| 1 |
Circulars dated 27 Oct 2021 regarding |
2021-Oct-27 |
|
901 KB |
| 2 |
Prior approval for Global Tender Enquiry under rule 161(Vi) of General Financial Rules (GFRs) |
2021-Oct-14 |
|
1338 KB |
| 3 |
Office Order regarding the Leaves(s) in respect of the officers of CDSCO |
2021-Oct-12 |
|
432 KB |
| 4 |
Office order regarding leaves granted to Officers of CDSCO |
2021-Aug-19 |
|
930 KB |
| 5 |
Circular regarding Azadi Ka Amrit Mahotsav |
2021-Aug-12 |
|
2039 KB |
| 6 |
Circular regarding attending office during Parliament Session |
2021-Aug-03 |
|
1880 KB |
| 7 |
Data for Income Tax Calculation for the Financial Year 2021-22 |
2021-Aug-02 |
|
3990 KB |
| 8 |
Clarification if change in a) Polymorphs/crystalline/amorphous/solvates/hydrate etc (b) salt and (c) Derivative/analogue/ester etc of already approved active substance to be considered as new drug if main active moiety (Active Pharmaceutical Ingredient-API) is same? |
2021-Jul-23 |
|
131 KB |
| 9 |
Circular regarding attending office regularly dated 07.07.2021 |
2021-Jul-07 |
|
602 KB |
| 10 |
Consolidated Instructions for Global Tender Enquiry (GTE) under Rule 161(iv) of General Financial Rules (GFRs), 2017 |
2021-Jul-07 |
|
3372 KB |
| 11 |
Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding 25 june 2021 |
2021-Jun-25 |
|
920 KB |
| 12 |
Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed |
2021-Apr-13 |
|
373 KB |
| 13 |
RT-PCR Test for COVID-19 of the staff of CDSCO at FDA bhawan |
2021-Apr-07 |
|
908 KB |
| 14 |
Declaration of Holiday on 14th April 2021 Dr. B R Ambedkar |
2021-Mar-31 |
|
334 KB |
| 15 |
Office Meorandum regarding for pusuing higher qualification |
2021-Mar-26 |
|
735 KB |
| 16 |
Office Memorandum regarding submission of immovable property retrun for the year 2020 |
2021-Jan-05 |
|
1811 KB |
| 17 |
Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed |
2020-Dec-18 |
|
983 KB |
| 18 |
Circulars dated 18 December 2020 |
2020-Dec-18 |
|
520 KB |
| 19 |
Clarification regarding admissibility of Transport allowance druing Nation-Wide Lockdown due to COVID-19 pandemic |
2020-Dec-08 |
|
328 KB |
| 20 |
Clarification regarding reference standards |
2020-Dec-04 |
|
260 KB |
| 21 |
Submmission on Leave application in i-connect leave management System |
2020-Oct-07 |
|
493 KB |
| 22 |
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 |
| 23 |
Circular regarding Extension of validity of BA/BE Study Centres regarding |
2020-Apr-30 |
|
344 KB |
| 24 |
Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic |
2020-Apr-03 |
|
454 KB |
| 25 |
Circular regarding exemption of biometric machine attendance till 31.03.2020 |
2020-Mar-06 |
|
857 KB |
| 26 |
Circular regarding disposal of the application of WC for active substances exported to the Eu for medicinal products for Human use in accordance with Acrticle 42(2) |
2020-Mar-04 |
|
664 KB |
| 27 |
Circular regarding Disposal of the application of WHO-GMP |
2020-Mar-03 |
|
617 KB |
| 28 |
Circular Submission of certifice copy of APAR for consideration for Promotion confirmation grant of MACP etc to CDSCO HQ |
2020-Feb-17 |
|
116 KB |
| 29 |
Circular regarding Rational use of Antibiotics for limiting Antimicrobial resistance |
2019-Dec-23 |
|
766 KB |
| 30 |
Information/Guidance regarding uploading of manufacturing site and formulations data on SUGAM Portal |
2019-Nov-29 |
|
384KB |
| 31 |
