |
Strengthening of Materiovigilance Programme of India (MvPI) in the country |
2019-Nov-26 |
|
56 KB |
| 345 |
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 |
| 346 |
Notice regarding equipments which are non notified but associated with notified devices |
2019-Nov-13 |
|
226 KB |
| 347 |
Notice regarding all implantable devices |
2019-Nov-08 |
|
252 KB |
| 348 |
Notice regarding exemption of drugs Sale License |
2019-Nov-08 |
|
235 KB |
| 349 |
Notice regarding environmental conditions for equipments |
2019-Nov-08 |
|
235 KB |
| 350 |
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 |
| 351 |
Notice regarding Monitoring the end use of drugs which are meant for dual use |
2019-Oct-18 |
|
352 KB |
| 352 |
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 |
| 353 |
Notice dated 18-10-2019 |
2019-Oct-18 |
|
470 KB |
| 354 |
External Performance evaluation of IVD's under MDR further guidance |
2019-Oct-11 |
|
328 KB |
| 355 |
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 |
| 356 |
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 |
| 357 |
Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory |
2019-Oct-04 |
|
2653 KB |
| 358 |
Public Notice regarding PRO divisions wise schedule dated 04-10-2019 |
2019-Oct-04 |
|
248 KB |
| 359 |
Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet-regarding |
2019-Sep-19 |
|
503 KB |
| 360 |
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 |
| 361 |
Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case of 294 FDCs |
2019-Aug-27 |
|
233 KB |
| 362 |
Public Notice regarding payment of fees through Bharatkosh Portal alongwith the application for grant of various licences/Permission |
2019-Aug-26 |
|
319 KB |
| 363 |
dvisory to follow the Apprentices Act, 1961-Regarding |
2019-Aug-26 |
|
66 KB |
| 364 |
Additional FAQ on New Drugs and Clinical Trial Rules, 2019 |
2019-Aug-23 |
|
152 KB |
| 365 |
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 |
| 366 |
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 |
| 367 |
Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP) |
2019-Aug-08 |
|
516 KB |
| 368 |
Public notice for online filing of applications for veterinary drugs |
2019-Jul-29 |
|
280 KB |
| 369 |
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 |
| 370 |
First Stakeholders National Consultation meeting of SNCM on 25th_july 2019 at ICMR New Delhi |
2019-Jul-19 |
|
88 KB |
| 371 |
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 |
| 372 |
Simplified auto-registration of beneficiaries (IEC holders) on ICEGATE for e-SANCHIT and other benefits |
2019-Jun-25 |
|
2365 KB |
| 373 |
Advisory to all Indian Pharmaceutical Industry Associations |
2019-Jun-25 |
|
52 KB |
| 374 |
Order regarding Luxury Lifestyle on 17.06.2019 |
2019-Jun-17 |
|
636 KB |
| 375 |
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 |
| 376 |
National List of Essential Medicines 2015 |
2019-Jun-11 |
|
1717 KB |
| 377 |
Details of IECGSTN code of all the beneficiaries (Stakeholders Importers Exporters Customs House Brokers)-Reg |
2019-Jun-11 |
|
475 KB |
| 378 |
Updated list of WHO GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPP) in various States of India as on May 2019 |
2019-May-30 |
|
2141 KB |
| 379 |
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 |
| 380 |
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 |
|
1410 KB |
| 381 |
Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs |
2019-May-15 |
|
2021 KB |
| 382 |
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 |
| 383 |
Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials |
2019-Apr-26 |
|
478 KB |
| 384 |
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 |
| 385 |
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 |
| 386 |
Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs-regarding |
2019-Apr-12 |
|
7,670KB |
| 387 |
Notice Uploading of applications through Sugam Portal in accordance with New Drugs and Clinical Trials Rules 2019 |
2019-Apr-10 |
|
471 KB |
| 388 |
FEEDBACK FORM to CDSCO (HQ) on the performance of PRO to improve the quality of services |
2019-Apr-03 |
|
96 KB |
| 389 |
Meeting Notice regarding Meeting with stakeholders for discussion on Zero Draft of new Veterinary Rules |
2019-Apr-03 |
|
376 KB |
| 390 |
Cancellation of Registration Certificate No. SVH-101 and Import License SVH-101-112 |
2019-Apr-01 |
|
3016 KB |
| 391 |
Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131 |
2019-Apr-01 |
|
2894 KB |
| 392 |
Order M/s Hasan Trading Inc Chennai |
2019-Mar-29 |
|
546 KB |
| 393 |
Order M/s united Distributors Incoporation |
2019-Mar-29 |
|
538 KB |
| 394 |
Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone sublingual tablets |
2019-Mar-28 |
|
1098 KB |
| 395 |
Safety warning for SGLT2 Inhibitors |
2019-Mar-25 |
|
9560 KB |
| 396 |
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 |
| 397 |
Draft Guidelines for Evaluation of Nanopharmaceuticals in India |
2019-Mar-07 |
|
31990 KB |
| 398 |
Import of duplicate product Siso Hair Color Shampoo regarding |
