Picture: Pixabay What is new drug Rule 122-E Definition of new drug.- 1 which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.] (b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration. (c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y.) Explanation.- For the purpose of this rule− (i) all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21; (ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval Also read: FAQs about New Drug, Banned drugs etc. About new drugs Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and Appendix I- XII of Schedule Y, describe the information/data required for approval of clinical trial and / or to import or manufacture of new drug for marketing in the country. RULES GOVERNING CLINICAL TRIALS Rule 122-A -Application for permission to import new drug Rule 122-B -Application for approval to manufacture new drug Rule 122-DA-Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug; Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation; Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance Rule 122 E-Definition of new drug Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug Good Clinical Practice Guidelines Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India FDCs - Fixed Dose Combination FDCs approved by DGCI since 1961 to 23rd June 2021, Click below link: FDCs-approved-by-DGCI-since-1961-to-23rd-June-2021 DCGI Notice dt 26-07-2021 – Evaluation of certain Pre 1988 permitted FDCs – without due approval from CLA DCGI-Notice-dt-26-07-2021-Evaluation-of-certain-Pre-1988-permitted-FDCs-without-due-approval-from-CLA DCGI Circular 08-09-2020 – regarding 294 rational FDCs – procedure to be followed DCGI-Circular-08-09-2020-regarding-294-rational-FDCs-procedure-to-be-followed DCGI has issued notice on 21-02-2020 regarding approval of FDCs containing new drugs DCGI-Notice-21-02-2020-regarding-approval-of-FDCs-containing-new-drugs DCGI has issued notice on 20-02-2020 regarding Considerations-of Honb'le Supreme Court of India in the case of 294 FDCs DCGI-Notice-20-12-2020-Considerations-of-Honble-Supreme-Court-of-India-in-the-case-of-294-FDCs DCGI Circular 23-07-2021 Already approved drugs is New Drug, if certain changes occur in Active substance DCGI-Circular-23-07-2021-Already-approved-drugs-is-New-Drug-if-certain-changes-occur-in-Active-substance GSR 99(E) dt 05-02-2021 -Draft notification For inclusion of provisions related to the registration of stand alone bio analytical laboratories in the NDCT Rules, 2019 GSR-99E-dt-05-02-2021-Draft-notification-For-inclusion-of-provisions-related-to-the-registration-of-stand-alone-bio-analytical-laboratories-in-the-NDCT-Rules-2019 GSR No. 354(E) dt 05-06-2020 - Regarding New Drugs and trial (Amendment) Rules 2020 draft GSR-No.-354E-05-06-2020-New-Drugs-and-trial-(Amendment)-Rules-2020-draft DCGI Notice 17-04-20 Clinical trial of convalescent plasma in COVID-19 Patients DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19-Patients DCGI Notice 13-03-20 – Guidelines for approval of synthetically manufactured drugs which has been previously approved as r-DNA derived drug DCGI-Notice-13-03-20-Guidelines-for-approval-of-synthetically-manufactured-drugs DCGI Notice 13-03-20 – Requirement of CMC documents for approval of additional indication of an already approved drug product DCGI-Notice-13-03-20-Requirement-of-CMC-documents-for-approval-of-additional-indication-of-an-already-approved-drug-product DCGI Notice 13-03-20 – Requirement of process validation report for permission to conduct Clinical trial / BA-BE studies DCGI-Notice-13-03-20-Requirement-of-process-validation-report-for-permission-to-conduct-Clinical-trial-BA-BE-studies DCGI Notice 13-03-20 – Testing of all categories of new drugs for their approval DCGI-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-their-approval DCGI has issued notice on 26-02-2020 regarding submission and processing of application for registration certificate and import license in parallel with new drug application DCGI-Notice-26-02-2020-Submission-and-processing-of-application-for-registration-certificate-and-import-license-in-parallel-with-new-drug-application DCGI has issued notice on 21-02-2020 regarding pre-submission meeting for new drugs and clinical trials DCGI-Notice-21-02-2020-regarding-pre-submission-meeting-for-new-drugs-and-clinical-trials DCGI has issued notice on 21-02-2020 regarding fixing of limit of impurities in the specifications of INDs DCGI-Notice-21-02-2020-regarding-fixing-of-limit-of-impurities-in-the-specifications-of-INDs FAQ dt 18-02-2020 by CDSCO on New Drugs and Clinical trial FAQ-dt-18-02-2020-CDSCO-on-New-Drugs-and-Clinical-Trial DCGI has issued notice on 07-02-2020 regarding Pathway for subsequent manufacture of category d FDCs as per Prof. Kokate Committee Report-extension in time limit for submission of application DCGI-Notice-07-02-2020-Pathway-for-subsequent-manufacture-of-category-d-FDCs-as-per-Prof.-Kokate-Committee-Report-extension-in-time-limit-for-submission-of-application DCG(I) has issued a letter on 28-01-2020 regarding the procedure to be followed for subsequent application in respect of 450 FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I). To download click below link. DCGI-letter-dt-28-01-2020-Procedure-450-FDCs-declared-as-rational-by-Prof.-Kokate-Committee-and-approved-by-DCGI FAQ dt 23-08-19 CDSCO on New Drugs and Clinical Trail FAQ-dt-23-08-19-CDSCO-on-New-Drugs-and-Clinical-Trail FAQ dt 26-04-19 CDSCO on New Drugs and Clinical Trial FAQ-dt-26-04-19-CDSCO-on-New-Drugs-and-Clinical-Trial Also read: Approval procedure of 2,131 FDCs: DCGI New Drugs and Clinical Trials Rules 2019 New-Drugs-and-Clinical-Trials-Rules-2019 Earlier stability data was to be submitted only for the Patent and Proprietary drugs. Now as per the notification GSR 360 (E) dated 10.04.2018 submission of stability data of every drug (including Patent and Proprietary and drugs mentioned in IP) is mandatory while applying for approval. Click below link for notification. G.S.R-360-E-dt.-10-04-2018-New-Drug-word-Patent-and-properietry-subsituted-as-word-Drug List of BA / BE centre DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019 DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019 List of new drugs Here are the lists of new drugs which have been approved till date, Click below links to download the list of new drugs for the relevant year: List-of-new-drugs-approval-2019 List-of-new-drugs-approval-2018 List-of-new-drugs-approval-2017 List-of-new-drugs-approval-2016 List-of-new-drugs-approval-2015 List-of-new-drugs-approval-2014 List-of-new-drugs-approval-2013 List-of-new-drugs-approval-2012 List-of-new-drugs-approval-2011 List-of-new-drugs-approval-2010 List-of-new-drugs-approval-2009 List-of-new-drugs-approval-2008 List-of-new-drugs-approval-2007 List-of-new-drugs-approval-2006 List-of-new-drugs-approval-2005 List-of-new-drugs-approval-2004 List-of-new-drugs-approval-2003 List-of-new-drugs-approval-2002 List-of-new-drugs-approval-2001 List-of-new-drugs-approval-1991-to-2000 List-of-new-drugs-approval-1981-to-1990 List-of-new-drugs-approval-1971-to-1980 List-of-new-drugs-approval-1961-to-1970 For notifications of Drugs Act, Drugs Rule and New Drugs, click below links: Notifications – Drugs Act Notifications – Drugs Rule Notification - New Drugs
https://thehealthmaster.com/drugs/new-drugs-fdcs/