Clarification on stability data requirement in case of CT and BABE study |
2019-Oct-18 |
|
516 KB |
| 32 |
Circular regarding clarification on stability data requirement in case of Clinical Trial and Bioavailability-Bioequivalance study |
2019-Oct-18 |
|
668 KB |
| 33 |
Circular regarding procedure for booking of air-tickets on LTC |
2019-Sep-30 |
|
235 KB |
| 34 |
Circulard dated 11 September 2019 |
2019-Sep-11 |
|
53 KB |
| 35 |
Circular regarding WC dated 9.9.2019 |
2019-Sep-09 |
|
755 KB |
| 36 |
Clarification on manufacturing of new drug by a manufacturer in their own multiple manufactring site |
2019-Aug-30 |
|
89 KB |
| 37 |
NOC for manufacture of Unapproved Banned New Drugs solely for Export purpose |
2019-Aug-05 |
|
425 KB |
| 38 |
Disposal of unserviceable/obsolete item of CDSCO |
2018-Dec-21 |
|
322 KB |
| 39 |
Pending Annual Performance Appraisal Report APARs of Drugs Inspectors in CDSCO regarding |
2018-Sep-27 |
|
735 KB |
| 40 |
Creation of Veterinary cell at CDSCO(HQ), New Delhi |
2018-Jul-03 |
|
388KB |
| 41 |
Gazette Notification of Drug Inspector |
2018-Apr-12 |
|
1,680lb |
| 42 |
Additional information regarding Medical Devices Rules 2017 |
2018-Mar-16 |
|
1,230kb |
| 43 |
NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd |
2018-Mar-14 |
|
904kb |
| 44 |
Request to advice the manufacturers to submit stability data of non patent and proprietary medicines for grant of permission |
2017-Aug-18 |
|
274kb |
| 45 |
Circular Establishment of facilities for ther activities of coating assembling of components, sterilization etc for devices |
2017-Aug-09 |
|
562kb |
| 46 |
Clarification regarding submission of application for post approval changes of human Vaccines |
2017-Jul-18 |
|
302kb |
| 47 |
Testing of Sample of Imported Vaccine |
2017-Jun-05 |
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1,420kb |
| 48 |
Acknowledgement for Level-III post approval changes Annual Notifications of biological products (vaccines &r-DNA) |
2017-May-26 |
|
485kb |
| 49 |
Delegation of Power to Sign Licence and Rigistration |
2017-Apr-13 |
|
2920kb |
| 50 |
Merit List based on the written examination held on 09.04.2017 at NIB Noida for WHO Roational Fellowhip Selection |
2017-Apr-10 |
|
3,500kb |
| 51 |
Circular regarding Human Vaccine |
2017-Feb-16 |
|
50kb |
| 52 |
Circular regarding first time import/manufacture in the country of Active Pharmaceutical Ingredient API of a drug which has earlier been approved as New Drug in Finished Formulation for import and marketing and /or allowed for import under import registration and Licensing |
2016-Dec-30 |
|
396kb |
| 53 |
Circular regarding NOC for export of biological products (Vaccine and r-DNA products) under Form 29 license to manufacture drugs for purposes of examination, test or analysis |
2016-Dec-13 |
|
237kb |
| 54 |
Circular regarding extension of Shelf Life within or up to the period of 60 Months for export purpose |
2016-Oct-27 |
|
309kb |
| 55 |
Circular regarding requirement of approval of Review Committee on Genetic Manipulation under Department of Biotechnology for r-DNA |
2016-Aug-30 |
|
487kb |
| 56 |
Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator |
2016-Aug-03 |
|
493kb |
| 57 |
Circular regarding Restriction of conducting three clinical trials per investigator |
2016-Aug-02 |
|
243kb |
| 58 |
Circular regarding Requirement of 50 bedded site for clinical trial |
2016-Aug-02 |
|
258kb |