2019-Mar-07 |
|
328 KB |
| 399 |
Notice regarding of the goods to be disposed 28 February 2019 |
2019-Feb-28 |
|
290 KB |
| 400 |
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 |
| 401 |
Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide |
2019-Feb-25 |
|
1430 KB |
| 402 |
Cancellation of Cosmetics Registration certificate No. RC/Cos-000107 M/s Aurelia International Pvt Ltd |
2019-Feb-19 |
|
422 KB |
| 403 |
Payment of Challan through Bharatkosh 15.02.2018 |
2019-Feb-15 |
|
287 KB |
| 404 |
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 |
| 405 |
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 |
| 406 |
Meeting Notice regarding Issues related to payment of Challan through Bharatkosh |
2019-Feb-11 |
|
397 KB |
| 407 |
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 |
| 408 |
Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of LicensesPermitsCertificatesOther Authorizations (LPCOs) by PGAs |
2019-Jan-29 |
|
1004 KB |
| 409 |
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 |
| 410 |
Inviting suggestions/comments on the recommendations of Expert Working Group constituted by the National Blood Transfusion Council (NBTC) on âreview and recommendations of manpower norms for blood bank |
2019-Jan-10 |
|
41 KB |
| 411 |
Payment of Challan through Bharatkosh |
2019-Jan-09 |
|
328 KB |
| 412 |
Condemnation/Disposal of Wooden/Steel junks |
2019-Jan-08 |
|
209 KB |
| 413 |
DCG(I) New Year Message 2019 |
2018-Dec-31 |
|
313 KB |
| 414 |
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 |
| 415 |
Disposal of unserviceable/obsolete item of CDSCO dated 21.12.2018 |
2018-Dec-21 |
|
322 KB |
| 416 |
Safety guidelines for Isotretinoin dated 19.12.2018 |
2018-Dec-19 |
|
403 KB |
| 417 |
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 |
| 418 |
Notice regarding sale of medicines without prescription |
2018-Dec-15 |
|
84 KB |
| 419 |
Order (Skin Aesthetics) |
2018-Dec-14 |
|
568 KB |
| 420 |
Office Memorandum dated 14.12.2018 (Ms. Galderma India) |
2018-Dec-14 |
|
318 KB |
| 421 |
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 |
| 422 |
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 |
| 423 |
Meeting Notice related to Draft Guidance for Industry Document for Veterinary Biologicals |
2018-Dec-06 |
|
313 |
| 424 |
Public Notice for feedback on SUGAM Online Portal |
2018-Dec-05 |
|
326 KB |
| 425 |
Feedback Form (Annexure-I) for SUGAM online portal |
2018-Dec-05 |
|
14 KB |
| 426 |
Feedback Form (Annexure-I) for Medical Device online portal |
2018-Dec-05 |
|
14 KB |
| 427 |
Public Notice for feedback on Medical Device Online Portal |
2018-Dec-05 |
|
325 KB |
| 428 |
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 |
| 429 |
Health Ministry approves compensation formula for Hip implant cases |
2018-Nov-29 |
|
157 KB |
| 430 |
Notice regarding Implementation of e-Governance has launched an online protal SUGAM dated 29.11.2018 |
2018-Nov-29 |
|
292 KB |
| 431 |
Notice regarding Uploading data of drug manufacturing facilities and approved drug formulations on SUGAM Portal dated 29.11.2018 |
2018-Nov-29 |
|
440 KB |
| 432 |
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 |
| 433 |
Application Form for Compensation-DePuy J &J ASR Hip Implant |
2018-Nov-20 |
|
168KB |
| 434 |
Application form for Compensation-DePuy_Johnson |
2018-Nov-15 |
|
118 KB |
| 435 |
Notice- Inviting, any objections / suggestion on the Draft Rules as New Drugs and Clinical Trials Rules, 2018 |
2018-Nov-14 |
|
53 KB |
| 436 |
To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants |
2018-Nov-08 |
|
439 KB |
| 437 |
Order SAE dated 29.10.2018 |
2018-Oct-29 |
|
61 KB |
| 438 |
Order regarding receipt related to SAE of Clinical Trials |
2018-Oct-25 |
|
2,210KB |
| 439 |
PUBLIC NOTICE Video Conferencing Facility for promotion of innovation & start up business in Pharmaceutical sector |
2018-Oct-03 |
|
559 KB |
| 440 |
Advertisement of ADI |
2018-Sep-30 |
|
425 KB |
| 441 |
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 |
| 442 |
Notice-27.09.2018_Draft Pharmacovigilance System Inspection Guideline |
2018-Sep-27 |
|
1567 KB |
| 443 |
Draft Guidelines on Good Distribution Practices for Pharmaceutical Products |
2018-Sep-25 |
|
2623 KB |
| 444 |
Notice regarding sugam blood products dated 19.09.2018 |
2018-Sep-19 |
|
265 KB |
| 445 |
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 |
| 446 |
Public notice related to ASR Hip Implants |
2018-Sep-11 |
|
400 KB |
| 447 |
Renaming of Central Drugs Standard Control Organization dated 06.09.2018 |
2018-Sep-07 |
|
496 KB |
| 448 |
Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K |
2018-Aug-30 |
|
72 KB |
| 449 |
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 |
| 450 |
Letter regarding MSC,NCC & performance certificate |
2018-Aug-08 |
|
407 KB |
| 451 |
Notice for meeting of stake holders-Regarding ONLINE SUGAM PORTAL for blood product |
2018-Aug-08 |
|
261 KB |
| 452 |
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 |
