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IN FORCE
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
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86 Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form 2025-Feb-17 325 KB
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168 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 2022-Oct-10 764 KB
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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
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45 Clarification for regulatory pathway for Cocrystals 2025-Sep-15 546 KB
IN FORCE Import policy & restrictions ·?
182 Clarification regarding import of non-drug / lab kits shipments related to clinical trial / clinical research purposes. 2022-Jul-07 341 KB
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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 K
IN FORCE Procedural & compliance ·?
104 Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country 2024-May-29 429 KB
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21 Carbimazole related agranulocytosis - Recommendations for the change in Prescribing Information Leaflets (PILs) 2026-Feb-17 518 KB
IN FORCE Import policy & restrictions ·?
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
Beauty Garage lndia Pvt. Ltd.
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19 Cancellation of Registration Certificates and lmport Registration Numbers for lmport of Cosmetics under the Cosmetics Rules, 2020- Regarding 2026-Feb-23 1314 KB
Kult App Pvt. Ltd.Kult E-Commerce Pvt. Ltd.Kutt App Pvt. Ltd.
IN FORCE Import policy & restrictions ·?
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
Esthetic Centers lnternational Pvt. Ltd.
IN FORCE Import policy & restrictions ·?
154 Cancellation letter of M/s. Crossline Communication 2023-May-02 358 KB
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81 Launching of registration of Clinical Research Organisation applications through SUGAM Portal 2025-Mar-04 1867 KB
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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 Chlori
Clarification for grant of permission for combipack product of lyophilised dry powder for injection/ 1.V. infusion and diluents for reconstitution such as sterile water for injection [Sodium Chloride Injection
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24 CDSCO updated list of Laboratories for conducting Performance Evaluation of In-Vitro Diagnostic Medical Device 2026-Jan-19 608 KB
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113 Public Notice regarding Draft CDSCO Guidance for Industry Version 1.2 2024-Apr-10 1184 KB
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97 Baxter recall letter for Product Fibrin Sealant Kit Brand name Tisseel Lyo manufactured in Vienna Austria 2024-Sep-02 1508 KB
Baxter (India) Pyt. Ltd.Baxter Healthcare Corporation
IN FORCE Export policy & incentives ·?
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-1
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25 Disposal/Rejection of Long-Pending Applications on Sugam Portal Awaiting Query Response 2026-Jan-16 96 KB
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126 Appointment of First Appellate Authority & CPIO for the purpose of RTI (Technical) matters 2024-Jan-30 362 KB
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39 The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded in 2025 2025-Oct-22 367 KB
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106 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 ch
Astrazeneca Pharma
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119 Manufacturing and marketing of unapproved drug Meropenem & Disodium EDTA for Injection 2024-Mar-08 383 KB
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135 Advisory to all manufacturer of cough syrup, various critical excipients 2023-Dec-05 418 KB
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73 Manufacturing and marketing of unapproved FDCs regarding 2025-Apr-11 223 KB
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181 Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 781 KB
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3 Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs 2026-May-18 75 KB
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180 Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 594 KB
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131 Launching of National Single Window System (NSWS) Portal 2024-Jan-01 3669 KB
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179 Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 702 KB
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160 Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2022 2023-Mar-15 7 KB
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161 Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2021 2023-Mar-15 7 KB
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159 Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2020 2023-Mar-15 7 KB
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93 Submission of Clinical Trial Site Addition and change of Principal Investigator applications through SUGAM Portal 2024-Dec-30 70 KB
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89 Reconstitution of Internal Complaint Committee on Sexual Harassment Mumbai West Zone 2023-Oct-09 178 KB
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193 Availability of H1N1 Vaccine 2015-Feb-17 48kb
Serum Institute of India Ltd.Panacea Biotec Ltd.Bharat Biotech International. Ltd.
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169 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
Bio Med Pvt. Ltd.Biomed Pvt. Ltd.
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67 Transfer order of CDSCO 2024 2024-May-14 1463 KB
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118 Transfer order for the year 2022-2023-4 2022-Sep-08 10353 KB
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124 Transfer order for the year 2022-2023-1 2022-Mar-10 1334 KB
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120 Transfer order for the year 2022-2023-2 2022-Jul-05 4607 KB
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173 Testing of Sample of Imported Vaccine 2017-Jun-05 1,420kb
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40 Suo-Moto Disclosure of Information Pertaining to CDSCO-HQ, Zonal, Sub-Zonal, Port Offices, and Laboratories for Third-Party Transparency Audit 2025-May-09 358 KB
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156 Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal 2019-Nov-29 384KB
IN FORCE Import policy & restrictions ·?
148 circular regarding Special Condition under which the permission for import of drug with residual shelf life less than 60 % is allowed 2020-Jul-10 212 KB
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76 Income Tax savings for FY- 2023-2024 2024-Feb-05 240 KB
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45 On line application for extension of time to comply with revised Sch M on ONDLS portal 2025-Mar-24 50 KB
IN FORCE Procedural & compliance ·?
183 Circular regarding Restriction of conducting three clinical trials per investigator 2016-Aug-02 243kb
IN FORCE Procedural & compliance ·?
184 Circular regarding Requirement of 50 bedded site for clinical trial 2016-Aug-02 258kb
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