| 59 |
Manufacturing and Marketing of Unapproval Drug, VitaminK2-7 |
2016-Jan-01 |
|
39kb |
| 60 |
Pre-Screening work |
2015-Dec-30 |
|
244kb |
| 61 |
Requirement of approval of Review Committee on Generic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like Insulin, Monoclonal antibody, etc |
2015-Nov-10 |
|
242kb |
| 62 |
Circular to all State/UT's Drugs Controller |
2015-Aug-06 |
|
46kb |
| 63 |
Draft Senority List of Assistant Drugs Inspectors CDSCO |
2015-Jul-13 |
|
752kb |
| 64 |
Draft Senority List of Drugs Inspectors CDSCO |
2015-Jul-01 |
|
3,240kb |
| 65 |
Circular regarding Import of Cosmetics |
2015-Jun-29 |
|
428kb |
| 66 |
|
2015-Jun-17 |
|
337kb |
| 67 |
Availability of H1N1 Vaccine |
2015-Feb-17 |
|
48kb |
| 68 |
Exemption of Veterinary products from the purview of DCG(I) Letter |
2015-Jan-15 |
|
361KB |
| 69 |
Circular regarding written confirmation certificate |
2014-Oct-22 |
|
92kb |
| 70 |
Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin |
2014-Oct-22 |
|
897kb |
| 71 |
Circular |
2014-Oct-01 |
|
111kb |
| 72 |
Minutes of Meeting |
2014-Sep-08 |
|
22kb |
| 73 |
Database of Fixed Dose Combinations (FDC's) Permitted for Manufacture for Sale in the Country |
2014-Sep-05 |
|
574kb |
| 74 |
Seventh Meeting of the Expert Committee on 29.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2014-Aug-29 |
|
262kb |
| 75 |
Sixth Meeting of the Expert Committee on 27.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2014-Aug-27 |
|
274kb |
| 76 |
Postponement of the Seventh Expert Committee Meeting from 29.08.2014 to 05.09.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2014-Aug-22 |
|
376kb |
| 77 |
Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents |
2014-Aug-07 |
|
359kb |
| 78 |
Clarification on Form-29 for the Manufacture of Clinical Trial Material |
2014-Jul-25 |
|
128kb |
| 79 |
Use of antibiotcs for Treatment of food producing animals and in animal feed |
2014-Jun-06 |
|
286kb |
| 80 |
Approval of the safety and efficacy of FDC permitted for manufacture for sale in the country without due approval form office of DCG(I) |
2014-Jun-05 |
|
167kb |
| 81 |
Manufacture for sale in the country without due approval from office of DCG(I) |
2014-May-26 |
|
174kb |
| 82 |
Third Meeting of the Expert Committee on 04.06.2014 to examine the matters related to approval of the safety and efficacy of FDC permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2014-May-26 |
|
170kb |
| 83 |
Fourth Meeting of the Expert Committee on 11.06.2014 to Examine the Matters Related to Approval of the safety and efficacy of FDC Permitted |
2014-May-26 |
|
132kb |
| 84 |
Second Meeting of the Expert Committee on 23.04.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2014-Apr-04 |
|
668kb |
| 85 |
Approval of the safety and efficacy of FDCs |
2014-Mar-28 |
|
311kb |
| 86 |
Restriction on use of formulations of Tramadol, Tapentadol as well as FDCs containing Tramadol |
2014-Feb-14 |
|
138kb |
| 87 |
Cancellation of Permission of FDC of Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide tablets |
2014-Feb-07 |
|
441kb |
| 88 |
Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC's Without Approval from DCG(I) |
2014-Feb-03 |
|
322KB |
| 89 |
Bringing details about Drug Import alert/restrictions imposed by regulatory authorities abroad |
2014-Jan-28 |
|
504KB |
| 90 |
Grant of Permission to Manufacture and Market FDC of Cefixime 200mg |