| 453 |
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 |
| 454 |
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 |
| 455 |
Notice regarding mandatory Ethics committee registration through SUGAM portal |
2018-Aug-01 |
|
2,281,472 KB |
| 456 |
Notice regarding Ethics committee registration through SUGAM portal |
2018-Aug-01 |
|
2,170KB |
| 457 |
Quality Control Testing of viral load monitoring kits HIV, HBV, HCV |
2018-Jul-24 |
|
640 KB |
| 458 |
Public Notice regarding Promotion of Innovation Startup business in India in Pharmaceutical sector |
2018-Jul-20 |
|
700 KB |
| 459 |
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 |
| 460 |
Public Notice for comments on proposed notification |
2018-Jun-25 |
|
33KB |
| 461 |
Office Memorandum |
2018-Jun-14 |
|
333KB |
| 462 |
Providing a separate shelf/rack for generic medicines in retail shops visible to the consumers |
2018-Jun-12 |
|
495KB |
| 463 |
Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg |
2018-Jun-11 |
|
359KB |
| 464 |
Revised List of Oxytocin Manufacturer |
2018-Jun-11 |
|
425KB |
| 465 |
Publication of Gazette Notification of Drugs Inspectors in CDSCO under Section 21 of Drugs & Cosmetic Act, 1940-reg |
2018-Jun-08 |
|
70KB |
| 466 |
Constitution of India Drug/Pharamacueticals Association Forum-Reg. |
2018-Jun-08 |
|
345KB |
| 467 |
DTAB Committee Meeting from 5 June,2018 till 22 June,2018 |
2018-Jun-06 |
|
302KB |
| 468 |
Minutes of the meeting of 14th CBBDTEC |
2018-Jun-05 |
|
2,853KB |
| 469 |
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 |
| 470 |
Office Order Disposal of matters referred by Public Relation Office, CDSCO (HQ) |
2018-May-24 |
|
295KB |
| 471 |
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 |
| 472 |
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 |
| 473 |
Office Memorandum regarding speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India |
2018-May-21 |
|
666KB |
| 474 |
Speical operation to prevent and detect illegal manufacturing of API formulations and Import of oxytocin in India |
2018-May-21 |
|
671KB |
| 475 |
Office Order |
2018-May-11 |
|
265KB |
| 476 |
Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO |
2018-May-01 |
|
548KB |
| 477 |
Notice regarding SUGAM for New Drugs FDC and SND |
2018-Apr-27 |
|
372KB |
| 478 |
Office Order regarding Public Relations Office at CDSCO (HQ) |
2018-Apr-23 |
|
245KB |
| 479 |
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 |
| 480 |
Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 |
2018-Apr-09 |
|
259 KB |
| 481 |
Name Of Approved Clinical Centres |
2018-Apr-08 |
|
262kb |
| 482 |
Notice regarding export NOC with respect to shipping Bills from the Port offices |
2018-Mar-23 |
|
332KB |
| 483 |
Grouping Guidelines for Medical Devices Applications |
2018-Mar-16 |
|
1,984kb |
| 484 |
Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum |
2018-Mar-14 |
|
295KB |
| 485 |
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 |
| 486 |
Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018 |
2018-Mar-07 |
|
310KB |
| 487 |
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 |
| 488 |
Public Notice regarding Restriction on Import manufacture, sale and distribution of Oxytocin to curb its misuse |
2018-Feb-27 |
|
572KB |
| 489 |
Designation of CMDTL & MDTL including IVDMD under MDR-2017 |
2018-Feb-27 |
|
327 KB |
| 490 |
Pre-screening checklist3 |
2018-Feb-23 |
|
158kb |
| 491 |
FDC Guidelines _ Revised1 |
2018-Feb-23 |
|
422kb |
| 492 |
rc & form 10 checklist |
2018-Feb-23 |
|
170kb |
| 493 |
notification 19-2015-2020 |
2018-Feb-23 |
|
422kb |
| 494 |
Order regarding transfer of the Deputy Drug Controllers in CDSCO |
2018-Feb-22 |
|
365KB |
| 495 |
Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017 |
2018-Feb-21 |
|
9728KB |
| 496 |
Office Corrigendum regarding Drugs Inspector's transfers in CDSCO |
2018-Feb-20 |
|
204KB |
| 497 |
Office Memorandum regarding Drugs Inspector's transfers in CDSCO |
2018-Feb-20 |
|
346KB |
| 498 |
Order regarding Drugs Inspector's/Technical officer's transfers |
2018-Feb-20 |
|
931KB |
| 499 |
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 |
| 500 |
Notice regarding Meeting of CDSCO with manufacturers of Oxytocin Formulation to discuss issue ralted to misuse of Oxytocin |
2018-Feb-16 |
|
302KB |
| 501 |
Office order regarding Grievance Redressal in CDSCO (HQ) |
2018-Feb-13 |
|
304KB |
| 502 |
List of meetings of Expert Committee for examination of vaccine PSUR |
2018-Feb-09 |
|
7KB |
| 503 |
Office Memorandum regarding Sampling of imported insuline formulations at port offices |
2018-Feb-07 |
|
343KB |
| 504 |
Order regarding creation of 'Ayush' vertical in CDSCO |
2018-Feb-05 |
|
734KB |
| 505 |
Office Memorandum regarding Rotational Transfer of CDSCO |
2018-Jan-24 |
|
1.23MB |
| 506 |
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 |
| 507 |
Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) |
2018-Jan-22 |
|
875KB |
| 508 |
Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis |
2018-Jan-22 |
|
823KB |
| 509 |
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 |
| 510 |
Office order regarding Import of Drugs by a Government Hospitals & Autonomus Medical Instituations under Form 11A |
2018-Jan-02 |
|
205kb |
| 511 |
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 |
| 512 |
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 |
| 513 |
Documents to be submitted for Bioequivalence Study for export applications |
2018-Jan-01 |
|
92kb |
| 514 |
Notice regarding human vacine appliation through SUGAM online Portal of CDSCO |
2017-Dec-26 |
|
584KB |
| 515 |
Office order regarding SUGAM Portal of CDSCO |
2017-Dec-11 |
|
180KB |
| 516 |
Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh |
2017-Dec-05 |
|
308kb |
| 517 |
Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO |
2017-Nov-21 |
|
1.96MB |
| 518 |
Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017 |
2017-Nov-01 |
|
4190 KB |
| 519 |
Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices |
2017-Oct-31 |
|
665KB |
| 520 |
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 |
| 521 |
NOTICE regarding Adhering to Rule 28 and 28A of Drugs and Cosmetics Act and Rules 1945 |
2017-Sep-28 |
|
257KB |
| 522 |
NOTICE regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse |
2017-Sep-22 |
|
586KB |
| 523 |
NOTICE regarding Not of Standard Quality Combipack ABD |
2017-Sep-15 |
|
72.8KB |
| 524 |
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 |
| 525 |
NOTICE regarding not of Standard Quality of Mediclone D |
2017-Sep-15 |
|
59.9KB |
| 526 |
NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories |
2017-Sep-12 |
|
566KB |
| 527 |
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 |
| 528 |
NOTICE regading Supreme court hearing in the matters relating to FDC |
2017-Sep-07 |
|
8.02MB |
| 529 |
NOTICE regading suggestions/comments of the stakeholders including manufacturers/marketers of HPMC capsules |
2017-Sep-05 |
|
257KB |
| 530 |
NOTICE to all Drugs Manufacturers and Pharmaceuticals Association |
2017-Aug-09 |
|
311KB |
| 531 |
NOTICE to all State Drugs Controller |
2017-Aug-09 |
|
325KB |
| 532 |
NOTICE - regardingLaunch of export NOC module under SUGAM Portal |
2017-Jul-26 |
|
316KB |
| 533 |
NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) |
2017-Jul-17 |
|
182KB |
| 534 |
NOTICE - regarding availability of essential mediines following implementation of GST |
2017-Jul-13 |
|
637KB |
| 535 |
corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit |
2017-Jul-12 |
|
41.9KB |
| 536 |
NOTICE - regarding meeting of the stakeholders for feedback on new modules in SUGAM |
2017-Jul-12 |
|
372kb |
| 537 |
NOTICE - Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST) |
2017-Jul-10 |
|
418KB |
| 538 |
Notice Order regarding Import of Cosmetic division Sugam Online |
2017-Jul-06 |
|
351KB |
| 539 |
Notice Order regarding draft classification of Medical Devices and IVDs |
2017-Jun-29 |
|
1.83MB |
| 540 |
Notice Order regarding Streamlining the regulatory procedures |
2017-Jun-27 |
|
212kb |
| 541 |
Notice Order regarding address the grievances/ appeals |
2017-Jun-22 |
|
642kb |
| 542 |
Notice Order regarding Oseltamivir and Zanamivir |
2017-Jun-22 |
|
1.14MB |
| 543 |
Notice Order regarding address the grievances appeals dated 22.06.2017 |
2017-Jun-22 |
|
643KB |
| 544 |
Notice regarding Draft SOP for handling of NSQ samples |
2017-Jun-13 |
|
5.57KB |
| 545 |
Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit |
2017-Jun-13 |
|
569KB |
| 546 |
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 |
| 547 |
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 |
| 548 |
Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017 |
2017-May-30 |
|
279KB |
| 549 |
Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) |
2017-May-16 |
|
471KB |
| 550 |
Dengue Chkngunya IgM Elisa |
2017-May-12 |
|
330 KB |
| 551 |
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 |
| 552 |
Office Memo Issue of reports for testanalysis in form 13 on SUGAM Portal-regarding |
2017-May-01 |
|
329KB |
| 553 |
Order regarding import of Radio-pharmaceuticals |
2017-May-01 |
|
1.98MB |
| 554 |
Order regarding radiopharmaceuticals |
2017-Apr-28 |
|
818KB |
| 555 |
NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi |
2017-Apr-24 |
|
37.5KB |
| 556 |
Notice regarding Meeting for the registration of notified body through online portal |
2017-Apr-07 |
|
542KB |
| 557 |
Public Notice regarding Price Control dated 06.04.2017 |
2017-Apr-06 |
|
578KB |
| 558 |
Notice regarding creation of databases of drug manufacturing facilities and approved drug formulation of SUGAM portal |
2017-Apr-03 |
|
386KB |
| 559 |
Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 |
2017-Mar-31 |
|
250KB |
| 560 |
Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse |
2017-Mar-30 |
|
213KB |
| 561 |
Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse |
2017-Mar-30 |
|
287KB |
| 562 |
Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO |
2017-Mar-20 |
|
433 KB |
| 563 |
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 |
| 564 |
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 |
| 565 |
Pubic Notice Notice regarding Public Consulatation Regarding Regulation of Sale of Drugs in the Country |
2017-Mar-16 |
|
429KB |
| 566 |
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 |
| 567 |
Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use |
2017-Feb-20 |
|
947KB |
| 568 |
Office Memorandum Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use |
2017-Feb-20 |
|
291KB |
| 569 |
Notice regarding Human Vaccines dated 15.02.2017 |
2017-Feb-15 |
|
59KB |
| 570 |
Public Notice regarding D-Penicillamine |
2017-Feb-10 |
|
44.6KB |
| 571 |
Notice regarding Online application for Human Vaccines on Sugam |
2017-Feb-06 |
|
270KB |
| 572 |
Notice regarding Ease of doing Business relating to export of Drugs |
2017-Feb-06 |
|
305KB |
| 573 |
Notice regarding Medical Devices Rules,2017 Notification No. 78E |
2017-Feb-02 |
|
23.0KB |
| 574 |
Notice regarding Streamline the grievance |
2017-Feb-02 |
|
362KB |
| 575 |
Notice regarding Rational use of antibiotics for limiting antimicrobial dated 01.02.2017 |
2017-Feb-01 |
|
343KB |
| 576 |
Notice regarding Rational use of antibiotics fro limiting antimicrobial reistance dated 01.02.2017 |
2017-Feb-01 |
|
348KB |
| 577 |
Notice- Extension of last date for submission of application for Skill development programme on pharmacovigilance |
2017-Jan-31 |
|
240KB |
| 578 |
Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 |
2017-Jan-17 |
|
47.6KB |
| 579 |
Notice with respect to Antimicrobial resistance dated 16.01.2017 |
2017-Jan-16 |
|
601KB |
| 580 |
Order of Annual Increments of CDSCO (HQ) Officials dated 06.01.2017 |
2017-Jan-06 |
|
847KB |
| 581 |
Notice for Import of Radiopharmaceutical Products dated 03.01.2017 |
2017-Jan-06 |
|
29.4KB |
| 582 |
List of clarifications and NOC issued from 2011 to 2017 |
2017-Jan-02 |
|
901kb |
| 583 |
Document required for approval of BA-BE center |
2017-Jan-01 |
|
58kb |
| 584 |
Notice for Import of Radiopharmaceutical Products |
2016-Dec-29 |
|
50.7kb |
| 585 |
Notice 26.12.2016 |
2016-Dec-26 |
|
1.20MB |
| 586 |
Notice Creation of Sub-login id(s) after primary registration in SUGAM portal |
2016-Dec-21 |
|
283KB |
| 587 |
Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated 20.12.2016 |
2016-Dec-20 |
|
290KB |
| 588 |
Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach |
2016-Dec-20 |
|
304KB |
| 589 |
Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change |
2016-Dec-13 |
|
269KB |
| 590 |
Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis for biological products ( Vaccine & r-DNA Products) |
2016-Dec-13 |
|
476Kb |
| 591 |
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 |
| 592 |
Order: Timeline for communication of recommendation to the stakeholders based on the minutes of meeting of various Committees |
2016-Dec-13 |
|
229KB |
| 593 |
Public Notice |
2016-Dec-08 |
|
2.21MB |
| 594 |
Notice Order regarding e-Governance project of CDSCO |
2016-Dec-02 |
|
156KB |
| 595 |
Pharmacovigilance Skill Development Programme |
2016-Nov-28 |
|
101KB |
| 596 |
Office Memorandum regarding clarification the receipt in G.R6 G.R 7 for payment made through Bharatosk |
2016-Nov-21 |
|
337KB |
| 597 |
Notice regarding NABL accredited Drug Testing Laboratories and Manufacturing Units certified withWHO-GMP for COPP |
2016-Nov-11 |
|
216KB |
| 598 |
Notice regarding Risk based inspections of the manufacturing facilities regarding |
2016-Nov-09 |
|
29KB |
| 599 |
Notice regarding D-Penicillamine Capsule |
2016-Nov-08 |
|
260KB |
| 600 |
Notice inviting quotation to dispose off unserviceable articles materials in CDL Kolkata Dated 08.11.2016 |
2016-Nov-08 |
|
714KB |
| 601 |
Notice Order regarding SUGAM ONLINE Dated 01.12.2016 |
2016-Nov-01 |
|
260KB |
| 602 |
Office memorandum regarding approval of the safety and efficacy of FDCs |
2016-Oct-26 |
|
320KB |
| 603 |
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 |
| 604 |
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 |
| 605 |
Notice Order |
2016-Oct-06 |
|
729KB |
| 606 |
Notice Order regarding SUGAM ONLINE |
2016-Oct-05 |
|
259KB |
| 607 |
Minutes of Meeting held on 30.09.2016 regarding the availabity of D-Penicillamine across India-Regarding |
2016-Sep-30 |
|
17KB |
| 608 |
Non availability of life saving drug(D-Penicillamine) across India-Regarding |
2016-Sep-28 |
|
43KB |
| 609 |
Notice regarding SUGAM Online |
2016-Sep-21 |
|
1,820KB |
| 610 |
Meeting notice of Vaccine manufacturers to discuss upon forthcoming NRA assesment and its tools |
2016-Sep-21 |
|
576KB |
| 611 |
Presentation for Rabies Vaccine- regarding |
2016-Sep-08 |
|
218KB |
| 612 |
Presentation for Rabies Vaccine |
2016-Sep-08 |
|
219KB |
| 613 |
Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. |
2016-Sep-05 |
|
45KB |
| 614 |
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 |
| 615 |