2013-Nov-11 |
|
184KB |
| 91 |
Grant of Permission to Manufacture and Market Certain FDC |
2013-Nov-05 |
|
154kb |
| 92 |
Grant of Permission to Manufacture and Market FDC of Ofloxacin 200mg |
2013-Oct-17 |
|
147KB |
| 93 |
Approval of the safety and efficacy of Fixed Dose Combinations(FDCs) permitted for manufacture for sale in country without due approval from office of DCG(I) |
2013-Sep-02 |
|
866kb |
| 94 |
Furnishing of information in respect of financial support, fees, honorarium, payments in kind etc to be paid to the investigator as per contract entered into by the sponsor with the investigator/ insititution in clinical trials |
2013-Aug-30 |
|
310kb |
| 95 |
Approval of the safety and efficacy of FDCs permitted for manufacture for sale in country without due approval form office of DCG(I) |
2013-Aug-26 |
|
567kb |
| 96 |
Circular dated 05.07.2013 regarding approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the country without due approval from office of DCG(I) |
2013-Jul-05 |
|
912kb |
| 97 |
Circular regarding drug import alert/ restrictions imposed by regulatory authorities abroad |
2013-Jun-26 |
|
343kb |
| 98 |
Circular regarding re-labeling/re-printing of revised prices as per NPPA's |
2013-Jun-26 |
|
499kb |
| 99 |
Sub -rule 3A of Rule 97 of drugs and cosmetics rules 1945 regarding withdrawal period |
2013-May-23 |
|
244kb |
| 100 |
Letter regarding safety and efficacy of FDCs permitted by State Licensing Authority without prior approval from DCG(I) |
2013-Mar-21 |
|
288kb |
| 101 |
Letter Approval of the safety and efficacy of Fixed Dose Combinations Permitted for manufacture for sale in the country without due approval form office of DCG(I) |
2013-Jan-15 |
|
681kb |
| 102 |
Letter To establish the safety and efficacy of the FDC of Flupenthixol+Melitracen on Indian population. |
2013-Jan-10 |
|
400kb |
| 103 |
Letter Cancellation of permission/License in case an applicant/manufacturer fails to launch their product within a period of six month from obtaining the permission/license from CDSCO |
2013-Jan-10 |
|
365kb |
| 104 |
General Information on antibiotics and antibiotic resistance. |
2012-Dec-10 |
|
84kb |
| 105 |
Order issued to CDSCO Zonal Offices on Special drive for assuring the quality of medicines. |
2012-Dec-05 |
|
384kb |
| 106 |
Letter on Important safety label changes to cholesterol lowering stating drug. |
2012-Nov-06 |
|
1,030kb |
| 107 |
Order regarding “Box Warning†on label/package insert of formulations containing Nimesulide. |
2012-Apr-14 |
|
280kb |
| 108 |
Clarification regarding Limiting of Acetaminophen (Paracetamol) in prescription combination products. |
2012-Apr-04 |
|
329kb |
| 109 |
Circular regarding import of Cosmetic |
2011-Nov-16 |
|
148kb |
| 110 |
Cosmetic NOC |
2011-Nov-16 |
|
144kb |
| 111 |
Letter regarding Limiting of Acetaminophen (Paracetamol) in Prescription Combination Products |
2011-Sep-23 |
|
116kb |
| 112 |
Letter regarding Phasing out of oral Single Drug Formulations of Artemisinin. |
2011-Apr-25 |
|
110kb |
| 113 |
Letter regarding Information for submission to Department related Parliament Standing Committee on H&FW |
2011-Feb-03 |
|
62kb |
| 114 |
Letter regarding Prohibition of manufacture and sale of Rosiglitazone. |
2010-Nov-16 |
|
156kb |
| 115 |
Letter regarding Suspension of import/manufacture of rosiglitazone in the country. |
2010-Oct-07 |
|
101kb |