Notice regarding Upgradation of Skill sets of persons employed in pharma manufacturing units |
2016-Aug-26 |
|
638KB |
| 616 |
Notice regarding checklist |
2016-Aug-23 |
|
292KB |
| 617 |
Notice regarding for online BA/BE for Export |
2016-Aug-22 |
|
1,290KB |
| 618 |
Notice regarding on "online Process for Grant of NOC for clinical Trials" |
2016-Aug-18 |
|
267KB |
| 619 |
Public Notice regarding online portal SUGAM |
2016-Aug-08 |
|
282KB |
| 620 |
Order regarding the revised transfer policy of Drugs Inspectors |
2016-Aug-03 |
|
796KB |
| 621 |
Notice ande Feedback |
2016-Aug-01 |
|
1,090KB |
| 622 |
Notice regarding meeting 12 july 2016 CDSCO |
2016-Jul-05 |
|
302KB |
| 623 |
Notice regarding transfer folicy for the officers/ Officials of CDSCO |
2016-Jun-24 |
|
290KB |
| 624 |
Notice regarding Examination for safety and Efficacy of FDCs |
2016-Jun-17 |
|
310KB |
| 625 |
Notice regarding not attending SEC Meeting |
2016-Jun-15 |
|
350KB |
| 626 |
Alert Notice |
2016-Jun-09 |
|
327KB |
| 627 |
Notice regarding Cosmetics and Ethicss Committee on SUGAM |
2016-Jun-07 |
|
317KB |
| 628 |
Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 |
2016-Jun-06 |
|
225KB |
| 629 |
Notice regarding Revisit of Drugs and Cosmetics Act 1940 and Rules 1945 |
2016-Jun-06 |
|
225KB |
| 630 |
Notice dated 30.5.2016 regarding Launch of Registration of Cosmetics and Ethics Committee Modules in Sugam Portal |
2016-May-30 |
|
487KB |
| 631 |
Public Notice |
2016-May-30 |
|
50KB |
| 632 |
Notice for dated 27.05.2016 regarding Launch of Test License Module in Sugam Portal |
2016-May-27 |
|
630KB |
| 633 |
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 |
| 634 |
Meeting Notice for medical devices and diagnostics stakeholders |
2016-May-23 |
|
84KB |
| 635 |
Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002 |
2016-May-20 |
|
94KB |
| 636 |
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 |
| 637 |
Notice regarding documents for applying as subject experts in various panels of CDSCO |
2016-May-10 |
|
1,220KB |
| 638 |
Notice dated 09.05.2016 regarding Sugam Online Medical Devices |
2016-May-09 |
|
264KB |
| 639 |
Notice inviting comments / Suggestions of Pharma and Medical Device Associations for Brining in ease of Drug Regulation |
2016-May-06 |
|
184KB |
| 640 |
Extending the validity of Free Sale certificate for notified medical devices |
2016-Apr-21 |
|
650KB |
| 641 |
Notice regarding Pending status |
2016-Apr-08 |
|
162KB |
| 642 |
Delhi High Court order dated 4.4.2016 for information of all concerned |
2016-Apr-04 |
|
1,510KB |
| 643 |
Notice regarding Gelatin Capsules with cellulose |
2016-Mar-30 |
|
18KB |
| 644 |
Capacity utilization for quality control testing for biological at NIB Noida |
2016-Mar-30 |
|
282 KB |
| 645 |
Notice |
2016-Mar-29 |
|
708KB |
| 646 |
Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics 2016 |
2016-Mar-26 |
|
48KB |
| 647 |
Notice regarding Preparation for global switch from tOPV to bOPV, 2016 |
2016-Mar-23 |
|
174KB |
| 648 |
Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016 |
2016-Mar-23 |
|
173KB |
| 649 |
Meeting Notice |
2016-Mar-21 |
|
658KB |
| 650 |
Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs & Cosmetics Act, 1940 |
2016-Mar-12 |
|
147KB |
| 651 |
Notice Track and Trace for Pharmaceutical Drug consignment |
2016-Mar-07 |
|
150KB |
| 652 |
Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics |
2016-Mar-04 |
|
673KB |
| 653 |
Notice regarding Creation of Speical Assistance Booth for addressing issues of submission of online applications |
2016-Mar-04 |
|
629KB |
| 654 |
Notice |
2016-Mar-03 |
|
780KB |
| 655 |
Notice Regarding Online Portal Sugam |
2016-Feb-18 |
|
714KB |
| 656 |
Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen |
2016-Feb-16 |
|
54KB |
| 657 |
Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent |
2016-Feb-16 |
|
55 KB |
| 658 |
Sale of Drugs over Internet contravening the provisions of Drugs and Cosmetics Rules, 1945 |
2015-Dec-30 |
|
973KB |
| 659 |
Clearance of Import and Export Consignments at Ports/Airports/Others Points |
2015-Dec-29 |
|
310KB |
| 660 |
National List of Essential Medicines (NLEM), 2015 |
2015-Dec-23 |
|
124KB |
| 661 |
Clarification for import of in Bulk form in Sutures |
2015-Dec-08 |
|
258kb |
| 662 |
Donation of organ(s) and/or tissues after being declared brain stem dead |
2015-Nov-20 |
|
320KB |
| 663 |
Public Notice |
2015-Nov-18 |
|
1,710KB |
| 664 |
Notice Dated 17.09.2015 Format for MOU |
2015-Sep-17 |
|
243KB |
| 665 |
Notice Dated 11.09.2015 regarding DTAB |
2015-Sep-11 |
|
707KB |
| 666 |
Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) |
2015-Sep-09 |
|
52KB |
| 667 |
Office Order 25.08.2015 regarding Parameter for writing and review of APAR's |
2015-Aug-25 |
|
270KB |
| 668 |
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 |
| 669 |
Transfer order |
2015-Jul-09 |
|
781KB |
| 670 |
Relieving order of ADC(I) |
2015-Jul-09 |
|
550KB |
| 671 |
Office Order for Old Drugs TL BA/BE (export) |
2015-Jul-03 |
|
366KB |
| 672 |
Reminder |
2015-May-12 |
|
52KB |
| 673 |
Office Memorandum Nomination of representatives for e-governance |
2015-Mar-26 |
|
62KB |
| 674 |
Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue |
2015-Feb-14 |
|
294KB |
| 675 |
Office Memorandum Grant of NOC for procuring unapproved/Approved New Drug |
2015-Feb-13 |
|
494KB |
| 676 |
Circular |
2015-Feb-03 |
|
291KB |
| 677 |
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 |
| 678 |
Meeting of all Vaccine Manufacutres & Importers on 15th January 2015 |
2014-Dec-26 |
|
513KB |
| 679 |
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 |
| 680 |
Notice dated 10.12.2014 |
2014-Dec-10 |
|
411KB |
| 681 |
Corrigendum |
2014-Nov-10 |
|
21KB |
| 682 |
Office order |
2014-Oct-21 |
|
738KB |
| 683 |
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 |
| 684 |
Office Memorandum dated 29.09.2014 reg. Relabeling or stickering on the label of cosmetics |
2014-Sep-29 |
|
320KB |
| 685 |
Notice 17 September 2014 |
2014-Sep-17 |
|
100KB |
| 686 |
CBBBTDEC Meeting Shedule for Year 2014-2015 |
2014-Sep-12 |
|
31KB |
| 687 |
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 |
| 688 |
Office order 29.08.2014 draft list of approved products for Veterinary drugs |
2014-Aug-29 |
|
41KB |
| 689 |
Specificaiton and Criteria for Acceptance_bood glucose test strip |
2014-Aug-07 |
|
460 KB |
| 690 |
Letter for States regarding Regulatory Inspection Procedure |
2014-Aug-06 |
|
148KB |
| 691 |
Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM |
2014-Jul-28 |
|
210KB |
| 692 |
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 |
| 693 |
Notice dated 7.07.2014 Hearing for redressal of Public Grievance |
2014-Jul-07 |
|
222KB |
| 694 |
Office Order dated 03.07.2014 - Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies |
2014-Jul-03 |
|
198KB |
| 695 |
Office Order dated 03.07.2014 - Approval of academic CT |
2014-Jul-03 |
|
146KB |
| 696 |
Office Order dated 03.07.2014 - Clinical Trial on Medical Device |
2014-Jul-03 |
|
164KB |
| 697 |
Office Order dated 03.07.2014 - Consideration of banning of a marketed drug |
2014-Jul-03 |
|
145KB |
| 698 |
Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs |
2014-Jul-03 |
|
211KB |
| 699 |
Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage |
2014-Jul-03 |
|
164KB |
| 700 |
Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time |
2014-Jul-03 |
|
158KB |
| 701 |
Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT |
2014-Jul-03 |
|
151KB |
| 702 |
Office Order dated 03.07.2014 - Placebo Controlled Trials |
2014-Jul-03 |
|
174KB |
| 703 |
Office Order dated 03.07.2014 - Procedure for review of application of CT and New drugs |
2014-Jul-03 |
|
205KB |
| 704 |
Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects |
2014-Jul-03 |
|
156KB |
| 705 |
Office Order dated 03.07.2014 - Requirement for filing of application to market new Chemical Entities |
2014-Jul-03 |
|
175KB |
| 706 |
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 |
| 707 |
Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs |
2014-Jul-03 |
|
152KB |
| 708 |
Office Order dated 27.6.2014 Daily Public hearing of respective division |
2014-Jun-27 |
|
283KB |
| 709 |
IVD Office Order |
2014-Jun-24 |
|
1436 KB |
| 710 |
Office Order dated 06.05.2014 reg. Constitution of Antimalarial Cell in CDSCO (HQ) |
2014-May-06 |
|
287KB |
| 711 |
Office Memorandum |
2014-Mar-28 |
|
415KB |
| 712 |
Inclusion of Schedule H1 under the Drugs and Cosmetics Rules Dated 19.03.2014 |
2014-Mar-19 |
|
340KB |
| 713 |
Constitution of In Vitro Diagnostic Device Advisory Committee |
2014-Mar-07 |
|
1200 KB |
| 714 |
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 |
| 715 |
Notice |
2014-Feb-20 |
|
396KB |
| 716 |
Notice Regarding Approvals of Stem Cells and Cell Based Products Dated 18.02.2014 |
2014-Feb-18 |
|
493KB |
| 717 |
PROPOSAL FOR CREATION OF IT ENABLED SYSTEM |
2014-Feb-17 |
|
211 KB |
| 718 |
Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits |
2014-Feb-14 |
|
250 KB |
| 719 |
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 |
| 720 |
Notce |
2014-Feb-13 |
|
297KB |
| 721 |
Delegation of the Powers- Import of Small Quantities of Drugs for Personal Use |
2014-Feb-12 |
|
462KB |
| 722 |
Public Information Cell |
2014-Feb-07 |
|
276KB |
| 723 |
Veterinary Cell Office Order |
2014-Feb-07 |
|
251KB |
| 724 |
Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv |
2014-Feb-01 |
|
327kb |
| 725 |
Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) |
2014-Jan-25 |
|
294kb |
| 726 |
Notice-Meeting of the Pharmaceuticals Industry Associations |
2014-Jan-07 |
|
256KB |
| 727 |
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 |
| 728 |
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 |
| 729 |
Notice Ethic Committee Clinical trial |
2013-Jul-30 |
|
317KB |
| 730 |
Office Order |
2013-Jul-10 |
|
245KB |
| 731 |
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 |
| 732 |
Office Order:-Constitution of High Powered Committee for the regulation of stem cell |
2013-Jun-03 |
|
555KB |
| 733 |
Delegation of powers of Licensing Authority under Rule 22 of Drugs & Cosmetics Rules |
2013-May-23 |
|
343KB |
| 734 |
Notice dated 08.05.2013: Clarification sought by the stakeholders |
2013-May-08 |
|
312KB |
| 735 |
Notice dated 10.04.2013 regarding prioritisation of activities at CDSCO |
2013-Apr-10 |
|
420KB |
| 736 |
Office Order dated 09.04.2013: International Cell in CDSCO(HQ) |
2013-Apr-09 |
|
290KB |
| 737 |
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 |
| 738 |
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 |
| 739 |
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 |
| 740 |
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 |
| 741 |
Notice - clarification and requirements related to post approval changes as per CDSCO Guidance for industry for biological products |
2013-Jan-18 |
|
603KB |
| 742 |
Notice - dated 17.01.2013: Admn |
2013-Jan-17 |
|
285KB |
| 743 |
Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 |
2012-Dec-27 |
|
235 KB |
| 744 |
Notice-dated 13.12.2012: DRUG ALERT |
2012-Dec-13 |
|
378KB |
| 745 |
Notice-dated 11.12.2012: Advisory notice on Clinical Trial |
2012-Dec-11 |
|
1,240Kb |
| 746 |
Notice-dated 03.12.2012: Group A Officer of CDSCO issued by Ministry of Health. |
2012-Dec-03 |
|
284KB |
| 747 |
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 |
| 748 |
Office Order-dated 21.11.12: Delegation of power to CDSCO (NZ) Ghaziabad. |
2012-Nov-21 |
|
311KB |
| 749 |
E.U-API - Written Confirmations Certificate |
2012-Nov-12 |
|
411KB |
| 750 |
Clarification-dated 12.11.12: Directions issued under Section 33P of D & C Act 1940. |
2012-Nov-12 |
|
1,070KB |
| 751 |
Notice-dated 29.10.12: Interactive meeting with stakeholders. |
2012-Oct-29 |
|
293KB |
| 752 |
Notice-dated 29.10.12: CDSCO Sr. Officers Meeting. |
2012-Oct-29 |
|
239KB |
| 753 |
Notice-dated 12.10.2012: Directions issued under Section 33P of D & C Act 1940. |
2012-Oct-12 |
|
1,220KB |
| 754 |
Notice-dated 01.10.2012 : Extension of implementations of GSR No. 426(E) dt 19.05.2010 |
2012-Oct-01 |
|
101KB |
| 755 |
Notice-dated 14.09.2012: Fake drug menace in India. |
2012-Sep-14 |
|
316KB |
| 756 |
Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) |
2012-Aug-29 |
|
297KB |
| 757 |
Notice-dated 28.08.2012: Expansion of Experts panel for evaluation of application of New Drugs etc. |
2012-Aug-28 |
|
1,260KB |
| 758 |
Office Order-dated 28.08.2012: Submission of Periodic Safety Update Reports (PSURs). |
2012-Aug-28 |
|
528KB |
| 759 |
Clarification reg NOC to import of diagnostics kit or reagent for ROU |
2012-Jul-13 |
|
201 KB |
| 760 |
Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012 |
2012-Jul-13 |
|
201 KB |
| 761 |
Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices |
2012-Mar-05 |
|
74 KB |
| 762 |
Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices |
2012-Feb-17 |
|
1292 KB |
| 763 |
GENERAL ORDER |
2012-Feb-17 |
|
140 KB |
| 764 |
MISCELLANEOUS ORDER |
2012-Feb-17 |
|
118 KB |
| 765 |
Advisory notice on clinical trial |
2012-Feb-17 |
|
1273 KB |
| 766 |
REPRODUCTIVE & UROLOGY ORDER |
2012-Feb-17 |
|
123 KB |
| 767 |
ORTHOPAEDIC ORDER |
2012-Feb-17 |
|
127 KB |
| 768 |
Office Order- dated 21.11.2011: For Pre Screening Applications |
2011-Nov-21 |
|
45KB |
| 769 |
Clarification to Office Order dated 21.11.2011 for Pre Screening of Applications. |
2011-Nov-21 |
|
57KB |
| 770 |
Office Order-dated 08.11.2011: Public Hearing and Monitoring Cell. |
2011-Nov-08 |
|
346KB |
| 771 |
Clarification for import of pre-filled syringe |
2011-Nov-07 |
|
282kb |
| 772 |
Office Order-dated 04.11.2011: Constitution of Special Public Hearing and monitoring cell. |
2011-Nov-04 |
|
367KB |
| 773 |
Clarification on regulation of staplers |
2011-Oct-04 |
|
54kb |
| 774 |
Office Memorandum-dated 16.08.2011: Monitoring of functioning of all Port Offices of CDSCO. |
2011-Aug-16 |
|
55KB |
| 775 |
Office Order-dated 01.06.2011 regarding delegation of powers to Zonal Officer of CDSCO. |
2011-Jun-01 |
|
74KB |
| 776 |
MDAC of Orthopedic |
2011-May-10 |
|
127 KB |
| 777 |
MDAC of Ophthalmic |
2011-May-10 |
|
126 KB |
| 778 |
MDAC of General Expert Pool |
2011-May-10 |
|
140 KB |
| 779 |
MDAC Miscellaneous Devices |
2011-May-10 |
|
118 KB |
| 780 |
MDAC Dental |
2011-May-10 |
|
119 KB |
| 781 |
MDAC of Reporductive and Urology |
2011-May-10 |
|
123 KB |
| 782 |
MDAC Cardiovascular order dated 10 May 2011 |
2011-May-10 |
|
129 KB |
| 783 |
Clarification with respect of the manufacturing and marketing of New Drugs |
2011-Mar-10 |
|
300 KB |
| 784 |
CARDIOVASCULAR ORDER |
2011-Feb-17 |
|
129 KB |
| 785 |
DENTAL ORDER |
2011-Feb-17 |
|
119 KB |
| 786 |
OPHTHALMIC ORDER |
2011-Feb-17 |
|
126 KB |
| 787 |
Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) |
2010-Sep-01 |
|
1248 KB |
| 788 |
Testing of Biochemical kits for estimation of glucose |
2010-Aug-26 |
|
133 KB |
| 789 |
List of Notified Medical devices |
2010-Apr-20 |
|
85 KB |
